chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Feeling abnormal, Lip swelling, Peripheral swelling, Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a little lousy), LIP SWELLING (Woke up, top lip was swelled up and then at night bottom lip swelled up, then the next day it was bottom lip and chin swelled), SWELLING FACE (Bottom lip and chin swelled), PERIPHERAL SWELLING (Her two hands began swelled up, husband had to cut her ring off) and ANKLE FRACTURE (Broken ankle) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 002C21A and 008B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Had Covid over Christmas break 2021) in 2021 and Muscle relaxant. Concurrent medical conditions included Chronic pain and Sleeplessness (Can't sleep). Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE; PARACETAMOL]) for Chronic pain, TIZANIDINE for Muscle relaxant, HYDROXYZINE for Sleeplessness, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS], SEROTONIN, DOCUSATE SODIUM (STOOL SOFTENER), SENNA [SENNA ALEXANDRINA] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Felt a little lousy). In March 2022, the patient experienced PERIPHERAL SWELLING (Her two hands began swelled up husband had to cut her ring off). On an unknown date, the patient experienced LIP SWELLING (Woke up, top lip was swelled up and then at night bottom lip swelled up, then the next day it was bottom lip and chin swelled), SWELLING FACE (Bottom lip and chin swelled) and ANKLE FRACTURE (Broken ankle). The patient was treated with Surgery for Ankle fracture. At the time of the report, FEELING ABNORMAL (Felt a little lousy), LIP SWELLING (Woke up, top lip was swelled up and then at night bottom lip swelled up, then the next day it was bottom lip and chin swelled), SWELLING FACE (Bottom lip and chin swelled), PERIPHERAL SWELLING (Her two hands began swelled up husband had to cut her ring off) and ANKLE FRACTURE (Broken ankle) outcome was unknown. Concomitant medication information includes OTC vitamin D 1,000 Units, serotonin 3 mg at bedtime. Patient did not had problems with breathing. Treatment information includes patient took around the clock Benadryl. This case was linked to MOD-2022-510833 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: felt like something was wrong with bone  in the arm/it felt bad to have that feeling; had pain in arm where he received the shot; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt like something was wrong with bone  in the arm/it felt bad to have that feeling) and PAIN IN EXTREMITY (had pain in arm where he received the shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 044A21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included ENALAPRIL for Blood pressure management.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced FEELING ABNORMAL (felt like something was wrong with bone  in the arm/it felt bad to have that feeling) and PAIN IN EXTREMITY (had pain in arm where he received the shot). At the time of the report, FEELING ABNORMAL (felt like something was wrong with bone  in the arm/it felt bad to have that feeling) and PAIN IN EXTREMITY (had pain in arm where he received the shot) had resolved.            Patient said it was tough for him to exercise due to this symptom. Patient reported that  occasionally he experienced a sensation in his arm, but it was not painful and had gotten much better. He says that the symptom eventually went away. No treatment medications was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved 1st dose of J&J and recievd 2nd dose of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter. Reporter was unable to verify if patient was immunocompromised or not.   This case was linked to MOD-2022-511288 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose J&J, 2nd dose of Moderna 0.5 mL given; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose J&J, 2nd dose of Moderna 0.5 mL given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J & J vaccine (1st dose). Past adverse reactions to the above products included No adverse event with J & J vaccine.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose J&J, 2nd dose of Moderna 0.5 mL given). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose J&J, 2nd dose of Moderna 0.5 mL given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter was unable to verify if patient was immunocompromised or not. No treatment medication information was given.   This case was linked to MOD-2022-511285 (Patient Link).   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient who is not immunocompromised received full 3rd dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient who is not immunocompromised received full 3rd dose). At the time of the report, ACCIDENTAL OVERDOSE (Patient who is not immunocompromised received full 3rd dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Pharmacist stated that the patient who received the primary doses in Jan-2021 and Feb-2021 from another store received a third full dose. When the patient came for the third dose, patient told the pharmacist that the patient was immunocompromised, however when pharmacist called the patient asking for the fourth dose, patient said he was not immunocompromised, but the patient takes care of wife who is immunocompromised. Information of first and second doses were unknown. No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hangover
