chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic side effects; Inbound call from HCP stating that a patient was inadvertently administered PNEUMOVAX 23 past it's expiration date.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 25-APR-2023, the patient was inadvertently vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (formulation prefilled syringe, 0.5 mL, lot #U026796, expiration date 28-JAN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No symptomatic side effects reported during time of a call. No additional adverse event (AE) details or product quality complaint (PQC).
Age: 20.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reported that a 20 years old patient received PROQUAD.; No additional AEs; This spontaneous report was received from the nurse, regarding to a patient of 20-year-old of unknown gender. The patient's pertinent medical history, current conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On an unknown date, at the age of 20 years-old (Product administered to patient of inappropriate age), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not reported).
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; a patient who is not on dialysis nor will be starting dialysis received the dialysis formulation of RECOMBIVAX HB (larger than recommended dose).; This spontaneous report was received from a pharmacist and referred to a patient with unknown age or gender. The patient's concurrent condition, concomitant therapy and medical history were not reported. The drug reactions/allergies were not reported.  On 03-APR-2023, the patient was administered with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (1 milliliter (ml), lot #, expiration date, route and anatomical location were not provided) for prophylaxis. The patient who was not on dialysis nor would be starting dialysis received the dialysis formulation of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (larger than recommended dose) (incorrect dose administered). No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse event; Pharmacist called because an expired MMR II was given to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported.  On 08-MAY-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with lot# t031436, expiry date 15-SEP-2022 (rHA - recombinant Human albumin) for prophylaxis (dose and route of administration were not provided) (expired product administered). The sterile diluent lot# was reported as u027011 with expiration date 02-MAR-2024.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cardiac failure congestive
Clinical narrative: Pneumonia secondary to COVID-19; Congestive heart failure; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 PNEUMONIA (Pneumonia secondary to COVID-19) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M2CA) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 1:40 PM, 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 COVID-19 PNEUMONIA (Pneumonia secondary to COVID-19) (seriousness criteria death and medically significant) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria death and medically significant). The patient died on 13-Aug-2021. The reported cause of death was pneumonia secondary to covid-19 and Congestive heart failure. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  Treatment information was not reported.  Company comment:This spontaneous case concerns a 75-years-old female patient, with no medical history reported, who experienced unexpected fatal serious (medically significant) event of Covid-19 pneumonia, cardiac failure congestive, which occurred unspecified days after the second dose of mRNA-1273 vaccination. The patient died on 13-Aug-2021. The reported cause of death was pneumonia secondary to covid-19 and Congestive heart failure. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2023-723375 (Linked Report).; Sender's Comments:  MOD-2023-723375:Father's case; Reported Cause(s) of Death: Pneumonia secondary to COVID-19; Congestive heart failure
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: COVID-19 Pneumonia; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 Pneumonia) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 1:40 PM, 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 COVID-19 PNEUMONIA (COVID-19 Pneumonia) (seriousness criteria death and medically significant). The patient died on 19-Aug-2021. The reported cause of death was COVID-19 pneumonia. It is unknown if an autopsy was performed.             Concomitant Medication use information was not provided by reporter. It was reported that the patient died after 6 months of receiving vaccine and manner was reported as natural. Treatment Medication use information was not provided by reporter. Company comment-This spontaneous case concerns a male patient aged 79 years with no medical history reported, who experienced unexpected serious fatal and (medically Significant) event of COVID-19 Pneumonia on an unknown date after receiving second dose of mRNA-1273 vaccine. Patient had received first and second dose of mRNA-1273 at an interval of 1 month. There was no information provided about the underlying medical conditions, concomitant medications, associated symptoms, diagnostic and treatment details, clinical course of the event leading to the fatal outcome. Patient died about 5 months 7 days after vaccination. It is not known if an autopsy was performed. The manner of death was reported as natural and underlying cause of death reported as covid-19 pneumonia. The event Covid-19 Pneumonia might be explained by current pandemic outbreak and elderly age could be a risk factor. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   This case was linked to MOD-2023-723358 (Linked Report).; Sender's Comments:  MOD-2023-723358: Mother's case; Reported Cause(s) of Death: COVID-19 Pneumonia
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine; patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine), COVID-19 IMMUNISATION (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 11-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 30 microgram. On 12-Apr-2023, the patient received second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 12-Apr-2023, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine) and COVID-19 IMMUNISATION (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine), COVID-19 IMMUNISATION (patient received one dose of Moderna Covid vaccine and a second Pfizer covid vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported. Vaccine was the adult gray cap monovalent vaccine.  Treatment drug was not reported.
