chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling face, Swelling of eyelid, Vomiting
Clinical narrative: SORE THROAT; STOMACH PAIN; FEEL MISERABLE; FACIAL SWELLING; SWELLING OF EYE LIDS; ITCHING; A LOT OF PAIN UNDER RIB CAGE; EXACERBATING FIBROMYALGIA; EXACERBATING INFLAMMATORY REACTION THROUGH BODY; PAIN; STOMACH SPASM; FEELING SO SICK; CHILLS; DIARRHEA; VOMITING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: concussion, and concurrent conditions included: autoimmune issues, genetic issues lump into fibromyalgia, and fibromyalgia in upper chest. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number series 1) (batch number:1805020) on 15-MAR-2021 for prophylactic vaccination; and experienced itching inside chest when treated with diphenhydramine hydrochloride for itching in chest ( dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin not reported, batch number: 1071855194, and expiry: UNKNOWN) dose was not reported,1 total, administered on 26-NOV-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced pain, stomach spasm, feeling so sick, chills, diarrhea and vomiting. On an unspecified date, the patient experienced exacerbating fibromyalgia, exacerbating inflammatory reaction through body, sore throat, stomach pain, feel miserable, facial swelling, swelling of eye lids, itching, and a lot of pain under rib cage  ( all events in dose number series 2). She denies having a temperature. She reports her symptoms are not in the medical books and she reacts differently than majority of the people. Treatment medications (dates unspecified) included: dicycloverine hydrochloride for stomach issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exacerbating fibromyalgia, chills, diarrhea, vomiting, pain, stomach spasm, feeling so sick, exacerbating inflammatory reaction through body, stomach pain, sore throat, feel miserable, facial swelling, itching, a lot of pain under rib cage and swelling of eye lids was not reported. This report was non-serious. This case, involving the same patient is linked to 20211206613.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Nervousness
Clinical narrative: SPENT A WHOLE DAY IN BED; FELT SO SHAKEY; WEIRD/OFF FOR 1 WEEK AFTERWARDS/FELT LIKE SHE WAS INJECTED WITH CAFFEINE; TIRED; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 27-FEB-2021 for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, a day after receiving the booster vaccine the patient spent a whole day in bed, felt so shakey, tired, weird and off for 1 week afterwards. In reference to the shakiness, reporter stated that the patient told "since the shot, for a week, it felt like she was injected with caffeine." (all events dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt so shakey, tired, weird/off for 1 week afterwards/felt like she was injected with caffeine and spent a whole day in bed was not reported. This report was non-serious. This case, from the same reporter is linked to 20211203873 and 20211204096.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED A HALF DOSE FOR THEIR  BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old 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 ad26. cov2. s (unspecified manufacturer) for prophylactic vaccination (dose series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: Unknown), 0.25 ml, 1 in total, administered on 27-NOV-2021 for prophylactic vaccination (dose series 2). No concomitant medications were reported.   On 27-Nov-2021, the patient received half dose of the Booster dose vaccine (off Label use). The reporter stated that something was printed and was disseminated which said to administer 0.25ml.(dose series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the received a half dose for their booster and off label use was not reported.  This report was non-serious.  This case, from the same reporter is linked to 20211201450, 20211202515, 20211202379, 20211202371, 20211202250, 20211202246, 20211202207, 20211202199, 20211202193, 20211202161, 20211201963, 20211201443, 20211201392, 20211201362, 20211201304, 20211201286, 20211201228, 20211201179, 20211201168, 20211201082, 20211201046, 20211200994, 20211200752, 20211200769, 20211200723, 20211200675, 20211200717 and 20211165041.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING INSIDE CHEST; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, and concussion, and other pre-existing medical conditions included: The patient had autoimmune issue and genetic issues, lump into fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported (dose number in series: 1), administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced itching inside chest (dose number in series: 1). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching inside chest was not reported. This report was non-serious. This case, involving the same patient is linked to 20211203557.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: CONGESTION (NASAL); FEELING ACHY; This spontaneous report received from a patient (physician) concerned a patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported,1 in total, (dose number in series: 2), administered on 30-NOV-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient started getting congestion (nasal). On the same day, the patient was also feeling achy, however was totally fine (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling achy on 02-DEC-2021, and had not recovered from congestion (nasal). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: ACHY; HEADACHE; This spontaneous report received from a parent via a company representative 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 was previously treated with covid-19 vaccine ad26. cov2. s (dose in series 1, unspecified manufacturer) for prophylactic vaccination.  The patient received booster dose with covid-19 vaccine ad26.cov2.s (Janssen series 2) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 30-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On the night of 30-NOV-2021, the patient experienced achy and headache (dose series 2), but by the next day morning he was able to work a full shift. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 (Dose number in series 1). 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.  On an unspecified date, the patient experienced side effects (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20211208442.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE, APPROXIMATELY AROUND 0.3ML; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 96 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to right arm on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced received less than 0.5ml of the Janssen covid-19 vaccine as the initial dose, approximately around 0.3ml and off label use(dose series 2). As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received less than 0.5ml of the Janssen covid-19 vaccine as the initial dose, approximately around 0.3m and off label use was unknown.  This report was non-serious.  This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211209551, 20211210160, 20211210058, 20211209843, 20211210588, 20211210610, 20211210159, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209679, 20211209706, 20211209740, 20211209775, 20211209798, 20211209874, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210067, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210824, 20211212082 and 20211212088.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: POSSIBLE VACCINE UNDERDOSE; This spontaneous report received from a health care professional concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination.  No concomitant medications were reported. On 01-DEC-2021, the patient experienced possible vaccine under dose. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome possible vaccine under dose was unknown. This report was non-serious.  This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211209976, 20211210160, 20211210588, 20211209775, 20211210159, 20211210610, 20211210555, 20211210408, 20211209551, 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209798, 20211209816, 20211209843, 20211209874, 20211209884, 20211209912, 20211209921, 20211210019, 20211210058, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210733, 20211210824, 20211212082, 20211212088 and 20211210684.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211210610, 20211210733, 20211210409, 20211210555, 20211209775, 20211209798, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211210019, 20211210106, 20211210107, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210197, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210824, 20211212082, 20211212088, 20211209782, 20211209740, 20211209706 and 20211209679.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: SICKNESS; This spontaneous report received from a health care professional concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received combination product golimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from AUG-2019 for an unspecified indication. Product constituent parts included smartject (route of admin, lot, serial number, model number, UDI number, and expiration were not 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 01-DEC-2021, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with golimumab was withdrawn. The outcome of sickness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. 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 report was associated with product quality complaint : 90000205851.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bell's palsy, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: BELLS PALSY IN MY LEFT CHEEK AFTER ONE J&J JAB WITH PAIN AROUND LEF JAW AND EAR; LUNGS FEEL LIKE THEY HAVE FLUID IN THEM; JOINTS ACHING; EXTREME FATIGUE; PAIN IN TRAPEZIUS; This spontaneous report received from a patient via a company representative 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 (series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total, start therapy date was 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 bells palsy in my left cheek after one j&j jab with pain around lef jaw and ear, lungs feel like they have fluid in them, joints aching, extreme fatigue and pain in trapezius. Patient did not get booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bells palsy in my left cheek after one j&j jab with pain around lef jaw and ear, lungs feel like they have fluid in them, joints aching, extreme fatigue and pain in trapezius was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211218021.; Sender's Comments: 20211217672-covid-19 vaccine ad26.cov2.s -Bells palsy in my left cheek after one j&j jab with pain around lef jaw and ear. 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: Anosmia, Asthenia
Clinical narrative: LOST SMELL COMPLETELY; ENERGY LEVELS DROPPED SIGNIFICANTLY AFTER SHOT; 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. The patient's past medical history included: covid-19. 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 lost smell completely, and energy levels dropped significantly after shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lost smell completely, and the outcome of energy levels dropped significantly after shot was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest X-ray, Chills, Injection site erythema
Clinical narrative: LATENT TUBERCULOSIS; JOINT PAIN; INJECTION SITE SWELLING; RED SKIN/MARK AT INJECTION SITE; CHILLS; This spontaneous report received from a patient concerned a 64 year old female of unspecified race and ethnicity. The patient's weight was 178 pounds, and height was 69 inches. The patient's past medical history included: migraine, and covid-19, and concurrent conditions included: non alcoholic, non tobacco user, bee sting allergy manifested by skin rashes, and crohns disease. The patient experienced anaphylactic reaction when treated with infliximab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 and expiry: unknown) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination (Dose number in series 1). Concomitant medications included calcium, clonazepam, colecalciferol, colestipol hydrochloride, ergocalciferol, isoniazid, mesalazine, methocarbamol, metoprolol, omega-3 nos, thiamine hydrochloride, trazodone hydrochloride, zolmitriptan.  On MAR-2021, patient experienced chills but other than that no other side effects. patient had chills for a couple hours, missed a few hours work. On MAR-2021, After blood work and patient tested positive for latent tuberculosis. patient was hospitalized (date unspecified and for unspecified days) due to this. On an unspecified date, the patient experienced joint pain, injection site swelling, and red skin/mark at injection site. On JUN-2021, Laboratory data included: Liver function test (NR: not provided) Normal function. On an unspecified date, patient stated a pulmonologist did a chest x-ray on her and everything came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from latent tuberculosis on 2021, and chills on MAR-2021, and the outcome of joint pain, injection site swelling and red skin/mark at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211218498-COVID-19 VACCINE AD26.COV2.S- Latent tuberculosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Latent tuberculosis, Liver function test
Clinical narrative: LATENT TUBERCULOSIS; JOINT PAIN; INJECTION SITE SWELLING; RED SKIN/MARK AT INJECTION SITE; CHILLS; This spontaneous report received from a patient concerned a 64 year old female of unspecified race and ethnicity. The patient's weight was 178 pounds, and height was 69 inches. The patient's past medical history included: migraine, and covid-19, and concurrent conditions included: non alcoholic, non tobacco user, bee sting allergy manifested by skin rashes, and crohns disease. The patient experienced anaphylactic reaction when treated with infliximab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 and expiry: unknown) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination (Dose number in series 1). Concomitant medications included calcium, clonazepam, colecalciferol, colestipol hydrochloride, ergocalciferol, isoniazid, mesalazine, methocarbamol, metoprolol, omega-3 nos, thiamine hydrochloride, trazodone hydrochloride, zolmitriptan.  On MAR-2021, patient experienced chills but other than that no other side effects. patient had chills for a couple hours, missed a few hours work. On MAR-2021, After blood work and patient tested positive for latent tuberculosis. patient was hospitalized (date unspecified and for unspecified days) due to this. On an unspecified date, the patient experienced joint pain, injection site swelling, and red skin/mark at injection site. On JUN-2021, Laboratory data included: Liver function test (NR: not provided) Normal function. On an unspecified date, patient stated a pulmonologist did a chest x-ray on her and everything came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from latent tuberculosis on 2021, and chills on MAR-2021, and the outcome of joint pain, injection site swelling and red skin/mark at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211218498-COVID-19 VACCINE AD26.COV2.S- Latent tuberculosis. 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: Death
Clinical narrative: PASSED AFTER TAKING THE VACCINE; This spontaneous report received from a consumer via social media 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 received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date reporter stated that "I never thought that seeing an ad for something would have me crying so violently this early in the morning. Earlier this year one of my close friends passed after taking the J and J vaccine. I was displaced after his passing and it has ruined me financially. I haven't been able to recover and it seems I'm close to a grippy socks vacation over all of this. I wish you would have care more J and J. I wish friend was still alive." On 2021, the patient died from unspecified cause of death. It was unspecified 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: 20211218656 -covid-19 vaccine ad26.cov2.s- passed after taking the vaccine. 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: UNSPECIFIED CAUSE OF DEATH
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 39 year old  male. The patient's height, and weight were not reported. The patient's past medical history included: kidney transplant (22 years ago at age 18), and concurrent conditions included: end-stage renal disease (ESRD), hemolytic uremic syndrome, and penicillin allergy. The patient experienced hives when treated with fexofenadine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 26-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient underwent antibody testing and was informed that he did not had any antibodies (confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) no antibodies found. 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 a product quality complaint: 90000206157.; Sender's Comments: V0:20211219532-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
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5 ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female. 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: 1822809 expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5 ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220916, 20211220216, 20211220460, 20211220206, 20211220178, 20211220527, 20211220262, 20211220552, 20211220619, 20211220697, 20211220754, 20211220764, 20211219871, 20211219714, 20211219701, 20211219926, 20211219926, 20211220129, 20211220177, 20211220262, 20211220233, 20211220177, 20211220152 and 20211220146.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: TWO STROKES; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. 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 not reported, batch number: UNKNOWN), 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. Vaccination dose series was 1. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced two strokes. The reporter stated as, "my sister has lost her peripheral vision permanently, because of vaccine. She had two strokes, it has changed her life forever. She can no longer drive". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two strokes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20211220048 -covid-19 vaccine ad26.cov2.s- two stroke This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: OFF LABEL USE; RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 47 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On an unspecified date, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220916, 20211219681, 20211220301, 20211220527, 20211220697 and 20211220928.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Feeling hot, Flushing
