chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, Extra dose administered, SARS-CoV-2 antibody test
Clinical narrative: ANTIBODY LEVELS WERE DOWN; RECEIVED 2 SHOTS OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced antibody levels were down, and received 2 shots of the janssen covid-19 vaccine. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) antibody levels were down. The action taken with covid-19 vaccine was not applicable. The outcome of the antibody levels were down and received 2 shots of the janssen covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000193034 The suspected product quality complaint has been confirmed to be voided based on the evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; ALL OF THE OUTLINE SYMPTOMS OF THE WARNING OF THE PAMPHLET ON THE FIRST PAGE OF DESCRIPTION OF COVID 19; SEVERE PAIN AND SCARED THEY ARE GOING TO DIE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer via a company representative via legal source concerned multiple patients of unspecified age, race and ethnic origin.  The patient's weight, height, and medical history were not reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose not reported, frequency time 1 total for prophylactic vaccination on an unspecified date. No concomitant medications were reported. On 10-JUL-2021, the patients experienced flu like symptoms. On an unspecified date, the patients experienced severe pain and scared they are going to die, cannot smell or taste, suspected clinical vaccine failure, and all the outline symptoms of the warning of the pamphlet on the first page of description of covid 19. The patients were quarantine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, severe pain and scared they are going to die, all of the outline symptoms of the warning of the pamphlet on the first page of description of covid 19 and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a RA: 90000192993. The suspected has been confirmed to be voided (did not meet criteria as reported complaints were adverse events) based on the evaluation/investigation performed. This case, from the same reporter is linked to 20210920740.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year  female. The patient's height, and weight were not reported. The patient's past medical history included: liver issue, and concurrent conditions included: non alcohol user, and social smoker (smokes once a while), and other pre-existing medical conditions included: Patient had no known allergies and patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1802070, and expiry: unknown) dose was not reported, 1 total administered on 11-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On around 15-AUG-2021, patient tested negative for antibody test. On 15-SEP-2021, patient again tested negative for covid-19 antibody rapid point of care (POC) test and type was immunoglobulin G(IgG)/immunoglobulin M(IgM) and had confirmed immunological vaccine failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193491. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210928925-Covid-19 vaccine ad26.cov2.s-Confirmed immunological 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: Death, Respiratory disorder, Septic shock, Vaccination complication
Clinical narrative: REACTION ASSOCIATED WITH VACCINE; SEPTIC SHOCK; RESPIRATORY ILLNESS; PASSED AWAY; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 16-SEP-2021. The patient's height, and weight were not reported. The patient was completely healthy before taking the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On 05-JUL-2021, the patient was admitted to hospital with a respiratory illness, within hours he went into septic shock and was admitted to the Intensive Care Unit (ICU) on a ventilator. After more than nine weeks the patient was still in the ICU on a ventilator and he had shown some signs of improvement. The cause of his severe illness was determined to be a reaction associated with the vaccine that he received a week earlier. On an unspecified date in SEP-2021, the patient had passed away from an unknown cause of death. It was unknown if an autopsy was performed. The duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from respiratory illness, septic shock, and reaction associated with vaccine. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0;- 20210931824-covid-19 vaccine ad26.cov2. s- Passed away, Respiratory illness, Septic shock, and Reaction associated with vaccine. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: MEDICATION ERROR (RECEIVED JANSSEN COVID-19 VACCINE AFTER 1ST DOSE  OF THE MODERNA VACCINE); This spontaneous report received from a pharmacist concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 16-SEP-2021, the patient experienced medication error (received janssen covid-19 vaccine after 1st dose of the moderna vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error (received janssen covid-19 vaccine after 1st dose of the moderna vaccine) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Parosmia
Clinical narrative: ALTERED SMELL SENSATION (SMELLED SMOKE FOR 3 DAYS); SHARP PAIN DOWN THE MIDDLE OF HEAD DOWN INTO FOREHEAD LIKE A BRIGHT WHITE LIGHT WHICH WAS SIMILAR TO A STROKE AND HEADACHE; This spontaneous report received from a patient 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, intramuscular, batch number: Unknown) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced altered smell sensation (smelled smoke for 3 days), and sharp pain down the middle of head down into forehead like a bright white light which was similar to a stroke and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sharp pain down the middle of head down into forehead like a bright white light which was similar to a stroke and headache and altered smell sensation (smelled smoke for 3 days) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal rigidity, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: STOMACH SPASM; NAUSEA; FEVER; TIREDNESS; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced fever. On 10-SEP-2021, the patient experienced tiredness. On 10-SEP-2021, the patient experienced muscle ache. On 12-SEP-2021, the patient experienced stomach spasm. On 12-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from nausea, and stomach spasm, and the outcome of fever, tiredness and muscle ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: FATIGUE; NAUSEA; MYALGIA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced fatigue, nausea, and myalgia. The action taken with covid-19 vaccine was not applicable. The outcome of the fatigue, nausea and myalgia was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Dyspnoea, Lung disorder, Pyrexia
