chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: 4 month old female / inadvertently administered Kinrix; received an expired Hiberix; This case was reported by a nurse 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 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 and Hib (Hiberix) (batch number G7C77, expiry date 24th October 2021) for prophylaxis.   On 17th November 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and Hiberix. On 17th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Hiberix, the patient experienced inappropriate age at vaccine administration and expired vaccine used. On an unknown date, the outcome of the inappropriate age at vaccine administration and expired vaccine used 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 provided were as follows: Nurse practitioner reports 4 month old patient came in for DTaP and IPV vaccines and was inadvertently administered Kinrix which led to inappropriate age at vaccine administration. The health care professional reported that the patient received an expired Hiberix vaccine on the same day of Kinrix which was expired on 24th October 2021 which led to expired vaccine used. No reactions were reported. The reporter consented to follow up. The health care professional gave permission for follow-up via email. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: inadvertently administered the Pediarix after the temperature excursion; This case was reported by a nurse and described the occurrence of incorrect product storage in a 6-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 8th April 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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: This case was reported by the Licensed Vocational Nurse. She stated that, they inadvertently administered the Pediarix after the temperature excursion to the patient in the left Vastus Lateralis, which led to incorrect product storage. The vaccine was exposed to 11.8 Fahrenheit 56 minutes. No Prior excursions. The reporter did not consent to follow up. This case has been linked with US2021AMR238664, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238664:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: pronounced redness at the site of previous dermal fillers; This case was reported by a consumer via call center representative and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2021, 1 hr after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient received Shingrix vaccine today (on the day of reporting) in the left arm.  About 1 hour after the Shingrix vaccine he noticed a redness at the site of previous dermal fillers. The patient stated that the redness was more pronounced 3 hours post Shingrix injection. The patient did not share his date of birth, address or how many sites were involved or location.  The patient would contact his health care professional. The reporter did not consent to follow-up.  The reporter does not give permission to contact health care professional.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: were overdue for dose two of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis  Previously administered products included Shingrix (1st dose received more than 6 months ago of 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this case. The reporter stated that, several patients (at least 4 last week of reporting) were overdue for dose two of Shingrix. Till the time of reporting, these patients did not receive second dose, which led to incomplete course of vaccination. No more details about these patients were available at the moment of the report. The reporter consented to follow up. This is one of the three cases, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238462:same reporter US-GLAXOSMITHKLINE-US2021238463:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: three doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. A pharmacist reported that a patient receive three doses of Shingrix, which led to extra dose administered. The reporter consented to follow up.  This case had been linked to US2021238462 and US2021238459, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238462:Same reporter US-GLAXOSMITHKLINE-US2021238459:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Splenic vein occlusion, Thrombosis with thrombocytopenia syndrome
Clinical narrative: SPLENIC VEIN BLOCKAGE; VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; This spontaneous report received from a patient through social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, (after taking the J&J vaccine) the patient was diagnosed with vaccine-induced thrombotic thrombocytopenia and was on blood thinner for life. The patient would be possibly facing a splenectomy in the near future since the splenic vein was completely blocked and it would not get any better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from splenic vein blockage, and the outcome of vaccine-induced thrombotic thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211139590-Covid-19vaccinead26.cov2.s- splenic vein blockage-This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211139590-Covid-19vaccinead26.cov2.s-vaccine-induced-thrombotic thrombocytopenia -This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased
Clinical narrative: HEART RATE SLOWED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart rate slowed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate slowed. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: RARE BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned an adult female (older than 50 years) of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose, therapy start date not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had rare blood clots (Clot blood) and died. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare blood clots was reported as fatal. This report was serious (Death). This case, from the same reporter is linked to 20210654540, 20211010045, 20210446964 and 20211023372.; Sender's Comments: V0:20211140935- covid-19 vaccine ad26.cov2.s -rare blood clots. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: RARE BLOOD CLOTS
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: THERE ARE A GOOD NUMBER OF VACCINATED PEOPLE WHO DID WIND UP IN THE HOSPITAL; This spontaneous report received from a consumer via a social media via a company representative concerned multiple patients of unspecified age, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, multiple patients experienced hospitalization for an unspecified number of days after taking vaccination. The reporter asked that why was it so hard to understand that there are a good number of vaccinated people who do wind up in the hospital. The reporter knew two of them, one of whom almost did not make it. The reporter mentioned that if knew two, how many are there? The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the multiple patients with there are a good number of vaccinated people who did wind up in the hospital was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-  20211141181 covid-19 vaccine ad26.cov2.s- Good number of vaccinated people who did wind up in the hospital. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Loss of consciousness
Clinical narrative: PASSING OUT SPELLS; A LOT OF HEALTH PROBLEMS WITH HEART; This spontaneous report received from a patient via social media through company representative concerned of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total 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, according to the reporter "You shot made me have a lot of health problems with my heart after I got the vivid shot. I have been in and out of hospital for the pass few months. I am now on heart meds and having passing out spells" and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from passing out spells, and the outcome of a  lot of health problems with heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211141724-covid-19 vaccine ad26.cov2.s- passing out spells and a  lot of health problems with heart. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media (Twitter) via company representative concerned a patient of unspecified age and sex of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter stated that, on an unspecified date the patient who was perfectly healthy, died. Reportedly, reporter had guaranteed that patient would not had died from the treatment. The cause of death was unknown. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death). This case, from the same reporter is linked to 20211141893.; Sender's Comments: V0: 20211141837-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date in APR-2021, the patient got a covid-19 infection (coded to suspected covid-19 infection and suspected clinical vaccination failure). The patient stated that, covid-19 was a mild and treated at home with vitamins and treatment medications included: Pedialyte (calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate) and vitamins. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000203066. This case, from the same reporter is linked to 20211142112.; Sender's Comments: V0:20211142018-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a white male of unspecified age with Hispanic or Latino ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient got the Covid-19 infection (suspected Covid-19 infection and suspected clinical vaccination failure). On an unspecified date, patient was hospitalized for 9 days with serious covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000203200. This case, from the same reporter is linked to 20211142018.; Sender's Comments: V2: 20211142112 -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 V2: 20211142112-Covid-19 vaccine ad26.cov2.s -Suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia
Clinical narrative: SHORTNESS OF BREATH; CHEST TIGHTNESS AS OF LAST NIGHT AND THIS MORNING; TINGLING; This spontaneous report received from a pharmacist concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to peg (poly ethylene glycol). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) dose was not reported, administered on 17-NOV-2021 17:45 for prophylactic vaccination. No concomitant medications were reported.  On 17-NOV-2021, the patient experienced shortness of breath. On 17-NOV-2021, the patient experienced chest tightness as of last night and this morning. On 17-NOV-2021, the patient experienced tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling, chest tightness as of last night and this morning, and shortness of breath. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, patient had Covid (coded to suspected clinical vaccination failure) and was positive (coded to suspected covid-19 infection) after being tested at the pharmacy in which he received the results 2 hours later. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000203023.; Sender's Comments: V0: 20211142926-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; LOSS OF APPETITE; This spontaneous report received from a consumer concerned a 71 year old male. The patient's weight was 230 pounds, and height was 67 inches. The patient's concurrent conditions included: high blood pressure, cholesterol, enlarged prostate, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no illicit drug usage or drug abuse. 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,1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. Concomitant medications included simvastatin for cholesterol, tamsulosin for enlarged prostate, and metoprolol for high blood pressure and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride (multivitamins) daily for drug used for unknown indication. On 20-OCT-2021, the patient developed symptoms of slight headache, nasal congestion, dry cough, fever, loss of appetite, weakness and fatigue. On 20-OCT-2021, the patient spoke with the nurse who recommended Advil for the headache and asked him to get tested for Covid-19. The exact date when the patient was tested for Covid-19 was not known. On OCT-2021, the patient tested for Covid-19 via nasal swab (COVID-19 PCR test) and the result came back positive (confirmed covid-19 infection and confirmed clinical vaccination failure) the next day after the test.  The slight headache was gone by next day (21-Oct-2021), the fever lasted four days (24-Oct-2021), the loss of appetite, the fatigue and weakness lasted for a week (27-Oct-2021) and the nasal congestion and the cough resolved a week ago (11-Nov-2021). There was no reaction or soreness after receiving the Janssen COVID-19 vaccine back in APR-2021. The patient had completely recovered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 11-NOV-2021 and loss of appetite on 27-OCT-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211142942- covid-19 vaccine ad26.cov2.s -confirmed 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: Blood test, Fatigue, Swelling face, Urticaria
