chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: vaccine in an unknown thigh; cellulitis; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) 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 (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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 reported. The pediatric patient received Kinrix in an unknown thigh which led to vaccine administered at inappropriate site.  Less than a week after receiving Kinrix, the patient developed cellulitis.  The reporter consented to follow up. The reporter and healthcare professional gave permission to contact them for further information. No other information was shared. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR154890:Same reporter US-GLAXOSMITHKLINE-US2021AMR154892:Same reporter US-GLAXOSMITHKLINE-US2021153977:Same reporter
Age: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: vaccine in an right thigh; cellulitis; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a 5-year-old patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) 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 (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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 pediatric patient received Kinrix in right thigh which led to vaccine administered at inappropriate site.  Less than a week after receiving Kinrix, the patient developed cellulitis.  The reporter consented to follow up. The reporter and healthcare professional gave permission to contact them for further information. No other information was shared. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR154891:Same reporter US-GLAXOSMITHKLINE-US2021153977:same reporter US-GLAXOSMITHKLINE-US2021AMR154890:same reporter
Age: 0.5
Sex: F
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose /injected after /finished 6th month /second dose in 8th month/reminding/booster dose should be injected; This case was reported by a consumer via media and described the occurrence of inappropriate age at vaccine administration in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero 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 are as follows: The case was reported by patient's parent. The reporter reported that, she had problem with Bexsero vaccination for her children. The patient received 1st dose after she finished 6th month and then 2nd dose in 8th month, which led to inappropriate age at vaccine administration. The reporter reported that from the card they could now read that 3rd dose which was reminding/booster dose should be injected.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: How long does the muscle/ ache / last /after receiving the 1st vaccine?; How long does the /joint ache / last /after receiving the 1st vaccine?; headache /last fir after receiving the 1st vaccine?; chills /last fir after receiving the 1st vaccine?; This case was reported by a consumer via media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, joint pain, headache and chills. On an unknown date, the outcome of the muscle pain, joint pain, headache and chills were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, joint pain, headache and chills to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced muscle/joint ache, headache and chills. The reporter asked  that how long did the muscle/joint ache, headache and chills lasted for after receiving the 1st vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to Covid, I did not get my second dose / in the recommended six months / can I take thesecond one 18 months after the first one?; This case was reported by a consumer via media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received, 18 months ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not applicable for this report. Due to Covid, the patient did not get 2nd dose of Shingrix in the recommended six months timeframe, which led to social problem. The patient asked does he/she have to take the 1st shot again, or could take the 2nd one 18 months after the 1st one. No contact details were available.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Infanrix to an adult patient about "2 months ago".; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In May 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. In May 2021, unknown after receiving Infanrix and Infanrix 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: The age at vaccination was not reported. About 2 months ago from the date of reporting, the adult patient received Infanrix which led to inappropriate age at vaccine administration. Reporter stated that, the patient was doing fine. Reporter did not have any additional demographic details about the patient. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered to patient at inappropriate age.; 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 12-year-old female patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2021, the patient received Infanrix (intramuscular) .5 ml and Infanrix Pre-Filled Syringe Device. On 28th June 2021, unknown after receiving Infanrix and Infanrix 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 reported as follows: The health care professional (Medical Assistant) reported that INFANRIX administered to a 11 years old patient which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary reporter. The reporter consented to follow up. This case has been linked with US2021152836,US2021152845 and US2021152840 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152845:same reporter US-GLAXOSMITHKLINE-US2021152840:same reporter US-GLAXOSMITHKLINE-US2021152836:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: was administered a dose of SHINGRIX VAC / that had been stored in a freezer  /had no symptoms; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number NE49X, expiry date 23rd August 2022) for prophylaxis.   