Age: 0.5
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label; No adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse reaction) in a 6-month-old patient of an unknown 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 first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label).    Concomitant products were not reported.  It was reported previously unvaccinated patient (6 months of age) was to receive Dose 1 of their vaccine series 0.25mL from vial with blue cap and gray bordered label. The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label.  Treatment medications were not reported.   This case was linked to MOD-2023-723728 (Linked Report).; Sender's Comments:  MOD-2023-723728:9-Months-old Infant case
Age: 0.75
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse event) in a 9-month-old patient of an unknown 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 first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label).    Concomitant medication of the patient was not reported.  It was reported that the patient was unvaccinated and was to receive dose 1 of vaccine series 0.25 mL from vial with blue cap and gray bordered label.  Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723727:6-Months-old Infant case
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Knee pain (Patient had problems with knees starting 15 years ago.).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine).    No concomitant medications were reported. Patient took the first two Moderna Covid-19 vaccine in the Primary Series and since then patient knees felt great. Patient was happy and patient had seen several Doctors over the 15 years and they recommended one of 3 treatments either get new knee replacements, receive an injection every 6 months, or take pain killers. The patient did not take any of these options over the years. The patient was very happy because he took the first two shots of the Moderna Covid-19 vaccine and noticed that  knees feel much better after receiving his first two doses of the Moderna Covid-19 vaccine. No treatment information was provided.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: her son caught covid; interval between the 1st and 2nd dose (8/19/22) and (10/29/22).; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (her son caught covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between the 1st and 2nd dose (8/19/22) and (10/29/22).) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between the 1st and 2nd dose (8/19/22) and (10/29/22).). On an unknown date, the patient experienced COVID-19 (her son caught covid). At the time of the report, COVID-19 (her son caught covid) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between the 1st and 2nd dose (8/19/22) and (10/29/22).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The reporter stated that the patient received a two-dose Moderna vaccine against COVID-19. The reporter would like to know if those shots was the monovalent covid-19 vaccine type or not. The reporter also stated that the reason for the interval between the 1st and 2nd dose was because the patient caught covid and they had to wait.  No treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2023: Live non significant follow up received. On 08-May-2023: Live non significant follow up received.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     It was reported that patient had no known allergies. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 08-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. Patient accidently received the third updated Bivalent dose. No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?"; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?") and NO ADVERSE EVENT (No adverse event) in an elderly female patient 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?") and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?") 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She is asking what is the dose for a 5th or 6th dose Bivalent Moderna COVID-19 vaccine (Booster) for a 65-year-old or older? Is it 0.5 ml?/"What if we administered only 0.2 ml or 0.25ml?").    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  Treatment medications were not provided.   Reporter did not allow further contact
Sex: F
Vaccine: PNC13
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: sore arm; patient received Prevnar subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "patient received Prevnar subcutaneously". Additional information: His wife had a sore arm for about a day after her pneumococcal pneumonia vaccine, but was unsure which brand she received. Pfizer Product Name: Prevnar. The reporter considered event as caused by suspect product.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300080379 Same reporter/patient, different drug/AE;
Sex: F
Vaccine: COVID19
Symptoms: HIV test, HIV test false positive
Clinical narrative: she's getting a false positive HIV test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 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: HIV TEST FALSE POSITIVE (non-serious), outcome "unknown", described as "she's getting a false positive HIV test". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported that she took the initial dose of the Pfizer covid-19 vaccine and she guessed that it induces our body to produce the S protein that can build immunity to the vaccine for the second dose. She reported that she is getting a false positive test result for HIV and trying to know if that is related to the covid-19 vaccine. She does not have the second dose yet. She asked whether her body continue to produce the spike protein if she only get one shot of Covid-19 vaccine and no 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus
Clinical narrative: Redness; Itchiness; This is a spontaneous report received from non-contactable reporter(s).  A female patient received pneumococcal 20-val conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; PRURITUS (non-serious), outcome "unknown", described as "Itchiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Thyroid stimulating immunoglobulin
Clinical narrative: four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine; This is report for the following source(s): "Thyroid Adverse Events after SARS-CoV-2 Vaccination".  An adult female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Thyroid stimulating immunoglobulin (6.21-11.87): positive.  Clinical course: It was described as four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine. All were females, median age 49 (range 44-59). Two patients presented with de novo (starting from the beginning) hyperthyroidism 25-29 days following SARS-CoV-2 mRNA vaccine. All four patients had TSH receptor antibodies positive (range 6.21-11.87IU/L); Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (HYPERTHYROIDISM ) and BNT162B2. 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.,Linked Report(s) : US-PFIZER INC-PV202300081270 Same article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hyperthyroidism
Clinical narrative: four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine; This is a literature report for the following literature source(s):  An adult female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Graves disease" (unspecified if ongoing), notes: in remission remission for longer than 3 years, and presented. The patient's concomitant medications were not reported. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: positive, notes: range 6.21-11.87 IU/L.  Clinical Information: Four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine. All were females, median age 49 (range 44-59). Two patients have previously had diagnosed Graves disease in remission for longer than 3 years and presented after 40-60 days after receiving SARS-CoV-2 mRNA vaccine. All four patients had TSH receptor antibodies positive.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events hyperthyroidism and suspect BNT162B2 cannot be excluded.This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300081270 Same article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hyperthyroidism
Clinical narrative: four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine; This is a literature report.  An adult female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Graves disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: positive, notes: range 6.21-11.87 IU/L.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event hyperthyroidism and suspect BNT162B2 cannot be excluded.This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300081270 Same article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Musculoskeletal stiffness, Vaccination site discomfort
Clinical narrative: arm at where the vaccination was placed the whole arm is stiff; all the joints are stiff in that arm; whole arm is stiff; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown", described as "arm at where the vaccination was placed the whole arm is stiff"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "all the joints are stiff in that arm"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "whole arm is stiff". Additional information: The reporter was calling for wife. The injection that she has gotten, the COVID-19 vaccination and she was experiencing something that she hasn't experienced before. In the arm at where the vaccination was placed the whole arm was stiff and all the joints are stiff in that arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1/Dose 2/Dose 3: Pfizer / BioNTech; Dose 4: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 24Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic intracranial hypertension" (unspecified if ongoing). Concomitant medication(s) included: ACETAZOLAMIDE, start date: 01Sep2020. Past drug history included: Sulfa drugs, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "not recovered", described as "Dose 1/Dose 2/Dose 3: Pfizer / BioNTech; Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182880 same reporter/patient, different drug/AE;
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid as treatment drug from 28Apr2023 to 03May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183755 same patient, different drug and different event;
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: both of her legs swelled up; heavy legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 12Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 12Jun2021, outcome "unknown", described as "both of her legs swelled up"; LIMB DISCOMFORT (non-serious) with onset Jun2021, outcome "not recovered", described as "heavy legs". The event "both of her legs swelled up" required physician office visit.  Additional information: Patient was vaccinated with Pfizer COVID vaccine on 12Jul2021. About 1 hour later, both of the legs swelled up and was consulted with doctor. After week of rest, patient went back for running with very heavy legs and these heavy legs have not gone away. Reporter stated that it was a reaction to the vaccine and possibly COVID as well. Reporter also stated that she wants patient's leg back as she is so young. Reporter asked whether anyone else had the problem and any solution   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Body temperature, Drug ineffective, Suspected COVID-19, Weight, Weight increased
