chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to the Fluarix QIV vaccine; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.   Additional details were reported as follows: The health care professional reported that patient had suffered an allergic reaction to the administration of the vaccine. The health care professional had few information regarding the matter due to the fact that the event happened in another facility from where she was working.  No further events were reported.  The health care professional agreed to be contacted for follow-up. The reporter consented for follow-up.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa (Infanrix) (batch number NG5GF, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assiatant stated that, the patient inadvertently administered an expired Infanrix in left thigh, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient was administered 10 mcg; Adult patient was administered 10 mcg; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 23-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th November 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 26th November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy manager called and reported that, the patient was administered 10 mcg of Engerix B, which led to underdose and adult use of a child product. The reporter stated that, the patient needed full immunity. Patient had not been exposed. The reporter declined to provide any vaccine or patient details. The reporter did not consent to follow up.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose of Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA57AA, expiry date 30th September 2021) 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 24th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 24th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient administered an expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Nausea; Fatigue; vomited for 8 hours; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting, nausea and fatigue. On an unknown date, the outcome of the vomiting, nausea and fatigue were recovered/resolved.   It was unknown if the reporter considered the vomiting, nausea and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after receiving the first dose of the shingrix vaccine, he vomited for 8 hours. After the vomiting resolved, patient reported nausea and fatigue that did not resolve for 10 days. All symptoms had resolved without intervention from health care professional.  The patient declined to provide any other information. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shot #1 on 11-Jan-2019, has yet to have dose #2; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced fever, headache and pain in arm. On an unknown date, the outcome of the fever, headache and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received her dose of the Shingrix vaccine in her left arm and she had a fever, a headache, and was experiencing arm pain. The reporter asked if she could take Tylenol for treatment. The reporter was referred caller to health care professional. The reporter did not consent to follow-up. No additional details provided by the reporter
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Ear discomfort, Muscular weakness, Paraesthesia
Clinical narrative: Severe dizzines; Confusion; Tinnitis; Ear pressure, currently intermittent; Vestibular neuritis; Leg weakness; Tingling; This case was reported by a consumer and described the occurrence of vestibular neuritis in a 30-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included egg flu vaccines with an associated reaction of no adverse event (received on an unknown date without an issue) and Fluzone quadrivalent with an associated reaction of no adverse event (received 3 doses on an unknown date with no issue). Concurrent medical conditions included egg allergy (itching and runny nose).   On 5th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. In September 2021, 12 hrs after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced lower extremities weakness of and tingling. On an unknown date, the patient experienced vestibular neuritis (serious criteria GSK medically significant), dizziness, confusion, tinnitus and sensation of pressure in ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the vestibular neuritis, dizziness, confusion and tinnitus were recovering/resolving and the outcome of the lower extremities weakness of and tingling were recovered/resolved and the outcome of the sensation of pressure in ear was not recovered/not resolved.   It was unknown if the reporter considered the vestibular neuritis, lower extremities weakness of, tingling, dizziness, confusion, tinnitus and sensation of pressure in ear to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. 12 hours after receiving Fluarix Quadrivalent, the patient had leg weakness and tingling, which resolved but less than 2 months of vaccination followed with 4 weeks of severe dizziness, confusion, tinnitus, ear pressure.  The events were partially resolved with 2 weeks of steroids.  Less than 2 months of vaccination, the patient also experienced vestibular neuritis. At the time of reporting, the patient was still experiencing intermittent ear pressure. The patient had 2 primary care visits, 3 ENT visits, 1 neurologist visit and 1 emergency room visit.
