chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: administering Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 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 26th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Association reported potential case of administering Bexsero instead of Menveo. Health care professional (HCP) said that the count of Bexsero and Menveo were off they realized the possible mistake. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero instead of Menveo, which led to wrong vaccine administered. This is one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056731:same reporter US-GLAXOSMITHKLINE-US2022056734:same reporter US-GLAXOSMITHKLINE-US2022056732:same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Powder component of Menveo reconstituted with sterile water; Powder component of Menveo reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 8mza576a, expiry date 31st July 2022) for prophylaxis.   On 4th March 2022, the patient received Menveo. On 4th March 2022, unknown after receiving Menveo, 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 Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: The patient was administrated with the powder component of Menveo reconstituted with sterile water.  No adverse event was reported. The reporter consented to follow up. The health care professional wants to remain anonymous. Additional Supportive Information:  The patient was administrated with the powder component of Menveo reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, has not received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 2 years before the reporting date).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: The exact date of first dose, lot number, and expiration date was not available to the pharmacist as the patient was not in their system and received the first dose at a different facility.   The pharmacist reported patient came into pharmacy stating she had her first dose of Shingrix series over 2 years prior to the reporting and had not yet received the second dose, which led to incomplete course of vaccination. The pharmacist gave permission for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Arm pain, radiated to neck and shoulder; Arm pain, radiated to neck and shoulder; Arm pain, radiated to neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st October 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, neck pain and shoulder pain. On 2nd October 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the neck pain and shoulder pain were unknown.   It was unknown if the reporter considered the pain in arm, fever, neck pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient reported that, she received Shingrix vaccine into the right arm and experienced arm pain and fever that started on the same day. The fever resolved the next day and the arm pain did not resolve until a month later. The patient described the pain as starting in her right arm and radiated to her neck and shoulder.  The reporter did not consent to follow-up. Additional supportive information:  This case has been linked to the case US2022056753 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056753:Same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: Has not received the second dose; Body ache and pain; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 30th June 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient received first dose of Shingrix vaccine and experienced body ache and pain. The patient stated that till this date she had not received the second dose. The patient was unsure if she will get the second dose. The patient gave medical disclaimer. Referred to HCP (Health Care Professional). Spoke per PI(Package insert) and content. The lot number was unavailable. The reporter consented to follow-up. Additional Supportive Information: The patient self-reported this case. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Adult patient inadvertently received pediatric dose; Adult patient inadvertently received pediatric dose of Engerix b; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: License practical nurse reported that an adult patient inadvertently received a pediatric dose of Engerix b instead of the adult dose. The patient's demographic details were asked, but health care professional did not have the information neither lot number or expiration date. The follow up could not be asked since health care professional hung up while trying to be transferred to 2nd line agent. No further details could be collected. The reporter did not consent to follow up. Additional Supportive Information: Adult patient inadvertently received a pediatric dose of Engerix b instead of the adult dose, which led to accidental underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, not received dose two; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2018).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The nurse practitioner reported that a patient had not received dose two. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: a 17-year-old received an adult dose of Havrix.; a 17-year-old received an adult dose of Havrix.; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments: Nurse reported that a 17 year old patient received an adult dose of Havrix.  The reporter consented to follow up. Additional Supportive Information: A 17 year old patient received an adult dose of Havrix, which led to overdose and inappropriate age at vaccine administration.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on September 23rd 2021, 2nd wasn't administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 23rd September 2021, batch number:DK23D,Expiry date:8th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date:30-Mar-2022 Reporter's Comment:The registered pharmacist reported that the patient showed up to the office to get second dose of Twinrix when they realised that more than 6 months had passed since 1st dose, which led to incomplete course of vaccination.  The reporter wanted to know how to proceed. The reporter consented to follow up via fax number as contact number.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Alopecia, Dermatitis bullous, Erythema, Herpes zoster
Clinical narrative: BULLOUS DISEASE; LOCAL SWELLING; LOCAL ERYTHEMA; PRURITUS; ZOSTER; PITYRIASIS ROSEA; ALOPECIA; OTHER CONDITIONS; MORBILLIFORM; URTICARIA; This spontaneous report was received from literature. This report concerned multiple patients (11 individuals) of age between 28-60 of an unspecified sex, race and ethnicity. The objective of the study is to describe the distribution of COVID-19 vaccine skin reactions was unclear and suggested we delineate each reaction pattern as local, distant, or generalized approach, study also captured an extensive vaccine reactogenicity profile or to highlight new data on skin reactions to other COVID-19 vaccines, Johnson & Johnson's Ad26.COV2.S. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, among 10 individuals (females), 15 vaccine reactions were experienced among patients which included,1 had bullous disease, 1 had local swelling, 1 had local erythema, 2 had pruritus, 2 had urticaria, 1 had morbilliform, 1 had zoster, 1 had pityriasis rosea, 2 had alopecia and 3 had other conditions (Adverse drug reaction NOS). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the local swelling, local erythema, pruritus, urticaria, morbilliform, zoster, pityriasis rosea, bullous disease, alopecia and other conditions was not reported. The authors emphasized that Analysis of the underlying mechanisms for each pattern of skin reaction and systematic characterization of these cutaneous manifestations are paramount to understanding how these side effects influence vaccine adoption, particularly as additional doses, boosters, and vaccine mixing become increasingly common. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220360358-COVID-19 VACCINE AD26.COV2.S-Bullous disease. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Pityriasis rosea, Pruritus, Rash morbilliform, Swelling, Urticaria
Clinical narrative: BULLOUS DISEASE; LOCAL SWELLING; LOCAL ERYTHEMA; PRURITUS; ZOSTER; PITYRIASIS ROSEA; ALOPECIA; OTHER CONDITIONS; MORBILLIFORM; URTICARIA; This spontaneous report was received from literature. This report concerned multiple patients (11 individuals) of age between 28-60 of an unspecified sex, race and ethnicity. The objective of the study is to describe the distribution of COVID-19 vaccine skin reactions was unclear and suggested we delineate each reaction pattern as local, distant, or generalized approach, study also captured an extensive vaccine reactogenicity profile or to highlight new data on skin reactions to other COVID-19 vaccines, Johnson & Johnson's Ad26.COV2.S. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, among 10 individuals (females), 15 vaccine reactions were experienced among patients which included,1 had bullous disease, 1 had local swelling, 1 had local erythema, 2 had pruritus, 2 had urticaria, 1 had morbilliform, 1 had zoster, 1 had pityriasis rosea, 2 had alopecia and 3 had other conditions (Adverse drug reaction NOS). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the local swelling, local erythema, pruritus, urticaria, morbilliform, zoster, pityriasis rosea, bullous disease, alopecia and other conditions was not reported. The authors emphasized that Analysis of the underlying mechanisms for each pattern of skin reaction and systematic characterization of these cutaneous manifestations are paramount to understanding how these side effects influence vaccine adoption, particularly as additional doses, boosters, and vaccine mixing become increasingly common. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220360358-COVID-19 VACCINE AD26.COV2.S-Bullous disease. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ARM; This spontaneous report received from a patient via a company representative concerned a 70 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 previously received with covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pain in arm (dose number in series 2). The pharmacist suggested patient a to take Motrin. The patient inquired about risk, as patient don't want to have stroke or heart attack (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: SKIN PROBLEM; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced skin problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin problem was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: I HAVE A COMPLAIN ON YOUR VACCINE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced i have a complain on your vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i have a complain on your vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED TWO WEEKS AFTER THE VACCINATION; This spontaneous report received from a parent via a company representative concerned a 52 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Two weeks after the vaccination on 23-APR-2021, patient had died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 23-APR-2021 the patient died. This report was serious (Death).; Sender's Comments: V0: 20220400589- covid-19 vaccine ad26.cov2.s-Died two weeks after the vaccination. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Gait inability, Limb mass, Muscle tightness, Oedema peripheral