Clinical narrative: HIVES/ WELTS ALL OVER BODY/ LIMBS; FATIGUE/ TIRED; FACIAL DROOPING/ SWELLING FROM EAR TO MOUTH; This spontaneous report received from a parent via a company representative concerned a 26 year old female. The patient's weight was 125 pounds, and height was 70 inches. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: Patient had no known allergies and no medical history otherwise healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 19-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced facial drooping/ swelling from ear to mouth. On an unspecified date, the patient experienced hives/ welts all over body/ limbs, and fatigue/ tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial drooping/ swelling from ear to mouth on 17-NOV-2021, and had not recovered from hives/ welts all over body/ limbs, and fatigue/ tired. This report was non-serious.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned an 88 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right hip replacement, and concurrent conditions included: hypertension, osteoarthritis, calcium channel blockers allergy, cholesterol medication allergy, dust allergy, mold allergy, pacemaker, and watchman. The patient experienced drug allergy when treated with hydromorphone hydrochloride, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 15-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-NOV-2021, the patient experienced swelling at injection site. On 16-NOV-2021, the patient experienced redness at injection site. On 16-NOV-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 16-NOV-2021, and had not recovered from redness at injection site, and swelling at injection site. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Grip strength, Insomnia, Magnetic resonance imaging neck
Clinical narrative: RIGHT HAND LOSS OF MOTOR CONTROL WRIST TO FINGERTIPS; RIGHT HAND LOSS OF SENSORY CONTROL WRIST TO  FINGERTIPS; COULD NOT SLEEP; SEVERE SHIVERING; SHAKING AS IF FEELING COLD COULD NOT GET WARM; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies and no other indication/ condition that may be related to the adverse symptom patient encountered. Patient is right hand dominant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced could not sleep. On 14-MAR-2021, the patient experienced severe shivering. On 14-MAR-2021, the patient experienced shaking as if feeling cold could not get warm. On 19-APR-2021, the patient experienced right hand loss of motor control wrist to fingertips. On 19-APR-2021, the patient experienced right hand loss of sensory control wrist to fingertips. On 01-SEP-2021, Laboratory data included: Cervical MRI (NR: not provided) Not provided. Laboratory data (dates unspecified) included: Grip strength (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand loss of motor control wrist to fingertips, and right hand loss of sensory control wrist to fingertips on 14-NOV-2021, and could not sleep, severe shivering, and shaking as if feeling cold could not get warm on 15-MAR-2021. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Sensory loss
Clinical narrative: RIGHT HAND LOSS OF MOTOR CONTROL WRIST TO FINGERTIPS; RIGHT HAND LOSS OF SENSORY CONTROL WRIST TO  FINGERTIPS; COULD NOT SLEEP; SEVERE SHIVERING; SHAKING AS IF FEELING COLD COULD NOT GET WARM; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies and no other indication/ condition that may be related to the adverse symptom patient encountered. Patient is right hand dominant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the patient experienced could not sleep. On 14-MAR-2021, the patient experienced severe shivering. On 14-MAR-2021, the patient experienced shaking as if feeling cold could not get warm. On 19-APR-2021, the patient experienced right hand loss of motor control wrist to fingertips. On 19-APR-2021, the patient experienced right hand loss of sensory control wrist to fingertips. On 01-SEP-2021, Laboratory data included: Cervical MRI (NR: not provided) Not provided. Laboratory data (dates unspecified) included: Grip strength (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand loss of motor control wrist to fingertips, and right hand loss of sensory control wrist to fingertips on 14-NOV-2021, and could not sleep, severe shivering, and shaking as if feeling cold could not get warm on 15-MAR-2021. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Fatigue
Clinical narrative: This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies. Patient had no drug abuse or illicit drug usage. Patient took the product as directed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-NOV-2021, the patient experienced initially felt energized. On 12-NOV-2021, the patient experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from initially felt energized on 11-NOV-2021, and felt tired on 13-NOV-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: HEART BEATING FAST; SLIGHT REACTION OF DIZZY/LIGHTHEADED; KIND OF LIKE THE FLU WHEN IT'S COMING ON/FELT TERRIBLE(FELT LIKE HAD FLU); ACHY ALL OVER; SWEATY HANDS; DID NOT SLEEP; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non-smoker, seasonal allergies, allergy to sulpha antibiotic, and autoimmune condition, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. The patient was previously treated with measles vaccine/mumps vaccine/rubella vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergy, and gabapentin. On 06-APR-2021, the patient experienced heart beating fast. On 06-APR-2021, the patient experienced slight reaction of dizzy/lightheaded. On 06-APR-2021, the patient experienced kind of like the flu when it's coming on/felt terrible (felt like had flu). On 06-APR-2021, the patient experienced achy all over. On 06-APR-2021, the patient experienced sweaty hands. On 06-APR-2021, the patient experienced did not sleep. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Normal, and Heart rate high (NR: not provided) heart was beating fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, slight reaction of dizzy/lightheaded, and sweaty hands on 06-APR-2021, and kind of like the flu when it's coming on/felt terrible(felt like had flu), achy all over, did not sleep, chills, and headache on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20211144902.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Insomnia, Pain
