chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Pruritus, Pyrexia
Clinical narrative: itching in various places / occurs all over / legs, midriff, scalp, face, feet, etc. / aren't any bite marks or bumps / not / continuously, but pretty frequently; high fever; was under the weather; little bit of weakness; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number KB97C, expiry date 13th November 2022) for prophylaxis.   On 16th July 2021, the patient received the 1st dose of Shingrix. On 17th July 2021, 1 days after receiving Shingrix, the patient experienced fever, feeling unwell and weakness. On an unknown date, the patient experienced pruritus. On 19th July 2021, the outcome of the feeling unwell and weakness were recovered/resolved. On an unknown date, the outcome of the fever and pruritus were unknown.   It was unknown if the reporter considered the fever, feeling unwell, weakness and pruritus to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. A health care provider (Immunizations director) reported that, the patient experienced high fever and was under the weather for about 2 days with a  little bit of weakness and itching. Since the patient got the shot, had been itching in various places to the point that and wonders if she had bugs in her clothes or bed (which the patient thought she did not since her husband had not been itching). The itching occured all over, sometimes patient´s legs, midriff, scalp, face, feet, etc.  There were not any bite marks or bumps in the skin where the itching occurs. The patient reported not itching continuously, but pretty frequently. The reporter consented to follow up.
Age: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient of 10 years old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number JP55J5, expiry date 13th 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 26th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 26th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The other health professional reported that, the patient received dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter wanted to know if this dose was valid or if needs to re done it. The reporter consented to follow up. This case was linked with case US2021160429, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160429:Same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pyrexia, Vertigo
Clinical narrative: shingles lesion on her waist; Headache; Vertigo; Fever; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th July 2021, 1 days after receiving Shingrix, the patient experienced headache, vertigo and fever. On 26th July 2021, the patient experienced shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On 27th July 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the shingles, headache and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the shingles, headache, vertigo and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received her second dose of Shingrix and experienced headache, vertigo, and a fever the next day. And the day after that she developed shingles lesion on her waist. She saw her dermatologist and was prescribed an antiviral medication. The fever was resolved till the time of reporting but other symptoms were still unresolved. Lot number for vaccine was unknown. The reporter declined to provide HCP information. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness
Clinical narrative: Headache; her legs are weak; This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than 3 weeks after receiving Shingrix, the patient experienced headache and lower extremities weakness of. On an unknown date, the outcome of the headache and lower extremities weakness of were not recovered/not resolved.   It was unknown if the reporter considered the headache and lower extremities weakness of to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The patient stated that she received dose of Shingrix and had a headache everyday and also her legs were weak on occasion since taking the shot. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: fatigue/ Tiredness; Headache; Shivering; Fever; Arm pain; This case was reported by a consumer and described the occurrence of tiredness in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2021, 1 days after receiving Shingrix, the patient experienced tiredness, headache, shivering, fever and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the tiredness, headache, shivering, fever and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache, shivering, fever and pain in arm to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The patient received dose of Shingrix on left deltoid at a clinic and on 27th July 2021, around mid-day she started experiencing side effects which are fever, shivering, headache, fatigue, tiredness, and arm pain.   The patient was currently taking Tylenol to treat the symptoms. From the time the symptoms started, they are getting worst, and therefore she took Tylenol. The patient mentioned that she had  colonoscopy and endoscopy procedure earlier and perhaps the tiredness and fatigue could be due to the procedure, but the patient was unsure.   The reporter did not asked further questions about the procedures(colonoscopy and endoscopy). The reporter did not had a lot number/expiration date and dose of Shingrix. The reporter gave a consent to follow up with HCP. However, the reporter did not had phone/ fax number and an email address to HCP. The reporter provided her email address.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: longer than recommended dosing interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2019).   