Clinical narrative: She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; Gained weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GJ377) at the age of 66 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL1284), in arm, on 25Jan2021 as dose 2, single (Lot number: EN538721), in arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 301558A), in arm and on 08Mar2022 as dose 4 (booster), single (Lot number: FJ5683), in arm for covid-19 immunisation. The patient's relevant medical history included: "Headache" (unspecified if ongoing); "Renal issue" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing). Concomitant medication(s) included: TIZANIDINE taken for headache; GABAPENTIN taken for headache; DILTIAZEM taken for headache; ACYCLOVIR [ACICLOVIR] taken for myocardial infarction, muscle spasms; BABY ASPIRIN taken for myocardial infarction, muscle spasms; SHINGRIX taken for immunisation as dose number unknown, single. The following information was reported: WEIGHT INCREASED (non-serious) with onset Feb2023, outcome "unknown", described as "Gained weight"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines". The patient underwent the following laboratory tests and procedures: Body temperature: 104.5 degree; Weight: 40 lbs, notes: gained in past 3 years. It was further reported that patient had a temp. of 104.5 degree F but did not lose her sense of smell and/or taste as she gained weight since having COVID. Patient was not prescribed with Paxlovid due to her renal issue.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Back pain, Blood glucose, Blood glucose increased, Body height, Chest pain
Clinical narrative: She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; Gained weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GJ377) at the age of 66 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL1284), in arm, on 25Jan2021 as dose 2, single (Lot number: EN538721), in arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 301558A), in arm and on 08Mar2022 as dose 4 (booster), single (Lot number: FJ5683), in arm for covid-19 immunisation. The patient's relevant medical history included: "Headache" (unspecified if ongoing); "Renal issue" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing). Concomitant medication(s) included: TIZANIDINE taken for headache; GABAPENTIN taken for headache; DILTIAZEM taken for headache; ACYCLOVIR [ACICLOVIR] taken for myocardial infarction, muscle spasms; BABY ASPIRIN taken for myocardial infarction, muscle spasms; SHINGRIX taken for immunisation as dose number unknown, single. The following information was reported: WEIGHT INCREASED (non-serious) with onset Feb2023, outcome "unknown", described as "Gained weight"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines". The patient underwent the following laboratory tests and procedures: Body temperature: 104.5 degree; Weight: 40 lbs, notes: gained in past 3 years. It was further reported that patient had a temp. of 104.5 degree F but did not lose her sense of smell and/or taste as she gained weight since having COVID. Patient was not prescribed with Paxlovid due to her renal issue.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Dyspnoea, Illness, Weight
Clinical narrative: She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines; Gained weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GJ377) at the age of 66 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL1284), in arm, on 25Jan2021 as dose 2, single (Lot number: EN538721), in arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 301558A), in arm and on 08Mar2022 as dose 4 (booster), single (Lot number: FJ5683), in arm for covid-19 immunisation. The patient's relevant medical history included: "Headache" (unspecified if ongoing); "Renal issue" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing); "Had MI due to spasm" (unspecified if ongoing). Concomitant medication(s) included: TIZANIDINE taken for headache; GABAPENTIN taken for headache; DILTIAZEM taken for headache; ACYCLOVIR [ACICLOVIR] taken for myocardial infarction, muscle spasms; BABY ASPIRIN taken for myocardial infarction, muscle spasms; SHINGRIX taken for immunisation as dose number unknown, single. The following information was reported: WEIGHT INCREASED (non-serious) with onset Feb2023, outcome "unknown", described as "Gained weight"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "She did get COVID in February of this year 2023, following 5 vaccines of the COVID vaccines". The patient underwent the following laboratory tests and procedures: Body temperature: 104.5 degree; Weight: 40 lbs, notes: gained in past 3 years. It was further reported that patient had a temp. of 104.5 degree F but did not lose her sense of smell and/or taste as she gained weight since having COVID. Patient was not prescribed with Paxlovid due to her renal issue.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; QNASL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2023 at 01:00, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2023) Positive, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment.  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.