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus, Vestibular neuronitis
Clinical narrative: Severe dizzines; Confusion; Tinnitis; Ear pressure, currently intermittent; Vestibular neuritis; Leg weakness; Tingling; This case was reported by a consumer and described the occurrence of vestibular neuritis in a 30-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included egg flu vaccines with an associated reaction of no adverse event (received on an unknown date without an issue) and Fluzone quadrivalent with an associated reaction of no adverse event (received 3 doses on an unknown date with no issue). Concurrent medical conditions included egg allergy (itching and runny nose).   On 5th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. In September 2021, 12 hrs after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced lower extremities weakness of and tingling. On an unknown date, the patient experienced vestibular neuritis (serious criteria GSK medically significant), dizziness, confusion, tinnitus and sensation of pressure in ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the vestibular neuritis, dizziness, confusion and tinnitus were recovering/resolving and the outcome of the lower extremities weakness of and tingling were recovered/resolved and the outcome of the sensation of pressure in ear was not recovered/not resolved.   It was unknown if the reporter considered the vestibular neuritis, lower extremities weakness of, tingling, dizziness, confusion, tinnitus and sensation of pressure in ear to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. 12 hours after receiving Fluarix Quadrivalent, the patient had leg weakness and tingling, which resolved but less than 2 months of vaccination followed with 4 weeks of severe dizziness, confusion, tinnitus, ear pressure.  The events were partially resolved with 2 weeks of steroids.  Less than 2 months of vaccination, the patient also experienced vestibular neuritis. At the time of reporting, the patient was still experiencing intermittent ear pressure. The patient had 2 primary care visits, 3 ENT visits, 1 neurologist visit and 1 emergency room visit.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: CHILLS; PAIN AT THE INJECTION SITE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported( dose number in series 1). The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, the patient experienced chills, pain at the injection site, and fatigue.( dose number in series 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the pain at the injection site, fatigue and chills was not reported.  This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: SICK; WICKED HEADACHE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (dose series 1, manufacturer not specified) for prophylactic vaccination. No adverse events associated with past vaccination (dose series 1,manufacturer not specified) were reported. The patient received an additional company suspect covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin not reported, batch number: 204B21A expiry: Unknown) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-OCT-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose series 2), the patient was sick and was having a wicked headache. On an unspecified date in OCT-2021, the patient took Tylenol (paracetamol) for the headache The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and wicked headache. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Nocturia, Oedema mouth
Clinical narrative: SWOLLEN MOUTH AND CHEEKS; INCREASED NOCTURNAL URINATION; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included: prostate surgery. On an unspecified date, 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, for prophylactic vaccination (manufacturer not specified).  On 25-OCT-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1872811, and expiry: UNKNOWN) dose was not reported, for prophylactic vaccination. No concomitant medications were reported.  On 25-OCT-2021, the patient experienced swollen mouth and cheeks at night. On 25-OCT-2021, the patient experienced possible increased nocturnal urination, but is not sure if that is associated with the vaccine since he has had prostate surgery. The swelling began subsiding throughout Tuesday, and continued to decrease till 27-OCT-2021, but not yet fully resolved. The swelling was mainly in the jowls area.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen mouth and cheeks, and the outcome of increased nocturnal urination was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Chills, Fatigue, Myalgia
Clinical narrative: MILD CHILLS; MILD ACHES ALL OVER; TIRED; 10% OF WHAT I FELT WITH J&J VAX; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. (dosage number in series 1)  On an unspecified date, the patient experienced  10% of what I felt with j&j vax (unspecified adverse events). (dosage number in series 1)  Non-company suspect vaccine included: mrna 1273 ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.(dosage number in series 2)  On an unspecified date, following vaccination with mrna 1273 booster dose, the patient experienced mild chills, mild aches all over, tired, the patient reported this events started after 27 hours post jab. (dosage number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the mild aches all over, tired, mild chills and 10% of what i felt with j&j vax was not reported.  This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dry mouth, Fatigue, Pain
