chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Tenderness, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingle vaccine (several years ago of reporting). In July 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine and less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, tenderness and blister. On an unknown date, the outcome of the vaccination failure, shingles, tenderness and blister were unknown. It was unknown if the reporter considered the vaccination failure, shingles, tenderness and blister to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingle vaccine several years ago of reporting, his/her physician urged to get the new Shingles vaccine, this year and the patient did get the 2 series of Shingles shot April and July 2021. A few weeks ago, of reporting, the patient broke out with a case of the classic shingles. The patient stated he/she was told at Urgent Care. The patient stated he/she was not sick, just had some tenderness and blisters all on one side of body. The patient asked question has anyone had this happen. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had them, popped up 3 days after my jab; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she was not a medical expert and never had shingles before. The patient got the shingle shot and shingle got popped up 3 days after jab. The patient had to wait 6 weeks in between the shingles vaccine and booster.  The patient told doctor that he/she want the shingles vaccine first because he/she rather take chances with COVID than go through that misery again.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin discomfort, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and skin discomfort. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin discomfort were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and skin discomfort to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and still had them. The patient still felt like he/she had a live wire running through his/her skin. The patient stated that it was terrible and could lasted forever. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date about an year ago from the date of reporting). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem 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 due to Covid-19. The reporter asked if it was recommended to restart the series or just to give the second dose as soon as possible. The reporter also asked if the patient required anything further and would this impact the efficacy of the vaccination. No further details were provided on web form. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Syringe issue
Clinical narrative: about half a dose was administered; leaked onto the patient's skin; leaked onto the patient's skin; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 27th November 2021, the patient received the 1st dose of Shingrix. On 27th November 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: Pharmacist was administering first dose of Shingrix to the patient and due to a needle malfunction, only about half a dose was administered and the other half leaked onto the patient's skin which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact.  No other symptoms were reported. Pharmacist was asking if an additional dose was to be given to make up for the underdose. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th November 2021, 1 days after receiving Shingrix, the patient experienced fever, headache, muscle pain and feeling unwell. On an unknown date, the outcome of the fever, headache, muscle pain and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, muscle pain and feeling unwell to be related to Shingrix. Additional details were provided as follows: The case was reported by patient herself. The patient received her first dose of Shingrix in left deltoid one day before reporting and on the day of reporting experienced fever, headache, muscle pain and felt like she just wanted to lay down. No lot or expiration date for vaccine was known. The reporter did not consent to follow-up. The reporter declined to provide health care professional contact information.
Age: 17.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Extra dose administered
Clinical narrative: extra dose of both HAVRIX and BOOSTRIX; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28th February 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th November 2021, the patient received Havrix, Havrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, their office had administered an extra dose of both Havrix and Boostrix to the same patient, which led to extra dose administered. No additional symptoms reported. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amaa19A, expiry date 21st October 2021) for prophylaxis.   On 30th November 2021, the patient received Menveo. On 30th November 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered an expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA66AA, expiry date 31st October 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 30th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 30th 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 age at vaccination was not reported. The patient came in to pharmacy for school shots Bexsero. After the dose was administered, pharmacist noticed the dose had expired, which led to expired vaccine used. The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: received 3 quarters of 1 ml dose of Engerix; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B adult) (batch number 53967F, expiry date 6th December 2021) for prophylaxis.   On 23rd November 2021, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: The patient received 3 quarters of 1 ml dose of Engerix , which led to underdose. The pharmacist wanted to know is dose sufficient  does or the dose need to be repeated. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2154, expiry date 3rd March 2023) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 23rd November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The medical assistant reports a dose of Kinrix was inadvertently administered to a 15 month old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: 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. In November 2021, the patient received Shingrix. In November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix reconstituted with sterile water instead of with the diluent portion of Shingrix, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021247311, reported by same reporter for different patient. Sender's Comments:  US-GLAXOSMITHKLINE-US2021247311:same reporter, other patient.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: 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. In November 2021, the patient received Shingrix. In November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix reconstituted with sterile water instead of with the diluent portion of Shingrix, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021247312, reported by same reporter for different patient. Sender's Comments: US-GLAXOSMITHKLINE-US2021247312:same reporter, other patient.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Vx expired on 11/07/2021 was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Hib (Hiberix) (batch number 3DK94, expiry date 7th November 2021) for prophylaxis.   On 1st December 2021, the patient received Hiberix. On 1st December 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The patient received dose of Hiberix that already got expired on 7th November 2021, which led to expired vaccine used. Health care professional gave consent for the safety team to follow up. The reporter consented to follow up.