Clinical narrative: HEART BEATING FAST; SLIGHT REACTION OF DIZZY/LIGHTHEADED; KIND OF LIKE THE FLU WHEN IT'S COMING ON/FELT TERRIBLE(FELT LIKE HAD FLU); ACHY ALL OVER; SWEATY HANDS; DID NOT SLEEP; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non-smoker, seasonal allergies, allergy to sulpha antibiotic, and autoimmune condition, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. The patient was previously treated with measles vaccine/mumps vaccine/rubella vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergy, and gabapentin. On 06-APR-2021, the patient experienced heart beating fast. On 06-APR-2021, the patient experienced slight reaction of dizzy/lightheaded. On 06-APR-2021, the patient experienced kind of like the flu when it's coming on/felt terrible (felt like had flu). On 06-APR-2021, the patient experienced achy all over. On 06-APR-2021, the patient experienced sweaty hands. On 06-APR-2021, the patient experienced did not sleep. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Normal, and Heart rate high (NR: not provided) heart was beating fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, slight reaction of dizzy/lightheaded, and sweaty hands on 06-APR-2021, and kind of like the flu when it's coming on/felt terrible(felt like had flu), achy all over, did not sleep, chills, and headache on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20211144902.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; 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: 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 patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20211144727.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Irritability, Paraesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: IRRITABILITY; FACIAL NUMBNESS; LIP TINGLING; NUMBNESS IN THE BACK OF THE THROAT; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. Patient had no any medical history. 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 19-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-NOV-2021, the patient experienced irritability. On 19-NOV-2021, the patient experienced facial numbness. On 19-NOV-2021, the patient experienced lip tingling. On 19-NOV-2021, the patient experienced numbness in the back of the throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial numbness, lip tingling, numbness in the back of the throat, and irritability. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE AND GIVEN TO ADOLESCENT AGE 14; This spontaneous report received from a patient concerned a 14 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, hyperlipidemia, and adhd, and other pre-existing medical conditions included: the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: 24-OCT-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced off label use, and product administered to patient of inappropriate age and given to adolescent age 14. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age and given to adolescent age 14 was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: FELT ITCHY FOR A FEW DAYS; RASH; WELT/HIVES; This spontaneous report received from a patient concerned a 53 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: 1805018, and expiry: 23-AUG-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced felt itchy for a few days. On 12-MAR-2021, the patient experienced rash. On 12-MAR-2021, the patient experienced welt/hives. Treatment medications (dates unspecified) included: hydrocortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt itchy for a few days on 19-MAR-2021, and rash on 12-MAR-2021, and the outcome of welt/hives was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Fatigue, Feeling hot, Paraesthesia, Pruritus
Clinical narrative: LEFT FOOT BECAME ITCHY; FLUID FILLED SPOT ON LEFT FOOT; LEFT FOOT BECAME WARM; LEFT FOOT TINGLY WHEN WALKS; FEELS LIKE DISSIPATING; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-NOV-2021, the patient experienced left foot became itchy. On 19-NOV-2021, the patient experienced fluid filled spot on left foot. On 19-NOV-2021, the patient experienced left foot became warm. On 19-NOV-2021, the patient experienced left foot tingly when walks. On 19-NOV-2021, the patient experienced feels like dissipating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left foot became itchy, fluid filled spot on left foot, left foot tingly when walks, left foot became warm, and feels like dissipating. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: MILD HEADACHES IN THE BACK OF HEAD; This spontaneous report received from a patient concerned a 46 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced mild headaches in the back of head. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from mild headaches in the back of head. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis, Muscle spasms, Tinnitus
Clinical narrative: SLIGHT LOSS OF HEARING IN RIGHT EAR; RINGING IN RIGHT EAR; LEFT LEG CRAMPING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had 2 beers and pizza for dinner around 5 pm that evening of 20-Nov-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 18-NOV-2021, the patient experienced left leg cramping. On 20-NOV-2021, the patient experienced slight loss of hearing in right ear. On 20-NOV-2021, the patient experienced ringing in right ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left leg cramping on 18-NOV-2021, and slight loss of hearing in right ear, and ringing in right ear on 20-NOV-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: FELT LIKE WATER RUSHING IN BOTH LEGS FOR 45 MINUTES, AFTER FIRST VACCINE SHOT/FLUSHING IN LEGS; This spontaneous report received from a pharmacist concerned a 60 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced felt like water rushing in both legs for 45 minutes, after first vaccine shot/flushing in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like water rushing in both legs for 45 minutes, after first vaccine shot/flushing in legs. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Menstrual disorder, Myalgia
Clinical narrative: DIARRHEA; HEADACHE; MUSCLE ACHES; FEVER; PERIOD CYCLE  STARTED 3 HOURS AFTER GETTING THE SHOT; DROWSINESS; BODY CHILLS; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was not reported and height was 67 inches. The patient's concurrent conditions included: penicillin allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-OCT-2021, the patient experienced period cycle started 3 hours after getting the shot. On 15-OCT-2021, the patient experienced drowsiness. On 15-OCT-2021, the patient experienced body chills. On 15-OCT-2021, the patient experienced headache. On 15-OCT-2021, the patient experienced muscle aches. On 15-OCT-2021, the patient experienced fever. On 22-OCT-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: bismuth subsalicylate, and loperamide hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from drowsiness, body chills, headache, muscle aches, and fever on 19-OCT-2021, had not recovered from diarrhea, and the outcome of period cycle started 3 hours after getting the shot was not reported. This report was non-serious.