On 29th April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The health care professional (Medical Assistant) reported On 29th April 2021 the patient was administered a dose of Shingrix vaccine 1D 50MCG/O.5ML that had been stored in a freezer which led to incorrect storage of drug. The reporter contacted the patient and the patient had no symptoms, Product Storage Error was resolved. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The Medical Assistant that administered the vaccine to the patient. This adverse event has been previously reported to the Vaccine Adverse Event Reporting System (VAERS) database by the medical clinic.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only the adjuvant portion of the vaccine; administration of only the adjuvant 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 16th July 2021, the patient received Menveo. On 16th July 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 case details were reported as follows: Age at vaccination was not reported. Pharmacist reported the administration of only the adjuvant portion of the Menveo vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The diluent was administrated on the same day of reporting.  The reporter had no details about the patient nor the expiration or lot number of the vial.  No further events were reported.  Health care professional (HCP) agreed to be contacted for follow-up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: vaccine in an unknown thigh; cellulitis; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) 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 (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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 reported. The patient received Kinrix in an unknown thigh which led to vaccine administered at inappropriate site.  Less than a week after receiving Kinrix, the patient developed cellulitis.  No other information was shared. The reporter consented to follow up. The reporter and healthcare professional gave permission to contact them for further information. This is 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR154890:Same reporter US-GLAXOSMITHKLINE-US2021AMR154891:Same reporter US-GLAXOSMITHKLINE-US2021AMR154892:same reporter
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 6-25-21 with first dose/  second dose was administered today (07/16/21); This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number DS754, expiry date 18th December 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 16th July 2021, the patient received the 2nd dose of Shingrix. On 16th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional case details were reported as follows: The Shingrix 1st dose received in 25th June 2021, batch number 5454X and Expiration date was 25th October 2022.  Health care professional reported regarding a patient vaccinated 2nd dose of Shingrix, on the day of reporting that was later than recommended schedule which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 / on :8 march 2019 dint get 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 8th 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 case details were reported as follows: The case was reported by the patient. Age at vaccination was not applicable for this report. The patient did not get 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. Health care professional (Hcp) also believed the wife may have also but unsure.  VAERS details were reported for 1st dose. No other detail of vaccine provided. The reporter consented to follow up. The case had been linked with US2021AMR155431 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR155431:Same reporter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Musculoskeletal discomfort, Musculoskeletal stiffness, Neck mass, Pharyngeal swelling
Clinical narrative: SWELLING IN THE CHIN; SWELLING IN THE DOWN THROAT; SWELLING IN THE NECK; THROAT IS GOING TO CLOSE; LUMP IN THE FRONT OF THE NECK; UNABLE TO TURN NECK OR SIT; PAINFUL TO LIE DOWN; 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 rheumatoid arthritis, and other pre-existing medical conditions included the patient had given the plant based trigger shot for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 10/JUL/2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced lump in the front of the neck. On APR-2021, the subject experienced unable to turn neck or sit. On APR-2021, the subject experienced painful to lie down. On 06-APR-2021, the subject experienced swelling in the neck. On 06-APR-2021, the subject experienced throat is going to close. On 14-JUL-2021, the subject experienced swelling in the chin. On 14-JUL-2021, the subject experienced swelling in the down throat. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL, Diagnostic ultrasound (NR: not provided) NORMAL, and X-ray (NR: not provided) NORMAL. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat is going to close, lump in the front of the neck, unable to turn neck or sit, and painful to lie down, and had not recovered from swelling in the neck, swelling in the chin, and swelling in the down throat. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Throat tightness, Ultrasound scan, X-ray
Clinical narrative: SWELLING IN THE CHIN; SWELLING IN THE DOWN THROAT; SWELLING IN THE NECK; THROAT IS GOING TO CLOSE; LUMP IN THE FRONT OF THE NECK; UNABLE TO TURN NECK OR SIT; PAINFUL TO LIE DOWN; 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 rheumatoid arthritis, and other pre-existing medical conditions included the patient had given the plant based trigger shot for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 10/JUL/2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced lump in the front of the neck. On APR-2021, the subject experienced unable to turn neck or sit. On APR-2021, the subject experienced painful to lie down. On 06-APR-2021, the subject experienced swelling in the neck. On 06-APR-2021, the subject experienced throat is going to close. On 14-JUL-2021, the subject experienced swelling in the chin. On 14-JUL-2021, the subject experienced swelling in the down throat. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL, Diagnostic ultrasound (NR: not provided) NORMAL, and X-ray (NR: not provided) NORMAL. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat is going to close, lump in the front of the neck, unable to turn neck or sit, and painful to lie down, and had not recovered from swelling in the neck, swelling in the chin, and swelling in the down throat. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear pain, Laryngitis, Suspected COVID-19, Vaccination failure
Clinical narrative: EAR ACHE; LARYNGITIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old female. Initial information was processed along with the additional information received on 16-JUL-2021 and 19-JUL-2021. The patient's weight was 137 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user and non smoker and also the patient was healthy. The patient experienced drug allergy when treated with codeine for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and  expiry: unknown) dose was not reported, 1 total administered on  05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-JUL-2021, the patient underwent a covid-19 test and on 14-JUL-2021, the results came as positive (suspected clinical vaccination failure and suspected covid-19 infection). It was reported that the patient's covid-19 symptoms started with an ear ache, scratchy throat and laryngitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure, ear ache and laryngitis was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality Complaint -90000186156.; Sender's Comments: V0:20210733616-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Blood test, Electrocardiogram
Clinical narrative: POTENTIAL BLOOD CLOT SIDE EFFECTS; 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 past medical history included child delivered. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced potential blood clot side effects. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, and EKG (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential blood clot side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood alkaline phosphatase, Blood alkaline phosphatase increased, Blood pressure measurement, Chest discomfort
Clinical narrative: FOGGY THINKING / OUT OF IT / FEEL LIKE BODY UNDERWATER; HIGH EOSINOPHILS; ALKALINE PHOSPHATASE LEVELS DOUBLED; INCREASED MEAN PLATELET VOLUME (MPV); HEART RACING / HEART RACING AT BEDTIME; SHAKING; DISCOMFORT IN CHEST / HEAVY FEELING /PRESSURE /TIGHT FEELING / TIGHTNESS; DIFFICULTY BREATHING DEEP; SWOLLEN GLANDS IN ARMPITS; NUMB TONGUE; GASTRO PAIN; LOOSE STOOLS; ELEVATED BLOOD PRESSURE; TONGUE SORES; EYE REDNESS; REDNESS CHEEKS WITH DRY FLAKY SKIN; HYPOTENSION (FELT FAINT/ LIGHT-HEAD/FATIGUE); INTENSE BODY PAIN; TINGLING IN CALVES; PAIN IN CHEST; ITCHY CHEEKS WITH DRY FLAKY SKIN; CHILLS; FEVER; 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 foggy thinking / out of it / feel like body underwater, high eosinophils, alkaline phosphatase levels doubled, increased mean platelet volume (mpv), heart racing / heart racing at bedtime, shaking, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, chills, and fever. Laboratory data (dates unspecified) included: Alkaline phosphatase (NR: not provided) Alkaline phosphatase levels doubled, Blood pressure (NR: not provided) elevated blood pressure, Eosinophils (NR: not provided) High eosinophils, and Mean platelet volume (NR: not provided) increase in mean platelet volume. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart racing / heart racing at bedtime, shaking, fever, chills, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, foggy thinking / out of it / feel like body underwater, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, high eosinophils, alkaline phosphatase levels doubled and increased mean platelet volume (mpv) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Dyspnoea, Eosinophil count
