chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neuropathy peripheral, Oropharyngeal pain, Pain
Clinical narrative: NEUROPATHY IN BOTH FEET THAT WENT UP HER LEGS/FINGERS AND HANDS; FEELING FLUSHED IN THE FACE; BODY ACHES; DIFFICULT TO WALK; SORE THROAT; SEVERE BONE PAIN; WORSE PAIN IN LEGS AND HIPS; FEELING FEVERISH; HEADACHE; WEAKNESS; FEELING VERY TIRED; SEVERE PAIN IN BOTH MUSCLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included chemotherapy performed on an unspecified date in NOV-2020, patient had no known allergies as pre-existing medical conditions, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported,1 total, administered on 14-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-SEP-2021, about 4 hours post vaccination, patient felt flushed in the face and feverish, although patient did not have a fever. Patient complained of a headache that would come and go for 2 days. Patient stated she had neuropathy in both feet that went up her legs and lasted over 24 hours, as well as neuropathy in her fingers and hands that was still persisted. Patient stated she had body aches described as both muscle and bone pain, that was so severe that it was difficult to walk. The pain begun 20 hours after the injection and lasted over 24 hours, and was worse in the legs and hips. Patient reported that 3 hours after the injection, she felt very tired, which lasted approximately 48 hours, as well as weakness that was associated with the body pain. Patient also experienced a sore throat. Patient compared the feeling to her chemotherapy treatment in NOV-2020. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, severe bone pain, worse pain in legs and hips, and severe pain in both muscle on SEP-2021, and headache, and feeling very tired on 16-SEP-2021, had not recovered from neuropathy in both feet that went up her legs/fingers and hands, and the outcome of feeling flushed in the face, feeling feverish, weakness, sore throat and difficult to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210935168-COVID-19 VACCINE AD26.COV2.S-neuropathy in both feet that went up her legs/fingers and hands. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: NEUROPATHY IN BOTH FEET THAT WENT UP HER LEGS/FINGERS AND HANDS; FEELING FLUSHED IN THE FACE; BODY ACHES; DIFFICULT TO WALK; SORE THROAT; SEVERE BONE PAIN; WORSE PAIN IN LEGS AND HIPS; FEELING FEVERISH; HEADACHE; WEAKNESS; FEELING VERY TIRED; SEVERE PAIN IN BOTH MUSCLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included chemotherapy performed on an unspecified date in NOV-2020, patient had no known allergies as pre-existing medical conditions, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported,1 total, administered on 14-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-SEP-2021, about 4 hours post vaccination, patient felt flushed in the face and feverish, although patient did not have a fever. Patient complained of a headache that would come and go for 2 days. Patient stated she had neuropathy in both feet that went up her legs and lasted over 24 hours, as well as neuropathy in her fingers and hands that was still persisted. Patient stated she had body aches described as both muscle and bone pain, that was so severe that it was difficult to walk. The pain begun 20 hours after the injection and lasted over 24 hours, and was worse in the legs and hips. Patient reported that 3 hours after the injection, she felt very tired, which lasted approximately 48 hours, as well as weakness that was associated with the body pain. Patient also experienced a sore throat. Patient compared the feeling to her chemotherapy treatment in NOV-2020. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, severe bone pain, worse pain in legs and hips, and severe pain in both muscle on SEP-2021, and headache, and feeling very tired on 16-SEP-2021, had not recovered from neuropathy in both feet that went up her legs/fingers and hands, and the outcome of feeling flushed in the face, feeling feverish, weakness, sore throat and difficult to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210935168-COVID-19 VACCINE AD26.COV2.S-neuropathy in both feet that went up her legs/fingers and hands. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Hypokinesia, Limb discomfort
Clinical narrative: UNCONTROLLABLE TREMORS; LOST ABILITY TO OPEN OR CLOSE HAND; ACHY(FLU-LIKE SYMPTOMS); SEVERE JOINT PAIN THROUGHOUT THE BODY; MINOR HEAVINESS IN THE ARM; FEVERISH; INTENSE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bullous pemphigoid. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced uncontrollable tremors. On 17-SEP-2021, the patient experienced lost ability to open or close hand. On 17-SEP-2021, the patient experienced achy (flu-like symptoms). On 17-SEP-2021, the patient experienced severe joint pain throughout the body. On 17-SEP-2021, the patient experienced minor heaviness in the arm. On 17-SEP-2021, the patient experienced feverish. On 17-SEP-2021, the patient experienced intense headache. Laboratory data included: Body temperature (NR: not provided) 103.5, 99.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from minor heaviness in the arm, feverish, achy(flu-like symptoms), uncontrollable tremors, severe joint pain throughout the body, intense headache, and lost ability to open or close hand. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: UNCONTROLLABLE TREMORS; LOST ABILITY TO OPEN OR CLOSE HAND; ACHY(FLU-LIKE SYMPTOMS); SEVERE JOINT PAIN THROUGHOUT THE BODY; MINOR HEAVINESS IN THE ARM; FEVERISH; INTENSE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bullous pemphigoid. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced uncontrollable tremors. On 17-SEP-2021, the patient experienced lost ability to open or close hand. On 17-SEP-2021, the patient experienced achy (flu-like symptoms). On 17-SEP-2021, the patient experienced severe joint pain throughout the body. On 17-SEP-2021, the patient experienced minor heaviness in the arm. On 17-SEP-2021, the patient experienced feverish. On 17-SEP-2021, the patient experienced intense headache. Laboratory data included: Body temperature (NR: not provided) 103.5, 99.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from minor heaviness in the arm, feverish, achy(flu-like symptoms), uncontrollable tremors, severe joint pain throughout the body, intense headache, and lost ability to open or close hand. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Limb mass, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: WHOLE BODY HURTS; FEVER; LYMPH NODES FEEL LIKE THEY ARE ON FIRE; BURNING TONGUE; LUMPS IN ARM PITS ONE ON THE RIGHT IS THE SIZE OF A GOLF BALL AND LEFT ONE IS NICKLE SIZE; BURNING THROAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-SEP-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-SEP-2021, the patient experienced burning tongue. On 20-SEP-2021, the patient experienced lumps in arm pits one on the right is the size of a golf ball and left one is nickle size. On 20-SEP-2021, the patient experienced burning throat. On 20-SEP-2021, the patient experienced lymph nodes feel like they are on fire. On 21-SEP-2021, the patient experienced whole body hurts. On 21-SEP-2021, the patient experienced fever. On 21-SEP-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 102.4 (units unspecified). On 21-SEP-2021 05:20, Laboratory data included: Body temperature (NR: not provided) 102.4 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lumps in arm pits one on the right is the size of a golf ball and left one is nickle size, whole body hurts, fever, and lymph nodes feel like they are on fire, and the outcome of burning throat and burning tongue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Throat irritation, Tongue discomfort
Clinical narrative: WHOLE BODY HURTS; FEVER; LYMPH NODES FEEL LIKE THEY ARE ON FIRE; BURNING TONGUE; LUMPS IN ARM PITS ONE ON THE RIGHT IS THE SIZE OF A GOLF BALL AND LEFT ONE IS NICKLE SIZE; BURNING THROAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-SEP-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-SEP-2021, the patient experienced burning tongue. On 20-SEP-2021, the patient experienced lumps in arm pits one on the right is the size of a golf ball and left one is nickle size. On 20-SEP-2021, the patient experienced burning throat. On 20-SEP-2021, the patient experienced lymph nodes feel like they are on fire. On 21-SEP-2021, the patient experienced whole body hurts. On 21-SEP-2021, the patient experienced fever. On 21-SEP-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 102.4 (units unspecified). On 21-SEP-2021 05:20, Laboratory data included: Body temperature (NR: not provided) 102.4 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lumps in arm pits one on the right is the size of a golf ball and left one is nickle size, whole body hurts, fever, and lymph nodes feel like they are on fire, and the outcome of burning throat and burning tongue was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Vaccination site pain
Clinical narrative: Limited strength in right arm; Pain; Had a right tender injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Limited strength in right arm), PAIN (Pain) and VACCINATION SITE PAIN (Had a right tender injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and GLIPIZIDE for Diabetes, SIMVASTATIN for High cholesterol.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Limited strength in right arm), PAIN (Pain) and VACCINATION SITE PAIN (Had a right tender injection site). At the time of the report, MUSCULAR WEAKNESS (Limited strength in right arm) and PAIN (Pain) outcome was unknown and VACCINATION SITE PAIN (Had a right tender injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment included Advil, Aleve, oils for injection site.   This case was linked to MOD-2021-310838 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Significant FU received on 14 Sep 2021,contain Reporter Address,Patient Height,Weight and Race Information and events were added. On 14-Sep-2021: Follow-up information included no new information
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Inappropriate schedule of product administration, Keratosis pilaris, Pruritus
Clinical narrative: A lot of Hives; Skin is hot; Skin is burning; Itchy Hives; May have Keratosis Pilaris; Second dose > 2 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A lot of Hives), FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives) and KERATOSIS PILARIS (May have Keratosis Pilaris) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced URTICARIA (A lot of Hives), FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives), KERATOSIS PILARIS (May have Keratosis Pilaris) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose > 2 months after first dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 UNK; LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK dosage form; HYDROXYZINE HCL at a dose of 25 mg once a day and CLOBETASOL PROPIONATE at a dose of 60 gram. On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose > 2 months after first dose) had resolved. At the time of the report, URTICARIA (A lot of Hives) had not resolved and FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives) and KERATOSIS PILARIS (May have Keratosis Pilaris) outcome was unknown.            