chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021 and 25 Nov 2021, Administered on 15 DEC 2021; Vaccine expired on 08-Nov-2021 and was administered on 15-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 15-Dec-2021) and PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021 and 25 Nov 2021, Administered on 15 DEC 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 15-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021 and 25 Nov 2021, Administered on 15 DEC 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 15-Dec-2021) and PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021 and 25 Nov 2021, Administered on 15 DEC 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Date moved to refrigeration reported as 11-Nov-2021 and 25-Nov-2021.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-570635, MOD-2022-570637, MOD-2022-570643, MOD-2022-578385 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: gave a full-dose as patient's booster shot.; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (gave a full-dose as patient's booster shot.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (gave a full-dose as patient's booster shot.). At the time of the report, ACCIDENTAL OVERDOSE (gave a full-dose as patient's booster shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. It was reported that HCP states she accidentally gave a full-dose as patient's booster shot. No treatment information was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dandruff, Dry skin, Pruritus
Clinical narrative: Really bad itchy scalp after receiving the first dose of the Moderna Covid 19 vaccine; dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine; dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine; Hair coming out after receiving the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Really bad itchy scalp after receiving the first dose of the Moderna Covid 19 vaccine), DRY SKIN (dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine), DANDRUFF (dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine) and ALOPECIA (Hair coming out after receiving the first dose of the Moderna Covid 19 vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Aspirin) and Drug allergy (Allergy to simvastatin).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (Really bad itchy scalp after receiving the first dose of the Moderna Covid 19 vaccine), DRY SKIN (dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine), DANDRUFF (dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine) and ALOPECIA (Hair coming out after receiving the first dose of the Moderna Covid 19 vaccine). At the time of the report, PRURITUS (Really bad itchy scalp after receiving the first dose of the Moderna Covid 19 vaccine), DRY SKIN (dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine) and DANDRUFF (dry scalp like dandruff after receiving the first dose of the Moderna Covid 19 vaccine) outcome was unknown and ALOPECIA (Hair coming out after receiving the first dose of the Moderna Covid 19 vaccine) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient never tested positive for Covid 19 No concomitant medication were reported.  Patient received the first dose of the Moderna Covid 19 vaccine and a week after developed really bad itchy scalp, dry scalp like dandruff and after that hair started coming out. It took months for hair  to regrow back.  As treatment patient used sulfates.   This case was linked to MOD-2022-579381 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash maculo-papular, Sinus tachycardia, Urticaria
Clinical narrative: Rash, wheals maculopapular raah all over my body. Fever chills sinus tachycardia
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight sore arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Slight sore arm). At the time of the report, PAIN IN EXTREMITY (Slight sore arm) outcome was unknown.            No concomitant medications reported. No treatment reported.  Patient had taken two Moderna vaccines and also the booster. Patient was considering whether or not to take the fourth dose. Patient wanted to know what is the risk of taking another booster, patient does not want it to damage the body. Patient would like to know what will be the risk of taking another dose.   This case was linked to MOD-2022-578357, MOD-2022-578383 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 08-Nov-2021, moved to refrigerator on 11-Nov-2021 and 25-Nov-2021, Administered on 16-Dec-2021; Vaccine expired on 08-Nov-2021 and was administered on 16-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 16-Dec-2021) and PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021, moved to refrigerator on 11-Nov-2021 and 25-Nov-2021, Administered on 16-Dec-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 16-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021, moved to refrigerator on 11-Nov-2021 and 25-Nov-2021, Administered on 16-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 16-Dec-2021) and PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021, moved to refrigerator on 11-Nov-2021 and 25-Nov-2021, Administered on 16-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Vaccines were moved to the refrigerator on 11-Nov-2021 and 25-Nov-2021.  Treatment information was not provided.   This case was linked to MOD-2022-570635, MOD-2022-570637, MOD-2022-570643, MOD-2022-578379 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022; expired booster dose given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster dose given) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster dose given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired booster dose given) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported Number of doses/vials reported was 1 dose (0.25 ml) The vial did not undergo any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. T60h21a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: Eng198 Location of injection: Arm Right) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (Unspecified drug).    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: negative negative and positive Positive.         Patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.   Patient reported that "I took Paxlovid and had rebound Covid-19 five days later".  Company comment- This spontaneous case concerns a patient of unknown age and gender with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. Patient took paxlovid and had rebound Covid-19 five days later. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. Patient took paxlovid and had rebound Covid-19 five days later. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Dysphagia, Dysphonia, Pyrexia
