chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: First dose / around May 2019 / second dose / about a year later; First dose around May 2019 / second about a year later / Shingles occurred 2 days ago/ Suspected Vaccination failure; Got shingles despite getting 2 doses / Shingles occurred 2 days ago; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, the patient received the 1st dose of Shingrix. On 7th June 2021, more than 2 years after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination for 2nd dose was not reported, however it could be 50 or 51 years. The first dose was given to the patient around May 2019 and second dose was given about a year later, which led to lengthening of vaccination schedule. The patient did not remember the exact date of administration. The patient mentioned that she got shingles despite getting 2 doses of Shingrix vaccine, shingles occurred 2 days ago from the time of reporting (7th June 2021). The patient inquired if Shingrix vaccine was not effective for her and if second dose of Shingrix vaccine was less effective because it was not given during 2-6-month window.  Shingles were not resolved.   The patient did not have lot number, expiration date, and dose of both doses of Shingrix. The reporter did not give a consent to follow up with healthcare professional. The reporter did not consent to follow up. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Age: 0.25
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age, Social problem
Clinical narrative: first dose of Shingrix on 12/12/2019 and didn't come in to get the second dose due to COVID pandemic; patient received the first dose of Shingrix on 12/12/2019; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 1-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 12th December 2019, the patient received the 1st dose of Shingrix. On 12th December 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the social problem and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The pharmacist reported that, the patient did not come in to get the 2nd dose due to COVID pandemic and its been over a year. At the time of administration of 1st dose of Shingrix, the patient was less than 50 years of age, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up. The case had been linked with US2020102684 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020102684:Same reporter
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: first dose of Engerix-b 20 mcg was given to a 18.5 yrs patient; first dose of Engerix-b 20 mcg was given to a 18.5 yrs patient; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe (batch number ASKU, expiry date unknown) for prophylaxis.   On 9th June 2021, the patient received the 1st dose of Engerix B 20 mcg/mg and Engerix B Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose 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 reported as follow: The 18.5 years patient received 1st dose of Engerix-B 20 mcg, which led to adult product administered to child and overdose. No vaccine details available. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered with a Shingrix dose reconstituted with sterile water instead the ASO1B adjuvant; administered with a Shingrix dose reconstituted with sterile water instead the ASO1B adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and incorrect dose administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and incorrect dose administered were unknown.  Additional details was reported as follows: The age at vaccination was not reported. The patient received shingrix reconstituted with sterile water instead of ASO1B adjuvant which led to wrong solution used in drug reconstitution and incorrect dose administered. The reporter consented to follow up. No other information was available.
Age: 0.5
Sex: M
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: received Rotarix instead of receiving the 3rd dose of Rotateq.; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3T77H, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE (ROTATEQ) for prophylaxis.   On 10th June 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, the patient received the 3rd dose of ROTATEQ. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 was reported as follows: The patient received Rotarix instead of 3rd dose of Rotateq which led to interchange of vaccine products. No other information was available. The reporter did not consent to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administrated with an early second dose of Bexsero. Two and half week after the first dose.; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 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 19th May 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The date of administration of 1st dose was not provided. The patient received 2nd dose of Bexsero two and half week after receiving 1st dose, which led to shortening of vaccination schedule. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Really doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix. On 11th June 2021, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and was not feeling well. The patient wasn't expecting any side efeects and she would like to know how long would this side effect last. No further information was provided. The reporter did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Used to have psoriasis / started with an break out all over her body(arms, back, legs); This case was reported by a pharmacist via call center representative and described the occurrence of psoriasis aggravated in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number NR55Z, expiry date 22nd October 2022) for prophylaxis.   Concurrent medical conditions included psoriasis.   On 15th May 2021, the patient received the 1st dose of Shingrix. In May 2021, 2 weeks after receiving Shingrix, the patient experienced psoriasis aggravated. On an unknown date, the outcome of the psoriasis aggravated was unknown.   It was unknown if the reporter considered the psoriasis aggravated to be related to Shingrix.  Additional details were provided as follows: The reporter was looking for information about Shingrix common side effects after 1st dose because the patient that used to have psoriasis received Shingrix 1st dose and two weeks later started with a breakout all over her body (arms, back, legs).  The reporter consented to follow up by phone.
