chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received / first dose of the shingrix / October of 2019 / received / second dose April 2021 / late dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in October 2019).   In April 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by the patient herself. The patient received second dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. No symptoms reported. Patient declined health care professional information. The reporter did not consent to follow up.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HAB (Twinrix) (batch number 3C422, expiry date 27th April 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th May 2021, unknown after receiving Twinrix and Twinrix 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 information was provided as follows:  The age at vaccination was not reported. On 4th May 2021, the patient received Twinrix which was expired on 27th April 2021, which led to expired vaccine used. The reporter stated that, it was the first dose of the vaccine, patient didn't take the vaccination record. No further events were reported at the time call. The reporter did not consent to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix to 4 month old baby / this was / 2nd dose for IPC and DTAP; Kinrix to 4 month old baby on 05/03/2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (Pediarix administered in February 2021).   On 3rd May 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were 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 Kinrix dose was given to the patient at 4 month old, which led to inappropriate age at vaccine administration. Reporter stated that this was patient's 2nd dose for IPC and DTAP, which led to inappropriate schedule of vaccine administered.  No side effects reported from parent.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administrated / expired dose / on April 30 2021. /expired on June 30 2020.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number ZY975, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra 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 information was provided as follows:  The age at vaccination was not reported. On 30th April 2021, the patient received Fluarix tetra vaccine which was already expired on 30th June 2020. No adverse events were reported. No patient identifiers were reported. The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 46 year old patient / received a dose of Shingrix on 27Jan2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 45-year-old female patient who received Herpes zoster (Shingrix) (batch number 295J3, expiry date 6th December 2021) for prophylaxis.   On 27th January 2021, the patient received the 1st dose of Shingrix. On 27th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The Pharmacy intern reported a 45 years old patient received dose of Shingrix vaccine, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo / reconstituted with Non-approved Diluent / administered to a patient; Menveo / reconstituted with Non-approved Diluent / administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA436A, expiry date 31st October 2021) for prophylaxis.   On 15th April 2021, the patient received Menveo. On 15th April 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows:  The patient received Menveo which was reconstituted with sterile diluent instead of correct diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Office Manager confirmed and reported Menveo Lyophilized Powder was reconstituted with non-approved Diluent and then administered to the patient.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix / on November 2019 and did not receive 2nd dose yet.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   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 information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient received 2nd dose of Shingrix, which led to incomplete course of vaccination. All patient identifiers were reported. No batch number or expiration date were available when asked. No more clarification was performed by HCP. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Iit is been one year and 5 months between doses; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th December 2019).   On 2nd May 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 2nd May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follow: The patient received 2nd dose of Shingrix after 1 year 5 months of receiving 1st dose, which led to lengthening of vaccination schedule. The reporter consented to follow up by fax. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Leg issues/leg pain; Joint pain/joint issue; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced leg pain and joint pain. On an unknown date, the outcome of the leg pain and joint pain were unknown.   It was unknown if the reporter considered the leg pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced leg issues and joint pain after the Shingrix vaccination. The patient disconnected the call abruptly and did not provide any additional information.  The reporter did not consent to follow-up.  Note- there was discrepancy in reported events. Leg issues mentioned in narrative but in event sections leg pain was reported, so event was coded as leg pain as seems appropriate. Same for joint issues/joint pain.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product communication issue
Clinical narrative: First dose / in July 2018 / unaware until now that there is a second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in July 2018 in left deltoid) and Zostavax (received Zostavax in 2014).   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 information was provided as follows:  The reporter was the patient herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired about second dose of Shingrix vaccine.  The patient received her first dose of Shingrix in July 2018 at the pharmacy and was unaware until now that there is a second dose of Shingrix that needs to be administered to complete the series.  The patient stated that, she was neither informed by doctor nor the pharmacist about the second dose of the vaccine to complete the series.  The patient really would not like to get shingles, it was terrible. The patient inquired whether she should restart the series, because it has been almost 3 years since the first dose.  The patient did not know the dose or an exact date of administration, she only remembers that it was given in July 2018 and mentioned that, it might have been given in left arm in the upper region (deltoid), she always get vaccine in her non-dominant arm so it would have been left arm." The patient did not have a doctor's fax number.  The patient stated that she received Zostavax in 2014 and then couple years later she read about Shingrix at the pharmacy and they said it was recommended to get Shingrix even if you had Zostavax before, so patient  said why not, the patient did not want to want to get shingles.  The patient also mentioned that she received a complete series of COVID vaccine (Moderna) in February 2021 (first dose in January 2021 and second dose in February 2021).  The reporter provided a consent to follow up with HCP.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 : sep 5th 2019 and Dose 2: nov 10 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th September 2019).   On 10th November 2020, the patient received the 2nd dose of Shingrix. On 10th November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows : The patient received the 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. There was a possibility of 3rd dose to be administered to patient but it was not confirmed as there were no other details about the vaccine was reported. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ultrasafe passive for ulcerative colitis, ultrasafe passive accessory for ulcerative colitis, and ustekinumab for ulcerative colitis. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Sensory loss
Clinical narrative: UNABLE TO FEEL LEFT SIDE OF BODY; SEVERE HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient via social media concerned a female of unspecified age. 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) dose was not reported, administered on 09-APR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, in APR-2021, the patient was unable to feel the left side of her body and had severe headaches and nausea and the patient was hospitalized for 5 days within a period of 3 weeks post receiving vaccine. It was also reported that the events had not gone away at the time of the report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to feel left side of body, severe headache, and severe nausea. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Unable to feel the left side of body . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. -Covid-19 vaccine ad26.cov2.s-Severe headache, Severe nausea. These events are labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: DIFFICULTY BREATHING; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration unknown, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after receiving the vaccination, the patient developed difficulty breathing. She was hospitalized within 24 hours of the onset of the event. She was admitted and stayed a few hours and received some medical treatment before being released later that day. Symptoms have resolved and the patient was currently in a great shape. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: -COVID-19 VACCINE AD26.COV2.S-Difficulty breathing. 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: UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: MILD TO SEVERE HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild to severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild to severe headaches was not reported. This report was non-serious.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; that patient received two doses of GARDASIL 9 at the pharmacy on 10/28/2020 and 12/02/2020, that patient actually had received a dose back on 12/07/2019; This spontaneous report was received from other reporter referring to 28-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.    On 07-DEC-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in one facility, then on 28-OCT-2020 and 02-DEC-2020, the patient was vaccinated with second and third dose, all three as prophylaxis (concentrations, dosages, routes of administration, anatomical locations, lot numbers and expirations date were not reported). Because the "interval was off," intern inquired if patient should receive a new 3rd dose. No additional adverse events reported (inappropriate schedule of product administration).
Age: 0.25
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Medication error
Clinical narrative: No additional adverse events reported; Nurse practitioner states a dose of PEDVAX HIB was given along with a dose PENTACEL on accident today; This spontaneous report was received from a nurse practitioner referring to a 12-week-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 03-MAY-2021, the patient was accidentally vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter, lot number T001208, expiration date 09-JUN-2022 (route of administration not reported) and hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid(PENTACEL) 0.5 milliliter, lot number UJ421AAA, expiration date 08-MAR-2022 (route of administration not reported) both for prophylaxis (medication error).
