chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose of Shingrix 2 years ago.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 17th May 2019, 2 years prior to reporting).   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 reporter consented to follow up via email. This case had been linked with US2019105061, reported by same reporter.; Sender's Comments: Pharmacist states that a patient received their first dose of Shingrix 2 years ago.  ~~~~~~~Consented to follow up.Call Notes:Please follow up via email. US-GLAXOSMITHKLINE-US2019105061:Same reporter
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month old patient accidentally received Kinrix; patient accidentally received Kinrix instead of Infanrix; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was practice manager.  The 4 month old patient accidentally received Kinrix instead of Infanrix which led to inappropriate age at vaccine administration and wrong vaccine administration. No symptoms were reported.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: rash under the right breast and along the right side/ affected area is/ painful/  pain has lessened significantly; affected area  /had a burning sensation/ the burning sensation under the skin has subsided; affected area is discolored,/discoloration is now minimal; rash under the right breast and along the right side/ affected area is / itchy/ rash is still very itchy; affected area is /warm to the touch; affected area is discolored, warm to the touch, painful; first/ in November of 2020/ 2nd dose in February of 2021/ an episode of Shingles/ suspected Vaccination failure; experiencing an episode of Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (episodes lasting between 2 and 3 weeks).   In February 2021, the patient received the 2nd dose of Shingrix. In November 2020, the patient received the 1st dose of Shingrix. In May 2021, less than 4 months after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash, burning sensation skin, skin discoloration, pruritus, skin warm and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, skin discoloration, pruritus, skin warm and pain were not recovered/not resolved and the outcome of the burning sensation skin was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, burning sensation skin, skin discoloration, pruritus, skin warm and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient reported that she have been experiencing an episode of Shingles for approximately 4 weeks. The patient reported symptoms include rash under the right breast and along the right side, affected area was discolored, warm to the touch, painful, itchy, and had a burning sensation under the skin. The patient reported discoloration was minimal at the time of reporting, the burning sensation under the skin had subsided, and the pain had lessened significantly. The rash was still very itchy. The patient stated this was the longest episode of Shingles she had experienced. This case was considered as suspected vaccination failure as laboratory test confirmation of shingles was unknown at the time of reporting. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Skin burning sensation, Skin discolouration, Skin warm, Vaccination failure
Clinical narrative: rash under the right breast and along the right side/ affected area is/ painful/  pain has lessened significantly; affected area  /had a burning sensation/ the burning sensation under the skin has subsided; affected area is discolored,/discoloration is now minimal; rash under the right breast and along the right side/ affected area is / itchy/ rash is still very itchy; affected area is /warm to the touch; affected area is discolored, warm to the touch, painful; first/ in November of 2020/ 2nd dose in February of 2021/ an episode of Shingles/ suspected Vaccination failure; experiencing an episode of Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (episodes lasting between 2 and 3 weeks).   In February 2021, the patient received the 2nd dose of Shingrix. In November 2020, the patient received the 1st dose of Shingrix. In May 2021, less than 4 months after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash, burning sensation skin, skin discoloration, pruritus, skin warm and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, skin discoloration, pruritus, skin warm and pain were not recovered/not resolved and the outcome of the burning sensation skin was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, burning sensation skin, skin discoloration, pruritus, skin warm and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient reported that she have been experiencing an episode of Shingles for approximately 4 weeks. The patient reported symptoms include rash under the right breast and along the right side, affected area was discolored, warm to the touch, painful, itchy, and had a burning sensation under the skin. The patient reported discoloration was minimal at the time of reporting, the burning sensation under the skin had subsided, and the pain had lessened significantly. The rash was still very itchy. The patient stated this was the longest episode of Shingles she had experienced. This case was considered as suspected vaccination failure as laboratory test confirmation of shingles was unknown at the time of reporting. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: liquid came out the needle during administration and the patient was administered less than the recommended dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number F93YS, expiry date 8th November 2022) for prophylaxis.   On 14th June 2021, the patient received Shingrix. On 14th June 2021, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: The reporter stated that Shingrix liquid came out of the needle during administration and the patient was administered less than the recommended dose which led to underdose. The reporter did not consent to follow up.  Note-As the exact significant amount of dose missed was not mentioned, event underdose was coded conservatively.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was the vaccine applied and Boostrix didn´t; Kinrix was the vaccine applied and Boostrix didn´t; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th April 2021, unknown after receiving Kinrix and an unknown time after starting Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not reported, however the patient could be 8 years or 9 years old at the time of vaccination. A health care provider informed that a  Patient received a Kinrix dose instead of Boostrix at an inappropriate age and wanted information to proceed in immunization against DTAP-IPV, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. This case is linked to US2021129069; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129069:same reporter