On 27th July 2021, the patient received the 2nd dose of Shingrix. On 27th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left deltoid at later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Shingrix was administered to a 21 year old; was accidental/was to receive the Boostrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   On 15th July 2021, the patient received Shingrix. On 15th July 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The patient received dose of Shingrix in left deltoid. The reporter stated that, the 21 years old patient received Shingrix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. At the time of the report the patient had not reported any issues. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given / second dose / 1 month after receiving the first dose; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 vaccination was not reported. The patient was given the 2nd dose of Shingrix early. The 2nd dose was given 1 month after receiving the 1st dose, which led to shortening of vaccination schedule.  There were no symptoms reported. The reported had no other information to report.  The reporter did not consent to follow-up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Rash
Clinical narrative: Had eye swelling; Had / a rash; This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than a day after receiving Shingrix, the patient experienced eye swelling and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the eye swelling and rash were unknown.   It was unknown if the reporter considered the eye swelling and rash to be related to Shingrix.  Additional details provided were as follows: The patient reported that he received the dose on 8th July 2021 or 9th July 2021 and the same day he experienced eye swelling and rash. The patient had started taking Benadryl to cope with the effects. Reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: was a shortage of /  vaccine at the time; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 09th February 2020 intramuscularly in the right arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix and was not told that he needed a 2nd dose. The patient states that the pharmacy reported that there was a shortage of Shingrix vaccine at that time, which led to product supply issue. Till the time of reporting, the patient did not receive 2nd dose of Shingrix. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up. No further information was available.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero by mistake/ Menveo should have been administrated; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXD27AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th July 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 27th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the patient's parent. The patient received the 3rd dose of Bexsero by mistake, when the dose of Menveo should had been administer, which led to wrong vaccine administered. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after / a Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In April 2021, between 2 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided are as follows: The reporter informed that the patient got shingles after she had been administered with a Shingrix vaccine. The reporter did not consent to follow-up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: DIZZINESS; FALLEN; COULD NOT SLEEP; DID NOT FELT GOOD; SLIGHT NAUSEA; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 55 year old male of unspecified race. The patient's weight was 155 pounds, and height was 69 inches. The patient's past medical history included knee surgery, shoulder surgery, blacked out, and panic attacks, and concurrent conditions included arthritis, alcohol user: two beers, and smoker: four cigarettes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-2021) dose was not reported,1 total, administered on 21-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that he did not felt real good for the weekend after getting vaccine on 21-MAR-2021. He had Flu-like symptoms and nausea. Dizziness started approximately one week after the vaccine injection that came on but it hit like a freight train by the end of the week more moderate and continued to the degree that was consistent. He mentioned he could not eat marijuana gummies but due to the dizziness, he felt like he did. He described as if he took four hits off a joint and severe as if he took LSD. He had a fall on the golf course from the dizziness and since then avoided driving which impacted on work. He also mentioned that if he worked really hard like in construction, his dizziness had gone away but when he stopped or as soon as he stepped into his car, it came back. He said that he could not sleep. He said he did not wanted to lose his ever loving mind. Physician gave him a medication after hospital discharge but it made him felt off like a bad acid and he discarded it. Laboratory data (dates unspecified) included: CT scan (NR: not provided) was negative for stroke. He made a trip to the emergency room, and made several VA visits to try to manage the symptoms. VA physician cleaned his ears which did not helped. He mentioned among his medical history that he had almost ten surgeries mostly on his knee and on his shoulder and he had arthritis because of that. He stated that he had blacked out couple of times in the past prior to being vaccinated. Physicians thought that it was related to his heart but he said his heart was strong. It seemed from the conversation that he had panic attacks in the past but he knew what controlled them. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, flu-like symptoms, slight nausea, did not felt good, fallen and could not sleep was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210755402.; Sender's Comments: V0:20210754977-COVID-19 VACCINE AD26.COV2.S-Dizziness. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chest discomfort, Dysphonia, Headache, Lung disorder