Clinical narrative: FOGGY THINKING / OUT OF IT / FEEL LIKE BODY UNDERWATER; HIGH EOSINOPHILS; ALKALINE PHOSPHATASE LEVELS DOUBLED; INCREASED MEAN PLATELET VOLUME (MPV); HEART RACING / HEART RACING AT BEDTIME; SHAKING; DISCOMFORT IN CHEST / HEAVY FEELING /PRESSURE /TIGHT FEELING / TIGHTNESS; DIFFICULTY BREATHING DEEP; SWOLLEN GLANDS IN ARMPITS; NUMB TONGUE; GASTRO PAIN; LOOSE STOOLS; ELEVATED BLOOD PRESSURE; TONGUE SORES; EYE REDNESS; REDNESS CHEEKS WITH DRY FLAKY SKIN; HYPOTENSION (FELT FAINT/ LIGHT-HEAD/FATIGUE); INTENSE BODY PAIN; TINGLING IN CALVES; PAIN IN CHEST; ITCHY CHEEKS WITH DRY FLAKY SKIN; CHILLS; FEVER; 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 foggy thinking / out of it / feel like body underwater, high eosinophils, alkaline phosphatase levels doubled, increased mean platelet volume (mpv), heart racing / heart racing at bedtime, shaking, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, chills, and fever. Laboratory data (dates unspecified) included: Alkaline phosphatase (NR: not provided) Alkaline phosphatase levels doubled, Blood pressure (NR: not provided) elevated blood pressure, Eosinophils (NR: not provided) High eosinophils, and Mean platelet volume (NR: not provided) increase in mean platelet volume. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart racing / heart racing at bedtime, shaking, fever, chills, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, foggy thinking / out of it / feel like body underwater, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, high eosinophils, alkaline phosphatase levels doubled and increased mean platelet volume (mpv) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eosinophil count increased, Erythema, Feeling abnormal, Hypertension, Hypoaesthesia oral
Clinical narrative: FOGGY THINKING / OUT OF IT / FEEL LIKE BODY UNDERWATER; HIGH EOSINOPHILS; ALKALINE PHOSPHATASE LEVELS DOUBLED; INCREASED MEAN PLATELET VOLUME (MPV); HEART RACING / HEART RACING AT BEDTIME; SHAKING; DISCOMFORT IN CHEST / HEAVY FEELING /PRESSURE /TIGHT FEELING / TIGHTNESS; DIFFICULTY BREATHING DEEP; SWOLLEN GLANDS IN ARMPITS; NUMB TONGUE; GASTRO PAIN; LOOSE STOOLS; ELEVATED BLOOD PRESSURE; TONGUE SORES; EYE REDNESS; REDNESS CHEEKS WITH DRY FLAKY SKIN; HYPOTENSION (FELT FAINT/ LIGHT-HEAD/FATIGUE); INTENSE BODY PAIN; TINGLING IN CALVES; PAIN IN CHEST; ITCHY CHEEKS WITH DRY FLAKY SKIN; CHILLS; FEVER; 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 foggy thinking / out of it / feel like body underwater, high eosinophils, alkaline phosphatase levels doubled, increased mean platelet volume (mpv), heart racing / heart racing at bedtime, shaking, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, chills, and fever. Laboratory data (dates unspecified) included: Alkaline phosphatase (NR: not provided) Alkaline phosphatase levels doubled, Blood pressure (NR: not provided) elevated blood pressure, Eosinophils (NR: not provided) High eosinophils, and Mean platelet volume (NR: not provided) increase in mean platelet volume. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart racing / heart racing at bedtime, shaking, fever, chills, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, foggy thinking / out of it / feel like body underwater, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, high eosinophils, alkaline phosphatase levels doubled and increased mean platelet volume (mpv) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Lymphadenopathy, Mean platelet volume, Mean platelet volume increased, Ocular hyperaemia
Clinical narrative: FOGGY THINKING / OUT OF IT / FEEL LIKE BODY UNDERWATER; HIGH EOSINOPHILS; ALKALINE PHOSPHATASE LEVELS DOUBLED; INCREASED MEAN PLATELET VOLUME (MPV); HEART RACING / HEART RACING AT BEDTIME; SHAKING; DISCOMFORT IN CHEST / HEAVY FEELING /PRESSURE /TIGHT FEELING / TIGHTNESS; DIFFICULTY BREATHING DEEP; SWOLLEN GLANDS IN ARMPITS; NUMB TONGUE; GASTRO PAIN; LOOSE STOOLS; ELEVATED BLOOD PRESSURE; TONGUE SORES; EYE REDNESS; REDNESS CHEEKS WITH DRY FLAKY SKIN; HYPOTENSION (FELT FAINT/ LIGHT-HEAD/FATIGUE); INTENSE BODY PAIN; TINGLING IN CALVES; PAIN IN CHEST; ITCHY CHEEKS WITH DRY FLAKY SKIN; CHILLS; FEVER; 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 foggy thinking / out of it / feel like body underwater, high eosinophils, alkaline phosphatase levels doubled, increased mean platelet volume (mpv), heart racing / heart racing at bedtime, shaking, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, chills, and fever. Laboratory data (dates unspecified) included: Alkaline phosphatase (NR: not provided) Alkaline phosphatase levels doubled, Blood pressure (NR: not provided) elevated blood pressure, Eosinophils (NR: not provided) High eosinophils, and Mean platelet volume (NR: not provided) increase in mean platelet volume. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart racing / heart racing at bedtime, shaking, fever, chills, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, foggy thinking / out of it / feel like body underwater, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, high eosinophils, alkaline phosphatase levels doubled and increased mean platelet volume (mpv) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Palpitations, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: FOGGY THINKING / OUT OF IT / FEEL LIKE BODY UNDERWATER; HIGH EOSINOPHILS; ALKALINE PHOSPHATASE LEVELS DOUBLED; INCREASED MEAN PLATELET VOLUME (MPV); HEART RACING / HEART RACING AT BEDTIME; SHAKING; DISCOMFORT IN CHEST / HEAVY FEELING /PRESSURE /TIGHT FEELING / TIGHTNESS; DIFFICULTY BREATHING DEEP; SWOLLEN GLANDS IN ARMPITS; NUMB TONGUE; GASTRO PAIN; LOOSE STOOLS; ELEVATED BLOOD PRESSURE; TONGUE SORES; EYE REDNESS; REDNESS