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: Got bexsero dose 1 a year ago / never got the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date, 1 year prior to reporting).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination. The reporter asked if series needed to be restarted. The Vaers details for 1st dose was reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received shot #1 of Shingrix/  October 2020/not yet gotten the second shot/6 month window has passed; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in October 2020 in an unspecified arm intramusclarly).   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: This case was reported by patient himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix and the 6 months window had passed, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rheumatoid arthritis
Clinical narrative: received first dose / around November 2020 / would like to wait for her mom to get second dose until RA symptoms stabilizes; patient was diagnosed with Rheumatoid Arthritis (RA); This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In April 2021, between 4 and 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the rheumatoid arthritis to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter. The patient received 1st dose of Shingrix around November 2020. In April 2021, the patient was diagnosed with rheumatoid arthritis. The reporter did not think rheumatoid arthritis was caused by Shingrix. The reporter concerned if the second dose will aggregate rheumatoid arthritis and would like to wait for the patient to get the second dose till the rheumatoid arthritis symptoms stabilizes, which led to incomplete course of vaccination. No other information was provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Erythema of eyelid, Pruritus, Swelling, Swelling of eyelid
Clinical narrative: swelling and redness of the left lower eyelid; swelling and redness of the left lower eyelid; itching and swelling below the area of a typical vaccine, mid-tricep area and not in deltoid; itching and swelling below the area of a typical vaccine, mid-tricep area and not in deltoid; slight redness which is not vesicular; This case was reported by a physician via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2021, the patient received the 1st dose of Shingrix. On 9th June 2021, 13 days after receiving Shingrix, the patient experienced pruritus, swelling and erythema. On 10th June 2021, the patient experienced swelling of eyelid and erythema eyelid. On an unknown date, the outcome of the pruritus and swelling were not recovered/not resolved and the outcome of the erythema, swelling of eyelid and erythema eyelid were unknown.   It was unknown if the reporter considered the pruritus, swelling, erythema, swelling of eyelid and erythema eyelid to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in left arm. Two days before day of reporting patient had onset of itching and swelling below the area of a typical vaccine, mid-tricep area and not in deltoid, with slight redness which was not vesicular. On day before reporting she had onset of swelling and redness of the left lower eyelid. No further details provided during the time of reporting. The reporter stated the dose was not administered by him, so he did not have the lot number available for the dose. The reporter consented to follow up..
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Lyme disease
Clinical narrative: 2 doses of / Moderna Covid-19 and / 2nd dose of Shingrix. Shortly after / diagnosed with Lyme's; This case was reported by a pharmacist via call center representative and described the occurrence of lyme disease in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) for covid-19 prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Covid 19 Moderna (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 2nd dose of COVID-19 VACCINE MODERNA. On an unknown date, immediately after receiving Shingrix, the patient experienced lyme disease (serious criteria GSK medically significant). On an unknown date, the outcome of the lyme disease was unknown.   It was unknown if the reporter considered the lyme disease to be related to Shingrix.  Additional details were provided as follows: The case was reported by retired pharmacist for himself. The age at vaccination was not reported. The patient recently received 2nd dose of Shingrix and 2 doses of the Moderna Covid-19 and shortly after, the patient was diagnosed with Lyme's disease, which was said to be latent.  The reporter consented to follow up.  No additional information was shared.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: pain, all over the body; shivering; fever; not feeling good for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching, shivering, fever and feeling bad. On an unknown date, the outcome of the generalized aching, shivering, fever and feeling bad were recovered/resolved.   It was unknown if the reporter considered the generalized aching, shivering, fever and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter called to report that a lot number for Shingrix has caused too many adverse events for patients and that they would stop administering this lot since this was very unusual. The patient received vaccine and reached back complaining about pain, all over the body, shivering, fever and not feeling good for 2 days. The reporter knew that these were common side effects and was aware that this happens but was concerned due to the fact that 3 patients received doses from the same lot and they all 3 felt bad enough to call the pharmacy. The reporter consented to follow up. The reporter stated that they can share patient information but during follow-up by safety. This is 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR128574:Same reporter US-GLAXOSMITHKLINE-US2021AMR128575:Same reporter