Clinical narrative: HOARSE VOICE; STILL IN CHEST; COVID HEADACHE; HIT LUNGS/TRYING TO BREATHE THROUGH COBWEBS; MUCUS IN THROAT; LOSS OF TASTE; WEIRD AND FUZZY TONGUE; FUZZY THROAT; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 220 pounds, and height was 66 inches. The patient's past medical history included encephalitis, covid-19, covid-19, pin head rash, and covid in her eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A,expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced weird and fuzzy tongue. On JUL-2021, the subject experienced fuzzy throat. On 13-JUL-2021, the subject experienced loss of taste. On 15-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 16-JUL-2021, the subject experienced mucus in throat. On 17-JUL-2021, the subject experienced hit lungs/trying to breathe through cobwebs. On 18-JUL-2021, the subject experienced covid headache. On 26-JUL-2021, the subject experienced hoarse voice. On 26-JUL-2021, the subject experienced still in chest. Treatment medications (dates unspecified) included: ergocalciferol, nicotinic acid, and cresol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hit lungs/trying to breathe through cobwebs, and covid headache on 18-JUL-2021, was recovering from loss of taste, had not recovered from hoarse voice, and still in chest, and the outcome of weird and fuzzy tongue, mucus in throat and fuzzy throat was not reported. This report was non-serious. This report was associated with a product quality complaint 90000187320. The suspected product quality complaint has been confirmed to be voided (confirmed no pqc was identified within the complaint reported.) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mucosal disorder, Paraesthesia oral, SARS-CoV-2 test, Sensory disturbance
Clinical narrative: HOARSE VOICE; STILL IN CHEST; COVID HEADACHE; HIT LUNGS/TRYING TO BREATHE THROUGH COBWEBS; MUCUS IN THROAT; LOSS OF TASTE; WEIRD AND FUZZY TONGUE; FUZZY THROAT; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 220 pounds, and height was 66 inches. The patient's past medical history included encephalitis, covid-19, covid-19, pin head rash, and covid in her eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A,expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced weird and fuzzy tongue. On JUL-2021, the subject experienced fuzzy throat. On 13-JUL-2021, the subject experienced loss of taste. On 15-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 16-JUL-2021, the subject experienced mucus in throat. On 17-JUL-2021, the subject experienced hit lungs/trying to breathe through cobwebs. On 18-JUL-2021, the subject experienced covid headache. On 26-JUL-2021, the subject experienced hoarse voice. On 26-JUL-2021, the subject experienced still in chest. Treatment medications (dates unspecified) included: ergocalciferol, nicotinic acid, and cresol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hit lungs/trying to breathe through cobwebs, and covid headache on 18-JUL-2021, was recovering from loss of taste, had not recovered from hoarse voice, and still in chest, and the outcome of weird and fuzzy tongue, mucus in throat and fuzzy throat was not reported. This report was non-serious. This report was associated with a product quality complaint 90000187320. The suspected product quality complaint has been confirmed to be voided (confirmed no pqc was identified within the complaint reported.) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test, Suspected COVID-19, Vaccine breakthrough infection
Clinical narrative: DEATH; BREAKTHROUGH COVID CASES; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient by other company (Pfizer Inc.) received on 23-JUL-2021 and concerned multiple patients. No past medical history or concurrent conditions were reported. The patients 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, 1 total administered for prophylactic vaccination. Concomitant medications included bnt 162, and mrna 1273. It was reported that there were 4450 breakthrough Covid cases. Among 4450 cases, 247 patients were hospitalized for suspected Covid 19 infection and 79 patients died among the population who were fully vaccinated by Pfizer or Moderna vaccine both doses or Janssen vaccine one dose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of breakthrough covid cases and suspected covid 19 infection was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:20210756412-covid-19 vaccine ad26.cov2.s-death,breakthrough covid cases. 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). 20210756412-covid-19 vaccine ad26.cov2.s -suspected covid 19 infection. This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect.; Reported Cause(s) of Death: CONFIRMED COVID-19 INFECTION
Sex: M
Vaccine: COVID19
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE; This spontaneous report received from a consumer and 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 test positive, and respiratory syncytial virus test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, and Respiratory syncytial virus infection (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive and respiratory syncytial virus test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Night sweats, Pain
Clinical narrative: NIGHT SWEATS; BODY ACHES; CHILLS IN THE NIGHT TIME; FATIGUE; MUSCLES ACHES; This spontaneous report received from a patient concerned an 87 year old male. The patient's weight was 230 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced night sweats. On JUL-2021, the subject experienced body aches. On JUL-2021, the subject experienced chills in the night time. On JUL-2021, the subject experienced fatigue. On JUL-2021, the subject experienced muscles aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, night sweats, chills in the night time, muscles aches and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210760407.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a physician 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.