chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 5 month and 9 days female patient received a dose of Kinrix; 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 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number Z9NZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical assistant reported that 5 months and 9 days old patient received Kinrix mistakenly, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain, Pain in extremity
Clinical narrative: mild flu symptoms; aches; just not feeling well all over; very sore arm that lasted 4 days; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, pain, pain in arm and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, pain, pain in arm and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, pain in arm and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient had received first Shingrix vaccine and experienced mild flu symptoms which included aches, very sore arm and just not feeling well all over. The reporter consented to follow up. For second dose tolerance case has been link with case US2021AMR151481 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151481:same patient, same reporter
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only the diluent portion of the vaccine; administration of only the diluent portion of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21st June 2021, the patient received Menveo. On 21st June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that the patient was administered only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further events were provided. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient was inadvertently given a third dose / on 26Jan2021; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number BA56K, expiry date unknown) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On 26th January 2021, the patient received the 3rd dose of Shingrix. On 26th January 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that the patient was inadvertently administered third dose of Shingrix, which led to extra dose administered. The pharmacist closed out the patient record before specialist could obtain the date on the call. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in November of 2020 / has not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal rigidity, Pain in extremity
Clinical narrative: her left arm was sore; had spasms in her abdomen; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2021, the patient received the 1st dose of Shingrix .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced pain in arm and abdominal spasm. On an unknown date, the outcome of the pain in arm and abdominal spasm were unknown.   It was unknown if the reporter considered the pain in arm and abdominal spasm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received her first Shingrix vaccine a week ago, and her left arm was sore and she had spasms in her abdomen. No further information was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on 21Jan2020 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st January 2020).   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 follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. No vaccine data, no other patient's data was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose / in 2019 and its been over a year and they haven't yet received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 31-year-old female patient who received HAV (Havrix 1440) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 (received 1st dose in 2019, Batch number- 2AD47 and expiration date- 31st January 2020).   On an unknown date, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Havrix 1440 as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up. This case had been linked with the case US2021AMR153871, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR153871:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn´t received second dose / 1st dose was given during 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021151599, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151599:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of shingrix on 12/3/2019 / refused the second dose / now wants to receive it; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th March 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 details were provided as follows:  The age at vaccination was not applicable for this report. The patient refused the second dose, and now wanted to receive it. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter asked if they could restart the series, or could they just give patient the second dose, despite the time element. No further information provided. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: report an interval of greater than 6 months since 1st dose of Shingrix / Second dose of Shingrix not yet administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th July 2019, batch number-P2275, expiry date- 25th September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The medical assistant called to report an interval of greater than 6 months since 1st dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received the adjuvant /AS01B adjuvant /(without the lyophilized antigen component).; only received the adjuvant /AS01B adjuvant /(without the lyophilized antigen component).; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient had administered only AS01B adjuvant of Shingrix (without the lyophilized antigen component) in the left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose /on December 9, 2020 /it has been 7 months since his first dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received HAB (Twinrix) 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.   Previously administered products included Twinrix (1st dose received on 9th December 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On 14th July 2021, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it had been 7 months since the patient's first dose of Twinrix. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination. The pharmacist stated that, the patient would receive dose 3, 3 to 5 months after dose 2. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Underdose
Clinical narrative: a patient was given a dose of Pediatric Havrix/to an adult patient/Mistake was confirmed on 14Jul2021; a patient was given a dose of Pediatric Havrix/to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 56-year-old female patient who received HAV (Havrix pediatric) (batch number 5575N, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B pediatric) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   On 13th July 2021, the patient received Havrix pediatric, Havrix Pre-Filled Syringe Device and the 1st dose of Engerix B pediatric. On 13th July 2021, unknown after receiving Havrix pediatric, Havrix Pre-Filled Syringe Device and Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product 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: It was reported that an adult patient was given a dose of Pediatric Havrix and a dose of Engerix-B, which led to accidental underdose and adult use of a child product. On 14th July 2021, the mistake was confirmed. The reporter consented to follow up via email. This case had been linked with the case US2020210333, reported by the same reporter. Note: Engerix B pediatric was conservatively captured as a suspect with events accidental underdose and adult use of a child product as it was not mentioned in narrative but was mentioned in structural field of the source document. The clarification has been raised for the same.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020210333:Same reporter