No concomitant product use was provided by the reporter.  Treatment medications included she visited several doctors and used Benadryl, Claritin, Hydroxyzine HCL 25 mg tab once daily and Clobetasol Propionate ointment O.5% 60 gram (does not use every day).   This case was linked to MOD-2021-315268 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A lot of Hives; Skin is hot; Skin is burning; Itchy Hives; May have Keratosis Pilaris; Second dose > 2 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A lot of Hives), FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives) and KERATOSIS PILARIS (May have Keratosis Pilaris) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced URTICARIA (A lot of Hives), FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives), KERATOSIS PILARIS (May have Keratosis Pilaris) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose > 2 months after first dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 UNK; LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK dosage form; HYDROXYZINE HCL at a dose of 25 mg once a day and CLOBETASOL PROPIONATE at a dose of 60 gram. On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose > 2 months after first dose) had resolved. At the time of the report, URTICARIA (A lot of Hives) had not resolved and FEELING HOT (Skin is hot), BURNING SENSATION (Skin is burning), PRURITUS (Itchy Hives) and KERATOSIS PILARIS (May have Keratosis Pilaris) outcome was unknown.            No concomitant product use was provided by the reporter.  Treatment medications included she visited several doctors and used Benadryl, Claritin, Hydroxyzine HCL 25 mg tab once daily and Clobetasol Propionate ointment O.5% 60 gram (does not use every day).   This case was linked to MOD-2021-315268 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Headache, Product dose omission issue
Clinical narrative: second vaccine not given\from the first vaccine given, and today would have been day 45; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PRODUCT DOSE OMISSION ISSUE (second vaccine not given\from the first vaccine given, and today would have been day 45) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN from 20-Aug-2021 to 24-Aug-2021 for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced HEADACHE (headache). On 27-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second vaccine not given\from the first vaccine given, and today would have been day 45). On 27-Aug-2021, PRODUCT DOSE OMISSION ISSUE (second vaccine not given\from the first vaccine given, and today would have been day 45) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Results were negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       X-ray of the left lung to check for Pneumonia, the results were negative  Concomitant medications also include Nitro used for unknown indication.  No Treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered past the 30 day refrigeration time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Swelling, Vaccination site pain
Clinical narrative: Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling; Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing; Head is Lumpy / head is swollen; The injection site hurts; Pain at the top of her head / Even when she moves her hair, it hurts / head is tender; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling), HYPOAESTHESIA (Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing), SWELLING (Head is Lumpy / head is swollen), VACCINATION SITE PAIN (The injection site hurts) and HEADACHE (Pain at the top of her head / Even when she moves her hair, it hurts / head is tender) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced HEADACHE (Pain at the top of her head / Even when she moves her hair, it hurts / head is tender). On 11-Sep-2021, the patient experienced PARAESTHESIA (Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling), HYPOAESTHESIA (Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing), SWELLING (Head is Lumpy / head is swollen) and VACCINATION SITE PAIN (The injection site hurts). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 mg. At the time of the report, PARAESTHESIA (Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling), HYPOAESTHESIA (Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing), SWELLING (Head is Lumpy / head is swollen), VACCINATION SITE PAIN (The injection site hurts) and HEADACHE (Pain at the top of her head / Even when she moves her hair, it hurts / head is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Movement disorder, Nasopharyngitis
Clinical narrative: Arm was swollen ,gigantic, humongous like the incredible hulk,; Can put their hand around it.; Cold and sweating; Couldn't sleep; Felt sick; Pain in their entire body; Headache; Fever; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen ,gigantic, humongous like the incredible hulk,), MOVEMENT DISORDER (Can put their hand around it.), NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep) and MALAISE (Felt sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004f21a and 078cz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep), MALAISE (Felt sick), PAIN (Pain in their entire body), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm was hurting). On 11-Sep-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen  ,gigantic, humongous like the incredible hulk,) and MOVEMENT DISORDER (Can put their hand around it.). The patient was treated with NAPROXEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 11-Sep-2021, NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep), MALAISE (Felt sick), PAIN (Pain in their entire body), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm was hurting) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm was swollen  ,gigantic, humongous like the incredible hulk,) had not resolved and MOVEMENT DISORDER (Can put their hand around it.) outcome was unknown.      