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administrated with an expired dose / expired on May 25 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-month-old male patient who received DTPa (Infanrix) (batch number G5BE3, expiry date 25th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Infanrix and Infanrix 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 age at the vaccination was not reported. The patient was administered Infanrix, which was already expired on 25th May 2021. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 07May2021, the patient received the first dose / on 14JUN2021 / received the second dose / too early; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 14th June 2021, the patient received the 2nd dose of Shingrix. On 14th June 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 details were provided as follows: The age at the vaccination was not reported. The pharmacist reported that the patient received first dose of Shingrix. The patient inadvertently received the second dose at shorter than recommended interval, which led to shortening of vaccination schedule.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: received a dose of Boostrix instead of a dose of Infanrix; received a dose of Boostrix / DOB 08-DEC-2014; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number CM7KN, expiry date unknown) for prophylaxis.   On 14th April 2021, the patient received Boostrix (intramuscular). On 14th April 2021, unknown after receiving Boostrix, the patient experienced accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The nurse reported that 6 year old patient received a dose of Boostrix instead of a dose of Infanrix vaccine, which led to accidental underdose and inappropriate age at vaccine administration. The reporter consented to follow up. The reporter did not have the expiration date for the product. No further information provided. This case was linked with case US2021129089, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129089:same reporter
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a female 2 year old patient on 6/11/21; 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 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, 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 11th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th June 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 provided were as follows: Health care professional called and reported that Kinrix vaccine was administered to a 2 year old patient which led to inappropriate age at vaccine administration. No further event was reported. The reporter did not consent nor declined follow-up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Therapeutic response unexpected
Clinical narrative: FELT BETTER/MORE ENERGY/ ABLE TO FUNCTION/ WEIGHT GAIN/ INCREASED APPETITE/BLOOD CLOTS IN LUNGS AND IN LEFT ARM GONE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included t-cell lymphoma in both lungs, inoperable pelvic tumor maybe be prostate, blood clots in lungs, and blood clots in left arm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1806609, expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included rivaroxaban for blood clot in left arm, and blood clot in lung. On 09-APR-2021, the subject experienced felt better/more energy/ able to function/ weight gain/ increased appetite/blood clots in lungs and in left arm gone. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, and CT scan (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt better/more energy/ able to function/ weight gain/ increased appetite/blood clots in lungs and in left arm gone was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Palpitations, Pyrexia
Clinical narrative: VERTIGO; RACING HEART; BLURRED VISION; CHILLS; FEVER; BODY ACHES AND PAIN; HEADACHE; This spontaneous report received from a parent concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient 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-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced body aches and pain. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced vertigo. On 03-JUN-2021, the subject experienced racing heart. On 03-JUN-2021, the subject experienced blurred vision. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, chills, body aches and pain, vertigo, and racing heart, and the outcome of blurred vision was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: VERTIGO; RACING HEART; BLURRED VISION; CHILLS; FEVER; BODY ACHES AND PAIN; HEADACHE; This spontaneous report received from a parent concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient 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-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced body aches and pain. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced vertigo. On 03-JUN-2021, the subject experienced racing heart. On 03-JUN-2021, the subject experienced blurred vision. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, chills, body aches and pain, vertigo, and racing heart, and the outcome of blurred vision was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia
Clinical narrative: INSOMNIA; PAIN IN HIP JOINT; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 198 pounds, and height was 63 inches. The patient's concurrent conditions included epilepsy, non-smoker, non-alcohol user, depression, and seizure, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, expiry: 18-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included escitalopram oxalate for depression, and phenytoin for seizure. On 06-JUN-2021, the subject experienced insomnia. On 06-JUN-2021, the subject experienced pain in hip joint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in hip joint, and had not recovered from insomnia. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Sleep apnoea syndrome