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1 week old vaccinated with Pediarix; 1 week old vaccinated with Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-day-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 3T77H, expiry date 11th July 2022) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st December 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 1st December 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient accidently vaccinated with both Pediarix and Rotarix at the age of 1 week old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 94.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 94-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number ZD3NZ, expiry date 30th June 2022) for prophylaxis.  Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 1st December 2021, the patient received FluLaval Quadrivalent 2021-2022 season (intravenous) and Flulaval Tetra Pre-Filled Syringe Device. On 1st December 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 received  FluLaval Quadrivalent via Intravenous route, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis. Previously administered products included Shingrix (received 1st dose in December 2019). On 1st December 2021, the patient received the 2nd dose of Shingrix. On 1st December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The patient due to a combination of COVID-19 pandemic and moving did not receive second dose of series until 1st December 2021. The patient received 2nd dose on 1st December 2021, later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 27th November 2021) and (batch number J3M5J, expiry date 2022) for prophylaxis. On 2nd December 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 2nd December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The patient was accidentally administered expired Shingrix vaccine on the date of reporting, which led to expired vaccine used. The reporter noted that, antigen had a lot number of H4H34 and expired 27th November 2021, and the adjuvant lot number was J3M5J and does not expired until 2022. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st December 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 2021, 1 days after receiving Shingrix, the patient experienced tiredness and dizziness. On an unknown date, the outcome of the tiredness and dizziness were not recovered/not resolved. It was unknown if the reporter considered the tiredness and dizziness to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient herself.  The reporter did not provide a batch or expiration date for the Shingrix. The patient had received a dose of Shingrix yesterday (from the date of reporting). This morning on the day of reporting, she began to feel dizzy and tired.  She had nothing else to report. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: SITE OF THE INJECTION HARD; SITE OF THE INJECTION RED; SITE OF THE INJECTION SORE; This spontaneous report received from a health care professional concerned a 72 year old female patient of an unspecified race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: Rheumatoid arthritis (RA), and other pre-existing medical conditions included: Patient reports no fever or other side effects.  On an unspecified date the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, for prophylactic vaccination. No adverse events were associated with pervious covid-19 vaccine ad26.cov2.s (unspecified manufacturer).  The patient received additional company suspect vaccine covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total, administered on 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included golimumab (SIMPONI) for RA.  On 02-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced site of the injection was hard, red and sore. (dose number in series 2)   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the site of the injection red, site of the injection hard and site of the injection sore was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20160420558 (SIMPONI) and 20200335343 (SIMPONI).  This case, from the same reporter is linked to 20140306760.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; COLD CHILLS; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (manufacturer not specified, date not specified) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported (Dose series 1). The patient experienced a few body aches overnight when treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) for prophylactic vaccination (dose series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in  2021 ("last week") for prophylactic vaccination (dose 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, following the booster dose, the patient experienced body aches, cold chills, and low fever but only for the night (dose series 2). The patient reported he was fine on the next morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, cold chills, and low fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain
Clinical narrative: PAINS/ACHES; CHILLS; HEADACHE; NOT FEELING REAL GOOD; This spontaneous report received from a consumer concerned a 59 year old female, race not reported.   The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date the patient received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (suspension for injection, route of admin not reported, and batch number: unknown and expiry: unknown) dose was not reported for prophylactic vaccination (dose series 1).  The batch number was not reported and has been requested.  On an unspecified date after receiving  covid-19 vaccine ad26.cov2.s (manufacturer not specified),  the patient had pains/aches, chills and headache (dose series 1). No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pains/aches, chills and headache was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on an unspecified date in OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in  OCT-2021, the patient experienced not feeling real good, pains/aches, chills and headache (dose series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling real good, pains/aches, chills and headache was not reported (dose series 2). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: SORE THROAT; SWOLLEN TONGUE; This spontaneous report received from a patient concerned an adult of an unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. On unspecified dates, the patient previously received 2 doses of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown), frequency time 01 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The patient had no adverse events following covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, (dose number in series 2), frequency time 01 in total administered on unspecified date for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for severe to moderate rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, following covid-19 vaccine ad26.cov2.s (dose number in series 2) the patient experienced sore throat, and swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, and swollen tongue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nasal congestion, Pyrexia
Clinical narrative: STUFFY NOSE; STARTED TO SWEAT; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 73 year old female.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, and batch number: 1808978) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination.   On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1), the patient experienced tired.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.   On 09-NOV-2021, the patient experienced stuffy nose, started to sweat, fever and headache.(dose number in series 2)   Treatment medications (dates unspecified) included: chlorphenamine maleate/paracetamol/pseudoephedrine hydrochloride.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from fever, and headache, had not recovered from stuffy nose, and the outcome of started to sweat was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211127601 (Dose series in number 1).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: FELT ACHY; CHILLS; This spontaneous report received from a consumer concerned a 63 year old male.  The patient's height, and weight were not reported. The patient does not have any medical conditions.  On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 2) 1 total administered on 10-NOV-2021 11:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-NOV-2021, between 19:00 and 20:00, the patient experienced felt achy and chills. Patient symptoms resolved 18 hours after that. (Dose Number in Series: 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from felt achy, and chills on 11-NOV-2021.  This report was non-serious.  This case, from the same reporter is linked to 20211130047.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; 101 DEGREE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination.  On 08-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-NOV-2021, the patient experienced chills. On 10-NOV-2021, the patient experienced 101 degree fever. Laboratory data included: Body temperature (NR: not provided) 101 degree fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and 101 degree fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Drug delivery system malfunction, Incorrect dose administered
