chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male of an unspecified race. Initial information was processed along with the additional information received from department on 28-OCT-2022. The patient's weight, height and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 18-FEB-2022) dose was not reported, 1 total administered to the left arm on 05-MAY-2021 for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with primary dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 08-SEP-2022) dose was not reported, 1 total administered to the left arm on 01-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 52 years old. No concomitant medications were reported. The patient stated that on the previous day of report, on 26-OCT-2022, at morning he coughed and was feeling rundown with a headache, chills and was just tired (coded as confirmed covid-19 infection which led to confirmed clinical vaccination failure). It was also reported that on the day of reporting, on 27-OCT-2022 , the patient got covid and was tested positive with a take home test (Binax Now from Abbott) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000257104.; Sender's Comments: V0: 20221057885- Confirmed clinical vaccination failure- The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain assessment, Pain in extremity
Clinical narrative: OFF LABEL DOSING FREQUENCY; ARM WAS SORE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total, administered on 06-MAR-2021 for covid-19 prophylaxis.  On an unspecified date in 2021, the patient experienced arm was sore with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient recovered from arm was sore on 2021. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, 1 total, administered on 06-OCT-2021 for covid-19 prophylaxis which was off label dosing frequency (Dose number in series 2). The product was associated with off label use. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced arm was sore for a couple of days, not long (Dose number in series 2). Patient had no redness or swelling. Laboratory data included: Pain scale 5/10 pain score. At the time of reporting, patient stated that the pain was fully gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore on 2021, and the outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221059775.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient did not receive the second dose of SHINGRIX; This case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th July 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The caller was a health-care professional called to report an adverse event for Shingrix.  The caller reported that a patient did not receive the second dose of Shingrix as recommended.  There was no additional information provided.  There was no additional adverse event reported.  There was no pharmaceutical product complaint reported. The permission for consent to follow-up was denied. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Exposure via breast milk, Pain, Rash
Clinical narrative: The rash severity increased to open sores and increased redness; The rash severity increased to open sores; About 15 min later a large rash (mild) was found on the the infant's leg; breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (The rash severity increased to open sores and increased redness), PAIN (The rash severity increased to open sores), RASH (About 15 min later a large rash (mild) was found on the the infant's leg) and EXPOSURE VIA BREAST MILK (breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son) in a 3-year-old male child exposed to mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) , while the mother received the product for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the child was diagnosed with ERYTHEMA (The rash severity increased to open sores and increased redness), PAIN (The rash severity increased to open sores), RASH (About 15 min later a large rash (mild) was found on the the infant's leg) and EXPOSURE VIA BREAST MILK (breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, ERYTHEMA (The rash severity increased to open sores and increased redness) and RASH (About 15 min later a large rash (mild) was found on the the infant's leg) had not resolved, PAIN (The rash severity increased to open sores) outcome was unknown and EXPOSURE VIA BREAST MILK (breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after. The milk was stored and then given to infant son) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Transmammary), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Breastfeeding mother, received the bivalent vaccine and pumped milk about 5 hours after.  The milk was stored and then given to infant son. About 15 min later a large rash (mild) was found on the the infants leg. The rash severity increased to open sores and increased redness.   It is unknown if the patient experienced any additional symptoms/events.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Each time the lymph node under her armpit swelled up like a kiwi; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Each time the lymph node under her armpit swelled up like a kiwi) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to antibiotic (Tetracycline).    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 LYMPHADENOPATHY (Each time the lymph node under her armpit swelled up like a kiwi). At the time of the report, LYMPHADENOPATHY (Each time the lymph node under her armpit swelled up like a kiwi) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2022, SARS-CoV-2 test: (Negative) Nasal Swab.         