Clinical narrative: TIREDNESS; MIGRAINE (WHICH WAS REACTION TO MOST THINGS); "CENTRAL APNEA NUMBERS" CHANGED ALL OF SUDDEN/HAD GRADUALLY INCREASED AND REMAINED HIGH WHICH MEANS MORE INTERRUPTIONS (MORE LIKELY TO STOP BREATHING) THROUGHOUT THE NIGHT WHEN SLEEPS; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included sleep apnea, hypothyroidism, and continuous positive airway pressure (uses cpap machine).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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced "central apnea numbers" changed all of sudden/had gradually increased and remained high which means more interruptions (more likely to stop breathing) throughout the night when sleeps. On 06-APR-2021, the subject experienced migraine (which was reaction to most things). On 30-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine (which was reaction to most things) on 07-APR-2021, had not recovered from tiredness, and the outcome of "central apnea numbers" changed all of sudden/had gradually increased and remained high which means more interruptions (more likely to stop breathing) throughout the night when sleeps was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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. 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 fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: VOMITING; HURTING ALL OVER; SEVERE HEADACHES; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 42 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: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced hurting all over. On 09-JUN-2021, the subject experienced severe headaches. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches, nausea, vomiting, hurting all over, and fever. This report was non-serious. This case, from the same reporter is linked to 20210619423, 20210619407 and 20210619408.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Peripheral swelling
Clinical narrative: NUMBNESS TO RIGHT SIDE; SWELLING OF RIGHT INDEX FINGER; EXTREME PAIN; This spontaneous report received from a patient via a company representative concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced numbness to right side, swelling of right index finger, and extreme pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness to right side, swelling of right index finger and extreme pain was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypervigilance, Pain in extremity, Therapeutic response unexpected, Tremor, Unevaluable event
Clinical narrative: HEARING IS BETTER/MENTAL FOCUS/VISION IS GETTING/BETTER THOUGH PROCESS; POSITIVE CHANGES; FEELING AWAKENED; TREMORS; SHOULDER AND ARM PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included shingles, car accident, nerve damage on the entire body, and tremor in the right side of his body. The patient was previously treated with polio vaccine 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: Unknown expiry date: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced tremors. On 05-JUN-2021, the subject experienced shoulder and arm pain. On 07-JUN-2021, the subject experienced hearing is better/mental focus/vision is getting/better though process. On 07-JUN-2021, the subject experienced positive changes. On 07-JUN-2021, the subject experienced feeling awakened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shoulder and arm pain, and tremors, and the outcome of hearing is better/mental focus/vision is getting/better though process, positive changes and feeling awakened was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Somnolence
Clinical narrative: REALLY SLEEPY; SORE AT INJECTION SITE; REALLY TIRED; 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 (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced really sleepy. On MAR-2021, the subject experienced sore at injection site. On MAR-2021, the subject experienced really tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from really sleepy, and really tired on MAR-2021, and sore at injection site on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210619423 and 20210619315.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: NAUSEA; SEVERE HEADACHES; VOMITTING; HURTING ALL OVER; This spontaneous report received from a consumer concerned a 25 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: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced vomitting. On 08-JUN-2021, the subject experienced hurting all over. On 08-JUN-2021, the subject experienced nausea. On 08-JUN-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomitting, hurting all over, and severe headaches. This report was non-serious. This case, from the same reporter is linked to 20210619423 and 20210619315.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: BODY ACHES; REMAINED IN BED MOST OF THE TIME; FELT OFF; ILL; CHILLS; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, remained in bed most of the time, felt off, ill, chills, fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, fatigue, body aches, headache, remained in bed most of the time, felt off and ill was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: BODY ACHES; REMAINED IN BED MOST OF THE TIME; FELT OFF; ILL; CHILLS; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, remained in bed most of the time, felt off, ill, chills, fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, fatigue, body aches, headache, remained in bed most of the time, felt off and ill was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vaccination complication
Clinical narrative: TYPICAL SIDE EFFECTS; FELT TIRED/FATIGUE; NEED OF MORE SLEEP THAN USUAL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-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 MAY-2021, the subject experienced need of more sleep than usual. On 26-MAY-2021, the subject experienced typical side effects. On 26-MAY-2021, the subject experienced felt tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from typical side effects on MAY-2021, had not recovered from felt tired/fatigue, and the outcome of need of more sleep than usual was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Product administration error, Pyrexia, Skin discolouration