Clinical narrative: patient has trouble swallowing; Problem with her voice box/Her voice is very high; got sick to her stomach; fever of 100 degrees Farenheight; This spontaneous case was reported by a patient and describes the occurrence of DYSPHAGIA (patient has trouble swallowing), DYSPHONIA (Problem with her voice box/Her voice is very high), ABDOMINAL DISCOMFORT (got sick to her stomach) and PYREXIA (fever of 100 degrees Farenheight) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced DYSPHONIA (Problem with her voice box/Her voice is very high). On an unknown date, the patient experienced DYSPHAGIA (patient has trouble swallowing), ABDOMINAL DISCOMFORT (got sick to her stomach) and PYREXIA (fever of 100 degrees Farenheight). At the time of the report, DYSPHAGIA (patient has trouble swallowing) and DYSPHONIA (Problem with her voice box/Her voice is very high) outcome was unknown and ABDOMINAL DISCOMFORT (got sick to her stomach) and PYREXIA (fever of 100 degrees Farenheight) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degrees Farenheight.         Concomitant medication of the patient was not reported.  The patient received the vaccine in her left arm shoulder deltoid muscle. The patient did not remember the date or month of administration, but she did remember that she received the Moderna COVID-19 vaccines in 2021.  Due to stomach sickness and fever, the patient drank water and stayed hydrated, and she got better. The patient did not visit a physician due to her voice problems. The patient reported that she first noticed the problem with her voice box after she went to a movie in December 2021 and laughed really hard at the movie.  The patient reported that her ex-husband also received the Moderna COVID-19 vaccine and reported no side effects and adverse events.  Treatment information for the events swallowing difficult and voice disturbance were not provided by the reporter.   This case was linked to MOD-2022-578403 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysphagia, Illness, Pyrexia
Clinical narrative: got sick to her stomach for 3 days after both of her primary Moderna Covid-19 doses; fever of 100 degrees Farenheight for 3 days  after both of her Moderna Covid-19 vaccine doses; The patient has trouble swallowing.; This spontaneous case was reported by a patient and describes the occurrence of DYSPHAGIA (The patient has trouble swallowing.), ILLNESS (got sick to her stomach for 3 days after both of her primary Moderna Covid-19 doses) and PYREXIA (fever of 100 degrees Farenheight for 3 days  after both of her Moderna Covid-19 vaccine doses) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced DYSPHAGIA (The patient has trouble swallowing.). On an unknown date, the patient experienced ILLNESS (got sick to her stomach for 3 days after both of her primary Moderna Covid-19 doses) and PYREXIA (fever of 100 degrees Farenheight for 3 days  after both of her Moderna Covid-19 vaccine doses). At the time of the report, DYSPHAGIA (The patient has trouble swallowing.) outcome was unknown and ILLNESS (got sick to her stomach for 3 days after both of her primary Moderna Covid-19 doses) and PYREXIA (fever of 100 degrees Farenheight for 3 days  after both of her Moderna Covid-19 vaccine doses) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 fever of 100 degrees Farenheight.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication details were not reported by the reporter. It was reported that the patient drank water and stayed hydrated and patient got better.   This case was linked to MOD-2022-578400 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (rebound day 5/positive covid) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Drug allergy. On 16-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (rebound day 5/positive covid). At the time of the report, COVID-19 (rebound day 5/positive covid) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date was reported as 26-May-2022. Company comment: This spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 248 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 12, 2022, patient was started on Paxlovid treatment regimen, on May 21, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 248 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 12, 2022, patient was started on Paxlovid treatment regimen, on May 21, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Influenza like illness, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: Felt like patient had the flu; swollen neck; swollen clavicle; fever; under each axillary swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like patient had the flu), SWELLING (swollen neck), BONE SWELLING (swollen clavicle), PYREXIA (fever) and LYMPHADENOPATHY (under each axillary swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like patient had the flu), SWELLING (swollen neck), BONE SWELLING (swollen clavicle), PYREXIA (fever) and LYMPHADENOPATHY (under each axillary swollen lymph nodes). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like patient had the flu) and PYREXIA (fever) outcome was unknown and SWELLING (swollen neck), BONE SWELLING (swollen clavicle) and LYMPHADENOPATHY (under each axillary swollen lymph nodes) had not resolved.            No concomitant medications were reported It was reported that after receiving the 2nd booster dose patient had fever, felt like patient had the flu. Patient had ongoing swollen neck, clavicle and under each axillary swollen lymph nodes which was ongoing. It was stated that the patient had to get a biopsy and stated it will cost a fortune. No treatment drugs were reported
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: recovering from cold; body ache; fever; side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effects), NASOPHARYNGITIS (recovering from cold), MYALGIA (body ache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (side effects), MYALGIA (body ache) and PYREXIA (fever). On 27-May-2022, the patient experienced NASOPHARYNGITIS (recovering from cold). At the time of the report, IMMUNISATION REACTION (side effects), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown and NASOPHARYNGITIS (recovering from cold) was resolving.    No concomitant products were reported. No treatment drugs were reported  It was reported that caller states that she had the 2nd dose of the Moderna Covid-19 vaccine a year ago and she had side effects, bodyache, fever and currently she is recovering from a cold. She adds that she has been away for several months and when she came back her doctor told her to get a booster dose. Reporter did not allow further contact
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Night sweats, Retching, Taste disorder
Clinical narrative: Worst taste in my mouth ever; Worst taste in my mouth ever - will not go away and makes me gag; Horrible night sweats; Difficulty sleeping; Muscle aches especially in legs; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Worst taste in my mouth ever), RETCHING (Worst taste in my mouth ever - will not go away and makes me gag), NIGHT SWEATS (Horrible night sweats), INSOMNIA (Difficulty sleeping) and MYALGIA (Muscle aches especially in legs) in a 25-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (Tree nuts) and Drug allergy (Ibuprofen). Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to an unknown date for COVID-19 treatment, FLUVOXAMINE, GUANFACINE and DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022 at 2:00 PM, the patient experienced TASTE DISORDER (Worst taste in my mouth ever), RETCHING (Worst taste in my mouth ever - will not go away and makes me gag), NIGHT SWEATS (Horrible night sweats), INSOMNIA (Difficulty sleeping) and MYALGIA (Muscle aches especially in legs). At the time of the report, TASTE DISORDER (Worst taste in my mouth ever), RETCHING (Worst taste in my mouth ever - will not go away and makes me gag), NIGHT SWEATS (Horrible night sweats), INSOMNIA (Difficulty sleeping) and MYALGIA (Muscle aches especially in legs) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Pfizer had permission to contact you about this report. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient was previously received COVID-19 vaccine.  Treatment medications were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021; received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: J&J COVID-19 vaccine (First COVID-19 full dose) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ACCIDENTAL OVERDOSE (received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine). On 30-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021). At the time of the report, ACCIDENTAL OVERDOSE (received a full dose Booster (3rd shot) of Moderna COVID-19 vaccine/received the 2nd full dose with Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received J&J COVID-19 vaccine on 12MAR2021 and received the 2nd full dose with Moderna COVID-19 vaccine on 30JUN2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  It was reported that she went to a different pharmacy and did not tell them that she had a dose of Janssen COVID-19 vaccine.  Treatment information was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Return of covid symptoms after Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Return of covid symptoms after Paxlovid treatment) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension, Immune disorder (NOS) (Weak immune response) and Allergy NOS. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) from 01-Jul-2021 to 26-May-2022 for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced COVID-19 (Return of covid symptoms after Paxlovid treatment). The patient was treated with AZITHROMYCIN for Adverse event, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Return of covid symptoms after Paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive Positive.         Company Comment: This spontaneous case concerns a 69-year-old male patient, with relevant medical history of asthma, hypertension, and immune system disorder, who experienced the unexpected non-serious AESI of COVID-19 that occurred 6 months and 19 days after the mRNA-1273 vaccine as 3rd dose. The event was supported with positive SARS-CoV-2 test. Patient took Azithromycin and completed Paxlovid as treatment regimen. Patient reported that COVID symptoms returned after Paxlovid treatment. Clinical course was not reported. The outcome of event was reported as not resolved. There was no information provided regarding the first 2 doses of vaccination. Patient's co-morbidities could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with relevant medical history of asthma, hypertension, and immune system disorder, who experienced the unexpected non-serious AESI of COVID-19 that occurred 6 months and 19 days after the mRNA-1273 vaccine as 3rd dose. The event was supported with positive SARS-CoV-2 test. Patient took Azithromycin and completed Paxlovid as treatment regimen. Patient reported that COVID symptoms returned after Paxlovid treatment. Clinical course was not reported. The outcome of event was reported as not resolved. There was no information provided regarding the first 2 doses of vaccination. Patient's co-morbidities could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included CABG and Stent placement. Concurrent medical conditions included Coronary artery disease, Hypertension, Hyperlipidemia, GERD, Drug allergy and Glucose abnormal (Abnormal glucose). Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CLONAZEPAM, CLOPIDOGREL, EPLERENONE, DOCUSATE, FINASTERIDE, FLUTICASONE, MONTELUKAST, HYDROCHLOROTHIAZIDE, PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]), LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], PANTOPRAZOLE, ROSUVASTATIN, SERTRALINE and ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose on 19-Jan-2021 and Moderna 2nd dose on 12-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported   This case was linked to MOD-2022-578981 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid positive again 8 days after last paxlovid pills; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid positive again 8 days after last paxlovid pills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid positive again 8 days after last paxlovid pills). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Covid positive again 8 days after last paxlovid pills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Covid positive.         No concomitant medications were reported.  Company comment: This spontaneous case concerns a 46 year old male patient, with no relevant medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient tested positive for COVID-19 and took Paxlovid for 5 days. About 8 days after the last dose of paxlovid, he tested positive for COVID-19 again. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 46 year old male patient, with no relevant medical history, who experienced the unexpected non serious  of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient tested positive for COVID-19 and took Paxlovid for 5 days. About 8 days after the last dose of paxlovid, he tested positive for COVID-19 again. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not have any adverse effects or symptoms from dose.; An expired dose of PROQUAD was given today, 02May2022; This spontaneous report was received from medical assistant and refers to a 12-month-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported.  On 02-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml/once, lot #T034613 (rHA), expiration date: 10-APR-2022 (expired product administered), administered for prophylaxis (strength, and route of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  No adverse symptoms were reported.