No concomitant medications were reported. The patient had received 3 COVID shots 2 Pfizer and 1 Moderna. Each time the lymph node under her armpit swelled up like a kiwi. The patient got her flu shot on 16-Oct-2022 in her left arm with no problem. On 21-Oct-2022 at 03:30 PM, the patient had received the most recent Pfizer Bivalent COVID-19 vaccine, dose 4, with lot GJ2524 in the right arm. She felt fine, not even a sore arm until 12 pm of 22-Oct-2022. All of a sudden, she felt sore all over, chills and checked her temperature which was 103.7. She took a shower and went to bed. She slept for 4 hours. When she woke up the lymph nodes under her arm, right breast and neck were all swollen and painful. Her husband called out doctor. She took Tylenol and Motrin and tandem  for the next 48 hours. This was the most extreme reaction she was yet to have in getting any of the COVID shots or boosters. The swelling in the lymph nodes still persisted but was improving. She no longer had a fever. She had never tested positive for COVID since she received this recent fourth dose of Covid vaccine. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Body temperature, Cough
Clinical narrative: cough; patient felt dizzy; weak; pulse of 121 bpm; blood pressure of 168/121; 101-degree F fever; body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm) and BLOOD PRESSURE INCREASED (blood pressure of 168/121) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm), BLOOD PRESSURE INCREASED (blood pressure of 168/121), PYREXIA (101-degree F fever) and MYALGIA (body aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 27-Oct-2022 at an unspecified dose and frequency. At the time of the report, COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm), PYREXIA (101-degree F fever) and MYALGIA (body aches) had not resolved and BLOOD PRESSURE INCREASED (blood pressure of 168/121) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2022, Blood pressure measurement: 168/121. On 27-Oct-2022, Body temperature: 101 degree F. On 27-Oct-2022, Heart rate: 121 bpm.         It was unknown if patient was under any concomitant or regular medication. Patient received First, second and booster dose on an unknown date. Patient stated he wanted to report a really severe reaction that his wife was experiencing after getting Moderna COVID-19 Vaccine Bivalent. Caller stated his wife got the bivalent on 27-Oct-2022 and during the night she experienced 101-degree F fever, blood pressure of 168/121, pulse of 121 bpm, cough, body aches, felt dizzy and weak, and took aspirin, helping for the blood pressure to drop. On 28-Oct-2022 around 6:00 AM patient needed to go to ER because of these symptoms. Caller mentioned he was running out of time because his wife was still in the hospital, and he had to attend calls from doctors and was not able to provide additional details about the AE.  It was unknown if patient was under any concomitant or regular medication. It was unknown if patient ever had COVID positive test or diagnosis. It was unknown if patient had Acute and Chronic illnesses at the time of vaccination. It was unknown if patient experienced a similar event in the past.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: cough; patient felt dizzy; weak; pulse of 121 bpm; blood pressure of 168/121; 101-degree F fever; body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm) and BLOOD PRESSURE INCREASED (blood pressure of 168/121) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm), BLOOD PRESSURE INCREASED (blood pressure of 168/121), PYREXIA (101-degree F fever) and MYALGIA (body aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 27-Oct-2022 at an unspecified dose and frequency. At the time of the report, COUGH (cough), DIZZINESS (patient felt dizzy), ASTHENIA (weak), HEART RATE INCREASED (pulse of 121 bpm), PYREXIA (101-degree F fever) and MYALGIA (body aches) had not resolved and BLOOD PRESSURE INCREASED (blood pressure of 168/121) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2022, Blood pressure measurement: 168/121. On 27-Oct-2022, Body temperature: 101 degree F. On 27-Oct-2022, Heart rate: 121 bpm.         It was unknown if patient was under any concomitant or regular medication. Patient received First, second and booster dose on an unknown date. Patient stated he wanted to report a really severe reaction that his wife was experiencing after getting Moderna COVID-19 Vaccine Bivalent. Caller stated his wife got the bivalent on 27-Oct-2022 and during the night she experienced 101-degree F fever, blood pressure of 168/121, pulse of 121 bpm, cough, body aches, felt dizzy and weak, and took aspirin, helping for the blood pressure to drop. On 28-Oct-2022 around 6:00 AM patient needed to go to ER because of these symptoms. Caller mentioned he was running out of time because his wife was still in the hospital, and he had to attend calls from doctors and was not able to provide additional details about the AE.  It was unknown if patient was under any concomitant or regular medication. It was unknown if patient ever had COVID positive test or diagnosis. It was unknown if patient had Acute and Chronic illnesses at the time of vaccination. It was unknown if patient experienced a similar event in the past.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Hunger, Mobility decreased
Clinical narrative: felt extremely hungry; severely fatigued/felt extremely fatigued; dizzy; needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizzy), MOBILITY DECREASED (needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours), HUNGER (felt extremely hungry) and FATIGUE (severely fatigued/felt extremely fatigued) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Congestive heart failure, Heart attack and Surgery. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Sep-2022, the patient experienced DIZZINESS (dizzy), MOBILITY DECREASED (needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours) and FATIGUE (severely fatigued/felt extremely fatigued). On 12-Sep-2022, the patient experienced HUNGER (felt extremely hungry). At the time of the report, DIZZINESS (dizzy), MOBILITY DECREASED (needed help getting to and from the restroom but mostly stayed in bed for approximately 16 hours), HUNGER (felt extremely hungry) and FATIGUE (severely fatigued/felt extremely fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Blood pressure measurement: Normal.   They went to an urgent care where he had his vitals checked, which were very normal. No fever, his O2 levels were normal, and his blood pressures were normal..  He currently takes Eliquis and other medications  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Somnolence