Clinical narrative: WHITE PATCHES ON THE BODY/PATCHES WORSENING; BODY ACHES; FEVER; PAIN IN INJECTION SITE; INJECTION GIVEN TWICE BY VACCINE FACILITY; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertilligo in childhood.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and batch number: 043A21A expiry: 21-AUG-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced injection given twice by vaccine facility. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced pain in injection site. On 10-MAY-2021, the subject experienced white patches on the body/patches worsening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 08-APR-2021, fever on 07-APR-2021, and pain in injection site on 19-APR-2021, was recovering from white patches on the body/patches worsening, and the outcome of injection given twice by vaccine facility was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Oral mucosal eruption
Clinical narrative: SWELLING IN MOUTH; RASH IN MOUTH TOWARDS RIGHT SIDE; This spontaneous report received from a parent concerned a 19 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 (suspension for injection, route of admin not reported, batch number: 1820096, expiry: 23-JUN-2021) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced swelling in mouth. On 07-JUN-2021, the subject experienced rash in mouth towards right side. On 09-JUN-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in mouth, and rash in mouth towards right side. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AT RANGE OF 1.6-2.0 CELSIUS FOR ABOUT 45 MINUTES; VACCINE STORED AT RANGE OF 1.6-2.0 CELSIUS FOR ABOUT 45 MINUTES; This spontaneous report received from a health care professional 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, and batch number: 1808980 expiry: 22-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced vaccine administered at range of 1.6-2.0 Celsius for about 45 minutes. On 09-JUN-2021, the subject experienced vaccine stored at range of 1.6-2.0 Celsius for about 45 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine administered at range of 1.6-2.0 Celsius for about 45 minutes, and the outcome of vaccine stored at range of 1.6-2.0 Celsius for about 45 minutes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210619366.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; This spontaneous report received from a consumer 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 11-MAR-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 MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a pharmacist 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. 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 shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY ACHES; CHILLS; MASSIVE HEADACHE LIKE HEAD WAS GOING TO EXPLODE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced body aches. On 09-JUN-2021, the subject experienced chills. On 09-JUN-2021, the subject experienced massive headache like head was going to explode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, massive headache like head was going to explode, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: FLU; This spontaneous report received from a patient concerned a 6 decade 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 (suspension for injection, route of admin not reported, batch number were not reported) dose was not reported, administered on 02-JUN-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 JUN-2021, the subject experienced flu. The action taken with covid-19 vaccine was not applicable. The patient recovered from flu on JUN-2021. This report was non-serious. This case, from the same reporter is linked to 20210623078.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORE FOR ONE DAY; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm sore for one day. The action taken with covid-19 vaccine was not applicable. The patient recovered from arm sore for one day. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Limb discomfort, Malaise
Clinical narrative: STRANGE FORMATION ON THE INNER UNDERSIDE OF ARM WHERE VACCINE WAS ADMINISTERED LEFT ARM THAT TURNED YELLOW; DIZZINESS; FOOT ACHE; MUSCLE ACHES UNDERNEATH LEFT ARM; NOT FEELING WELL SINCE RECEIVING THE VACCINE; FALL; FEELING WOBBLY; This spontaneous report received from a patient concerned a 66 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 (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced feeling wobbly. On MAY-2021, the subject experienced fall. On 14-MAY-2021, the subject experienced not feeling well since receiving the vaccine. On an unspecified date, the subject experienced strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, dizziness, foot ache, and muscle aches underneath left arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, feeling wobbly, not feeling well since receiving the vaccine, and muscle aches underneath left arm, and the outcome of dizziness, foot ache and fall was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site reaction
Clinical narrative: STRANGE FORMATION ON THE INNER UNDERSIDE OF ARM WHERE VACCINE WAS ADMINISTERED LEFT ARM THAT TURNED YELLOW; DIZZINESS; FOOT ACHE; MUSCLE ACHES UNDERNEATH LEFT ARM; NOT FEELING WELL SINCE RECEIVING THE VACCINE; FALL; FEELING WOBBLY; This spontaneous report received from a patient concerned a 66 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 (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced feeling wobbly. On MAY-2021, the subject experienced fall. On 14-MAY-2021, the subject experienced not feeling well since receiving the vaccine. On an unspecified date, the subject experienced strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, dizziness, foot ache, and muscle aches underneath left arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, feeling wobbly, not feeling well since receiving the vaccine, and muscle aches underneath left arm, and the outcome of dizziness, foot ache and fall was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: SHIVERING; FEVER; TIRED; FELT ACHY; This spontaneous report received from a patient concerned a 63 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 (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced felt achy. On 10-JUN-2021, the subject experienced shivering. On 10-JUN-2021, the subject experienced fever. On 10-JUN-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 102.7-102.9 Unit not reported. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, felt achy, tired, and shivering. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin 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 headache, fever, and fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the headache, fever and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210624217 and 20210627468.