Clinical narrative: felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed; felt like she had a hangover; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed) and HANGOVER (felt like she had a hangover) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 007M20A and 039D21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma (non-Hodgkin's) (Active case of Non Hodgkin's Lymphoma).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed) and HANGOVER (felt like she had a hangover). At the time of the report, FEELING ABNORMAL (felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed) and HANGOVER (felt like she had a hangover) was resolving.            The  concomitant medications on use were not provided.  The patient was considered to be immune compromised and received a third full dose of the vaccine after her first two full doses. The patient reported no adverse reactions or side effects to the first dose and third dose.   No treatment information was provided.   This case was linked to MOD-2022-511194 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Follow up  information included no new information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site pain, Weight increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain after 2nd shot), LETHARGY (Lethargy after 2nd shot) and VACCINATION SITE PAIN (Sore left arm after 2nd shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The patient's past medical history included Thalassemia. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced WEIGHT INCREASED (Weight gain after 2nd shot), LETHARGY (Lethargy after 2nd shot) and VACCINATION SITE PAIN (Sore left arm after 2nd shot). On 14-Apr-2021, LETHARGY (Lethargy after 2nd shot) and VACCINATION SITE PAIN (Sore left arm after 2nd shot) had resolved. At the time of the report, WEIGHT INCREASED (Weight gain after 2nd shot) outcome was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2022-511431, MOD-2022-511410 (Patient Link). Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Irritability
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Irritating) and VACCINATION COMPLICATION (Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABILITY (Irritating) and VACCINATION COMPLICATION (Side effect). At the time of the report, IRRITABILITY (Irritating) and VACCINATION COMPLICATION (Side effect) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No Concomitant Medications were provided by the Reporter. Patient was due for booster shot. No Treatment Medications were provided by the Reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Lethargy, Vaccination site pain, Weight increased
Clinical narrative: TSH level were high months after booster; Weight gain (15-20 lbs.) after booster shot; After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back; Lethargy after booster shot/The following day she had lethargy; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain (15-20 lbs.) after booster shot), BLOOD THYROID STIMULATING HORMONE INCREASED (TSH level were high months after booster), LETHARGY (Lethargy after booster shot/The following day she had lethargy) and VACCINATION SITE PAIN (After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 036B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thalassemia.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LETHARGY (Lethargy after booster shot/The following day she had lethargy). On 27-Nov-2021, the patient experienced WEIGHT INCREASED (Weight gain (15-20 lbs.) after booster shot) and VACCINATION SITE PAIN (After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back). In February 2022, the patient experienced BLOOD THYROID STIMULATING HORMONE INCREASED (TSH level were high months after booster). The patient was treated with LEVOTHYROXINE SODIUM (SYNTHROID) at an unspecified dose and frequency. At the time of the report, WEIGHT INCREASED (Weight gain (15-20 lbs.) after booster shot) and BLOOD THYROID STIMULATING HORMONE INCREASED (TSH level were high months after booster) outcome was unknown, LETHARGY (Lethargy after booster shot/The following day she had lethargy) had resolved and VACCINATION SITE PAIN (After booster dose, her left arm was sore/soreness of the injected arm, went away but it keeps coming back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Blood thyroid stimulating hormone: high (High) High.         No concomitant medication were reported by the reporter.  After booster shot her left arm was sore. The following day she had lethargy. The symptoms lasted for 2-4 days. Patient stated that she did not have history of Thyroid disease, but patient has had Thalassemia for many years. The vaccine did not change her lab values for Thalassemia. Her Thalassemia lab values were the same after vaccination.   This case was linked to MOD-2022-511410, MOD-2022-511425 (Patient Link).   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (After 1st dose she felt like she had gotten the flu shot and got the flu) and FEELING ABNORMAL (She felt really bad) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Grass allergy, Allergy to plants (weed), Food allergy (Corn) and Heart disorder (Heart patient). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (After 1st dose she felt like she had gotten the flu shot and got the flu) and FEELING ABNORMAL (She felt really bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA (After 1st dose she felt like she had gotten the flu shot and got the flu) and FEELING ABNORMAL (She felt really bad) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications were not reported. The patient had never tested positive for COVID-19. This case was linked to MOD-2022-511473 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had severe side effect when received the first covid vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (had severe side effect when received the first covid vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had severe side effect when received the first covid vaccine). At the time of the report, VACCINATION COMPLICATION (had severe side effect when received the first covid vaccine) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Reporter stated that patient lived alone and patient was undergoing chemotherapy and therefore had a thoroughly weakened immune system.   