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received a dose of expired Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HBV (Engerix B) (batch number GR55T, expiry date 28th August 2020) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Engerix B (intramuscular) and Engerix B Pre-Filled Syringe Device. On 13th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received a dose of expired Engerix-B. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of SHINGRIX 2 years ago/ 2nd one on July 13th, 2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, 2 years ago from the date of reporting).   On 13th July 2021, the patient received the 2nd dose of Shingrix. On 13th July 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: The age at vaccination was not reported. The pharmacist reported that, patient (around 50-60 years old ) received the 1st dose of Shingrix 2 years ago, and the 2nd one later than the recommended interval, which led to lengthening of vaccination schedule. No further details were provided at the time of the call since the pharmacist was not in the office. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / on 27Sep2018. Second dose had not been given at time of call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The 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 lot number and expiration date not available to reporter. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Diarrhoea, Ear infection
Clinical narrative: CONCERNED ABOUT AUTOIMMUNE DISORDERS DUE TO THAT EXPERIENCING SOME THINGS; BILATERAL EAR INFECTION (INNER AND OUTER EAR); DIARRHEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown), dose was not reported, 1 total, administered on 14-JUN-2021 into left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUL-2021, the patient experienced tinnitus, bilateral ear infection (inner and outer ear), diarrhea. The patient was generally a healthy person and did not get sick. On an unspecified date, the patient was concerned about autoimmune disorders and due to that patient had experienced some things. On 10-JUL-2021, the patient saw a physician who gave antibiotic (amoxicillin) for the ear infection. The physician was surprised since the patient was not exposed to anything that would cause the side effects.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bilateral ear infection (inner and outer ear), and diarrhea, and the outcome of concerned about autoimmune disorders due to that experiencing some things was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210726085-covid-19 vaccine ad26.cov2.s-concerned about autoimmune disorders due to that experiencing some things. 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: Neurological symptom
Clinical narrative: POSSIBLE GUILLAIN BARRE SYNDROME SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient 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-JUL-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 JUL-2021, the subject experienced possible guillain barre syndrome symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible guillain barre syndrome symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SUFFERED BY PREETY BAD HEADACHE FOR 3 WHOLE DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUL-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 JUL-2021, the subject experienced suffered by preety bad headache for 3 whole days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffered by preety bad headache for 3 whole days was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Hypoaesthesia, Ocular discomfort
Clinical narrative: RIGHT EYE STARTED ACTING UP; ANXIETY; NUMB FACE/JAW/CHEEK/FOREHEAD; HEADACHE; This spontaneous report received from a patient concerned a 74 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: 1808982, and expiry: 07-AUG-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced numb face/jaw/cheek/forehead.  On an unspecified date, the subject experienced right eye started acting up, and anxiety. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 13-MAY-2021, had not recovered from numb face/jaw/cheek/forehead, and the outcome of right eye started acting up and anxiety was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Maternal exposure during pregnancy, Myalgia, Nausea
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; FEELING UNWELL; FATIGUE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a patient concerned a 32 year old female. The patient was enrolled in a non-company sponsored study regulatory authority: COVID 19 Vaccines regulatory authority Registry number: C00103). The patient's weight was 90.7 kilograms, and height was not reported.  The patient's concurrent conditions included anxiety, asthma, depression, and polycystic ovarian syndrome. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prevention covid-19 (covid-19 immunisation). Concomitant medications included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide.  On MAR-2021, the patient experienced maternal exposure during pregnancy. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced muscle pain. On MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, feeling unwell, muscle pain, sore arm, maternal exposure during pregnancy and nausea was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, feeling unwell, fatigue, muscle pain, and nausea was related.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; FEELING UNWELL; FATIGUE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a patient concerned a 32 year old female. The patient was enrolled in a non-company sponsored study regulatory authority: COVID 19 Vaccines regulatory authority Registry number: C00103). The patient's weight was 90.7 kilograms, and height was not reported.  The patient's concurrent conditions included anxiety, asthma, depression, and polycystic ovarian syndrome. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prevention covid-19 (covid-19 immunisation). Concomitant medications included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide.  On MAR-2021, the patient experienced maternal exposure during pregnancy. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced muscle pain. On MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, feeling unwell, muscle pain, sore arm, maternal exposure during pregnancy and nausea was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm, feeling unwell, fatigue, muscle pain, and nausea was related.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Muscle rupture, Skin discolouration
Clinical narrative: TORE RIGHT LEG MUSCLE AND RIGHT ARM MUSCLE; BLACKENED RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 69 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: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, the patient experienced tore in a muscle in the right leg that turned black while getting off the couch and the blackened right arm leg was covered from the knee down. The patient went to the hospital for evaluation. It was concluded that it was not a blood clot.  On 27-APR-2021, the patient experienced tore in a muscle in the right arm which also turned black and the blackened right arm extended from the shoulder to the wrist down. Medical providers indicated it was not a blood clot. The patient right leg and arm was healed in 6 and 4 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tore right leg muscle and right arm muscle and blackened right arm extended from the shoulder to the wrist down on to blackened right arm and right leg 01-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210727926- Covid-19 vaccine ad26.cov2.s- tore right leg muscle and right arm muscle. 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.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Disorientation, Eye pain, Feeling abnormal, Headache