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site bruising, Sensory disturbance, Urticaria
Clinical narrative: SHE FELT LIKE GOT HIT BY A TRUCK; FLU LIKE SYMPTOMS; URTICARIA (RASH ALL OVER BODY EXCEPT NECK  AND FACE AND SCALP); INJECTION SITE BRUISING; This spontaneous report received from a consumer concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and stress induced rash, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced injection site bruising. On 03-JUN-2021, the subject experienced she felt like got hit by a truck. On 03-JUN-2021, the subject experienced flu like symptoms. On 03-JUN-2021, the subject experienced urticaria (rash all over body except neck and face and scalp). The action taken with covid-19 vaccine was not applicable. The patient was recovering from urticaria (rash all over body except neck and face and scalp), and injection site bruising, and the outcome of flu like symptoms and she felt like got hit by a truck was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Biopsy, Fatigue, Photodermatosis, Skin cancer
Clinical narrative: TWO SMALL SPOTS OF SKIN CANCER/SKIN CANCER TAKEN OFF FACE; SUN DAMAGE SKIN; MORE TIRED AND THAN USUAL; This spontaneous report received from a patient via other manufacturer AbbVie concerned a 78 year old male with unknown race and ethnicity. The patient's weight was 162 pounds, and height was 70.8 inches. The patient was non tobacco user, and abstained from alcohol. The patient's concurrent conditions included nerve pain and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg daily from 2016 for moderate to severe rheumatoid arthritis. Concomitant medications included gabapentin for nerve pain, folic acid, methotrexate and prednisone for rheumatoid arthritis.  On an unspecified date, the patient had two small spots of  basal cell carcinoma (skin cancer/skin cancer taken off face) probably from sun damage which were removed by Mohs surgery from his neck and jaw and more tired and than usual. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from two small spots of skin cancer/skin cancer taken off face, and more tired and than usual, and the outcome of sun damage skin was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210614453-covid-19 vaccine ad26.cov2.s -Two small spots of skin cancer/skin cancer taken off face. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient 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: 205AZ1A, expiry: UNKNOWN) .5 ml, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced confirmed covid-19 infection. On 08-JUN-2021, 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 patient had not recovered from confirmed covid-19 infection. This report was non-serious. This report was associated with product quality complaint: 90000182110. The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the pqc evaluation/investigation performed. based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED TO PATIENT AFTER IT HAD BEEN IN ROOM TEMPERATURE FOR 7 HOURS; VACCINE LEFT OUT AT ROOM TEMPERATURE FOR 7 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced vaccine administered to subject after it had been in room temperature for 7 hours. On 09-JUN-2021, the subject experienced vaccine left out at room temperature for 7 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient after it had been in room temperature for 7 hours and vaccine left out at room temperature for 7 hours was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Gait disturbance, Hypermobility syndrome, Joint swelling
Clinical narrative: SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSCLE SPASMS; SEVERE MUSCLE CRAMPS; DIFFICULTY WALKING/BARELY MOBILE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 180898L (or a 2 for last digit)) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle spasms. On 06-APR-2021, the subject experienced severe muscle cramps. On 06-APR-2021, the subject experienced difficulty walking/barely mobile. On 06-APR-2021, the subject experienced charley horse. On 06-APR-2021, the subject experienced high fever (3 degrees over normal). On 06-APR-2021, the subject experienced severe fatigue. On 12-MAY-2021, the subject experienced swollen knees. On 12-MAY-2021, the subject experienced loose joints. On 04-JUN-2021, Laboratory data included: Blood test (NR: not provided) No blood clots detected., and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient recovered from high fever (3 degrees over normal), and severe fatigue on 14-APR-2021, and had not recovered from muscle spasms, severe muscle cramps, difficulty walking/barely mobile, swollen knees, loose joints, and charley horse. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia, X-ray