Age: 19.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse event; inadvertently gave a patient a dose of PROQUAD and a dose of VARlVAX on the same day; This spontaneous report was received from a medical assistant referring to a 19-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 04-MAY-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 millilitre, lot number T021639, expiration date 21-DEC-2021 (route of administration was not provided) and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T020650, expiration date 16-JUN-2022 (route of administration was not provided), both for prophylaxis (accidental overdose). No adverse event was reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Headache, Hypoxia, Lethargy
Clinical narrative: FEELS LIKE NOT GETTING ENOUGH OXYGEN; CHEST HEAVINESS; LETHARGIC; MIGRAINES; BODY ACHES; NO ENERGY; HEADACHE; 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 past medical history included tested positive for Covid-19, and concurrent conditions included extreme fatigue. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on MAR-2021 (approximately 2 weeks prior to the pause) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021 (after receiving vaccination), the patient developed migraines, no energy, headache, body aches, lethargic and a chest heaviness that felt like she was "not getting enough oxygen." She mentioned that she has seen by her primary care providers (PCP)/ health case professional (HCP) for the symptoms for evaluation and treatment. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic, migraines, headache, body aches, chest heaviness, no energy and feels like not getting enough oxygen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210502472-Covid-19 vaccine.Ad 26.Cov2.S-Feels like not getting enough oxygen. 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: Migraine, Pain
Clinical narrative: FEELS LIKE NOT GETTING ENOUGH OXYGEN; CHEST HEAVINESS; LETHARGIC; MIGRAINES; BODY ACHES; NO ENERGY; HEADACHE; 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 past medical history included tested positive for Covid-19, and concurrent conditions included extreme fatigue. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on MAR-2021 (approximately 2 weeks prior to the pause) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021 (after receiving vaccination), the patient developed migraines, no energy, headache, body aches, lethargic and a chest heaviness that felt like she was "not getting enough oxygen." She mentioned that she has seen by her primary care providers (PCP)/ health case professional (HCP) for the symptoms for evaluation and treatment. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic, migraines, headache, body aches, chest heaviness, no energy and feels like not getting enough oxygen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210502472-Covid-19 vaccine.Ad 26.Cov2.S-Feels like not getting enough oxygen. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: MUSCLE ACHE (A LITTLE BIT); SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 55 year old female. 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: 1805029,expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced muscle ache (a little bit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and muscle ache (a little bit), and had not recovered from nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Fatigue, Mental impairment
Clinical narrative: DIFFICULTY THINKING; SHORTNESS OF BREATH; PAINFUL BREATH; FEVER; BODY ACHES; CHILLS; EXHAUSTION; NIGHT SWEATS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, 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 not reported, batch number: UNKNOWN) dose was not reported, 1 total administered on 01-MAY-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021 approximately 16:00, the patient experienced fever, difficulty thinking, shortness of breath, painful breath, body aches, chills, exhaustion to the point of falling asleep in the middle of tasks and night sweats.  On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 02-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and body aches, and the outcome of difficulty thinking, shortness of breath, painful breath, chills, exhaustion and night sweats was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210502600-Covid vaccine coad26.cov2.s-Difficulty thinking, shortness of breath, painful breath. 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: Night sweats, Pain, Painful respiration, Pyrexia
Clinical narrative: DIFFICULTY THINKING; SHORTNESS OF BREATH; PAINFUL BREATH; FEVER; BODY ACHES; CHILLS; EXHAUSTION; NIGHT SWEATS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, 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 not reported, batch number: UNKNOWN) dose was not reported, 1 total administered on 01-MAY-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021 approximately 16:00, the patient experienced fever, difficulty thinking, shortness of breath, painful breath, body aches, chills, exhaustion to the point of falling asleep in the middle of tasks and night sweats.  On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 02-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and body aches, and the outcome of difficulty thinking, shortness of breath, painful breath, chills, exhaustion and night sweats was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210502600-Covid vaccine coad26.cov2.s-Difficulty thinking, shortness of breath, painful breath. 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased immune responsiveness, Ear pain, Oropharyngeal pain
Clinical narrative: VACCINE TEMPORARILY WEAKENED IMMUNE SYSTEM; SORENESS IN THROAT; EAR PAIN; HEADACHE, ACHES, FATIGUE; .This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included arthritis, bursitis, kidney issues, hernia, angioplasty, and dental implant, and concurrent conditions included microbial or viral present in jaw, and other pre-existing medical conditions included the patient was non alcoholic, non smoker and had no known drug allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin were not reported) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine temporarily weakened immune system, soreness in throat, ear pain, and headache, aches, fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in throat, vaccine temporarily weakened immune system, ear pain and headache, aches, fatigue was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 53 year old male. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced flu-like symptoms. On 01-MAY-2021, the subject experienced ache. On 01-MAY-2021, the subject experienced fever. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, ache, fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Head discomfort, Musculoskeletal discomfort
