chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 MONTHS YO patient received 1st dose of rotarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number PC473, expiry date 27th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th January 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On an unknown date, the patient started Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that a 5 months old patient received his first dose of Rotarix on the day of reporting, which led to  inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received dose 2 yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25 February2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the concerned patient.  The age at vaccination was not applicable to this report. The patient stated she had received dose 1 of SHINGRIX.  The patient had not received dose 2 yet which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Limb discomfort, Pain
Clinical narrative: Discomfort in left arm; Painful when moving the left arm; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th December 2021, immediately after receiving Shingrix, the patient experienced arm discomfort and pain upon movement. On an unknown date, the outcome of the arm discomfort and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort and pain upon movement to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix on left deltoid. After receiving Shingrix patient experienced discomfort in left arm right away after the vaccination and discomfort in arm means painful when moving arm. The symptoms had not resolved. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Discomfort in left arm; Painful when moving the left arm; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th December 2021, immediately after receiving Shingrix, the patient experienced arm discomfort and pain upon movement. On an unknown date, the outcome of the arm discomfort and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort and pain upon movement to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix on left deltoid. After receiving Shingrix patient experienced discomfort in left arm right away after the vaccination and discomfort in arm means painful when moving arm. The symptoms had not resolved. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Dose administered after freezing temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MR5FK, expiry date 21st September 2023) for prophylaxis.   On 17th December 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The case was reported by Nurse Practitioner.  The reporter reported that it was discovered that facility's vaccine fridge experienced two alarms in November.  On 19th November 2021, the temperature reached minus 3 degree Celsius for 1 hour and 0.7 degree Celsius for 5 hours.  On 22nd November 2021 the temperature reached 1.0 degrees Celsius for 2 hours.  The reporter reported that it was discovered that the temperature probe had shifted in the fridge and was touching the wall, so reporter believed that might have been the cause of the low readings.  The reporter checked clinic records and discovered that one dose of Boostrix was administered following the freezing temperature reading which led to incorrect storage of drug.  At the time of the report, the dose had not been repeated.  The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received HBV (Engerix B pediatric) (batch number LX4XP, expiry date 6th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by registered nurse.  The reporter called in to inquire if Engerix dose was invalid.  The patient received Engerix b pediatric vaccine in left thigh. The reporter stated they inadvertently administered an expired Engerix b pediatric vaccine to the patient which led to expired vaccine used.  The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 49-year-old Not Hispanic or Latino male. 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 (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 to the left shoulder for prophylactic vaccination. It was unknown whether the patient had any adverse event following vaccination with covid-19 vaccine. (Dose number in series: 1). The patient received covid-19 vaccine (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-OCT-2021 to the left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2022, following vaccination with covid-19 vaccine. the patient had a break through case of covid-19 (suspect COVID-19) and the patient also stated that he had the symptoms of headache, fever, runny nose, congestion, cough and body ache(entire body). The patient also mentioned that his smell and taste were intact. On same day patient confirmed with a binax (covid-19 rapid test) test that he had a covid (coded as suspected COVID-19 and suspected clinical vaccination failure) and on 04-JAN-2022, the patient went for a PCR (polymerase chain reaction) test, but the results were pending. (Dose number in series: 2). The action taken with covid-19 vaccine was not applicable. The outcome of the reported as suspected COVID-19 and suspected clinical vaccination failure were unknown. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number requested.; Sender's Comments: V0: 20220104537-covid-19 vaccine Suspected 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Injection site pain, Mobility decreased, Rash, SARS-CoV-2 test
Clinical narrative: COULDN'T LIFT/ MOVE HER RIGHT ARM; RASH TO HER CHEST, ARMS, LEGS; PAINFUL AT INJECTION SITE; HAIR STARTED FALLING OUT; SCALP IS SORE/BURNING; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 145 pounds, and height was 62 inches. The patient's concurrent conditions included: sleep/anxiety, seasonal allergies, and environmental allergies, and other pre-existing medical conditions included: Patient was not pregnant at the time of report. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 23-AUG-2021) dose was not reported, 1 total, administered to right arm on 10-MAR-2021 for prophylactic vaccination.  On an unspecified date, the patient was not feeling well following vaccination with covid-19 vaccine ad26.cov2.s and went to the Emergency Department and there had a positive COVID-19 PCR (polymerase chain reaction) test confirmation of COVID -19 infection. The patient was subsequently hospitalized for 3 days. On an unspecified date, the patient experienced confirmed clinical vaccination failure (dose number in series: 1). On 28-SEP-2021, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 1 total, administered to right arm on 28-OCT-2021 for prophylactic vaccination. Concomitant medications included alprazolam for sleep/anxiety.  On an unspecified date, the patient experienced couldn't lift/ move her right arm, rash to her chest, arms, legs, and painful at injection site following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2). It was reported that the patient's hair/scalp felt strange ever since positive COVID diagnosis. The patient added that she was told by her HCP that if not for being vaccinated, she may have needed intubation. (dose number in series: 2) On 16-DEC-2021, the patient experienced hair started falling out, and scalp is sore/burning dose number in series: 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash to her chest, arms, legs, and painful at injection site, had not recovered from hair started falling out, and the outcome of couldn't lift/ move her right arm and scalp is sore/burning was not reported. This report was non-serious. This case, involving the same patient is linked to 20220104484. (dose number in series: 1)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: COULDN'T LIFT/ MOVE HER RIGHT ARM; RASH TO HER CHEST, ARMS, LEGS; PAINFUL AT INJECTION SITE; HAIR STARTED FALLING OUT; SCALP IS SORE/BURNING; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 145 pounds, and height was 62 inches. The patient's concurrent conditions included: sleep/anxiety, seasonal allergies, and environmental allergies, and other pre-existing medical conditions included: Patient was not pregnant at the time of report. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 23-AUG-2021) dose was not reported, 1 total, administered to right arm on 10-MAR-2021 for prophylactic vaccination.  On an unspecified date, the patient was not feeling well following vaccination with covid-19 vaccine ad26.cov2.s and went to the Emergency Department and there had a positive COVID-19 PCR (polymerase chain reaction) test confirmation of COVID -19 infection. The patient was subsequently hospitalized for 3 days. On an unspecified date, the patient experienced confirmed clinical vaccination failure (dose number in series: 1). On 28-SEP-2021, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 1 total, administered to right arm on 28-OCT-2021 for prophylactic vaccination. Concomitant medications included alprazolam for sleep/anxiety.  On an unspecified date, the patient experienced couldn't lift/ move her right arm, rash to her chest, arms, legs, and painful at injection site following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2). It was reported that the patient's hair/scalp felt strange ever since positive COVID diagnosis. The patient added that she was told by her HCP that if not for being vaccinated, she may have needed intubation. (dose number in series: 2) On 16-DEC-2021, the patient experienced hair started falling out, and scalp is sore/burning dose number in series: 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash to her chest, arms, legs, and painful at injection site, had not recovered from hair started falling out, and the outcome of couldn't lift/ move her right arm and scalp is sore/burning was not reported. This report was non-serious. This case, involving the same patient is linked to 20220104484. (dose number in series: 1)
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID 19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, (dose number in series 1), 01 in total administered, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, (dose number in series 2), 01 in total administered, 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 following administration of covid-19 vaccine ad26.cov2.s, the patient tested positive for Covid-19 at home on a rapid antigen test one month after getting his booster dose (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was unknown (dose number in series 2). This report was non-serious. This report is associated with a product quality complaint (PQC) number: 90000210253. The suspected product quality complaint has been confirmed to be voided. This case does not qualify for a PQC since the only indication is that the patient had Covid but does not refer to any symptoms based on the PQC evaluation/investigation performed.; Sender's Comments: V0:  Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: GOT SICK; IT WAS LIKE THE FLU; This spontaneous report received from a consumer concerned an 18 year old male of unspecified race and ethnic origin. 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, (dose number in series 1), start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, 10 hours after he got the vaccine (during night) the patient got sick and it was like the flu for 8 hours (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received covid-19 vaccine ad26. cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 2) 01 in total, administered dose was not reported for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 2). The patient recovered from got sick, and it was like the flu. This report was non-serious. This case, from the same reporter is linked to 20220110608, 20211265856 and 20220110776.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report received from a patient concerned a 66 year old white non-Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: Unknown) dose was not reported, dose number in series 1, 01 in total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. On an unspecified date, following administration of Covid-19 vaccine ad26.cov2.s, the patient experienced blotchiness on the skin, sore arm and tender when treated with Covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, dose number in series 2, 01 in total, administered on 04-JAN-2022 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in JAN-2022, following administration of Covid-19 vaccine ad26.cov2.s, the patient experienced tender arm (dose number in series 2). On 04-JAN-2022, the patient experienced aches and pains in joints, and sore arm (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches and pains in joints, sore arm/ arm still hurt, and tender arm (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20210424792. This case, from the same reporter is linked to 20220112619.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED VACCINATION FAILURE; COVID-19 INFECTION; PAIN IN KNEES; This spontaneous report received from a patient 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 previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A expiry: Unknown) dose was not reported, frequency one total, administered left arm on 07-MAY-2021 for prophylactic vaccination. It was unknown if the patient had any adverse event with (dose number in series 1). The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, frequency one total, administered left arm on 03-NOV-2021 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported. On 06-JAN-2022, the patient experienced diarrhea, sore throat, headaches, muscle pain, pain in legs and knees. Laboratory data included: COVID-19 antigen test (NR: not provided) positive (coded as covid-19 infection and suspected vaccination failure).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in knees and covid-19 infection and the outcome of suspected vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint:90000211250; Sender's Comments: V0:20220112320-COVID-19 VACCINE AD26.COV2.S-Suspected 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Feeling abnormal, Oropharyngeal pain, Pain
Clinical narrative: SCRATCHY THROAT; SORE THROAT; COUGHING; WANT TO SPIT OUT MUCUS; BODY ACHING; FELT LIKE WORSE; LEGS AND KNEES HURT; FELT WEAK; SORE ARM; This spontaneous report received from a patient concerned a 52 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination.  The patient experienced unspecified adverse reaction when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, 1 total administered to left deltoid on 30-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced sore arm. On an unspecified date, the patient experienced scratchy throat, sore throat, coughing, want to spit out mucus, body aching, legs and knees hurt, and felt weak. The patient stated, she felt like worse after receiving booster (dose number in series 2) than before. Treatment medications (dates unspecified) included: Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and had not recovered from scratchy throat, legs and knees hurt, felt weak, sore throat, coughing, want to spit out mucus, body aching, and felt like worse (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220116291.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Secretion discharge, Throat irritation
Clinical narrative: SCRATCHY THROAT; SORE THROAT; COUGHING; WANT TO SPIT OUT MUCUS; BODY ACHING; FELT LIKE WORSE; LEGS AND KNEES HURT; FELT WEAK; SORE ARM; This spontaneous report received from a patient concerned a 52 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination.  The patient experienced unspecified adverse reaction when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, 1 total administered to left deltoid on 30-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced sore arm. On an unspecified date, the patient experienced scratchy throat, sore throat, coughing, want to spit out mucus, body aching, legs and knees hurt, and felt weak. The patient stated, she felt like worse after receiving booster (dose number in series 2) than before. Treatment medications (dates unspecified) included: Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and had not recovered from scratchy throat, legs and knees hurt, felt weak, sore throat, coughing, want to spit out mucus, body aching, and felt like worse (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220116291.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: SORE ARM; ACHES AND PAINS IN JOINTS; TENDER; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) (dose number in series 1), 01 in total was administered, dose was not reported for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, she had sore arm and just tender (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, dose number in series 2, 01 in total was administered on 04-JAN-2022 at left deltoid for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced tender. On 04-JAN-2022, she had side effects of sore arm, and aches and pains in joints (dose number in series 2), and also stated that her arms still hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and aches and pains in joints, and the outcome of tender was not reported (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220112619. This case, from the same reporter is linked to 20220112654 and 20220112293.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Feeling abnormal, General physical health deterioration, Hypersomnia, Loss of consciousness
Clinical narrative: CORE EMBOLISM IN BOTH LUNGS; COULD NOT THINK CLEARLY; PASSING OUT; MEMORY LOSS FOR A FEW HOURS; UNAWARE IT WAS IF A FOG WAS OVER MY BRAIN; QUALITY OF LIFE CHANGED; FELT SO TERRIBLE SLEPT FOR 3 DAYS; This spontaneous report received from a patient concerned a 43 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose and 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 core embolism in both lungs, could not think clearly, passing out ( In the course of about 2-3 months was passing out, then passing out more often, then It got to the point was passing out every time stood up), on third day memory loss for a few hours, unaware it was if a fog was over my brain, quality of life changed forever due to the sever reaction of the vaccine, and felt so terrible slept for 3 days. While in the middle of other life issues (my Husband abandoning me) and other issues of that nature (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from memory loss for a few hours, and felt so terrible slept for 3 days, had not recovered from passing out, could not think clearly, and quality of life changed, and the outcome of unaware it was if a fog was over my brain and core embolism in both lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220114341-COVID-19 VACCINE AD26.COV2.S- Core embolism in both lungs ,Could not think clearly, Passing out 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: Mental impairment, Pulmonary embolism
Clinical narrative: CORE EMBOLISM IN BOTH LUNGS; COULD NOT THINK CLEARLY; PASSING OUT; MEMORY LOSS FOR A FEW HOURS; UNAWARE IT WAS IF A FOG WAS OVER MY BRAIN; QUALITY OF LIFE CHANGED; FELT SO TERRIBLE SLEPT FOR 3 DAYS; This spontaneous report received from a patient concerned a 43 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose and 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 core embolism in both lungs, could not think clearly, passing out ( In the course of about 2-3 months was passing out, then passing out more often, then It got to the point was passing out every time stood up), on third day memory loss for a few hours, unaware it was if a fog was over my brain, quality of life changed forever due to the sever reaction of the vaccine, and felt so terrible slept for 3 days. While in the middle of other life issues (my Husband abandoning me) and other issues of that nature (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from memory loss for a few hours, and felt so terrible slept for 3 days, had not recovered from passing out, could not think clearly, and quality of life changed, and the outcome of unaware it was if a fog was over my brain and core embolism in both lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220114341-COVID-19 VACCINE AD26.COV2.S- Core embolism in both lungs ,Could not think clearly, Passing out 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
Clinical narrative: 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, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced Covid-19 infection. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20220116907. This report was associated with product quality complaint: 90000211011.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Gastrointestinal haemorrhage, Haemoglobin, Haemoglobin abnormal
Clinical narrative: This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. In APR-2021, the patient became bedridden. On an unspecified date, the patient experienced taking iron puts me in the hospital with gastrointestinal bleeding, and was unable to maintain a normal hemoglobin level. On an unspecified date, patient was hospitalized. Laboratory data (dates unspecified) included: Hemoglobin level (NR: not provided) abnormal. Patient reported that "I have been bedridden since the jnj vaccine in April. I am unable to maintain a normal hemoglobin level and taking iron puts me in the hospital with bleeding in my GI." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bedridden, unable to maintain a normal hemoglobin level and taking iron puts me in the hospital with gastrointestinal bleeding was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220118407-COVID-19 VACCINE AD26.COV2.S-bedridden, unable to maintain a normal hemoglobin level and taking iron led to gastrointestinal bleeding . 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: Myocardial infarction, Thrombosis
Clinical narrative: HEART ATTACK; BLOOD CLOT; This spontaneous report received from a consumer via social media  through a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total 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 reporter stated "My cousin died from a heart attack because the johnson and johnson vaccine caused a blood clot. Because she trusted people like you". On an unspecified date, the patient died from heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0.20220118705-covid-19 vaccine ad26.cov2.s -Heart attack, Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: LOST ANOTHER ONE TO THE JAB; This spontaneous report received from a consumer via media concerned a patient of unspecified age, sex, race and ethnic origin. 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 and start therapy date were not reported, 1 total administered 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 died from unknown cause of death. The reporter stated that "Lost another one to the jab ". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220118906-COVID-19 VACCINE AD26.COV2.S-Lost another one to the jab. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: 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, and batch number were not reported) 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 or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced having problems. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having problems was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; 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, and batch number were not reported) 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 chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYZED; This spontaneous report received from a consumer 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, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was 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 paralyzed. Reporter stated that "I bet he does not come here and see my friend who is paralyzed from the vaccine." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220121326-COVID-19 VACCINE AD26.COV2.S- paralyzed. 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: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: ATRIAL FIBRILLATION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex and unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, 1 total administered and 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 stated that, "The J&J vax gave me afib (atrial fibrillation)" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0:20220121347-COVID-19 VACCINE AD26.COV2.S-Atrial fibrillation. 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: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: DROWSINESS; SLEPT THE WHOLE DAY; FELT SLOW; COULD NOT REALLY MOVE; JOINT ACHES IN LEGS; TIREDNESS; HEADACHES; MUSCLE ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (2 beers a week), and non smoker, and other 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: 211D21A expiry: UNKNOWN) dose was not reported, administered on 10-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced drowsiness, slept the whole day, felt slow, could not really move, joint aches in legs, tiredness, headaches, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches in legs, and muscle aches on 12-JAN-2022, was recovering from tiredness, and drowsiness, had not recovered from headaches, and the outcome of could not really move, slept the whole day and felt slow was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Somnolence
Clinical narrative: DROWSINESS; SLEPT THE WHOLE DAY; FELT SLOW; COULD NOT REALLY MOVE; JOINT ACHES IN LEGS; TIREDNESS; HEADACHES; MUSCLE ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (2 beers a week), and non smoker, and other 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: 211D21A expiry: UNKNOWN) dose was not reported, administered on 10-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced drowsiness, slept the whole day, felt slow, could not really move, joint aches in legs, tiredness, headaches, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches in legs, and muscle aches on 12-JAN-2022, was recovering from tiredness, and drowsiness, had not recovered from headaches, and the outcome of could not really move, slept the whole day and felt slow was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood viscosity increased, Hepatic enzyme increased, Mood altered, Palpitations
Clinical narrative: HEART PALPITATIONS; MY BLOOD IS THICKENING; IT IS SHOWING THAT IT IS REGULATING AN IRATE; 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, and batch number were not reported) 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 heart palpitations, my blood is thickening, and it is showing that it is regulating an irate. Laboratory data (dates unspecified) included: Elevated liver enzyme levels (NR: not provided) Developed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, my blood is thickening and it is showing that it is regulating an irate was not reported. This report was non-serious.