Clinical narrative: SEVERE ACHING (ACROSS SHOULDER, BACK AND BOTH ARMS); FELT COTTON-MOUTH WHERE MOUTH WAS VERY DRY; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 74 year old female with unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol consumption (once a month), non smoker. The patient had no known drug allergies, no drug abuse or illicit drug usage. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry was not reported), 1 in total, dose was not reported (dose number series 1) on 07-Apr-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s.(dose number series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) 1 in total, dose was not reported (dose number  series was 2) on 27-OCT-2021 at 10:45 vaccinated on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-OCT-2021 at 20:30, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (dose number series 2), the patient started experiencing severe aching (across shoulder, back and both arms), felt cotton-mouth where mouth was very dry, chills and fatigue. On unspecified date in OCT-2021, laboratory data included: Body temperature (NR: not provided) Normal. Treatment medications (on unspecified date in OCT-2021) included: Three Ibuprofen tablets. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe aching (across shoulder, back and both arms), felt cotton-mouth where mouth was very dry, and chills on 28-OCT-2021, and was recovering from fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Headache, Pain, Pyrexia
Clinical narrative: BAD REACTION; BODY HURTS; FEVER; MASSIVE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, weight and pre-existing medical conditions were not reported. No concomitant medications were reported.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.   On an unspecified date, the patient experienced bad reaction (dose number in series 1). Non-company (manufacturer unspecified) suspect vaccine (booster dose) included: covid-19 vaccine (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 23-OCT-2021 for prophylactic vaccination.   On 23-OCT-2021, the patient experienced fever on and off since vaccination. On OCT-2021, the patient experienced massive headache. On 27-OCT-2021, the patient experienced body hurts (all  3 events dose number series 2). The patient had no injection site tenderness at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad reaction, fever, massive headache and body hurts was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: SORENESS AT THE INJECTION SITE; SORE ARMS, LEGS AND BACK; FEELING TIRED; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) for prophylactic vaccination. No adverse events were experienced. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2)(suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, 1 total administered on 26-OCT-2021 01:30 to Right Arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included influenza vaccine administered on 26-OCT-2021 to right arm for prophylactic vaccination. On 27-OCT-2021,the caller reported that he was given booster dose on 26-OCT-2021 (dose number in series 2) at 1:30 pm and Flu shot in the other arm at the same appointment. He also mentioned that he usually does not take the Flu shot but his doctor advised him that he needs to get it this year. The patient was okay until the next day (27-OCT-2021), around 10 am he experienced sore arms, legs and back, feeling tired (all events dose number in series 2). He was inquiring if it was due to Janssen COVID 19 Vaccine or the Flu shot or due to the fact that he had blood drawn on the morning 26-OCT-2021. On an unspecified date, the patient experienced soreness at the injection site. The patient was taking two pills of Tylenol every once in a while and took two pills yesterday and two this morning and probably take two more around bedtime tonight. He felt better and believed that there was something to do with time not the Tylenol. He received his Primary dose of the Janssen COVID 19 Vaccine in March 2021 and also mentioned that he did not experienced any of this symptoms after the initial dose. Caller refused to answer any further questions or provide any additional information. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling tired, and sore arms, legs and back, and the outcome of soreness at the injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Chills, Limb discomfort, Pain
Clinical narrative: BODY ACHES; CHILLS; ARM VERY SORE; SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) 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, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced side effects of chills, body aches (achy), arm very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the side effects, body aches, chills and arm very sore on an unspecified date.  On an unspecified date, the patient received additional Non-company suspect vaccine included mrna 1273 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for an prophylactic vaccination. On an unspecified date, the patient experienced side effects which were familiar to earlier shot (Johnson & Johnson), had chills, body aches overnight, and arm very sore. The pharmacist confirmed it was safe to take Tylenol (paracetamol), so the patient took two capsules starting at around 10 PM that night and every four hours until no longer felt achy, which was until about noon the following day. Also arm felt very sore for about 24 hours, so the patient skipped going to the gym the next day. The action taken with mrna 1273, was not applicable. The patient recovered from the body aches, (achy captured under body aches). The outcome for the events of very sore and side effects was not reported.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pain
Clinical narrative: STUFFY NOSE; ACHES; TIRED; This spontaneous report received from a consumer concerned a male patient of unspecified age.   The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (Dose Number In Series 1: route and form of admin, batch number not reported) (unspecified manufacturer).   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 30-OCT-2021 for prophylactic vaccination (Dose Number In Series 2). 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 experienced stuffy nose, aches, and tired (dose series 2). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the tired, stuffy nose and aches was not reported.  This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Nausea, Pain in extremity
Clinical narrative: VERY SLEEPY; NO APPETITE; TROUBLE BREATHING THAT COULD BE DUE TO ALLERGIES; FELT THE NEEDLE GO IN AND FELT LEFT ARM WAS SORE AFTER; FELT TIRED/ FATIGUED; NAUSEA; FELT FEVERISH AT THE TIME BUT NO ACTUAL TEMPERATURE WAS RECORDED; This spontaneous report received from a consumer concerned a 70 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient experienced no adverse event when treated with covid-19 vaccine ad26. cov2. s (manufacturer unspecified) (series 1) for prophylactic vaccination on MAR-2021.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1822811, expiry: unknown) dose was not reported, 01 total administered on left arm on 28-OCT-2021 for prophylactic vaccination (series 2). No concomitant medications were reported.  On 28-OCT-2021, the patient experienced the needle go in and felt her left arm was sore, within few hours she felt tired, fatigued and was very sleepy, felt nausea and had no appetite. She had trouble breathing but as per the reporter that could be due to her allergies as well. She felt feverish at the time but no actual temperature was recorded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the needle go in and felt left arm was sore after, very sleepy, felt tired/ fatigued, nausea, no appetite, trouble breathing that could be due to allergies, and felt feverish at the time but no actual temperature was recorded. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: VERY SLEEPY; NO APPETITE; TROUBLE BREATHING THAT COULD BE DUE TO ALLERGIES; FELT THE NEEDLE GO IN AND FELT LEFT ARM WAS SORE AFTER; FELT TIRED/ FATIGUED; NAUSEA; FELT FEVERISH AT THE TIME BUT NO ACTUAL TEMPERATURE WAS RECORDED; This spontaneous report received from a consumer concerned a 70 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient experienced no adverse event when treated with covid-19 vaccine ad26. cov2. s (manufacturer unspecified) (series 1) for prophylactic vaccination on MAR-2021.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1822811, expiry: unknown) dose was not reported, 01 total administered on left arm on 28-OCT-2021 for prophylactic vaccination (series 2). No concomitant medications were reported.  On 28-OCT-2021, the patient experienced the needle go in and felt her left arm was sore, within few hours she felt tired, fatigued and was very sleepy, felt nausea and had no appetite. She had trouble breathing but as per the reporter that could be due to her allergies as well. She felt feverish at the time but no actual temperature was recorded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the needle go in and felt left arm was sore after, very sleepy, felt tired/ fatigued, nausea, no appetite, trouble breathing that could be due to allergies, and felt feverish at the time but no actual temperature was recorded. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Discomfort, Laryngitis, Malaise, Movement disorder
Clinical narrative: LARYNGITIS; SORE NOSE; BLISTERS; SORE THROAT; RED THROAT; BAD INJECTION TECHNIQUE; NAUSEA; MALAISE; EAR BUZZING/(HORRIFIC) IN EARS; SEVERE DIFFICULTY MOVING ARM; SOME PAIN; DISCOMFORT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose, route of administration and batch number were not reported) (unspecified manufacturer). The Company is unable to perform follow-up to request batch/lot numbers.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, dose and batch number were not reported), 1 total administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-OCT-2021, initially the patient experienced nausea, as week progressed buzzing (horrific) in ears worsened each day. The patient also experienced malaise. Also due to bad injection technique created one week severe difficulty moving arm, some pain and discomfort. On 23-OCT-2021, the patient experienced red throat. On 25-OCT-2021, the patient had sore nose / blisters and sore throat. On 27-OCT-2021, the patient had laryngitis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 25-OCT-2021, and the outcome of ear buzzing/(horrific) in ears, malaise, red throat, sore nose, blisters, sore throat, laryngitis, severe difficulty moving arm, some pain, discomfort and bad injection technique was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nasal discomfort, Nausea, Oropharyngeal pain, Pain, Pharyngeal erythema
Clinical narrative: LARYNGITIS; SORE NOSE; BLISTERS; SORE THROAT; RED THROAT; BAD INJECTION TECHNIQUE; NAUSEA; MALAISE; EAR BUZZING/(HORRIFIC) IN EARS; SEVERE DIFFICULTY MOVING ARM; SOME PAIN; DISCOMFORT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose, route of administration and batch number were not reported) (unspecified manufacturer). The Company is unable to perform follow-up to request batch/lot numbers.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, dose and batch number were not reported), 1 total administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-OCT-2021, initially the patient experienced nausea, as week progressed buzzing (horrific) in ears worsened each day. The patient also experienced malaise. Also due to bad injection technique created one week severe difficulty moving arm, some pain and discomfort. On 23-OCT-2021, the patient experienced red throat. On 25-OCT-2021, the patient had sore nose / blisters and sore throat. On 27-OCT-2021, the patient had laryngitis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 25-OCT-2021, and the outcome of ear buzzing/(horrific) in ears, malaise, red throat, sore nose, blisters, sore throat, laryngitis, severe difficulty moving arm, some pain, discomfort and bad injection technique was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Wrong technique in product usage process
