chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications. On an unknown date the patient was vaccinated with Measles, Mumps, and Rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin) (M-M-R II) 0.5 milliliter (ml) (unspecified route, lot # S036664, expiration date: 14-NOV-2021), for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (lot# T009584 is an invalid lot number for sterile diluent (STERILE DILUENT) and a request for lot verification was sent to Lot Verification team, dose and anatomical location was not reported), both for prophylaxis. It was reported that patient received an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin) (M-M-R II) vaccine which did not have any temperature excursions. The vaccine had expired on 14-NOV-2021 and was administered on 07-DEC-2021. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Illness, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via interactive via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced illness, shingles and incomplete course of vaccination. On an unknown date, the outcome of the illness, shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the illness to be related to Shingrix. The reporter considered the shingles to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that the Shingrix vaccine caused the patient to become violently ill and 30 days later, the patient ended up with shingles. The patient refused to receive second dose of Shingrix, which led to incomplete course of vaccination. Consent to follow up was possible as contact details were not available.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In November 2021, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the activities of daily living impaired was recovered/resolved. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to Shingles vaccine. Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine on last Monday of reporting date. The patient stated, the shot dropped him/her off and was in bed for 4 days. The patient's arm was still sore. Consent to follow up was possible as contact details were not available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Tongue swelling; broke out in hives and Welts; Itchingvery bad itching across her hands, feet, and bottom; burning in body, hands, feet, and bottom; This case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced swollen tongue, hives, pruritus and burning sensation. The patient was treated with steroids nos (Oral Steroids), cortisone (non-proprietary) (Cortisone Cream) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the swollen tongue, hives, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the swollen tongue, hives, pruritus and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and had a bad reaction to the vaccine and had been experiencing side effects, which lasted a few months. The patient experienced tongue swelling, broke out in hives, welts, very bad itching, and burning in various areas of her body across her hands, feet, and bottom.  The patient stated that it lasted for a few months, but it subsided for a while. The patient stated that the symptoms had returned but were less severe. The patient received oral steroids, cortisone cream and Benadryl for treatment for her symptoms.  The patient was inquiring about how long these symptoms would occur and recommendations for treatment and management of symptoms. The reporter provided permission to contact healthcare professional. The reporter consented to follow-up. No additional details were provided.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: malaise /  feels like  he got hit by a bus; Body aches/he got hit by a bus; This case was reported by a consumer via call center representative and described the occurrence of malaise in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2021, less than a day after receiving Shingrix, the patient experienced malaise and general body pain. On an unknown date, the outcome of the malaise and general body pain were not recovered/not resolved.   The reporter considered the malaise and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was self-reported by the patient. The patient stated that about 10 to 12 hours post getting his 2nd Shingrix vaccine in left arm, he started with body aches and malaise.  The patient felt like got hit by a bus.  The patient also asked what he could do for these symptoms and if this was normal.  The reporter did not want to provide his full contact information. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned a female of unspecified age. 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, and batch number: unknown expiry: unknown) dose, 1 total, dose number in series 1, start therapy date were not reported 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 an unspecified date, (six or seven weeks after shot) the patient got COVID (suspected covid-19 infection and suspected clinical vaccination failure). Patient was just as sick as if patient never got the vaccine. As per reporter, "Don't be so sure about fully protected. You can still get COVID. My friend got the J&J shot and 6 or 7 weeks later she got COVID. She was just as sick as if she never got the vaccine, so be careful. Pretend you never got the shot. That way you will be diligent about staying safe." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000206783.; Sender's Comments: V0: 20211229553-Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: BLOOD CLOT; HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a 59 year old male of unknown race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that, "Second vax death in my family. My 33 year old brother died from a blood clot causing a stroke. 2 months after his 2nd pfz shot. Now my 59 year old uncle died from a blood clot causing a heart attack. 3 months after his only J&J shot. When will people realise that it's not safe?". It was unspecified if an autopsy was performed. On an unspecified date, the patient died from blood clot, and heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20211229627-Covid-19 vaccine ad26.cov2.s -Blood clot, heart attack. 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).; Reported Cause(s) of Death: BLOOD CLOT; HEART ATTACK