Clinical narrative: LUNG ISSUES; DIFFICULTY BREATHING AND CANT GET A FULL BREATH IN; A REACTION THATS PRETTY TYPICAL FOR SOME WITH THE  EXCEPTION; HIGH FEVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known drug allergies and drug abuse and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: J9J202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced a reaction that is pretty typical for some with the exception. On SEP-2021, the patient experienced high fever. On 09-SEP-2021, the patient experienced lung issues. On 09-SEP-2021, the patient experienced difficulty breathing and cant get a full breath in. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing and cant get a full breath in, and the outcome of lung issues, high fever and a reaction that is pretty typical for some with the exception was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Dizziness, Headache, Insomnia, Malaise
Clinical narrative: KEPT HER UP ALL NIGHT; DIZZY; WANTED TO BE NEAR THE TOILET; FELT SICK; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced kept her up all night, dizzy, wanted to be near the toilet, felt sick, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kept her up all night, felt sick, dizzy, headache and wanted to be near the toilet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: HAS BEEN SICK FOR 2  WEEKS; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 experienced has been sick for 2 weeks. The action taken with covid-19 vaccine was not applicable. The outcome of has been sick for 2 weeks was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS REACTION IN THE ARM; This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type ii diabetes. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness reaction in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness reaction in the arm. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Influenza like illness, Pain, Pain in extremity
Clinical narrative: SCAR/KELOID PAIN; SHOULDERS AND ARMS BURNING; SHOULDERS AND ARMS STABBING; FLU LIKE SYMPTOMS; SEVERE PAIN IN ARM; JOINT PAIN/ SEVERE PAIN IN SHOULDERS; SHOULDERS AND ARMS TINGLING; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stomach cancer, surgeries, and wounds, and other pre-existing medical conditions included: Patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced scar/keloid pain. On MAR-2021, the patient experienced shoulders and arms burning. On MAR-2021, the patient experienced shoulders and arms stabbing. On MAR-2021, the patient experienced flu like symptoms. On MAR-2021, the patient experienced severe pain in arm. On MAR-2021, the patient experienced joint pain/ severe pain in shoulders. On MAR-2021, the patient experienced shoulders and arms tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, and had not recovered from severe pain in arm, joint pain/ severe pain in shoulders, scar/keloid pain, shoulders and arms tingling, shoulders and arms burning, and shoulders and arms stabbing. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Scar pain
Clinical narrative: SCAR/KELOID PAIN; SHOULDERS AND ARMS BURNING; SHOULDERS AND ARMS STABBING; FLU LIKE SYMPTOMS; SEVERE PAIN IN ARM; JOINT PAIN/ SEVERE PAIN IN SHOULDERS; SHOULDERS AND ARMS TINGLING; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stomach cancer, surgeries, and wounds, and other pre-existing medical conditions included: Patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced scar/keloid pain. On MAR-2021, the patient experienced shoulders and arms burning. On MAR-2021, the patient experienced shoulders and arms stabbing. On MAR-2021, the patient experienced flu like symptoms. On MAR-2021, the patient experienced severe pain in arm. On MAR-2021, the patient experienced joint pain/ severe pain in shoulders. On MAR-2021, the patient experienced shoulders and arms tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, and had not recovered from severe pain in arm, joint pain/ severe pain in shoulders, scar/keloid pain, shoulders and arms tingling, shoulders and arms burning, and shoulders and arms stabbing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury, Sensory disturbance
Clinical narrative: NERVE DAMAGE TO THAT ARM; FELT LIKE IT WAS FALLING OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 experienced nerve damage to that arm, and felt like it was falling off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nerve damage to that arm and felt like it was falling off was not reported. This report was non-serious.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-SEP-2021, the patient experienced off label use. On 17-SEP-2021, the patient experienced drug administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and drug administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: SHOULDER PAIN; BICEPS PAIN; INJECTION SITE TENDERNESS AND INJECTION SITE STINGING; PAIN IN BOTH ARM; This spontaneous report received from a patient concerned a 59 year old male. 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 not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced pain in both arm. On 14-JUN-2021, the patient experienced injection site tenderness and injection site stinging. On 27-JUN-2021, the patient experienced shoulder pain. On 27-JUN-2021, the patient experienced biceps pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site tenderness and injection site stinging on 15-JUN-2021, and had not recovered from shoulder pain, biceps pain, and pain in both arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site mass