Clinical narrative: slept all day; feels tired; Fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), FATIGUE (feels tired) and HEART RATE INCREASED (Fast heart beat) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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 SOMNOLENCE (slept all day), FATIGUE (feels tired) and HEART RATE INCREASED (Fast heart beat). At the time of the report, SOMNOLENCE (slept all day), FATIGUE (feels tired) and HEART RATE INCREASED (Fast heart beat) outcome was unknown.            No concomitant medication information were provided. Patient received 2nd booster dose. No treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2022: Live Non Significant follow up appended.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: last booster was done in his thigh; Had COVID-19 in Aug 2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had COVID-19 in Aug 2022) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (last booster was done in his thigh) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02E21A, 048A21A and 015M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Had COVID-19 in Aug 2022). On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (last booster was done in his thigh). At the time of the report, COVID-19 (Had COVID-19 in Aug 2022) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (last booster was done in his thigh) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: Positive. In August 2022, SARS-CoV-2 test: Positive.         Concomitant medications were not reported.   Patient had no allergies.  Patient and her wife was searching for some place for most recent booster that will inject her husband in his thigh muscle. The last booster was done in his thigh by a hospital clinic service.   Patient had not experienced a similar event in the past.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-666579 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2022: Live Follow-up received include patient details added, suspect product coding updated, Event added, iNarrative updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received updated booster before primary series/Patient received the Moderna bivalent vaccine instead of the first dose of her Moderna primary series vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received updated booster before primary series/Patient received the Moderna bivalent vaccine instead of the first dose of her Moderna primary series vaccine.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received updated booster before primary series/Patient received the Moderna bivalent vaccine instead of the first dose of her Moderna primary series vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received updated booster before primary series/Patient received the Moderna bivalent vaccine instead of the first dose of her Moderna primary series vaccine.) 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 received updated booster before primary series/Patient received the Moderna bivalent vaccine instead of the first dose of her Moderna primary series vaccine.).    Concomitant medications were not reported.   The patient signed up to receive the Moderna Covid-19 vaccine bivalent dose on 31OCT2022. Patient was accidentally vaccinated on 29-Oct-2022 with Moderna COVID-19 Vaccine Bivalent before getting the primary series.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2022: Live Follow-up received include :Suspect (Moderna Bivalent) Date of administration updated On 31-Oct-2022: Live Follow-up received include : Patient details updated, Suspect (Moderna Vaccine ) lot number added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: arm pain; body ache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain), MYALGIA (body ache) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient was never diagnosed with COVID-19 prior to vaccination.  Concurrent medical conditions included Contrast media allergy (contrast dye), Drug allergy (Levaquin), Drug allergy (Statins) and Tinnitus (had it over more than 10 years).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021 at 4:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022 at 2:30 AM, 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 PAIN IN EXTREMITY (arm pain), MYALGIA (body ache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (arm pain), MYALGIA (body ache) and FATIGUE (fatigue) had resolved.            No concomitant medication information was reported.  The patient did not receive any other vaccines within 4 weeks prior to the  COVID vaccine. The patient had previously received a COVID-19 Vaccine. The patient had not been ever tested for COVID-19 since the vaccination. All Moderna shots caused a day of body ache, arm pain, fatigue in the patient's life.  It was reported that patient had received fifth dose as a Pfizer shot on 28-Sep-2022 on the left arm. After a day or two after the Pfizer shot, it was noticed that her usually mild tinnitus (ringing) of more than 10 years increased significantly. It was ongoing and very loud enough to distract from the patient from all activities including watching television, working outdoors, having conversations, working indoors, reading, and writing this description. It decreased the patient's quality of life. If she had known that it would have happened, she would have found the Moderna vaccine somewhere else. The patient reported that the online sites described about reports/articles about experiencing more instances of tinnitus like symptoms more after receiving Pfizer COVID-19 vaccine than that of Moderna vaccine. It was also reported that there were some educated older people who would not get latest booster because of severe tinnitus that appeared immediately following a COVID shot.  No treatment medication information was reported.  Device Date reported as 03-Oct-2022.   This case was linked to MOD-2022-666569 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pruritus, Vaccination site pain
Clinical narrative: Flu like symptoms; Injection site itching; Sore arm with Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Sore arm with Covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Sore arm with Covid vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Sore arm with Covid vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. The reporter's causality for the events of Flu like symptoms, Injection site itching and Sore arm with Covid vaccine with Humira (adalimumab) Solution for Injection was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (metallic taste) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 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 DYSGEUSIA (metallic taste). At the time of the report, DYSGEUSIA (metallic taste) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.  No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: mild Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (mild Cold symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE for an unknown indication.    No Medical History information was reported.   In 2020, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form. In 2020, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient received fifth dose of COVID-19 VACCINE (unknown route) 1 dosage form. In June 2022, received sixth dose of COVID-19 VACCINE (unknown route) dosage was changed to 1 dosage form. In October 2022, received seventh dose of COVID-19 VACCINE (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (mild Cold symptoms). At the time of the report, NASOPHARYNGITIS (mild Cold symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.         Concomitant medication not reported. Treatment medication not reported.  The patient got quick 24-hour turnaround PCR testing plus two types of rapid testing when he got mild cold symptoms (covid-19 negative).
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Inappropriate schedule of product administration, Infection, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Had trouble with red swelling of leg), ERYTHEMA (Had trouble with red swelling of leg), INFECTION (Infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 10-Jun-2021 and second on 29-Jun-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    The patient's past medical history included COVID-19 in January 2022, Crohn's in March 2022 and Diarrhea (was prescribed antibiotics and had helped with the issues).   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate Free. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 10-Jun-2021 and second on 29-Jun-2021). In June 2022, the patient experienced INFECTION (Infection). On an unknown date, the patient experienced PERIPHERAL SWELLING (Had trouble with red swelling of leg) and ERYTHEMA (Had trouble with red swelling of leg). At the time of the report, PERIPHERAL SWELLING (Had trouble with red swelling of leg) and ERYTHEMA (Had trouble with red swelling of leg) was resolving and INFECTION (Infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 10-Jun-2021 and second on 29-Jun-2021) outcome was unknown.      The patient had diarrhea and was prescribed antibiotics and had helped with the issues. In Mar 2022, went to hospital in regard to Crohn's after catching covid in beginning of year. Concomitant medication not reported. It was reported that on unknown date the patient experienced Itching after Humira injections and Bleeding after taking Humira injections. The reporter's causality for the event(s) of Bleeding after taking Humira injections, had trouble with red swelling of leg unknown onset, Infection, Itching after Humira injections with Adalimumab Solution for Injection was Not Provided.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Rash, Skin disorder
Clinical narrative: dermatology related skin issues; FLARE UP; rash; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (dermatology related skin issues), CONDITION AGGRAVATED (FLARE UP) and RASH (rash) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        Patient had no known allergies.    On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (dermatology related skin issues), CONDITION AGGRAVATED (FLARE UP) and RASH (rash). At the time of the report, SKIN DISORDER (dermatology related skin issues), CONDITION AGGRAVATED (FLARE UP) and RASH (rash) outcome was unknown.            Concomitant products were not reported.  It was reported that it was unknown if patient was enrolled in COVID-19 vaccine trail. Reporter did not have the lot number information, because the packing was discarded. The causality with jassen for event rash and condition aggravated was not reported and for the event skin disorder reported as possible. Causality with Humira for event skin disorder and condition aggravated was not reported and for rash it was not related.  