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER 16 HOURS STORED IN REFRIGERATION; VACCINE  STORED OUTSIDE RECOMMENDED  CONDITIONS; This spontaneous report received from a pharmacist concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced patient received vaccine after 16 hours stored in refrigeration. On 08-DEC-2021, the patient experienced vaccine stored outside recommended conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received vaccine after 16 hours stored in refrigeration and vaccine stored outside recommended conditions was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: severe refractory immune thrombocytopenia; This literature-non-study case was reported and describes the occurrence of IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Rapid response to mycophenolate mofetil in combination with romiplostim in a case of severe refractory immune thrombocytopenia post 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 IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) (seriousness criterion medically significant). The patient was treated with ROMIPLOSTIM for Immune thrombocytopenia, at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL for Immune thrombocytopenia, at an unspecified dose and frequency. At the time of the report, IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (severe refractory immune thrombocytopenia) to be related.    No concomitant information were reported.  Patient developed severe refractory ITP with multiple bleeding sites post second dose of COVID-19 vaccination.  Treatment resulted in rapid platelet count recovery.  Company comment: This literature-non-study case concerns a 25-year-old female patient with no medical history reported, who experienced unexpected event of  immune thrombocytopenia. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient developed severe refractory ITP with multiple bleeding sites, she was treated with ROMIPLOSTIM  and MYCOPHENOLATE MOFETIL at an unspecified dose and frequency. Treatment resulted in rapid platelet count recovery. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 25-year-old female patient with no medical history reported, who experienced unexpected event of  immune thrombocytopenia. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient developed severe refractory ITP with multiple bleeding sites, she was treated with ROMIPLOSTIM  and MYCOPHENOLATE MOFETIL at an unspecified dose and frequency. Treatment resulted in rapid platelet count recovery. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeding disorder, Hypoaesthesia oral, Pain in extremity
Clinical narrative: Weak; arm is very sore; lips and bottom gums are tingling; lips and bottom gums are numb; haven't ate or drank anything; arms and hands itched; Chills; FEVER; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb) and FEEDING DISORDER (haven't ate or drank anything) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb), FEEDING DISORDER (haven't ate or drank anything), PRURITUS (arms and hands itched), CHILLS (Chills), PYREXIA (FEVER) and VOMITING (throwing up). In December 2021, PRURITUS (arms and hands itched) had resolved. At the time of the report, ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb), FEEDING DISORDER (haven't ate or drank anything), CHILLS (Chills), PYREXIA (FEVER) and VOMITING (throwing up) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-408953 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Pyrexia, Vomiting
Clinical narrative: Weak; arm is very sore; lips and bottom gums are tingling; lips and bottom gums are numb; haven't ate or drank anything; arms and hands itched; Chills; FEVER; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb) and FEEDING DISORDER (haven't ate or drank anything) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb), FEEDING DISORDER (haven't ate or drank anything), PRURITUS (arms and hands itched), CHILLS (Chills), PYREXIA (FEVER) and VOMITING (throwing up). In December 2021, PRURITUS (arms and hands itched) had resolved. At the time of the report, ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb), FEEDING DISORDER (haven't ate or drank anything), CHILLS (Chills), PYREXIA (FEVER) and VOMITING (throwing up) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-408953 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chest discomfort, Cough, Dizziness
Clinical narrative: low blood pressure; chest tightness; coughing; weakness; Aches; dizziness; vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (low blood pressure), CHEST DISCOMFORT (chest tightness), COUGH (coughing), ASTHENIA (weakness) and PAIN (Aches) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 001B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included AMIODARONE, APIXABAN (ELIQUIS), FOLIC ACID, OMEPRAZOLE, POTASSIUM, PRAVASTATIN, TORSEMIDE, CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), VITAMIN B12 [VITAMIN B12 NOS], ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]) and MAGNESIUM HYDROXIDE (MILK OF MAGNESIA) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-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 HYPOTENSION (low blood pressure), CHEST DISCOMFORT (chest tightness), COUGH (coughing), ASTHENIA (weakness), PAIN (Aches), DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (Nausea). At the time of the report, HYPOTENSION (low blood pressure), CHEST DISCOMFORT (chest tightness), COUGH (coughing), ASTHENIA (weakness), PAIN (Aches), DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: results not reported (Low) Low blood pressure.         The  concomitant medications on use also include Calcium/Magnesium/Zinc Vitamin D3 (Combination drug) used for unknown indication.  No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Nausea, Pain, Vomiting
Clinical narrative: low blood pressure; chest tightness; coughing; weakness; Aches; dizziness; vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (low blood pressure), CHEST DISCOMFORT (chest tightness), COUGH (coughing), ASTHENIA (weakness) and PAIN (Aches) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 001B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included AMIODARONE, APIXABAN (ELIQUIS), FOLIC ACID, OMEPRAZOLE, POTASSIUM, PRAVASTATIN, TORSEMIDE, CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), VITAMIN B12 [VITAMIN B12 NOS], ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]) and MAGNESIUM HYDROXIDE (MILK OF MAGNESIA) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-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 HYPOTENSION (low blood pressure), CHEST DISCOMFORT (chest tightness), COUGH (coughing), ASTHENIA (weakness), PAIN (Aches), DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (Nausea). At the time of the report, HYPOTENSION (low blood pressure), CHEST DISCOMFORT (chest tightness), COUGH (coughing), ASTHENIA (weakness), PAIN (Aches), DIZZINESS (dizziness), VOMITING (vomiting) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: results not reported (Low) Low blood pressure.         The  concomitant medications on use also include Calcium/Magnesium/Zinc Vitamin D3 (Combination drug) used for unknown indication.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Insomnia, Lymphoedema, Overdose, Peripheral swelling
Clinical narrative: Received booster dose they gave me 0.5ml, they didn't give me 0.25ml; Lymphedema; Swollen arm; Bad sleep at night; Whole face is red / chest is red; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night), ERYTHEMA (Whole face is red / chest is red) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (NOS) (Had cancer twice), Autoimmune thyroid disorder and Asthma. Concomitant products included TAMOXIFEN for Cancer (NOS).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Received booster dose they gave me 0.5ml, they didn't give me 0.25ml). In December 2021, the patient experienced LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night), ERYTHEMA (Whole face is red / chest is red) and PYREXIA (Fever). On 10-Dec-2021, OVERDOSE (Received booster dose they gave me 0.5ml, they didn't give me 0.25ml) had resolved. In December 2021, PYREXIA (Fever) had resolved. At the time of the report, LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night) and ERYTHEMA (Whole face is red / chest is red) outcome was unknown.            Concomitant products used included Tamoxifen to prevent estrogen from cancer, thyroid medicines and immunomodulator.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Received booster dose they gave me 0.5ml, they didn't give me 0.25ml; Lymphedema; Swollen arm; Bad sleep at night; Whole face is red / chest is red; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night), ERYTHEMA (Whole face is red / chest is red) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (NOS) (Had cancer twice), Autoimmune thyroid disorder and Asthma. Concomitant products included TAMOXIFEN for Cancer (NOS).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Received booster dose they gave me 0.5ml, they didn't give me 0.25ml). In December 2021, the patient experienced LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night), ERYTHEMA (Whole face is red / chest is red) and PYREXIA (Fever). On 10-Dec-2021, OVERDOSE (Received booster dose they gave me 0.5ml, they didn't give me 0.25ml) had resolved. In December 2021, PYREXIA (Fever) had resolved. At the time of the report, LYMPHOEDEMA (Lymphedema), PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Bad sleep at night) and ERYTHEMA (Whole face is red / chest is red) outcome was unknown.            Concomitant products used included Tamoxifen to prevent estrogen from cancer, thyroid medicines and immunomodulator.  No treatment medication was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21H, 041L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced URTICARIA (developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw). At the time of the report, URTICARIA (developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw) outcome was unknown.            After second dose a day and a half after developed hives, covered the trunk, abdomen and back, upper leg down to the knees, neck and ears and kinda urn the jaw. It did not itch. No concomitant and treatment medications were reported.   This case was linked to MOD-2021-409888, MOD-2021-409905 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: an aftertaste in his mouth; the headache got worse despite taking Tylenol.; nausea; headache; Body soreness in his arms & legs; fever; body aches / body soreness in his arms & legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Body soreness in his arms & legs), DYSGEUSIA (an aftertaste in his mouth), HEADACHE (the headache got worse despite taking Tylenol.), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janseen & Janseen vaccine (Janssen as his primary vaccine on 10Apr2021) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with Janseen & Janseen vaccine.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PAIN IN EXTREMITY (Body soreness in his arms & legs), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs). On 12-Dec-2021, the patient experienced HEADACHE (headache). On 13-Dec-2021, the patient experienced DYSGEUSIA (an aftertaste in his mouth) and NAUSEA (nausea). 13-Dec-2021, the patient experienced HEADACHE (the headache got worse despite taking Tylenol.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 for Headache, Fever and General body pain, at a dose of every 6 Hr; PARACETAMOL (TYLENOL [PARACETAMOL]) on 12-Dec-2021 for Headache, Fever and General body pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) on 13-Dec-2021 for Headache, Fever and General body pain, at an unspecified dose and frequency. On 12-Dec-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Body soreness in his arms & legs), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs) was resolving and DYSGEUSIA (an aftertaste in his mouth), HEADACHE (the headache got worse despite taking Tylenol.) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO Concomitant drug reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: an aftertaste in his mouth; the headache got worse despite taking Tylenol.; nausea; headache; Body soreness in his arms & legs; fever; body aches / body soreness in his arms & legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Body soreness in his arms & legs), DYSGEUSIA (an aftertaste in his mouth), HEADACHE (the headache got worse despite taking Tylenol.), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janseen & Janseen vaccine (Janssen as his primary vaccine on 10Apr2021) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with Janseen & Janseen vaccine.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PAIN IN EXTREMITY (Body soreness in his arms & legs), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs). On 12-Dec-2021, the patient experienced HEADACHE (headache). On 13-Dec-2021, the patient experienced DYSGEUSIA (an aftertaste in his mouth) and NAUSEA (nausea). 13-Dec-2021, the patient experienced HEADACHE (the headache got worse despite taking Tylenol.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 for Headache, Fever and General body pain, at a dose of every 6 Hr; PARACETAMOL (TYLENOL [PARACETAMOL]) on 12-Dec-2021 for Headache, Fever and General body pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) on 13-Dec-2021 for Headache, Fever and General body pain, at an unspecified dose and frequency. On 12-Dec-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Body soreness in his arms & legs), PYREXIA (fever) and MYALGIA (body aches / body soreness in his arms & legs) was resolving and DYSGEUSIA (an aftertaste in his mouth), HEADACHE (the headache got worse despite taking Tylenol.) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO Concomitant drug reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Incorrect dose administered
Clinical narrative: Patient was upset/e patient was not happy about this; first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Patient was upset/e patient was not happy about this) and INCORRECT DOSE ADMINISTERED (first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ANXIETY (Patient was upset/e patient was not happy about this) and INCORRECT DOSE ADMINISTERED (first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose). At the time of the report, ANXIETY (Patient was upset/e patient was not happy about this) outcome was unknown and INCORRECT DOSE ADMINISTERED (first dose of Moderna but a 0.25 mL,Two boosters given as a primary dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient came in to get the first dose of Moderna but a 0.25 mL booster dose and HCP again give a second 0.25 mL booster dose was given to make a total 0.5 mL and patient was not happy about this, but was not experiencing any side effects.   No Concomitant product use was reported. No treatment information was provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 4 doses of Covid Vaccine, 2 different manufacturer.; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 4 doses of Covid Vaccine, 2 different manufacturer.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astra Zeneca (Patient received two doses of vaccine in fall 2020 as part of the Astra Zeneca trial) in 2020. Past adverse reactions to the above products included No adverse event with Astra Zeneca.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 4 doses of Covid Vaccine, 2 different manufacturer.). In March 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 4 doses of Covid Vaccine, 2 different manufacturer.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Patient  was not sure which arm of the AZ trial he was in at that time, so opted to receive Moderna Patient found out later that he had received active AZ vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 104.5 after booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever of 104.5 after booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 104.5 after booster shot). At the time of the report, PYREXIA (Fever of 104.5 after booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.5 (High) 104.5 degree fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Vaccination site pain
Clinical narrative: 24 hours later the patient was sweaty; did not get a good nights sleep/Tossed and Turned; Sore left arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (24 hours later the patient was sweaty), INSOMNIA (did not get a good nights sleep/Tossed and Turned) and VACCINATION SITE PAIN (Sore left arm for 3 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Bronchitis.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), NIFEDIPINE, RABEPRAZOLE SODIUM (ACIPHEX), HYOSCYAMINE SULFATE (LEVSINEX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm for 3 days). On 09-Feb-2021, the patient experienced HYPERHIDROSIS (24 hours later the patient was sweaty) and INSOMNIA (did not get a good nights sleep/Tossed and Turned). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 10-Feb-2021, VACCINATION SITE PAIN (Sore left arm for 3 days) had resolved. At the time of the report, HYPERHIDROSIS (24 hours later the patient was sweaty) and INSOMNIA (did not get a good nights sleep/Tossed and Turned) outcome was unknown.      This case was linked to MOD-2021-410038, MOD-2021-410019 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Erythema, Feeling hot, Rash erythematous
Clinical narrative: hot to the touch; weak; little red; dizzy; covid arm; red rash on the side of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), FEELING HOT (hot to the touch), ASTHENIA (weak) and ERYTHEMA (little red) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING HOT (hot to the touch). In February 2021, the patient experienced VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), ASTHENIA (weak), ERYTHEMA (little red) and DIZZINESS (dizzy). On 18-Feb-2021, FEELING HOT (hot to the touch) had resolved. At the time of the report, VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), ASTHENIA (weak), ERYTHEMA (little red) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown.   This case was linked to MOD-2021-410109 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: hot to the touch; weak; little red; dizzy; covid arm; red rash on the side of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), FEELING HOT (hot to the touch), ASTHENIA (weak) and ERYTHEMA (little red) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING HOT (hot to the touch). In February 2021, the patient experienced VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), ASTHENIA (weak), ERYTHEMA (little red) and DIZZINESS (dizzy). On 18-Feb-2021, FEELING HOT (hot to the touch) had resolved. At the time of the report, VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on the side of arm), ASTHENIA (weak), ERYTHEMA (little red) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown.   This case was linked to MOD-2021-410109 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Feeling abnormal, Pyrexia, Vaccination complication
Clinical narrative: pressure in chest; a reaction; solid 55 hours it was awful; 103.8 fever that wouldn't break/fever was still high; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction), FEELING ABNORMAL (solid 55 hours it was awful) and PYREXIA (103.8 fever that wouldn't break/fever was still high) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-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 CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction), FEELING ABNORMAL (solid 55 hours it was awful) and PYREXIA (103.8 fever that wouldn't break/fever was still high). At the time of the report, CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction) and FEELING ABNORMAL (solid 55 hours it was awful) outcome was unknown and PYREXIA (103.8 fever that wouldn't break/fever was still high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High. On an unknown date, X-ray: result not reported (Inconclusive) Result not reported (2 X-rays).         Concomitant medication include blood pressure medication.  Patient reported after IV, and 2 X-rays her fever was still high, they gave her meds and in 10 hours she was fine. Treatment included extra strength Tylenol.   This case was linked to MOD-2021-410125, MOD-2021-410145 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: pressure in chest; a reaction; solid 55 hours it was awful; 103.8 fever that wouldn't break/fever was still high; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction), FEELING ABNORMAL (solid 55 hours it was awful) and PYREXIA (103.8 fever that wouldn't break/fever was still high) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-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 CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction), FEELING ABNORMAL (solid 55 hours it was awful) and PYREXIA (103.8 fever that wouldn't break/fever was still high). At the time of the report, CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction) and FEELING ABNORMAL (solid 55 hours it was awful) outcome was unknown and PYREXIA (103.8 fever that wouldn't break/fever was still high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High. On an unknown date, X-ray: result not reported (Inconclusive) Result not reported (2 X-rays).         Concomitant medication include blood pressure medication.  Patient reported after IV, and 2 X-rays her fever was still high, they gave her meds and in 10 hours she was fine. Treatment included extra strength Tylenol.   This case was linked to MOD-2021-410125, MOD-2021-410145 (Patient Link).