Clinical narrative: MEMORY LOSS; DISORIENTATION; EYE PAIN; FEELING WEIRD; FEVER; VERY INTENSE HEADACHES/ PRESSURE IN THE HEAD; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies, drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced memory loss. On 23-MAY-2021, the subject experienced disorientation. On 23-MAY-2021, the subject experienced eye pain. On 23-MAY-2021, the subject experienced feeling weird. On 23-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced very intense headaches/ pressure in the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye pain, and fever on 24-MAY-2021, had not recovered from very intense headaches/ pressure in the head, disorientation, and memory loss, and the outcome of feeling weird was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MEMORY LOSS; DISORIENTATION; EYE PAIN; FEELING WEIRD; FEVER; VERY INTENSE HEADACHES/ PRESSURE IN THE HEAD; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies, drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced memory loss. On 23-MAY-2021, the subject experienced disorientation. On 23-MAY-2021, the subject experienced eye pain. On 23-MAY-2021, the subject experienced feeling weird. On 23-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced very intense headaches/ pressure in the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye pain, and fever on 24-MAY-2021, had not recovered from very intense headaches/ pressure in the head, disorientation, and memory loss, and the outcome of feeling weird was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: TINGLING IN BOTH LEGS; NUMBNESS IN BOTH LEGS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use and no diagnostic data available. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, and expiry: 06-SEP-2021) .5 ml, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced tingling in both legs. On 01-JUN-2021, the subject experienced numbness in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in both legs, and numbness in both legs. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankle fracture, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: BROKEN ANKLE; TWO DEEP VEIN THROMBOSIS IN LEFT LEG; PULMONARY EMBOLISM IN BOTH LUNGS; This spontaneous report received from a patient concerned a 44-year-old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drug included Skyrizi (risankizumab) [form of administration unknown, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date (reported as several months earlier), the patient broke her ankle. On unspecified date, in JUN-2021, the patient had pain and swelling in her left leg. The patient went to an urgent care to check it and discovered that she had two deep vein thrombosis in her left leg and pulmonary embolism in both lungs. She received treatment (unspecified) for it and was recovering. The patient's physician felt that the events was not due to Skyrizi but possibly due to Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from two deep vein thrombosis in left leg, and pulmonary embolism in both lungs, and the outcome of broken ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210729466-covid-19 vaccine ad26.cov2.s  two deep vein thrombosis in left leg, and pulmonary embolism in both lungs. This event(s) is considered unassessable. The event(s) has a unknown 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: Adverse event
Clinical narrative: ADVERSE EVENT NOT SPECIFIED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from adverse event not specified. This report was non-serious.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. The patient's weight was 95.5 kilograms, and height was 187.9 centimeters.  The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205AZ1A and expiry: UNKNOWN),at a frequency of one total, dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced clinical vaccine failure and confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive, and PCR (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number: 90000185952.; Sender's Comments: V0: 20210731093-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical 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
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Dizziness, Gait disturbance, Neuralgia, Paraesthesia
Clinical narrative: NERVE PAIN (SHOOTING PAIN IN BOTH LEGS, BOTH ARMS AND IN BETWEEN SHOULDERS AND UPPER BACK); CONSTANT TINGLING SENSATION; DISCOMFORT WHEN WALKING (ALMOST FELL DOWN ONCE); BRAIN FEELS DIZZY (LIGHTHEADEDNESS); MINOR ADVERSE EVENTS; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's past medical history included back pain (nerve pain), and marijuana abuse, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with gabapentin for back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced minor adverse events. On 07-JUL-2021, the subject experienced nerve pain (shooting pain in both legs, both arms and in between shoulders and upper back). On 07-JUL-2021, the subject experienced constant tingling sensation. On 07-JUL-2021, the subject experienced discomfort when walking (almost fell down once). On 07-JUL-2021, the subject experienced brain feels dizzy (lightheadedness). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor adverse events on 02-JUL-2021, and had not recovered from nerve pain (shooting pain in both legs, both arms and in between shoulders and upper back), constant tingling sensation, discomfort when walking (almost fell down once), and brain feels dizzy (lightheadedness). This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site pain, Lip blister, Paraesthesia oral
Clinical narrative: TWO LITTLE BLISTERS ON LOWER LIP; TINGLING SENSATION ON LOWER LIP; MILD DIARRHEA; PAIN ON THE INJECTION SITE LEFT ARM; TIREDNESS; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight was 190 pounds, and height was 195.58 centimeters. The patient's pre-existing medical conditions included the patient at the time of reporting was not pregnant .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced pain on the injection site left arm. On 26-JUN-2021, the subject experienced tiredness. On 27-JUN-2021, the subject experienced mild diarrhea. On 10-JUL-2021, the subject experienced tingling sensation on lower lip. On 13-JUL-2021, the subject experienced two little blisters on lower lip. The patient visited to the Doctor/healthcare professional office for the blisters in lower lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild diarrhea on 27-JUN-2021, tingling sensation on lower lip on 11-JUL-2021, pain on the injection site left arm on 29-JUN-2021, and tiredness on 26-JUN-2021, and had not recovered from two little blisters on lower lip. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-JUN-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 11-JUL-2021, the subject experienced covid-19 test positive. Laboratory data 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 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000185972.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia, Poor peripheral circulation
Clinical narrative: TOES ARE TINGLING; POOR CIRCULATION; NUMBNESS; JOINT PAIN; This spontaneous report received from a patient 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-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 toes are tingling, poor circulation, numbness, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the toes are tingling, poor circulation, numbness and joint pain was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS TO FLARE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced psoriasis to flare. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of psoriasis to flare was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.