Clinical narrative: LUMPS AT SITE OF INJECTION; INFLAMMATION AT SITE OF INJECTION; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lumps at site of injection, and inflammation at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lumps at site of injection and inflammation at site of injection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced incorrect product storage. On 10-SEP-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Skin wrinkling, Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC EFFECT; WRINKLED SKIN; SKIN DRIED UP; This spontaneous report received from a patient concerned a 78 year old male. The patient's weight was 230 pounds, and height was 70 inches. The patient's past medical history included: polymyalgia rheumatica, two stent for mild heart attack, and lump on the thigh that would also swell and leak blood, and concurrent conditions included: cyst/lump and it would swell and leak, temporal arteritis, legally blind in right eye, alcoholic, and smoker, and other pre-existing medical conditions included: The patient had not changed anything in his life such as food intake. The patient experienced drug allergy when treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 06-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced unexpected therapeutic effect. On JUL-2021, the patient experienced wrinkled skin. On JUL-2021, the patient experienced skin dried up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unexpected therapeutic effect, wrinkled skin and skin dried up was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Insomnia, Pain
Clinical narrative: BODY ACHES; SHORTNESS OF BREATH; TIREDNESS; SWEATY AROUND HIS NECK AREA, PERSPIRING  FROM BACK AND SHOULDER AREA, FELT WATER COMING THROUGH THE BACK; WAKING UP IN THE MORNING; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient has been working outdoor for many year, he was not one of those people that sweat that much, he never experienced such events before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-SEP-2021, the patient experienced sweaty around his neck area, perspiring from back and shoulder area, felt water coming through the back. On 07-SEP-2021, the patient experienced waking up in the morning. On an unspecified date, the patient experienced body aches, shortness of breath, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shortness of breath, and tiredness, and had not recovered from sweaty around his neck area, perspiring from back and shoulder area, felt water coming through the back, and waking up in the morning. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Dyspnoea, Feeling abnormal, Paraesthesia
Clinical narrative: SHORTNESS OF BREATH; BURNING SENSATION IN BOTH ARMS AND LEGS; TINGLING IN BOTH ARMS AND LEGS; FOGGY FEELING; ANXIETY; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced anxiety. On 08-SEP-2021, the patient experienced foggy feeling. On 13-SEP-2021, the patient experienced shortness of breath. On 13-SEP-2021, the patient experienced burning sensation in both arms and legs. On 13-SEP-2021, the patient experienced tingling in both arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from foggy feeling, had not recovered from tingling in both arms and legs, and the outcome of shortness of breath, burning sensation in both arms and legs and anxiety was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: SWEATING; PAIN IN LEFT LEG; This spontaneous report received from a consumer concerned a male 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating and pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating and pain in left leg was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Gait disturbance
Clinical narrative: DIFFICULTY WALKING; CONDITION SEEMS TO BE WORSENING; MAJOR FATIGUE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced difficulty walking, condition seems to be worsening, and major fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the major fatigue, difficulty walking and condition seems to be worsening was not reported. This report was non-serious. This case, from the same reporter is linked to 20210935247.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysgeusia, Dysphonia, Paraesthesia oral
Clinical narrative: METALLIC TASTE; HOARSE; CLEAR THROAT; CHILLS; MOUTH TINGLING; FEVER 103 DEGREES; SWOLLEN TONGUE; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, the patient experienced swollen tongue. On an unspecified date, the patient experienced metallic taste, hoarse, clear throat, chills, mouth tingling, and fever 103 degrees. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen tongue on 20-AUG-2021, and the outcome of metallic taste, hoarse, clear throat, mouth tingling, fever 103 degrees and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal disorder, Pyrexia, Swollen tongue
Clinical narrative: METALLIC TASTE; HOARSE; CLEAR THROAT; CHILLS; MOUTH TINGLING; FEVER 103 DEGREES; SWOLLEN TONGUE; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, the patient experienced swollen tongue. On an unspecified date, the patient experienced metallic taste, hoarse, clear throat, chills, mouth tingling, and fever 103 degrees. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen tongue on 20-AUG-2021, and the outcome of metallic taste, hoarse, clear throat, mouth tingling, fever 103 degrees and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: DIFFICULTY WALKING; MAJOR FATIGUE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reportedly was very healthy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced difficulty walking, and major fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from major fatigue, and difficulty walking. This report was non-serious. This case, from the same reporter is linked to 20210935204.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: SLEEP AFTER GETTING VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sleep after getting vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sleep after getting vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Pruritus
Clinical narrative: ENTIRE FACE PUFFY; LIPS SWOLLEN; JAWLINE ITCHY AND TENDER; UPPER LEFT ARM STARTED TO ACHE A BIT; GLANDS UNDER JAW STARTED TO SWELL; SCATTERED HIVES THAT ITCHED LIKE MADNESS INCLUDING A FEW ON FACE AND LIPS; THROAT STARTED TO HURT, SORE THROAT THAT FEELS LIKE SWALLOWING SHARDS OF GLASS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 10:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced throat started to hurt, sore throat that feels like swallowing shards of glass. On 16-SEP-2021, the patient experienced upper left arm started to ache a bit. On 16-SEP-2021, the patient experienced glands under jaw started to swell. On 16-SEP-2021, the patient experienced scattered hives that itched like madness including a few on face and lips. On 17-SEP-2021, the patient experienced entire face puffy. On 17-SEP-2021, the patient experienced lips swollen. On 17-SEP-2021, the patient experienced jawline itchy and tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throat started to hurt, sore throat that feels like swallowing shards of glass, scattered hives that itched like madness including a few on face and lips, entire face puffy, lips swollen, and jawline itchy and tender, and the outcome of glands under jaw started to swell and upper left arm started to ache a bit was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: ENTIRE FACE PUFFY; LIPS SWOLLEN; JAWLINE ITCHY AND TENDER; UPPER LEFT ARM STARTED TO ACHE A BIT; GLANDS UNDER JAW STARTED TO SWELL; SCATTERED HIVES THAT ITCHED LIKE MADNESS INCLUDING A FEW ON FACE AND LIPS; THROAT STARTED TO HURT, SORE THROAT THAT FEELS LIKE SWALLOWING SHARDS OF GLASS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 10:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced throat started to hurt, sore throat that feels like swallowing shards of glass. On 16-SEP-2021, the patient experienced upper left arm started to ache a bit. On 16-SEP-2021, the patient experienced glands under jaw started to swell. On 16-SEP-2021, the patient experienced scattered hives that itched like madness including a few on face and lips. On 17-SEP-2021, the patient experienced entire face puffy. On 17-SEP-2021, the patient experienced lips swollen. On 17-SEP-2021, the patient experienced jawline itchy and tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throat started to hurt, sore throat that feels like swallowing shards of glass, scattered hives that itched like madness including a few on face and lips, entire face puffy, lips swollen, and jawline itchy and tender, and the outcome of glands under jaw started to swell and upper left arm started to ache a bit was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: FELT LIKE HIT BY A TRUCK; SORE THROAT; BODY ACHES; HEADACHE; FEVER; FEELING REALLY BAD; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced feeling really bad. On 16-SEP-2021, the patient experienced felt like hit by a truck. On 16-SEP-2021, the patient experienced sore throat. On 16-SEP-2021, the patient experienced body aches. On 16-SEP-2021, the patient experienced headache. On 16-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like hit by a truck, sore throat, headache, fever, body aches, and feeling really bad. This report was non-serious. This case, from the same reporter is linked to 20210936144.
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder, Headache, Hypersomnia, Illness, Nausea
Clinical narrative: STRUGGLE TO OPEN EYES; SICK FOR 3 DAYS; SLEPT FOR 3 DAYS FULL; NAUSEA WHEN SEE FOOD; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced struggle to open eyes, sick for 3 days, slept for 3 days full, nausea when see food, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from sick for 3 days, and slept for 3 days full, and the outcome of headache, struggle to open eyes and nausea when see food was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nervousness
Clinical narrative: NERVOUS; MUSCLE ACHE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced nervous. On 16-SEP-2021, the patient experienced muscle ache. On 16-SEP-2021, the patient experienced headache. On 16-SEP-2021, the patient experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache, headache, and fatigue, and the outcome of nervous was not reported. This report was non-serious. This case, from the same reporter is linked to 20210936062.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid, and other pre-existing medical conditions included: Patient was a 63 years old male, very good health. 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 09-APR-2021, and dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced inappropriate schedule of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000193904.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia, Sensory disturbance
Clinical narrative: FEELING LIKE HE WAS HIT BY A TRUCK; SORE THROAT; BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a parent concerned a male 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 not reported, batch number: Unk) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced feeling like he was hit by a truck. On SEP-2021, the patient experienced sore throat. On SEP-2021, the patient experienced body aches. On SEP-2021, the patient experienced headache. On SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling like he was hit by a truck, sore throat, headache, fever and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210936091.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; VERY SICK; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore throat, very sick, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, chills, fever, and headache, and the outcome of very sick was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash, Skin disorder
Clinical narrative: CHANGE THE TEXTURE OF HIS SKIN; WARM TO THE TOUCH; ACHINESS; CHILLS; RASH; FEVER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hives, and concurrent conditions included: acid reflux, and amoxicillin allergy, and other pre-existing medical conditions included: The patient had no trouble with his breathing. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced change the texture of his skin. On 16-SEP-2021, the patient experienced warm to the touch. On 16-SEP-2021, the patient experienced achiness. On 16-SEP-2021, the patient experienced chills. On 16-SEP-2021, the patient experienced rash. On 16-SEP-2021, the patient experienced fever. Treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol.  The patient recovered from achiness, chills, and fever on 18-SEP-2021, had not recovered from rash, and the outcome of change the texture of his skin and warm to the touch was not reported. This report was non-serious.