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Antibody test negative, Viral titre decreased
Clinical narrative: a 22-year-old male is requesting revaccination with VARIVAX as he has had titers drawn and had a negative titer "for everything".; This spontaneous report was received from a pharmacist concerning to a 22-year-old male patient. The patient's concomitant therapies were not reported, he had no medical conditions or known allergies.  The patient was fully vaccinated (unspecified) as a child, however, the vaccines and dates when these products were administered were not reported nevertheless he never had an issue.   On an unspecified date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) (reported as the pharmacist does not know if patient received varicella virus vaccine live (VARIVAX) or another varicella containing vaccine) and sterile diluent (manufacturer unknown) for prophylaxis (indication reported as lack of titer, doses, strengths, lot #, and expiry dates were not provided).   On an unspecified date, the patient had antibody titers (unspecified) drawn by the air force, nevertheless, he had a negative titers results for varicella and everything else (antibody test negative), as reported both by him and his mother. He was revaccinated for some other negative titers (unspecified) "at another clinic" and for this reason he was now requesting revaccination with varicella virus vaccine live (VARIVAX) (it was stated by the reporter, that although the patient did not specified which varicella virus vaccine was received or what tests were negative, the report was submitted for  varicella virus vaccine live (VARIVAX) as a precautionary measure, since it was the only vaccine, that the patient was requesting), it was reported that there was no treatment given for the event (conflicting information, it was reported that revaccination with other products was received), further information was not provided. At the reporting time, the outcome of antibody test negative was unknown.  The causal relationship, between the suspect vaccines and the event of antibody test negative was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, Suspected COVID-19, Vaccination failure, Vomiting
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BITTER TASTE; BITTER SMELL; VOMITING; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 42 year old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sea food and shell fish allergy, and asthma, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient was other health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: Unknown) dose was not reported, 1 total administered to left arm on 10-SEP-2021 11:00 for prophylactic vaccination. Age at time of vaccination 41 years old.  The non-company co-suspect drug Paxlovid (nirmatrelvir, ritonavir) (form of admin, route of admin not reported, batch number: FY7031, expiry: Unknown) dose was not reported, administered on 20-MAY-2022 for Covid-19 treatment. No concomitant medications were reported.  On an unspecified date, the patient had covid-19 infection (suspected clinical vaccination failure). On 20-MAY-2022, the patient started treatment with Paxlovid. At 19:00 the patient experienced bitter taste, bitter smell, and vomiting.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, bitter taste, and bitter smell, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: 20220562698 -Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound COVID on day 13; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID on day 13) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulfa).    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (Rebound COVID on day 13). At the time of the report, COVID-19 (Rebound COVID on day 13) had not resolved.            No concomitant medication information provided. It was reported that patient received unknown drug for treatment of COVID-19 from 13-May-2022 till 18-May-2022. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that on 25-May-2022, rebound covid on day 13. Patient previously had received a COVID-19 Vaccine.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19, approximately 7 months after the third dose of mRNA-1273 vaccine, no details of previous doses were reported. As per source document, the patient experienced a rebound of COVID-19 after receiving Covid-19 treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19, approximately 7 months after the third dose of mRNA-1273 vaccine, no details of previous doses were reported. As per source document, the patient experienced a rebound of COVID-19 after receiving Covid-19 treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (name of the drug is not reported).    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication of the patient was not reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 vaccine.  Company Comment:  This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 as the third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, three days after the completion of Paxlovid treatment, patient reported recurrence of COVID-19 and its symptoms. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 as the third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, three days after the completion of Paxlovid treatment, patient reported recurrence of COVID-19 and its symptoms. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028KZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 02-Apr-2022 at 1:15 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022 at 2:00 AM, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information  Company Comment: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. No details on the previous vaccinations were given. As reported patient had recurrence of COVID-19 nine days after receiving the treatment Paxlovid. No other clinical or treatment details were given. It was reported that the outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. No details on the previous vaccinations were given. As reported patient had recurrence of COVID-19 nine days after receiving the treatment Paxlovid. No other clinical or treatment details were given. It was reported that the outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.