Clinical narrative: DEPRESSION; HEAD PRESSURE; NECK PRESSURE; This spontaneous report received from a patient concerned a 40 year old female. 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) dose was not reported, administered on 11-MAR-2021 13:00 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 APR-2021, the subject experienced depression. On APR-2021, the subject experienced head pressure. On APR-2021, the subject experienced neck pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from depression, head pressure, and neck pressure. This report was non-serious. This case, from the same reporter is linked to 20210502135.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE PAIN IN THE ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-APR-2021, the subject experienced little pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain in the arm on 2021. This report was non-serious. This case, from the same reporter is linked to 20210507957.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash erythematous, Skin warm
Clinical narrative: WARM TO TOUCH; TINGLING A LITTLE; RED RASH MEASURING ABOUT 3 INCHES; This spontaneous report received from a pharmacist concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1816022 expiry: 01-JUL-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced warm to touch. On 03-MAY-2021, the subject experienced tingling a little. On 03-MAY-2021, the subject experienced red rash measuring about 3 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red rash measuring about 3 inches, warm to touch and tingling a little was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fluid retention, Oedema peripheral, Peripheral swelling
Clinical narrative: FEET SWELLING UP; EDEMA IN LEGS; PRESSURE ON CHEST; WATER RETENTION; This spontaneous report received from a patient via a company representative concerned a 51 year old female. 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced water retention. On 18-MAR-2021, the subject experienced feet swelling up. On 18-MAR-2021, the subject experienced edema in legs. On 18-MAR-2021, the subject experienced pressure on chest. Treatment medications (dates unspecified) included: furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pressure on chest, feet swelling up, and edema in legs, and the outcome of water retention was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Peripheral swelling, Swelling
Clinical narrative: NECK SWOLLEN; LEFT ARM SWOLLEN TO WRIST; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced neck swollen, and left arm swollen to wrist. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck swollen and left arm swollen to wrist was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: BRUISING AT INJECTION SITE; DARKER DISCOLORATION ON OUTSIDE AND A LIGHTER COLOR ON INSIDE OF BANDAGE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included arthritis, and smoker, and concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no other bruises recently or petechia, chest pain, leg or abdominal pain, difficulty breathing, headache or blurred vision and no allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for arthritis. On 27-APR-2021, the subject experienced pain at injection site. On 29-APR-2021, the subject experienced bruising at injection site. On 29-APR-2021, the subject experienced darker discoloration on outside and a lighter color on inside of bandage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruising at injection site, had not recovered from pain at injection site, and the outcome of darker discoloration on outside and a lighter color on inside of bandage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: SWOLLEN LEG; CALF PAIN; This spontaneous report received from a patient concerned a 49 year old female. 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: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced swollen leg. On 19-APR-2021, the subject experienced calf pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen leg and calf pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: MINIMUM CHILLS; ARM PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced arm pain. On 01-APR-2021, treatment medications included: paracetamol. On 02-APR-2021, the subject experienced minimum chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minimum chills on 02-APR-2021, and arm pain on APR-2021. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a 60 year old male. 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: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site soreness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503868.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE (ANTIBODY TEST); This spontaneous report received from a consumer concerned a three male of unspecified age. 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) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced suspected immunological vaccine failure (antibody test). Laboratory data included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure (antibody test) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504960- JANSSEN COVID-19 VACCINE Ad26.COV2. S- Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Nasopharyngitis, Oropharyngeal pain, Somnolence
Clinical narrative: COLD LIKE SYMPTOMS; FUNNY TASTE IN MOUTH; SORE THROAT; SLEEPY; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included ruptured disc in back, and concurrent conditions included high blood pressure, seasonal allergies, fluid retention, and sulfa allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced cold like symptoms. On 08-MAR-2021, the subject experienced funny taste in mouth. On 08-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy on 08-MAR-2021, and had not recovered from cold like symptoms, funny taste in mouth, and sore throat. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 31 year old male. 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: Unk) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.; Sender's Comments: V0:As per standard protocol, No MAC comment is required for non serious case