CHEEKS WITH DRY FLAKY SKIN; HYPOTENSION (FELT FAINT/ LIGHT-HEAD/FATIGUE); INTENSE BODY PAIN; TINGLING IN CALVES; PAIN IN CHEST; ITCHY CHEEKS WITH DRY FLAKY SKIN; CHILLS; FEVER; 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 foggy thinking / out of it / feel like body underwater, high eosinophils, alkaline phosphatase levels doubled, increased mean platelet volume (mpv), heart racing / heart racing at bedtime, shaking, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, chills, and fever. Laboratory data (dates unspecified) included: Alkaline phosphatase (NR: not provided) Alkaline phosphatase levels doubled, Blood pressure (NR: not provided) elevated blood pressure, Eosinophils (NR: not provided) High eosinophils, and Mean platelet volume (NR: not provided) increase in mean platelet volume. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart racing / heart racing at bedtime, shaking, fever, chills, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, foggy thinking / out of it / feel like body underwater, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, high eosinophils, alkaline phosphatase levels doubled and increased mean platelet volume (mpv) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tongue ulceration, Tremor
Clinical narrative: FOGGY THINKING / OUT OF IT / FEEL LIKE BODY UNDERWATER; HIGH EOSINOPHILS; ALKALINE PHOSPHATASE LEVELS DOUBLED; INCREASED MEAN PLATELET VOLUME (MPV); HEART RACING / HEART RACING AT BEDTIME; SHAKING; DISCOMFORT IN CHEST / HEAVY FEELING /PRESSURE /TIGHT FEELING / TIGHTNESS; DIFFICULTY BREATHING DEEP; SWOLLEN GLANDS IN ARMPITS; NUMB TONGUE; GASTRO PAIN; LOOSE STOOLS; ELEVATED BLOOD PRESSURE; TONGUE SORES; EYE REDNESS; REDNESS CHEEKS WITH DRY FLAKY SKIN; HYPOTENSION (FELT FAINT/ LIGHT-HEAD/FATIGUE); INTENSE BODY PAIN; TINGLING IN CALVES; PAIN IN CHEST; ITCHY CHEEKS WITH DRY FLAKY SKIN; CHILLS; FEVER; 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 foggy thinking / out of it / feel like body underwater, high eosinophils, alkaline phosphatase levels doubled, increased mean platelet volume (mpv), heart racing / heart racing at bedtime, shaking, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, chills, and fever. Laboratory data (dates unspecified) included: Alkaline phosphatase (NR: not provided) Alkaline phosphatase levels doubled, Blood pressure (NR: not provided) elevated blood pressure, Eosinophils (NR: not provided) High eosinophils, and Mean platelet volume (NR: not provided) increase in mean platelet volume. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart racing / heart racing at bedtime, shaking, fever, chills, discomfort in chest / heavy feeling /pressure /tight feeling / tightness, difficulty breathing deep, swollen glands in armpits, numb tongue, gastro pain, loose stools, elevated blood pressure, tongue sores, eye redness, redness cheeks with dry flaky skin, foggy thinking / out of it / feel like body underwater, hypotension (felt faint/ light-head/fatigue), intense body pain, tingling in calves, pain in chest, itchy cheeks with dry flaky skin, high eosinophils, alkaline phosphatase levels doubled and increased mean platelet volume (mpv) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia
Clinical narrative: 103 DEGREE FEVER; COULD NOT SLEEP OR ANYTHING; This spontaneous report received from a consumer concerned an 18 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, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced could not sleep or anything. Treatment medications included: paracetamol. On 23-JUN-2021, the subject experienced 103 degree fever. Laboratory data included: Fever (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever on 24-JUN-2021, and the outcome of could not sleep or anything was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Hypokinesia, Muscular weakness, Pain in extremity
Clinical narrative: COUGHING; DULL CHEST PAIN; TINGLING IN ARMS DURING THE NIGHT MORNING; WAKE UP IN THE NIGHT IN PAIN; CANNOT USE ARMS; PAIN IN UPPER ARM TOWARD NECK, UPPER LEGS AND FINGERS; WEAKNESS IN ARMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced coughing, dull chest pain, tingling in arms during the night morning, wake up in the night in pain, cannot use arms, pain in upper arm toward neck, upper legs and fingers, and weakness in arms. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in arms during the night morning, had not recovered from pain in upper arm toward neck, upper legs and fingers, and coughing, and the outcome of dull chest pain, weakness in arms, wake up in the night in pain and cannot use arms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: COUGHING; DULL CHEST PAIN; TINGLING IN ARMS DURING THE NIGHT MORNING; WAKE UP IN THE NIGHT IN PAIN; CANNOT USE ARMS; PAIN IN UPPER ARM TOWARD NECK, UPPER LEGS AND FINGERS; WEAKNESS IN ARMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced coughing, dull chest pain, tingling in arms during the night morning, wake up in the night in pain, cannot use arms, pain in upper arm toward neck, upper legs and fingers, and weakness in arms. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in arms during the night morning, had not recovered from pain in upper arm toward neck, upper legs and fingers, and coughing, and the outcome of dull chest pain, weakness in arms, wake up in the night in pain and cannot use arms was not reported. This report was non-serious.