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, 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 suspected covid-19 infection (breakthrough infection) and suspected clinical vaccine failure and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report associated with product complaint number: 90000187772.; Sender's Comments: V0:20210758266 - Covid-19 vaccine ad26.cov2.s - Suspected Covid 19 infection. 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). 20210758266 - Covid-19 vaccine ad26.cov2.s - Suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: BLOOD CLOTS ALL OVER BRAIN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity unknown. 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) frequency one total, 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.  It was reported on an unspecified date, that the patient experienced blood clots all over his brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots all over brain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210758279 -covid-19 vaccine ad26.cov2. s Blood clots all over brain. 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a pharmacist via company representative concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 28-JUL-2021. 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,1 total administered 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 acquired COVID and was hospitalized in the past weekend (JUL-2021) of the day of reporting. Number of days of hospitalization was not reported and it was unsure that the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint number 90000187388.; Sender's Comments: V0. 20210758452-covid-19 vaccine ad26.cov2.s- Covid-19. These events are considered unassessable. The events has an unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Erythema, Hypokinesia, Joint swelling
Clinical narrative: PAIN IN THE NECK; BACK PAIN; TROUBLE IN RAISING HER ARM; DAILY LIVING ACTIVITY AFFECTED; SWELLING ON THE LEFT ARM; SWELLING ON THE LEFT SHOULDER; REDNESS ON THE LEFT SHOULDER AND ARM; PAIN IN LEFT SHOULDER; PAIN IN LEFT ARM; 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 egg allergy, antibiotic medication allergy, non smoker, and abstains from alcohol. The patient was not pregnant at the time of report. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 and expiry: 26/MAY/2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced pain in the neck. On 22-MAR-2021, the subject experienced back pain. On 22-MAR-2021, the subject experienced trouble in raising her arm. On 22-MAR-2021, the subject experienced daily living activity affected. On 22-MAR-2021, the subject experienced swelling on the left arm. On 22-MAR-2021, the subject experienced swelling on the left shoulder. On 22-MAR-2021, the subject experienced redness on the left shoulder and arm. On 22-MAR-2021, the subject experienced pain in left shoulder. On 22-MAR-2021, the subject experienced pain in left arm. On APR-2021, Laboratory data included: Clot blood (NR: not provided) Negative. Treatment medications (dates unspecified) included: codeine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on the left arm, swelling on the left shoulder, and redness on the left shoulder and arm on MAY-2021, was recovering from pain in left arm, pain in left shoulder, pain in the neck, and back pain, and the outcome of daily living activity affected and trouble in raising her arm was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Neck pain, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: PAIN IN THE NECK; BACK PAIN; TROUBLE IN RAISING HER ARM; DAILY LIVING ACTIVITY AFFECTED; SWELLING ON THE LEFT ARM; SWELLING ON THE LEFT SHOULDER; REDNESS ON THE LEFT SHOULDER AND ARM; PAIN IN LEFT SHOULDER; PAIN IN LEFT ARM; 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 egg allergy, antibiotic medication allergy, non smoker, and abstains from alcohol. The patient was not pregnant at the time of report. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 and expiry: 26/MAY/2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced pain in the neck. On 22-MAR-2021, the subject experienced back pain. On 22-MAR-2021, the subject experienced trouble in raising her arm. On 22-MAR-2021, the subject experienced daily living activity affected. On 22-MAR-2021, the subject experienced swelling on the left arm. On 22-MAR-2021, the subject experienced swelling on the left shoulder. On 22-MAR-2021, the subject experienced redness on the left shoulder and arm. On 22-MAR-2021, the subject experienced pain in left shoulder. On 22-MAR-2021, the subject experienced pain in left arm. On APR-2021, Laboratory data included: Clot blood (NR: not provided) Negative. Treatment medications (dates unspecified) included: codeine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on the left arm, swelling on the left shoulder, and redness on the left shoulder and arm on MAY-2021, was recovering from pain in left arm, pain in left shoulder, pain in the neck, and back pain, and the outcome of daily living activity affected and trouble in raising her arm was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient 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: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 05-JUN-2021 for preventing illness. No concomitant medications were reported. On 23-JUL-2021, the patient tested positive for Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. Reporter stated that over the weekend patient began experiencing night sweats, chills in the night time, fatigue, muscles aches, body aches. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 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: 90000187779. This case, from the same reporter is linked to 20210757977.; Sender's Comments: V0: 20210760407-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: Choking, Feeling abnormal, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CHOKING; FELT  BAD; This spontaneous report received from a patient concerned a 59 year old male.. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) .5 ml,1 total, administered on 08-MAR-2021 to left arm as prophylactic vaccination.  No concomitant medications were reported. On 24-JUL-2021 patient was felt bad and choking, had symptom coughing, hard to breath, nausea ,diarrhea for the past 5 days.  On 28-JUL-2021 had rapid test  and revealed that he has suspected clinical vaccination failure and suspected covid-19 infection Laboratory data included: SARS-CoV-2 rapid POC test (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, suspected clinical vaccination failure, choking and felt bad was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210760895. This report was associated with product quality complaint:90000187582; Sender's Comments: V0: 20210760417-Covid-19 vaccine ad26.cov2.s -Choking. 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. 20210760417-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