Concomitant product use was not provided by the reporter. it was reported Paitent arm was still gigantic.   This case was linked to MOD-2021-295327 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Arm was swollen ,gigantic, humongous like the incredible hulk,; Can put their hand around it.; Cold and sweating; Couldn't sleep; Felt sick; Pain in their entire body; Headache; Fever; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen ,gigantic, humongous like the incredible hulk,), MOVEMENT DISORDER (Can put their hand around it.), NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep) and MALAISE (Felt sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004f21a and 078cz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep), MALAISE (Felt sick), PAIN (Pain in their entire body), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm was hurting). On 11-Sep-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen  ,gigantic, humongous like the incredible hulk,) and MOVEMENT DISORDER (Can put their hand around it.). The patient was treated with NAPROXEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 11-Sep-2021, NASOPHARYNGITIS (Cold and sweating), INSOMNIA (Couldn't sleep), MALAISE (Felt sick), PAIN (Pain in their entire body), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm was hurting) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm was swollen  ,gigantic, humongous like the incredible hulk,) had not resolved and MOVEMENT DISORDER (Can put their hand around it.) outcome was unknown.      Concomitant product use was not provided by the reporter. it was reported Paitent arm was still gigantic.   This case was linked to MOD-2021-295327 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: Had been sick for 3 days; Headache was tolerable; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Had been sick for 3 days) and HEADACHE (Headache was tolerable) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 042L20A and 004F211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergic to almost everything (did not specify)) and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, RIVAROXABAN (XARELTO) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Had been sick for 3 days) and HEADACHE (Headache was tolerable). At the time of the report, ILLNESS (Had been sick for 3 days) had resolved and HEADACHE (Headache was tolerable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included Supplements and cholesterol medication, for unknown indication.  Patient did not consult with MD yet. Patient was unsure of the last 3 digits of dose 3 LOT due to poor handwriting.   This case was linked to MOD-2021-317581, MOD-2021-317587 (Patient Link).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: Greater than 35 days since first dose; Inadvertently administered dose to a teenager; Sore arm; Mild headache; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Sore arm), HEADACHE (Mild headache), PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced MYALGIA (Sore arm) and HEADACHE (Mild headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager). On 30-Jul-2021, MYALGIA (Sore arm) and HEADACHE (Mild headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Joint inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Joint inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Joint inflammation). At the time of the report, ARTHRITIS (Joint inflammation) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported. No treatment medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Gait disturbance, Hypokinesia, Pain
Clinical narrative: I can hardly walk; If I sit down for a few minutes, I could hardly move them (knees); I've had pain ever since; knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful; starting having pain in my right arm where I had the second shot; not real good; pain in my right arm and still gets pain/pain in his right arm stuck with him; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him), FEELING ABNORMAL (not real good) and PAIN (I've had pain ever since) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him). On 13-Sep-2021, the patient experienced FEELING ABNORMAL (not real good). On an unknown date, the patient experienced GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), PAIN (I've had pain ever since), ARTHRALGIA (knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful) and VACCINATION SITE PAIN (starting having pain in my right arm where I had the second shot). The patient was treated with VITAMIN D2 (oral) for Knee pain, at a dose of 50000 unit once a week. At the time of the report, GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), FEELING ABNORMAL (not real good), PAIN (I've had pain ever since) and ARTHRALGIA (knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful) outcome was unknown and PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him) and VACCINATION SITE PAIN (starting having pain in my right arm where I had the second shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient reports taking the vitamin D2 50,000 unit capsules once a week, and he's into the sixth week now.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-317664 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: I can hardly walk; If I sit down for a few minutes, I could hardly move them (knees); I've had pain ever since; knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful; starting having pain in my right arm where I had the second shot; not real good; pain in my right arm and still gets pain/pain in his right arm stuck with him; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him), FEELING ABNORMAL (not real good) and PAIN (I've had pain ever since) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him). On 13-Sep-2021, the patient experienced FEELING ABNORMAL (not real good). On an unknown date, the patient experienced GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), PAIN (I've had pain ever since), ARTHRALGIA (knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful) and VACCINATION SITE PAIN (starting having pain in my right arm where I had the second shot). The patient was treated with VITAMIN D2 (oral) for Knee pain, at a dose of 50000 unit once a week. At the time of the report, GAIT DISTURBANCE (I can hardly walk), HYPOKINESIA (If I sit down for a few minutes, I could hardly move them (knees)), FEELING ABNORMAL (not real good), PAIN (I've had pain ever since) and ARTHRALGIA (knees are very painful/ His knees give him trouble all the time/pain in his both knees. It's pretty painful) outcome was unknown and PAIN IN EXTREMITY (pain in my right arm and still gets pain/pain in his right arm stuck with him) and VACCINATION SITE PAIN (starting having pain in my right arm where I had the second shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient reports taking the vitamin D2 50,000 unit capsules once a week, and he's into the sixth week now.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-317664 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Peripheral swelling
Clinical narrative: swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.; lips were swollen; her inner mouth as well(swelling); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.), LIP SWELLING (lips were swollen) and MOUTH SWELLING (her inner mouth as well(swelling)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Swelling of tongue. Concurrent medical conditions included Fruit allergy (Allergic to kiwi), Allergy to nuts (hazelnut) and Allergy to sting (bee stings).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.), LIP SWELLING (lips were swollen) and MOUTH SWELLING (her inner mouth as well(swelling)). At the time of the report, PERIPHERAL SWELLING (swelling at the bottom of the foot, Swelling was more like she was standing on a golf ball.), LIP SWELLING (lips were swollen) and MOUTH SWELLING (her inner mouth as well(swelling)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were reported i.e., Liver support pills and collagen powder drink. No treatment information was reported.   This case was linked to MOD-2021-317669 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not administered beyond 35 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not administered beyond 35 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not administered beyond 35 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not administered beyond 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: full dose was not given due to leaking; full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (full dose was not given due to leaking) and DEVICE CONNECTION ISSUE (full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNK and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced INCORRECT DOSE ADMINISTERED (full dose was not given due to leaking) and DEVICE CONNECTION ISSUE (full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking). At the time of the report, INCORRECT DOSE ADMINISTERED (full dose was not given due to leaking) and DEVICE CONNECTION ISSUE (full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient on Saturday, 11Sept2021 and the syringe and barrel were not put on tightly so the full dose was not given due to leaking. The note said that the provider had a gut feeling that more than half of the dose was injected Concomitant medications was not provided by the reporter. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Phlebitis
Clinical narrative: Three separate spots of phlebitis on my legs/These are technically not "blood clots"; This spontaneous case was reported by a consumer and describes the occurrence of PHLEBITIS (Three separate spots of phlebitis on my legs/These are technically not "blood clots") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHLEBITIS (Three separate spots of phlebitis on my legs/These are technically not "blood clots"). At the time of the report, PHLEBITIS (Three separate spots of phlebitis on my legs/These are technically not "blood clots") outcome was unknown.      Concomitant product use was not provided.   Treatment information was not provided.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: Greater than 35 days since first dose; Sore arm; Mild headache; Inadvertently administered dose to a teenager; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager), PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose), MYALGIA (Sore arm) and HEADACHE (Mild headache) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager), MYALGIA (Sore arm) and HEADACHE (Mild headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) had resolved. On 30-Jul-2021, MYALGIA (Sore arm) and HEADACHE (Mild headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            No Concomitant and Treatment information reported.