Clinical narrative: NEEDLE FELL OFF OF THE SYRINGE; AT GIVING VACCINE THE PATIENT GOT MOST OF IT; This spontaneous report received from a health care professional concerned a female 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 vaccinated with covid-19 vaccine (unspecified manufacturer) (suspension for injection, route of admin and batch number not reported) dose was not reported for prophylactic vaccination (dose series 1). No adverse events associated with previous covid-19 vaccine (unspecified manufacturer) past vaccination were reported (dose series 1).  The patient received additional covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin and batch number not reported) dose was not reported, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced needle fell off of the syringe (drug delivery system malfunction) and at time of vaccine administration the patient got most of it (Inappropriate dose of vaccine administered). The patient reported while getting the Johnson and Johnson booster the needle fell off the syringe while being administered but she was told that she "got most of it" (dose series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the needle fell off of the syringe and at giving vaccine the patient got most of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SICK WITH SLIGHT FEVER; 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. On an unspecified date, the patient received covid-19 vaccine ad26. cov2. s (manufacturer unspecified)(suspension for injection, route of admin, and batch number were not reported) dose was not reported (dose series 1) , for prophylactic vaccination.  On an unspecified date in NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported (dose series 2), 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 in  NOV-2021, the patient experienced sick with slight fever (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick with slight fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20211134099.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; VACCINE DOSE PREPARED IN A SYRINGE AND ADMINISTERED AFTER AROUND 24 HOURS; This spontaneous report received from a pharmacist concerned a 76 year old of unspecified 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 (dose number in series 1) (unspecified manufacturer) for prophylactic vaccination. The patient received a booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809, and  expiry: 07-MAR-2022) dose was not reported,1  in total, administered on 13-NOV-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 13-NOV-2021, the patient was administered expired vaccine. It was reported that, the pharmacy prepared the vaccine for patient in a syringe on 12-NOV-2021. Patient wanted to talk to doctor before administration. Pharmacy prepared a new dose and when delivered it was discovered that, a Nurse gave the previously drawn up dose. The dose was in the syringe around 24 hours. Patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and vaccine dose prepared in a syringe and administered after around 24 hours was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 71 year old female.  The patient's height, and weight were not reported.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination on left arm (dose number in series 1). No concomitant medications were reported. the patient did no have a sore arm.  On MAR-2021, the patient experienced urinary tract infection and slight headache.  (dose number in series 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from slight headache, and the outcome of urinary tract infection was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211137873 (Dose number in series 2).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: SORE THROAT; RUNNY NOSE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and allergic to sulpha based drugs. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021as a booster for prophylactic vaccination into right arm. No concomitant medications were reported.  On unspecified date in NOV-2021, the patient experienced symptoms (sore throat, runny nose, headache) after receiving the Janssen Covid-19 vaccine booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, runny nose, and headache. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a 74 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with MRNA 1273 for prophylactic vaccination (dose number in series 1). The patient subsequently received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 026C21A; expiry: 24-OCT-2021) dose was not reported, 1 in total, administered on 25-OCT-2021 as a booster for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient was administered expired vaccine. 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.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Vomiting
Clinical narrative: CHILLS; THROWING UP; This spontaneous report received from a consumer (patient's wife) concerned a male of unspecified age, race and ethnicity.  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 (unspecified manufacturer). (Dose number in series 1)  The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiration date were not reported) dose was not reported, 1 total administered on 09-NOV-2021 for prophylactic vaccination.(Dose number in series 2) The batch number was not reported and has been requested. Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 09-NOV-2021 for an unspecified indication. No concomitant medications were reported.   On 09-NOV-2021 in the morning, the patient got the flu shot (influenza vaccine) then in afternoon he got the booster dose of the Johnson and Johnson COVID vaccine. At the time of report, the patient was at home and had chills and was throwing up.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the chills and throwing up was not reported.  This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR HER BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned two 28 years old female patients of unknown race and ethnicity. No past medical history or concurrent conditions were reported. The patients received vaccination with covid-19 vaccine ad26. cov2.s (Series 1) (suspension for injection, route of administration was not reported, batch number: Unknown expiry: Unknown) dose was not reported, start therapy date were not reported, for prophylactic vaccination. No adverse events were reported following vaccination. (dose number in series 1) The patients received covid-19 vaccine ad26.cov2.s (Series 2) (suspension for injection, route of administration not reported, batch number: was either 1822809 or 211A21A expiry: UNKNOWN) dose was not reported, 01 total, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient received half dose for her booster dose, off label use. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for her booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202371, 20211202199 and 20211202469.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; HAD A ROUGH CASE OF COVID; This spontaneous report received from a patient via social media 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 and expiry: Unknown) dose was not reported, 1 total, administered on MAR-2021 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. The reporter stated that "I took the J & J in March and still had a rough case of Covid in July." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a rough case of covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000205017.; Sender's Comments: V0: 20211203782- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS