chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bowel movement irregularity, Chest pain, Constipation, Dyspepsia, Dyspnoea
Clinical narrative: Pericarditis and Myocarditis: still persistent  Muscle pains, pain in fingertips responding to touch, limited blood flow (cold limbs) , chest pains, difficulty/painful breathing, digestive system slowed/improper bowel movements, constipation
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Myocarditis, Pain in extremity, Painful respiration, Pericarditis
Clinical narrative: Pericarditis and Myocarditis: still persistent  Muscle pains, pain in fingertips responding to touch, limited blood flow (cold limbs) , chest pains, difficulty/painful breathing, digestive system slowed/improper bowel movements, constipation
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness
Clinical narrative: Pericarditis and Myocarditis: still persistent  Muscle pains, pain in fingertips responding to touch, limited blood flow (cold limbs) , chest pains, difficulty/painful breathing, digestive system slowed/improper bowel movements, constipation
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-423971 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non significant follow up
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Laboratory test, Mycoplasma test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; UNABLE TO SLEEP LYING DOWN AND HAD TO SIT IN BED TO  SLEEP; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included: bilateral pneumonia, and concurrent conditions included: asthma, non smoker, and abstains from alcohol, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 07-APR-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 20-DEC-2021, the patient experienced confirmed clinical vaccination failure. The patient experienced very bad symptoms that started on (monday) 20-DEC-2021: difficulty breathing, fever of 101.9 F, could not sleep down and had to sit in bed to sleep, headaches and body aches and went to Emergency room on same day. On 20-DEC-2021 Laboratory data included: Body temperature (NR: not provided) 101.9 F, Influenza A virus test (NR: not provided) Not reported., Influenza B virus test (NR: not provided) Not reported., Laboratory test (NR: not provided) Not reported., and Mycoplasma test (NR: not provided) Not reported. The doctors said that it was probably related to history of asthma and was discharged home with treatment medications dextromethorphan hydrobromide/promethazine hydrochloride, and prednisolone.  The patient stated that symptoms were getting worse, and went to emergency room again on 22-DEC-2021, there laboratory data included: Chest X-ray (NR: not provided). Physicians stated that lungs were very inflamed but no liquid present, so they ruled out pneumonia. Treatment medications included: dexamethasone. On 23-DEC-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The patient stated that difficulty breathing and the fact he needs to sit up to sleep are still present until 25-DEC-2021. Fever, body aches and headache gone since 23-DEC-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and unable to sleep lying down and had to sit in bed to sleep, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208727.; Sender's Comments: V0. 20211256656-Covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination 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
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain, Pain in extremity, Pruritus, Rash macular
Clinical narrative: arm soreness; feeling achy; blisters on his hands and arms; Itching; red splotches on the back of his right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th December 2021, 3 days after receiving Shingrix, the patient experienced pain in arm, pain, blister, pruritus and red blotches. On an unknown date, the outcome of the pain in arm, pain, blister, pruritus and red blotches were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, pain, blister, pruritus and red blotches to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and about 3 days later experienced arm soreness and felt achy. The patient also experienced blisters on his hands and arms that caused itching and red splotches on the back of his right arm.  The above symptoms had not resolved. The patient asked GlaxoSmithKline if this was a common reaction and if it was okay to receive the second dose. No lot number or expiration date was provided. Provided medical disclaimer and referred him to his HCP.  The reporter consented to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: VERY MILD BREAKTHROUGH CASE OF COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age and race. 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 (dose number in series was 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on an unspecified date of APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date of AUG-2021, the patient experienced very mild breakthrough case of covid, and had suspected clinical vaccination failure. As per the reporter "I had the Johnson and Johnson vaccine in April of 2021. I had a very mild breakthrough case of Covid in August of 2021. Now I need the Booster. I am being told not to get the JNJ booster but to get one of the mRNA (messenger ribonucleic acid) boosters. What should I get". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild breakthrough case of covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC) 90000208725.; Sender's Comments: V0: 20211255562-COVID-19 VACCINE AD26.COV2.S- Very mild breakthrough case of Covid. This event is considered unassessable. The event 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. 20211255562-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
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 parent via social media via a company representative 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 (dose number in series-1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, 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, the patient got sick, and covid (suspected covid-19 infection, suspected clinical vaccination failure). The reporter stated, "I believe that vaccine affected my daughter, she's sick alot since, and got covid anyhow".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208729.; Sender's Comments: V0- 20211256165-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (A little dizzy and feel really dizzy now,afraid to get up) and COUGH (Coughing a lot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 025B21A and 045B21A) for COVID-19 vaccination. The patient's past medical history included Breast cancer. Concurrent medical conditions included Lymphedema, Asthma, Cholesterol, Thrombosis and Blood pressure high.Concomitant products included OMALIZUMAB (XOLAIR) for Asthma, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Thrombus, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced DIZZINESS (A little dizzy and feel really dizzy now,afraid to get up) and COUGH (Coughing a lot). At the time of the report, DIZZINESS (A little dizzy and feel really dizzy now,afraid to get up) and COUGH (Coughing a lot) had not resolved.The patient got the 2 vaccines from Moderna back in April and May 2021 and had no side effects. The patient got the Moderna booster on 29-Nov-2021 and ton 30-Nov-2021 morning was feeling a little dizzy, and it was getting worse, they almost fell over, and were also coughing a lot. They stated they felt really dizzy now and were afraid to get up.The patient also reported they had asthma since they were 18 and had 2 shot of Xolair for it every 2 weeks and has got one 6 days ago. It was also reported that the patient had lymphedema on their left arm from having breast cancer twice. Other concomitant medication reported were high blood pressure medication, cholesterol medication, lymphedema medication, 2 inhalers for asthma every morning.No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Infection, Scar, Skin ulcer
Clinical narrative: scarring on the right hand; Open sores/there are no more open sores on the hand./legs are still covered with what looks like small ulcers; Blister starts; Infection/infection comes back again if they are open and has scabs over it; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scarring on the right hand), SKIN ULCER (Open sores/there are no more open sores on the hand./legs are still covered with what looks like small ulcers), BLISTER (Blister starts) and INFECTION (Infection/infection comes back again if they are open and has scabs over it) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and METOPROLOL for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCAR (scarring on the right hand), SKIN ULCER (Open sores/there are no more open sores on the hand./legs are still covered with what looks like small ulcers), BLISTER (Blister starts) and INFECTION (Infection/infection comes back again if they are open and has scabs over it). The patient was treated with CEFTRIAXONE (CEFTIN [CEFTRIAXONE]) at an unspecified dose and frequency and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at an unspecified dose and frequency. At the time of the report, SCAR (scarring on the right hand), SKIN ULCER (Open sores/there are no more open sores on the hand./legs are still covered with what looks like small ulcers), BLISTER (Blister starts) and INFECTION (Infection/infection comes back again if they are open and has scabs over it) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications include Adderall and metoprolol(Toprol)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Nasal congestion, Night sweats, Oropharyngeal pain
Clinical narrative: Night sweats/Woke up in the middle of the night just drenched; Woke up in the middle of the night just drenched; sore throat; Congested; Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (Congested), NIGHT SWEATS (Night sweats/Woke up in the middle of the night just drenched), HYPERHIDROSIS (Woke up in the middle of the night just drenched) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose) in a 54-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: Pfizer covid -19 vaccine (primary series dose of the Pfizer covid-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer covid -19 vaccine.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose). On 10-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (Congested). On an unknown date, the patient experienced NIGHT SWEATS (Night sweats/Woke up in the middle of the night just drenched) and HYPERHIDROSIS (Woke up in the middle of the night just drenched). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 23-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a primary series dose of the Pfizer covid-19 vaccine, then received a booster dose) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (Congested), NIGHT SWEATS (Night sweats/Woke up in the middle of the night just drenched) and HYPERHIDROSIS (Woke up in the middle of the night just drenched) outcome was unknown.            No concomitant medication were provided.  Patient was driving and had a sore throat, and became very congested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old was inadvertently given the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently given the Moderna COVID-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently given the Moderna COVID-19 vaccine). On 17-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently given the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient was not experiencing any symptoms
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 31-Aug-2021 and vaccine was administered on 07-Sep-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 31-Aug-2021 and vaccine was administered on 07-Sep-2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. Concurrent medical conditions included Fish allergy, Diabetes mellitus (No recent change in status of chronic condition.), Smoker (No recent change in status of chronic condition.), Hypertriglyceridemia (No recent change in status of chronic condition.), Depression (No recent change in status of chronic condition.) and GERD (No recent change in status of chronic condition.)Concomitant products included GLIPIZIDE, OMEPRAZOLE, FLUOXETINE, METFORMIN and PRAVASTATIN for an unknown indication.On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 31-Aug-2021 and vaccine was administered on 07-Sep-2021). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 31-Aug-2021 and vaccine was administered on 07-Sep-2021) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications information was reported.No acute illnesses at the time of vaccination and up to one month before.The patient had not been diagnosed with tested positive for COVID-19. There was no adverse reaction.There was no temperature excursion.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rhinorrhoea, Vaccination site pain, Wheezing
Clinical narrative: Runny nose; Extremely mild wheezing; Very tired; sore arm (left arm) where he got injected; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), WHEEZING (Extremely mild wheezing), FATIGUE (Very tired) and VACCINATION SITE PAIN (sore arm (left arm) where he got injected) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 940877) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (he had an allergic reaction that presented in the form of an asthmatic reaction.). Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Second dose) in June 2021 and PFIZER BIONTECH COVID-19 VACCINE (First dose) in June 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Rhinitis, Nasal allergy and Dust allergy (He is allergic to concentrated dust, such as on top of curtains that hasn't been changed for years.).    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced RHINORRHOEA (Runny nose), WHEEZING (Extremely mild wheezing), FATIGUE (Very tired) and VACCINATION SITE PAIN (sore arm (left arm) where he got injected). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose), WHEEZING (Extremely mild wheezing), FATIGUE (Very tired) and VACCINATION SITE PAIN (sore arm (left arm) where he got injected) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details also included rhinitis medication.  Reporter stated that under very rare circumstances the patient had an allergic reaction that presented in the form of an asthmatic reaction. The second asthmatic allergic reaction was when he took sulfa, but he was not sure if that was necessarily asthma or just skin reaction.  It was reported that this is an extremely low allergic reaction, He senses that the wheezing is dissipating already. If it started as a level 5, it has come down to 3 or 4 already, and he thinks it'll continue to drop. He has actually taken 3 "shots" of the albuterol inhaler that he has for emergency reactions.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Follow-up received contains no new information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose from vial puncture more than 12 hours before administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose from vial puncture more than 12 hours before administration) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose from vial puncture more than 12 hours before administration). On 24-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered expired dose from vial puncture more than 12 hours before administration) 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. The vial was initially stored in the refrigerator on 23DEC2021. The  vial was first punctured on 23DEC2021 at  11:00AM and after post puncture vial was stored in refrigerator.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Problem with his knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Problem with his knee) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ARTHRALGIA (Problem with his knee). At the time of the report, ARTHRALGIA (Problem with his knee) outcome was unknown.            No concomitant medications were reported.  Not  taken any treatment at the time of reporting. It was reported that the patient will be seeing his doctor on 23 Mar 2021 for a problem with his knee and expects to receive a steroid injection.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet; Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet; Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet), PRURITUS (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet) and RASH (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet), PRURITUS (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet) and RASH (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet), PRURITUS (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet) and RASH (Contracted skin rash/itches/hives appears and goes anywhere on the body ,mostly  arms, upper body, palms and feet) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Treatment activities for event was also done with anti itch cream and it helped. The events had been ongoing for two weeks.
Sex: F
Vaccine: COVID19
Symptoms: Myositis, Pain
Clinical narrative: Myositis; Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOSITIS (Myositis) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 MYOSITIS (Myositis) and PAIN (Pain). At the time of the report, MYOSITIS (Myositis) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-426881, MOD-2021-426900, MOD-2021-426905 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Migraine, Pain
Clinical narrative: migraine; body aches; feeling sick; joint pains; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains) and CHILLS (chills) 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.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse effect with JANSSEN COVID-19 VACCINE.    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 MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (fever). At the time of the report, MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant and treatment products were reported. It was reported the Moderna vaccine was full some toxic. The patient had initially Johnsonand Johnson with zero problem. The patient got booster dose and experienced body aches, migraine, fever, chill and joint pain.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: migraine; body aches; feeling sick; joint pains; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains) and CHILLS (chills) 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.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse effect with JANSSEN COVID-19 VACCINE.    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 MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (fever). At the time of the report, MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant and treatment products were reported. It was reported the Moderna vaccine was full some toxic. The patient had initially Johnsonand Johnson with zero problem. The patient got booster dose and experienced body aches, migraine, fever, chill and joint pain.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse effect of the Moderna booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect of the Moderna booster vaccine) 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 VACCINATION COMPLICATION (adverse effect of the Moderna booster vaccine). At the time of the report, VACCINATION COMPLICATION (adverse effect of the Moderna booster vaccine) outcome was unknown.            Patient reported an adverse effect of the Moderna booster vaccine. No concomitant medication were provided. No treatment information were given.
Age: 74.0
Sex: F
Vaccine: HEP
Symptoms: Ataxia, Dysarthria, Facial paralysis, Memory impairment
Clinical narrative: Questionable minor CVA/TIA.  Ataxia, slurring of words, drooping left lower lip that wasn't there prior to vaccine, and memory deficits x 72 hrs. Drooping left lower lip persists. All over symptoms gone
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Chills Left arm pain
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: varicella-type rash; fever; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unspecified age. The pt's concurrent conditions, concomitant medications and medical history were unknown. On or around 06-JAN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, rout of administration, lot# and expire date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 09-JAN-2015 (reported as three days after receiving zoster vaccine live (ZOSTAVAX) vaccine), she suffered fever and a rash on her upper right arm and was diagnosed with a varicella-type rash. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of fever and varicella-type rash was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events of fever and varicella-type rash were considered as disabled by the lawyer.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Crying, Herpes zoster, Pain, Rash, Scar
Clinical narrative: I had it, I got both shots/suspected vaccination failure; I had it on my back and chest,; pain was terrible, like someone threw a pot of grits on me, I cried; terrible scars; Rash; cried like a baby for a month it looked like someone; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, scar, crying and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, crying and rash were recovered/resolved and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, scar, crying and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles on back and chest.  The pain was terrible and he/she cried like a baby for a month they looked like someone threw a pot of grits on the patient. Shingles recovered within a month.  The patient experienced shingles again, refer case US2021AMR261359 second outbreak. The patient's doctor said the patient was a carrier of the virus and event after getting both shots, the patient would get the rash as if the patient had got shingles always. It left the patient with terrible scars. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR261359:2nd outbreak
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: I had it, I got both shots/suspected vaccination failure; I had it on my back and chest,; pain was terrible, like someone threw a pot of grits on me, I cried; terrible scars; Rash; cried like a baby for a month it looked like someone; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, scar, crying and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, crying and rash were recovered/resolved and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, scar, crying and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles on back and chest.  The pain was terrible and he/she cried like a baby for a month they looked like someone threw a pot of grits on the patient. Shingles recovered within a month.  The patient experienced shingles again, refer case US2021AMR261359 second outbreak. The patient's doctor said the patient was a carrier of the virus and event after getting both shots, the patient would get the rash as if the patient had got shingles always. It left the patient with terrible scars. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR261359:2nd outbreak
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race, and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 07-APR-2021, the patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, (Dose number in series 1), 1 in total, for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-DEC-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. On an unspecified date, following vaccination with covid-19 vaccine, the patient experienced mild case with congestion, headache, mild fever (confirmed covid-19 infection) and confirmed clinical vaccination failure (dose number in series 1). The action taken with covid-19 vaccine was not applicable. The patient did not recover from confirmed covid-19 infection. The outcome of the confirmed clinical vaccination failure was unknown. On 25-OCT-2021, the patient received booster dose non-company vaccine mRNA 1273 (form of admin, route of admin, and batch number were not reported) dose was not reported (dose number in series 2), for prophylactic vaccination. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000207466.; Sender's Comments: V0: 20211237695-covid-19 vaccine confirmed clinical vaccination 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: Thrombosis
Clinical narrative: This spontaneous report received from a consumer via social media a company representative concerned a male of unspecified age, race, and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (suspension for injection, route of admin and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine. The patient received booster of covid-19 vaccine (suspension for injection, route of admin and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots (Dose number in series 1). The reporter stated that her son-in-law had to take both J and J covid jabs and he then developed blood clots. She also stated that he was healthy but forced to take the shot and now he was not the same.  The action taken with covid-19 vaccine was not applicable. The outcome of the blood clots was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211249099-covid-19 vaccine blood clots. 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: COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female patient of unspecified age, 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 (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) (dose number in series was 1), 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the "patient got covid-19 and suspected clinical vaccination failure (dose number in series was 1) and patient received treatment medications (dates unspecified) included: ivermectin, ascorbic acid, zethrimician, colecalciferol, hydroxychloroquine and monoclonal iv (intravenous)". The action taken with covid-19 vaccine s was not applicable. The outcome of covid-19 and suspected clinical vaccination failure was not reported (dose number in series was 1). This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208210.; Sender's Comments: V0:20211251654-covid-19 vaccine suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20211251654-covid-19 vaccine covid-19. 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).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Tenderness, Vaccination complication
Clinical narrative: A lot of side effects/felt like covid; Arm tenderness; Feeling dreadful for a weekend; Horrible headache; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A lot of side effects/felt like covid), TENDERNESS (Arm tenderness), FEELING ABNORMAL (Feeling dreadful for a weekend), HEADACHE (Horrible headache) and FATIGUE (Exhaustion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (A lot of side effects/felt like covid), TENDERNESS (Arm tenderness), FEELING ABNORMAL (Feeling dreadful for a weekend), HEADACHE (Horrible headache) and FATIGUE (Exhaustion). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. In 2021, FEELING ABNORMAL (Feeling dreadful for a weekend) and FATIGUE (Exhaustion) had resolved. At the time of the report, VACCINATION COMPLICATION (A lot of side effects/felt like covid), TENDERNESS (Arm tenderness) and HEADACHE (Horrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product used for birth control. The patient received the vaccine in left side and experienced the longest and worst side effects with the first dose, exhaustion and feeling dreadful for a weekend.   This case was linked to MOD-2021-426900, MOD-2021-426905, MOD-2021-426691 (Patient Link).