Clinical narrative: LARYNGITIS; SORE NOSE; BLISTERS; SORE THROAT; RED THROAT; BAD INJECTION TECHNIQUE; NAUSEA; MALAISE; EAR BUZZING/(HORRIFIC) IN EARS; SEVERE DIFFICULTY MOVING ARM; SOME PAIN; DISCOMFORT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose, route of administration and batch number were not reported) (unspecified manufacturer). The Company is unable to perform follow-up to request batch/lot numbers.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, dose and batch number were not reported), 1 total administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-OCT-2021, initially the patient experienced nausea, as week progressed buzzing (horrific) in ears worsened each day. The patient also experienced malaise. Also due to bad injection technique created one week severe difficulty moving arm, some pain and discomfort. On 23-OCT-2021, the patient experienced red throat. On 25-OCT-2021, the patient had sore nose / blisters and sore throat. On 27-OCT-2021, the patient had laryngitis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 25-OCT-2021, and the outcome of ear buzzing/(horrific) in ears, malaise, red throat, sore nose, blisters, sore throat, laryngitis, severe difficulty moving arm, some pain, discomfort and bad injection technique was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: SHAKING CHILLS; FEVER (104); SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total,  start therapy date was not reported for prophylactic vaccination (dose number In Series 1). 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 experienced super sick with a 104 fever and shaking chills (both event dose number In Series 1). Laboratory data (dates unspecified) included: Body temperature 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever (104) and shaking chills was unknown. On an unspecified date, the patient received additional non-company suspect vaccine bnt 162 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination (dose number In Series 2).  On an unspecified date, following vaccination with bnt 162, the patient experienced recurrence of sore arm (dose number In Series 2). The action taken with bnt 162 was not applicable. The outcome of sore arm was unknown. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an Unspecified date the patient was previously treated with covid-19 vaccine from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events (dose series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 23-AUG-2021) dose was not reported, (Dose Number in Series: 2), 1 total administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced expired vaccine administered (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211108380.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: SOME MILD BODY ACHES; HEADACHE/SINUS HEADACHE; ARM ACHED MILDLY; SLIGHT FEVER; FELT MILDLY BAD; HORRIBLE NIGHT SLEEP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose Number In Series 1) (unspecified manufacturer).  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 01-NOV-2021 for prophylactic vaccination (Dose Number In Series 2). 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 01-NOV-2021, the patient experienced felt mildly bad. On 01-NOV-2021, the patient experienced horrible night sleep. On 02-NOV-2021, the patient experienced some mild body aches. On 02-NOV-2021, the patient experienced headache/sinus headache. On 02-NOV-2021, the patient experienced arm ached mildly. On 02-NOV-2021, the patient experienced slight fever. Laboratory data (dates unspecified) included: Body temperature (not provided) 100 deg, 98.4 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, and the outcome of felt mildly bad, horrible night sleep, headache/sinus headache, arm ached mildly and some mild body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sinus headache, Sleep disorder
Clinical narrative: SOME MILD BODY ACHES; HEADACHE/SINUS HEADACHE; ARM ACHED MILDLY; SLIGHT FEVER; FELT MILDLY BAD; HORRIBLE NIGHT SLEEP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose Number In Series 1) (unspecified manufacturer).  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 01-NOV-2021 for prophylactic vaccination (Dose Number In Series 2). 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 01-NOV-2021, the patient experienced felt mildly bad. On 01-NOV-2021, the patient experienced horrible night sleep. On 02-NOV-2021, the patient experienced some mild body aches. On 02-NOV-2021, the patient experienced headache/sinus headache. On 02-NOV-2021, the patient experienced arm ached mildly. On 02-NOV-2021, the patient experienced slight fever. Laboratory data (dates unspecified) included: Body temperature (not provided) 100 deg, 98.4 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, and the outcome of felt mildly bad, horrible night sleep, headache/sinus headache, arm ached mildly and some mild body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; LOW GRADE FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia. No concomitant medications were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (Dose Number In Series 1) ( form of admin, route not reported and  batch number: Unknown).  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 (Dose Number In Series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced low grade fever, body aches, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, body aches, headache and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Thirst
Clinical narrative: UNUSUAL THIRST; BRIEF HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date, the patient was previously treated with covid-19 ad26.cov2.s vaccine for prophylactic vaccination. (Dose number in series: 1)  On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) (dose number in series: 2), frequency 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient reported shortly after booster approval, booked appointment at site. Initial 24 hours after booster The patient experienced unusual thirst, and brief headache. (Dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the brief headache and unusual thirst was not reported.  This report was non-serious.