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Bell's palsy, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: POSSIBLE BELL'S PALSY; SENSATIONS SUCH AS TOUCH FELT GONE; NUMBNESS IN BOTH HANDS; TINGLING IN BOTH HANDS; WEAKNESS IN BOTH LEGS; ASYMPTOMATIC COVID-19; This spontaneous report was received from a 46-year-old, male patient. The patient's height, and weight were not reported. The patient's concurrent condition included penicillin allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 29-APR-2021 for prophylactic vaccination. The patient had taken the product as directed. The patient was not taking any concomitant medication.  The patient was asymptomatic for coronavirus disease (COVID-19) but got a COVID-19 test done as his daughter tested positive, and on 02-MAY-2021, he received a positive result for the COVID-19 test. On 03-MAY-2021, he developed numbness and tingling in both hands and mentioned that some sensations such as touch felt gone but he could still taste. On the same day, he also experienced weakness in both legs and stated that he couldn't even go for a jog. On 28-JUN-2021 (about 1 month before reporting), he developed intermittent numbness and tingling on the left side of his face. The patient went to his health care professional (HCP) on 23-JUL-2021 (Friday) and the HCP mentioned it could be Bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in both hands, weakness in both legs, possible Bell's palsy, tingling in both hands, and sensations such as touch felt gone, and the outcome of asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210760472-Covid-19 vaccine ad26.cov2.s-Possible Bell's palsy. 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: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sensory loss
Clinical narrative: POSSIBLE BELL'S PALSY; SENSATIONS SUCH AS TOUCH FELT GONE; NUMBNESS IN BOTH HANDS; TINGLING IN BOTH HANDS; WEAKNESS IN BOTH LEGS; ASYMPTOMATIC COVID-19; This spontaneous report was received from a 46-year-old, male patient. The patient's height, and weight were not reported. The patient's concurrent condition included penicillin allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 29-APR-2021 for prophylactic vaccination. The patient had taken the product as directed. The patient was not taking any concomitant medication.  The patient was asymptomatic for coronavirus disease (COVID-19) but got a COVID-19 test done as his daughter tested positive, and on 02-MAY-2021, he received a positive result for the COVID-19 test. On 03-MAY-2021, he developed numbness and tingling in both hands and mentioned that some sensations such as touch felt gone but he could still taste. On the same day, he also experienced weakness in both legs and stated that he couldn't even go for a jog. On 28-JUN-2021 (about 1 month before reporting), he developed intermittent numbness and tingling on the left side of his face. The patient went to his health care professional (HCP) on 23-JUL-2021 (Friday) and the HCP mentioned it could be Bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in both hands, weakness in both legs, possible Bell's palsy, tingling in both hands, and sensations such as touch felt gone, and the outcome of asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210760472-Covid-19 vaccine ad26.cov2.s-Possible Bell's palsy. 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: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Muscular weakness, Neurological symptom, Paraesthesia
Clinical narrative: POSSIBLE BELL'S PALSY; SENSATIONS SUCH AS TOUCH FELT GONE; NUMBNESS IN BOTH HANDS; TINGLING IN BOTH HANDS; WEAKNESS IN BOTH LEGS; ASYMPTOMATIC COVID-19; This spontaneous report was received from a 46-year-old, male patient. The patient's height, and weight were not reported. The patient's concurrent condition included penicillin allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 29-APR-2021 for prophylactic vaccination. The patient had taken the product as directed. The patient was not taking any concomitant medication.  The patient was asymptomatic for coronavirus disease (COVID-19) but got a COVID-19 test done as his daughter tested positive, and on 02-MAY-2021, he received a positive result for the COVID-19 test. On 03-MAY-2021, he developed numbness and tingling in both hands and mentioned that some sensations such as touch felt gone but he could still taste. On the same day, he also experienced weakness in both legs and stated that he couldn't even go for a jog. On 28-JUN-2021 (about 1 month before reporting), he developed intermittent numbness and tingling on the left side of his face. The patient went to his health care professional (HCP) on 23-JUL-2021 (Friday) and the HCP mentioned it could be Bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in both hands, weakness in both legs, possible Bell's palsy, tingling in both hands, and sensations such as touch felt gone, and the outcome of asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210760472-Covid-19 vaccine ad26.cov2.s-Possible Bell's palsy. 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).