Treatment medications were not reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: vaccine squirted out; Caller believes it was faulty needle; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (vaccine squirted out), NEEDLE ISSUE (Caller believes it was faulty needle) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) 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 UNDERDOSE (vaccine squirted out), NEEDLE ISSUE (Caller believes it was faulty needle) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (vaccine squirted out), NEEDLE ISSUE (Caller believes it was faulty needle) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No Concomitant medications were provided.  It was reported that patient received Moderna Covid Bivalent booster the new one and when they entered the needle into the patients arm the vaccine squirted out.   No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got COVID-19 in a very slight form, like almost nothing; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19 in a very slight form, like almost nothing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2022, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2022, the patient experienced COVID-19 (Patient got COVID-19 in a very slight form, like almost nothing). At the time of the report, COVID-19 (Patient got COVID-19 in a very slight form, like almost nothing) outcome was unknown.            No concomitant medications were reported.  On an unknown date, patient received the 1st booster dose of Moderna COVID-19 Vaccine. In May-2022, patient received the 2nd booster dose of Moderna COVID-19 Vaccine.  It was unknown if any treatment was given to the patient.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Immunisation reaction, Influenza like illness, Movement disorder
Clinical narrative: really bad reaction; couldn't lift it; flu like symptoms; couldn't get out of bed; arm was so sore/ leg pains; aches; general fatigue; still have nausea; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed) and PAIN IN EXTREMITY (arm was so sore/ leg pains) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed), PAIN IN EXTREMITY (arm was so sore/ leg pains), MYALGIA (aches), FATIGUE (general fatigue) and NAUSEA (still have nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed), PAIN IN EXTREMITY (arm was so sore/ leg pains) and FATIGUE (general fatigue) outcome was unknown, MYALGIA (aches) was resolving and NAUSEA (still have nausea) had not resolved.            The patient had all Moderna vaccines and later had one bivalent vaccine two weeks ago , on 11-Oct-2022. The adverse reactions made the patient paused on the decision whether or not to get another vaccination.  The patient was on some medication before getting the vaccine but nothing that should interfere the vaccination. The concomitant  medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: really bad reaction; couldn't lift it; flu like symptoms; couldn't get out of bed; arm was so sore/ leg pains; aches; general fatigue; still have nausea; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed) and PAIN IN EXTREMITY (arm was so sore/ leg pains) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed), PAIN IN EXTREMITY (arm was so sore/ leg pains), MYALGIA (aches), FATIGUE (general fatigue) and NAUSEA (still have nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed), PAIN IN EXTREMITY (arm was so sore/ leg pains) and FATIGUE (general fatigue) outcome was unknown, MYALGIA (aches) was resolving and NAUSEA (still have nausea) had not resolved.            The patient had all Moderna vaccines and later had one bivalent vaccine two weeks ago , on 11-Oct-2022. The adverse reactions made the patient paused on the decision whether or not to get another vaccination.  The patient was on some medication before getting the vaccine but nothing that should interfere the vaccination. The concomitant  medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe Chronic Plaque Psoriasis).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis). At the time of the report, PSORIASIS (Psoriasis) was resolving.            No concomitant medication was provided by the reporter. It was reported that the covid 19 vaccine might had caused her psoriasis. No treatment medication was provided by the reporter. The reporter's causality for the event of Psoriasis with Skyrizi (Risankizumab)  Solution for Injection Single-Dose Prefilled Syringe with Needle Guard was not Provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pruritus, Pyrexia, Skin exfoliation
Clinical narrative: itching two inches under breast/red dots on buttock that itch and itch scalp; itching two inches under breast/red dots on buttock that itch and itch scalp; skin flaky/scale; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (itching two inches under breast/red dots on buttock that itch and itch scalp), PRURITUS (itching two inches under breast/red dots on buttock that itch and itch scalp), SKIN EXFOLIATION (skin flaky/scale), CHILLS (Chills) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782589) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (itching two inches under breast/red dots on buttock that itch and itch scalp), PRURITUS (itching two inches under breast/red dots on buttock that itch and itch scalp), SKIN EXFOLIATION (skin flaky/scale), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ERYTHEMA (itching two inches under breast/red dots on buttock that itch and itch scalp), PRURITUS (itching two inches under breast/red dots on buttock that itch and itch scalp), SKIN EXFOLIATION (skin flaky/scale), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. The reporter causality for the event(s) of chills, fever, itching two inches under breast/red dots on buttock that itch and itch scalp unknown onset, skin flaky/scale with SKYRIZI was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment medications were reported.