Clinical narrative: HEADACHES; HIVES; LIGHTHEADEDNESS; FLUSHED; WARM; BALANCE ISSUES; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, inflammatory condition, and immune dysregulation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced balance issues. On APR-2021, the patient experienced fatigue. On 06-APR-2021, the patient experienced lightheadedness. On 06-APR-2021, the patient experienced flushed. On 06-APR-2021, the patient experienced warm. On 07-APR-2021, the patient experienced hives. On an unspecified date, the patient experienced headaches. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, balance issues, and fatigue on APR-2021, and hives on 13-APR-2021, was recovering from flushed, and warm, and the outcome of headaches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: HEADACHES; HIVES; LIGHTHEADEDNESS; FLUSHED; WARM; BALANCE ISSUES; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, inflammatory condition, and immune dysregulation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced balance issues. On APR-2021, the patient experienced fatigue. On 06-APR-2021, the patient experienced lightheadedness. On 06-APR-2021, the patient experienced flushed. On 06-APR-2021, the patient experienced warm. On 07-APR-2021, the patient experienced hives. On an unspecified date, the patient experienced headaches. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, balance issues, and fatigue on APR-2021, and hives on 13-APR-2021, was recovering from flushed, and warm, and the outcome of headaches was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: OVERDOSE (RECEIVED 2.5 ML OF THE JANSSEN COVID-19 VACCINE); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 79 year old female. 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: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced overdose (received 2.5 ml of the janssen covid-19 vaccine). On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the overdose (received 2.5 ml of the janssen covid-19 vaccine) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220262, 20211220206, 20211220527, 20211220178, 20211220537, 20211220552, 20211220155, 20211220697, 20211220754, 20211219731, 20211219701, 20211219807, 20211219714, 20211220233, 20211220460, 20211220216 and 20211220177.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: DID NOT FEEL GOOD FOR 3 DAYS; ARM WAS REALLY TIRED; This spontaneous report received from a patient concerned a 61 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced did not feel good for 3 days, and arm was really tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good for 3 days, and the outcome of arm was really tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20211154414.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 22 year old female. 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: 1822809 and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: OVERDOSE (RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE); This spontaneous report received from a health care professional concerned a 37 year old female. 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: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced overdose (received 2.5ml of the janssen covid-19 vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of overdose (received 2.5ml of the janssen covid-19 vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219681, 20211219953, 20211220301, 20211220527, 20211220178, 20211220177, 20211220552, 20211220619, 20211220146, 20211220754, 20211220129, 20211220764, 20211219701, 20211219871, 20211219926, 20211219714, 20211219701, 20211220145 and 20211220928.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old female. 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: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: ADMINISTERED ANOTHER DOSE OF VACCINE IN JUNE AS THEY DIDN'T KNOW HE HAD HIS INITIAL DOSE IN MARCH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: alzheimer's The patient's pre-existing medical conditions included: After the first dose of vaccine the patient was admitted to a residential facility due to his alzheimer that he had from before. 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 MAR-2021, and dose was not reported, administered on JUN-2021 for prophylactic vaccination, and prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administered another dose of vaccine in june as they didn't know he had his initial dose in march. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered another dose of vaccine in june as they didn't know he had his initial dose in march was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Tinnitus, Vision blurred
Clinical narrative: VISION FADING; RINGING IN EARS; FEELING OF LACK OF BLOOD (CIRCULATION CUT OFF) IN LEFT SIDE OF BODY INCLUDING LEFT LEGS AND LEFT ARM; 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 06-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-DEC-2021, the patient experienced feeling of lack of blood (circulation cut off) in left side of body including left legs and left arm. On 09-DEC-2021, the patient experienced vision fading. On 09-DEC-2021, the patient experienced ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vision fading, and ringing in ears, and had not recovered from feeling of lack of blood (circulation cut off) in left side of body including left legs and left arm. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 58 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 ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1822809 expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5 ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219731, 20211219686, 20211220537, 20211219807 and 20211220948.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 14 year old female. 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: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 18-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-SEP-2021, the patient experienced off label use. On 18-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient of inappropriate age and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218297, 20211218548 and 20211218731.