This case was linked to MOD-2022-511048 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was opened for more than 12 hours, left outside in room temperature, and administered to the patient.  No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: hair started falling out in August 2021; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair started falling out in August 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug-Lisinopril  reaction-cough) and Sulfonamide allergy (Drug-Sulfa drugs).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (hair started falling out in August 2021). At the time of the report, ALOPECIA (hair started falling out in August 2021) had not resolved.            Patient never had diagnosis of COVID-19 and states that he was very healthy.  Patient took Booster dose: 22Dec2021 Lot 045J1A  Patient visits dermatologist once a month  Concomitant medications details were not reported by the reporter. Treatment details includes Steroid injections and antibiotics .
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Pruritus, Skin irritation
Clinical narrative: hair started falling out in August 2021; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair started falling out in August 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug-Lisinopril  reaction-cough) and Sulfonamide allergy (Drug-Sulfa drugs).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (hair started falling out in August 2021). At the time of the report, ALOPECIA (hair started falling out in August 2021) had not resolved.            Patient never had diagnosis of COVID-19 and states that he was very healthy.  Patient took Booster dose: 22Dec2021 Lot 045J1A  Patient visits dermatologist once a month  Concomitant medications details were not reported by the reporter. Treatment details includes Steroid injections and antibiotics .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Tinnitus
Clinical narrative: worsening on the ringing in his ears after vaccination; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (worsening on the ringing in his ears after vaccination) and MYALGIA (sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (worsening on the ringing in his ears after vaccination) and MYALGIA (sore arm). At the time of the report, TINNITUS (worsening on the ringing in his ears after vaccination) and MYALGIA (sore arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient Height was reported 7 6 not provides values. Concomitant medication was reported as "a bunch". Patient completed all 3 doses. Adverse event did not cause to seek medical care (office visit, Urgent care, ER, hospitalized) to the patient. The patient was experienced a similar event in the past.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had fever) and FATIGUE (Patient was tired for about two or three days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Patient had fever) and FATIGUE (Patient was tired for about two or three days). At the time of the report, PYREXIA (Patient had fever) and FATIGUE (Patient was tired for about two or three days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Treatment included Painkillers, physical therapy and acupuncture. Patient didn't had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient tested positive on 24-Dec-21 and tested positive some more times but doesn´t remember the dates. This case was linked to MOD-2022-511845, MOD-2022-511849 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Headache, Myalgia
Clinical narrative: headache; chills; fever/temperature of 103.2; body aches; big huge red knot; about the size of a golf ball that stuck up about 2 cm; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (big huge red knot), SWELLING (about the size of a golf ball that stuck up about 2 cm), CHILLS (chills), PYREXIA (fever/temperature of 103.2) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 076L21D and 045L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 12-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2022, the patient experienced ERYTHEMA (big huge red knot) and SWELLING (about the size of a golf ball that stuck up about 2 cm). On 13-Mar-2022, the patient experienced CHILLS (chills), PYREXIA (fever/temperature of 103.2) and MYALGIA (body aches). On 14-Mar-2022, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of Tylenol about every 2 hours and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of Motrin about every 2 hours. At the time of the report, ERYTHEMA (big huge red knot) and SWELLING (about the size of a golf ball that stuck up about 2 cm) outcome was unknown, CHILLS (chills) and PYREXIA (fever/temperature of 103.2) had resolved with sequelae and MYALGIA (body aches) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2022, Body temperature: 103.2 (High) fever/temperature of 103.2.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient experienced symptoms saturday evening after receiving the second dose of the vaccine. Patient asked her HCP for Decadron or steroids, who denied her request.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: headache; chills; fever/temperature of 103.2; body aches; big huge red knot; about the size of a golf ball that stuck up about 2 cm; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (big huge red knot), SWELLING (about the size of a golf ball that stuck up about 2 cm), CHILLS (chills), PYREXIA (fever/temperature of 103.2) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 076L21D and 045L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 12-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2022, the patient experienced ERYTHEMA (big huge red knot) and SWELLING (about the size of a golf ball that stuck up about 2 cm). On 13-Mar-2022, the patient experienced CHILLS (chills), PYREXIA (fever/temperature of 103.2) and MYALGIA (body aches). On 14-Mar-2022, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of Tylenol about every 2 hours and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of Motrin about every 2 hours. At the time of the report, ERYTHEMA (big huge red knot) and SWELLING (about the size of a golf ball that stuck up about 2 cm) outcome was unknown, CHILLS (chills) and PYREXIA (fever/temperature of 103.2) had resolved with sequelae and MYALGIA (body aches) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2022, Body temperature: 103.2 (High) fever/temperature of 103.2.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient experienced symptoms saturday evening after receiving the second dose of the vaccine. Patient asked her HCP for Decadron or steroids, who denied her request.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Daughter received the booster dose while being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Daughter received the booster dose while being pregnant) in a 30-year-old female patient 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Daughter received the booster dose while being pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Daughter received the booster dose while being pregnant) had resolved.            No concomitant and treatment medication were reported.  The reporter wanted to know why in the  it was mentioned that patients should tell if they are pregnant as the reporter's daughter received the booster dose while being pregnant.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (Back pain) 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.    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 BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-511426 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 3rd dose given as half dose in an immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3rd dose given as half dose in an immunocompromised patient) 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 Immunocompromised.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (3rd dose given as half dose in an immunocompromised patient). At the time of the report, ACCIDENTAL UNDERDOSE (3rd dose given as half dose in an immunocompromised patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Patient had received half dose of third dose and patient was requested for a full 4th dose of the vaccine and they walked out when the pharmacist mentioned that they were going to be given a half dose.   No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Patient administered vaccine after 12 hours post punctured; Patient administered the vaccine after 12 hours post punctured and temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 12 hours post punctured) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered the vaccine after 12 hours post punctured and temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 12 hours post punctured) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered the vaccine after 12 hours post punctured and temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 12 hours post punctured) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered the vaccine after 12 hours post punctured and temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 10JAN202.  Maximum or minimum temperatures reached, as applicable (specify temp is in C or F) is Min: 36F, Max: 54.47F Excursion duration was 50 minutes.  No concomitant medication were provided No treatment details were provided
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Serious itching on the skin on lower legs after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Serious itching on the skin on lower legs after first dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PRURITUS (Serious itching on the skin on lower legs after first dose). On 10-Jun-2021, PRURITUS (Serious itching on the skin on lower legs after first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-512309, MOD-2022-512313 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Worst itching ever, all over his body after booster; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Worst itching ever, all over his body after booster) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Worst itching ever, all over his body after booster). The patient was treated with TRIAMCINOLONE for Itching all over, at an unspecified dose and frequency. At the time of the report, PRURITUS (Worst itching ever, all over his body after booster) had not resolved.            No concomitant medication were provided. Patient visited his internist and the doctor prescribed Triamcinolone cream. The medicine did not help and he still has a problem, itching all over the body.   This case was linked to MOD-2022-512258, MOD-2022-512309 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia
Clinical narrative: Her husband got complete numbness from his shoulder to his neck and jaw; it could be a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 26May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Her husband got complete numbness from his shoulder to his neck and jaw"; ANXIETY (non-serious), outcome "unknown", described as "it could be a heart attack".  Additional information: Caller is not sure who to talk to. She called the CDC, and they couldn't give her information. Her and her husband got the first dose of the COVID vaccine on 26May2021. It had been like 99 days since their first day. They didn't get the second vaccine. They were both scared to get the second dose because of everything they heard about the second dose. Her husband got complete numbness from his shoulder to his neck and jaw. He said it was like the dentist gave him Novocain. It didn't wear off for 5 hours. They called his doctor and she said to call # that it could be a heart attack. Then, in regards to her getting the vaccine, she has a history of autoimmune disorders. She had a heart issue which developed after the COVID vaccine. They are now putting her on a 24 hour heart monitor. They are both scared because COVID is getting worse. They want to know if it is it too late to get the second dose 99 days apart. Her husband is really worried. They gave her vaccine high up in her arm. Her husband got his way lower than hers. She honestly didn't get side effects. Her arm didn't hurt. She did get headaches a couple of days out. They were pretty bad. She also has IBS issues. Her digestive issues got worse. She doesn't know if it was because of the vaccine or because of stress. She doesn't want to do a report. She would just like more information on the second dose. She needs to decide if she is getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added event "Impending doom". Sender's Comments: Linked Report(s) : US-PFIZER INC-202101145230 similar report from same reporter;US-PFIZER INC-202101176377 similar report from same reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm from vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE taken for breast cancer, start date: 04Jun2021, stop date: 14Sep2021; FASLODEX. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm from vaccine".  Additional Information: it was reported that patient received current dosing 100mg 1 tablet by mouth for 21 days, then off for 7 days. It started 04Jun2021 and hold on 14Sep2021. Faslodex injections.  Patient reported Ibrance still on hold due to vacation since 14Sep2021. Patient planned to restart ibrance 04Nov2021 reported usual ongoing tiredness since start of therapy. No ad-verse effects from medication hold. she did receive pfizer booster vaccine 26Oct2021 when she arrived home to . reports sore arm from vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: so tired; some body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose covid-19 vaccine), administration date: Apr2021, for Covid-19 immunization, reaction(s): "Chills", "really tired", "some body aches", "golf ball sized" bubble or lump appear on her arm". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "so tired"; PAIN (non-serious), outcome "unknown", described as "some body aches"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: The caller proceeded with her second dose and this type of reaction did not occur. The caller states that she did have some systemic reaction to the first dose and described it as, "I was really tired, like too tired to play with my kids because I did not even want to get out of the chair. The tiredness started that afternoon and lasted through the next day." She also endorsed systemic type side effects with her second dose which were more intense than the first dose and described those side effects as, "I just went to bed because I was so tired. I had some body aches and chills as well. It was much more than I had with the first dose." Caller asks if she should get tested for antibodies to assess whether or not she is protected from COVID after receiving the primary vaccine series.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: had a nodule under his armpit for 3 months now/he has had a nodule under his arm for over two months. He had the first one two months ago and then the second one; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 21 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NODULE (non-serious) with onset 2021, outcome "not recovered", described as "had a nodule under his armpit for 3 months now/he has had a nodule under his arm for over two months. He had the first one two months ago and then the second one".  Additional information: Reporter stated her 21 year old son received the Pfizer COVID vaccine and had a nodule under his armpit for 3 months now. He proceeded to receive the second dose in which the second shot also resulted in a nodule under his armpit, but not as big. Both arms under armpits have the nodules, they are not painful, but they are just there and the first one that he got, it didn't has not gone away yet..  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A little headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "A little headache".  Follow-up (17Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in her upper thigh; numbness and tingling in her upper thigh; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "unknown" and all described as "numbness and tingling in her upper thigh".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Vaccination site pain
Clinical narrative: Pains in my shoulder at the injection site; Causing discomfort when trying to move my shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "Pains in my shoulder at the injection site"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Oct2021, outcome "not recovered", described as "Causing discomfort when trying to move my shoulder".  Additional information: Forwarded as an Adverse Event by the team on 11Nov2021. Reporter provided verification of contact address on 10Nov2021. I received my second dose about a month ago. I was still having pains in my shoulder at the injection site causing discomfort when trying to move my shoulder.  Follow-up attempts are completed. No further information is expected.