Clinical narrative: ONGOING LEFT FOOT INTERMITTENT SWELLING; ONGOING LEFT ARM LUMP OR KNOT STARTED A DAY OR SO AFTER RECEIVING THE VACCINE; UNABLE TO WALK WHEN FOOT SWELLING WAS PRESENT; TIGHTNESS DUE TO FOOT SWELLING; DISCOMFORT DUE TO FOOT SWELLING; LEFT ARM INTERMITTENT RASH STARTED ON THE SAME DAY WHEN SHE GOT VACCINATED AND WAS ONGOING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: back problems (L4, L5), penicillin allergy, non alcohol user, and cigarette smoker (One pack per 3 days on average.), and other pre-existing medical conditions included: The patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced ongoing left foot intermittent swelling, ongoing left arm lump or knot started a day or so after receiving the vaccine, unable to walk when foot swelling was present, tightness due to foot swelling, discomfort due to foot swelling, and left arm intermittent rash started on the same day when she got vaccinated and was ongoing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ongoing left foot intermittent swelling, ongoing left arm lump or knot started a day or so after receiving the vaccine, left arm intermittent rash started on the same day when she got vaccinated and was ongoing, discomfort due to foot swelling, unable to walk when foot swelling was present, and tightness due to foot swelling. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: ONGOING LEFT FOOT INTERMITTENT SWELLING; ONGOING LEFT ARM LUMP OR KNOT STARTED A DAY OR SO AFTER RECEIVING THE VACCINE; UNABLE TO WALK WHEN FOOT SWELLING WAS PRESENT; TIGHTNESS DUE TO FOOT SWELLING; DISCOMFORT DUE TO FOOT SWELLING; LEFT ARM INTERMITTENT RASH STARTED ON THE SAME DAY WHEN SHE GOT VACCINATED AND WAS ONGOING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: back problems (L4, L5), penicillin allergy, non alcohol user, and cigarette smoker (One pack per 3 days on average.), and other pre-existing medical conditions included: The patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced ongoing left foot intermittent swelling, ongoing left arm lump or knot started a day or so after receiving the vaccine, unable to walk when foot swelling was present, tightness due to foot swelling, discomfort due to foot swelling, and left arm intermittent rash started on the same day when she got vaccinated and was ongoing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ongoing left foot intermittent swelling, ongoing left arm lump or knot started a day or so after receiving the vaccine, left arm intermittent rash started on the same day when she got vaccinated and was ongoing, discomfort due to foot swelling, unable to walk when foot swelling was present, and tightness due to foot swelling. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE REACTION; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine reaction was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT DIFFERENT/FELT LIKE COMING DOWN WITH SOMETHING/FELT NOT 100 PERCENT/DID NOT FELT BEST; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had excellent health and took vitamin supplements only. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced felt different/felt like coming down with something/felt not 100 percent/did not felt best. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt different/felt like coming down with something/felt not 100 percent/did not felt best. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; This spontaneous report received from a consumer via a company representative concerned a female 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 previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Concomitant medications included omeprazole. On 16-DEC-2021, the patient had not been feeling well (dose number in series 2). She was taking Prilosec (omeprazole) and patient's husband asked if there was a problem taking it with Motrin (ibuprofen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. 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: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fever (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pacemaker. The patient previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included rivaroxaban (Xarelto) 20 mg at night. On an unspecified date, the patient experienced pain (dose number in series 2). It was reported that sister of patient suggested to take Tylenol to aid from pain. But the label showed warning about taking blood thinning medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pyrexia, Suspected COVID-19
Clinical narrative: COVID-like symptoms; A terrible reaction to it; Fever; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (COVID-like symptoms), VACCINATION COMPLICATION (A terrible reaction to it) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 041l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SUSPECTED COVID-19 (COVID-like symptoms), VACCINATION COMPLICATION (A terrible reaction to it) and PYREXIA (Fever). In February 2021, SUSPECTED COVID-19 (COVID-like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION COMPLICATION (A terrible reaction to it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received over the counter concomitant medication.  Following vaccination with the 2nd dose patient experienced within 24hours, COVID-like symptoms, fever but the next day it was gone.  No treatment drug details was reported.  Company Comment: This case concerns a 30-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of Suspected COVID-19 and non serious events of Vaccination complication and Pyrexia which occurred on the same day after the second dose of mRNA-1273 vaccine. Its reported following vaccination with the 2nd dose patient experienced within 24hours, COVID-like symptoms, fever but the next day it was gone. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-525710, MOD-2022-525739 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up received contains no new information to add.; Sender's Comments: This case concerns a 30-year-old female patient with no medical history reported, who experienced the unexpected non serious AESI of Suspected COVID-19 and non serious events of Vaccination complication and Pyrexia which occurred on the same day after the second dose of mRNA-1273 vaccine. Its reported following vaccination with the 2nd dose patient experienced within 24hours, COVID-like symptoms, fever but the next day it was gone. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Urticaria
Clinical narrative: body was hot; hives "every day appearing over nowhere waking her up"/skin whelping with hives/itchiness; This spontaneous case was reported by a nurse and describes the occurrence of FEELING HOT (body was hot) and URTICARIA (hives "every day appearing over nowhere waking her up"/skin whelping with hives/itchiness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058h21a, 011m20a and 041l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced FEELING HOT (body was hot) and URTICARIA (hives "every day appearing over nowhere waking her up"/skin whelping with hives/itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK, bid and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at a dose of UNK, bid. At the time of the report, FEELING HOT (body was hot) and URTICARIA (hives "every day appearing over nowhere waking her up"/skin whelping with hives/itchiness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FEELING HOT (body was hot) and URTICARIA (hives "every day appearing over nowhere waking her up"/skin whelping with hives/itchiness) to be related.    Concomitant medications include over the counter medication for unknown indication.  It was reported that, following vaccination with the 3rd dose after 2 weeks patient started to experiencing events. Patient went to the Urgent Care.   Patient received treatment with steroids which patient took for 7 days and then Zyrtec and Allegra together, twice a day. Later, patient stated symptoms reappearing when patient stopped taking medication, and stated medication messing patient's immune system. Patient stated that the symptoms were ongoing and that it was unbearable. Skin whelping with hives were affecting patients life.   This case was linked to MOD-2022-525727, MOD-2022-525710 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow-up document received includes no new information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: after receiving both Moderna primary doses, he got COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (after receiving both Moderna primary doses, he got COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (after receiving both Moderna primary doses, he got COVID-19). At the time of the report, COVID-19 (after receiving both Moderna primary doses, he got COVID-19) outcome was unknown.            No concomitant medications were reported. No treatment  medications were reported.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 , unspecified days after receiving the second dose of mRNA-1273 vaccine. No details regarding the vaccination dates or COVID 19 test were available in the report. The outcome of the event was 'unknown'.The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-525740, MOD-2022-525891 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 , unspecified days after receiving the second dose of mRNA-1273 vaccine. No details regarding the vaccination dates or COVID 19 test were available in the report. The outcome of the event was 'unknown'.The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: about 4 months after having the booster patient got two blood clots in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (about 4 months after having the booster patient got two blood clots in leg) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Prostate surgery in September 2021. Previously administered products included for COVID-19 vaccination: Johnson and Johnson vaccine on 15-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Cancer.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (about 4 months after having the booster patient got two blood clots in leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (about 4 months after having the booster patient got two blood clots in leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: blood clots Blood clots were there for a long time..         Concomitant drugs were not reported. Treatment medications were not provided.   It was reported that patient received the JNJ vaccine last February 2021 and Moderna vaccine around July or August 2021 and did not know exact dates or have lot information. Caller stated the technician who did the ultrasound said the blood clots were there for a long time.  Company comment: This spontaneous case concerns an elderly male patient (age not specified) with relevant medical history of cancer, which is unspecified and prostate surgery, who experienced the unexpected serious AESI Thrombosis, approximately four months after the booster dose of mRNA-1273. The patient experienced two blood clots in leg' and the ultrasound confirmed on the same having blood clots. No further details were reported. The event outcome was unknown. Medical history of cancer which is unspecified could be the risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient (age not specified) with relevant medical history of cancer, which is unspecified and prostate surgery, who experienced the unexpected serious AESI Thrombosis, approximately four months after the booster dose of mRNA-1273. The patient experienced two blood clots in leg' and the ultrasound confirmed on the same having blood clots. No further details were reported. The event outcome was unknown. Medical history of cancer which is unspecified could be the risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to drug Percocet.), Latex allergy, Rubber sensitivity and Fruit allergy.   On 31-Dec-2020 at 10:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Jan-2021 at 10:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no chronic or long-standing health conditions. The patient did not have any acute illness at the time of vaccination and up to one month before.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: This spontaneous case concerns a 34 year old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID 19, approximately 11 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was reported. The interval between the 2 doses was approximately 28 days. The patient tested positive for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-504317 (Patient Link).; Sender's Comments: This spontaneous case concerns a 34 year old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID 19, approximately 11 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was reported. The interval between the 2 doses was approximately 28 days. The patient tested positive for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.