Clinical narrative: SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSCLE SPASMS; SEVERE MUSCLE CRAMPS; DIFFICULTY WALKING/BARELY MOBILE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 180898L (or a 2 for last digit)) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle spasms. On 06-APR-2021, the subject experienced severe muscle cramps. On 06-APR-2021, the subject experienced difficulty walking/barely mobile. On 06-APR-2021, the subject experienced charley horse. On 06-APR-2021, the subject experienced high fever (3 degrees over normal). On 06-APR-2021, the subject experienced severe fatigue. On 12-MAY-2021, the subject experienced swollen knees. On 12-MAY-2021, the subject experienced loose joints. On 04-JUN-2021, Laboratory data included: Blood test (NR: not provided) No blood clots detected., and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient recovered from high fever (3 degrees over normal), and severe fatigue on 14-APR-2021, and had not recovered from muscle spasms, severe muscle cramps, difficulty walking/barely mobile, swollen knees, loose joints, and charley horse. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POSSIBLE TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, 202A21A, and 205A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced possible temperature excursion. On 11-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible temperature excursion and out of specification product use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: HAD LOWER BACK PAIN FOR AWHILE PRIOR TO VACCINE, AND IT WENT AWAY AFTER VACCINE AND HAD STAYED GONE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included back pain. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced had lower back pain for awhile prior to vaccine, and it went away after vaccine and had stayed gone. The action taken with covid-19 vaccine was not applicable. The outcome of had lower back pain for awhile prior to vaccine, and it went away after vaccine and had stayed gone was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; VACCINE PLACE IN THE FRIDGE LONGER THAN THE 6HR PERIOD; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced out of specification product use. On 09-JUN-2021, the subject experienced vaccine place in the fridge longer than the 6hr period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and vaccine place in the fridge longer than the 6hr period was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Feeling abnormal, Headache
Clinical narrative: PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELING CRAPPY; NO APPETITE; RACING HEART; DON'T FEEL WELL AND ILL ALL OVER; VERY WEAK; HEADACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe nausea, and heart race, and concurrent conditions included depression, penicillin allergy, non alcohol user, and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, erythromycin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 13:30 for prophylactic vaccination. Concomitant medications included citalopram for depression.  On 06-JUN-2021, the subject experienced profuse sweating. On 06-JUN-2021, the subject experienced felt like i wanted to pass out and dizziness. On 06-JUN-2021, the subject experienced feel icky all over my body and feeling crappy. On 06-JUN-2021, the subject experienced no appetite. On 06-JUN-2021, the subject experienced racing heart. On 06-JUN-2021, the subject experienced don't feel well and ill all over. On 06-JUN-2021, the subject experienced very weak. On 06-JUN-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from profuse sweating, felt like i wanted to pass out and dizziness, racing heart, and headaches, and had not recovered from don't feel well and ill all over, very weak, feel icky all over my body and feeling crappy, and no appetite. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Palpitations
Clinical narrative: PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELING CRAPPY; NO APPETITE; RACING HEART; DON'T FEEL WELL AND ILL ALL OVER; VERY WEAK; HEADACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe nausea, and heart race, and concurrent conditions included depression, penicillin allergy, non alcohol user, and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, erythromycin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 13:30 for prophylactic vaccination. Concomitant medications included citalopram for depression.  On 06-JUN-2021, the subject experienced profuse sweating. On 06-JUN-2021, the subject experienced felt like i wanted to pass out and dizziness. On 06-JUN-2021, the subject experienced feel icky all over my body and feeling crappy. On 06-JUN-2021, the subject experienced no appetite. On 06-JUN-2021, the subject experienced racing heart. On 06-JUN-2021, the subject experienced don't feel well and ill all over. On 06-JUN-2021, the subject experienced very weak. On 06-JUN-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from profuse sweating, felt like i wanted to pass out and dizziness, racing heart, and headaches, and had not recovered from don't feel well and ill all over, very weak, feel icky all over my body and feeling crappy, and no appetite. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Underdose, Wrong technique in product usage process
Clinical narrative: PATIENT GIVEN A SYRINGE WITH AIR INSTEAD OF VACCINE; VACCINE WAS DRAWN 8 TIMES RATHER THAN 5 TIMES FROM THE VIAL.; PAIN DOWN THE ARM; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced subject given a syringe with air instead of vaccine. On 07-JUN-2021, the subject experienced vaccine was drawn 8 times rather than 5 times from the vial. On 07-JUN-2021, the subject experienced pain down the arm. The action taken with covid-19 vaccine was not applicable. The outcome of the patient given a syringe with air instead of vaccine, pain down the arm and vaccine was drawn 8 times rather than 5 times from the vial. was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182251.  The suspected product quality complaint has been confirmed to be void:y. it was reported that the nurse drew up 8 doses from the vial, which are 3 doses beyond what a vial should provide. therefore, the nurse might have administered air instead of vaccine into the consumer, who experienced pain on the administered arm. no product quality issue for janssen covid-19 vaccine is identified in this report. confirmed no pqc was identified within the reported complaint reported. based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: BODY PAIN; HEADACHE; 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 expiry date: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On 10-JUN-2021, the subject experienced body pain. On 10-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and body pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: IMMUNE TO EVERYTHING/ CURED LIVER ISSUES/INVINCIBLE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced immune to everything/ cured liver issues/invincible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune to everything/ cured liver issues/invincible was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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. The patient's pre-existing medical conditions included patient was taking allergy medicines. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Lip swelling, Pruritus, Skin irritation
Clinical narrative: SWOLLEN LIPS; BODY BROKE OUT INTO HIVES; ITCH; ARMS BECOME EXTREMELY IRRITATED; ARMS BECOME EXTREMELY RED; SKIN FEELS LIKE IT'S IN FLAMES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced itch. On JUN-2021, the subject experienced arms become extremely irritated. On JUN-2021, the subject experienced arms become extremely red. On JUN-2021, the subject experienced skin feels like it's in flames. On 09-JUN-2021, the subject experienced body broke out into hives. On 11-JUN-2021, the subject experienced swollen lips. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body broke out into hives, swollen lips, itch, arms become extremely irritated, arms become extremely red and skin feels like it's in flames was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: SWOLLEN LIPS; BODY BROKE OUT INTO HIVES; ITCH; ARMS BECOME EXTREMELY IRRITATED; ARMS BECOME EXTREMELY RED; SKIN FEELS LIKE IT'S IN FLAMES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced itch. On JUN-2021, the subject experienced arms become extremely irritated. On JUN-2021, the subject experienced arms become extremely red. On JUN-2021, the subject experienced skin feels like it's in flames. On 09-JUN-2021, the subject experienced body broke out into hives. On 11-JUN-2021, the subject experienced swollen lips. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body broke out into hives, swollen lips, itch, arms become extremely irritated, arms become extremely red and skin feels like it's in flames was not reported. This report was non-serious.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Retinal haemorrhage
Clinical narrative: BLOOD BEHIND THE RETINA; FATIGUE/FEELING TIRED; This spontaneous report received from a consumer concerned an 86 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, latex tape allergy, alcohol user (once in a while), and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The consumer reported that after taking the vaccine, for the first week the patient had no side effect and felt fine. In APR-2021 (about 3 weeks after vaccination), the patient experienced  fatigue and feeling tired and both eyes got blurry and cloudy (left eye more severe than the right eye). Further consumer stated that, the patient went to see an eye doctor because the blurry cloudy vision persisted. The eye doctor referred him to a more specialized eye doctor who diagnosed him with blood behind the retina and gave him shots in the eye to help the blood dissipate. The patient's right eye had been cleared but the blurriness in the left eye had not been resolved. The consumer was concerned that it could had been a blood clot that traveled to the eye because the patient never had any issues like that before. And also mentioned that it could had been some age related eye issue but he was not sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue/feeling tired, and blood behind the retina. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626620-covid-19 vaccine ad26.cov2.s-blood behind the retina- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE