chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 18-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Polyarticular juvenile rheumatoid arthritis, chronic or unspecified.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving. Not provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product was provided. No treatment information was provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trail. Primary reporters contact for lot number information was unsuccessful. Company comment-This spontaneous case concerns a female patient aged 18 years with no medical history reported, who experienced the unexpected non serious of Covid 19 on an unknown date after receiving a dose (dose number not specified) of mRNA-1273 vaccine in the covid 19 vaccination series. COVID-19 test done on unknown date in 2022 was positive. No further clinical course, other lab results or treatment details were reported.  Outcome of the event covid-19 is resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 18 years with no medical history reported, who experienced the unexpected non serious of Covid 19 on an unknown date after receiving a dose (dose number not specified) of mRNA-1273 vaccine in the covid 19 vaccination series. COVID-19 test done on unknown date in 2022 was positive. No further clinical course, other lab results or treatment details were reported.  Outcome of the event covid-19 is resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial vaginosis, Fungal infection
Clinical narrative: Yeast infections; Bacterial vaginosis; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast infections) and BACTERIAL VAGINOSIS (Bacterial vaginosis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FUNGAL INFECTION (Yeast infections) and BACTERIAL VAGINOSIS (Bacterial vaginosis). At the time of the report, FUNGAL INFECTION (Yeast infections) and BACTERIAL VAGINOSIS (Bacterial vaginosis) was resolving.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The causality for the events of yeast infections and bacterial vaginosis with Humira was provided as no reasonable possibility.  No treatment information was provided.   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: pain in neck; sore arm/ Pain in arm; pain in shoulder; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (pain in neck), PAIN IN EXTREMITY (sore arm/ Pain in arm) and ARTHRALGIA (pain in shoulder) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 077C21B, 007M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced NECK PAIN (pain in neck), PAIN IN EXTREMITY (sore arm/ Pain in arm) and ARTHRALGIA (pain in shoulder). In June 2022, NECK PAIN (pain in neck), PAIN IN EXTREMITY (sore arm/ Pain in arm) and ARTHRALGIA (pain in shoulder) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that after taking his last booster on 10-Jun-2022, he had a sore arm, pain in arm, shoulder and neck and each time pain lasted 1 day.  No treatment medications were reported.   This case was linked to MOD-2022-588957, MOD-2022-588873, MOD-2022-589013, MOD-2022-589031, MOD-2022-589045 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/sore arm following each COVID vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Miscarriage, Tiredness, Tenderness, Medical marijuana therapy in 1994, Cyst removal (Ganglion cyst removal) in 2007, Cholecystectomy in 2017, Tubulization nerve repair in 2019 and Abortion. Concurrent medical conditions included Alcohol use (Eight glasses) since 1994, Tobacco user (Two packs of cigarettes per week) since 1994, Latex allergy (Allergy manifested by scratchy throat, swelling and hives.), Carpal tunnel syndrome since March 2008 and Crohn's disease. Concomitant products included MESALAZINE (APRISO) for Crohn's disease, INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm following each covid vaccine). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/sore arm following each covid vaccine) outcome was unknown. Not provided.         It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.   This case was linked to MOD-2022-589105, MOD-2022-589108 (Patient Link).   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination Site Pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Miscarriage, Carpal tunnel syndrome in March 2008, Tiredness, Tenderness, Cyst removal (Ganglion cyst removal) in 2007, Cholecystectomy in 2017, Tubulization nerve repair in 2019 and Abortion. Concurrent medical conditions included Alcohol abuse (Eight glass) since 1994, Tobacco user (Two packs of Cigarette per week.) since 1994, Medical marijuana therapy since 1994 and Latex allergy (Manifested by scratchy throat, swelling and hives.). Concomitant products included MESALAZINE (APRISO) for Crohn's disease.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination Site Pain). At the time of the report, VACCINATION SITE PAIN (Vaccination Site Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2022-589107, MOD-2022-589105 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug interaction
Clinical narrative: Drug interaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Drug interaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). At the time of the report, DRUG INTERACTION (Drug interaction) outcome was unknown.            Reported that on an unknown date, the patient experienced Humira did not work well by itself. Moderna covid-19 vaccine (Elasomeran) was also considered suspect.  Reported Causality for Drug effect incomplete (Humira did not work well by itself) for Moderna COVID-19 vaccine reported as Possible.  It was unknown whether patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Swollen tongue
Clinical narrative: My tongue is swelling up; My left ear is really in pain; This spontaneous case was reported by a patient and describes the occurrence of SWOLLEN TONGUE (My tongue is swelling up) and EAR PAIN (My left ear is really in pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On 14-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced SWOLLEN TONGUE (My tongue is swelling up) and EAR PAIN (My left ear is really in pain). At the time of the report, SWOLLEN TONGUE (My tongue is swelling up) and EAR PAIN (My left ear is really in pain) outcome was unknown.            No concomitant medications were reported.  Reported that patient received third Moderna shot and It was the one for immunocompromised.  No treatment medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pain in extremity
Clinical narrative: Back is hurting, but that is happening since the baby was born.; Got chills/is still having chills and stuff; Headache; Got a sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Got a sore arm), BACK PAIN (Back is hurting, but that is happening since the baby was born.), CHILLS (Got chills/is still having chills and stuff) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (COVID positive test or diagnosis in dec-2021) in December 2021.    On 10-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jun-2022, the patient experienced PAIN IN EXTREMITY (Got a sore arm). On 13-Jun-2022, the patient experienced CHILLS (Got chills/is still having chills and stuff) and HEADACHE (Headache). On an unknown date, the patient experienced BACK PAIN (Back is hurting, but that is happening since the baby was born.). At the time of the report, PAIN IN EXTREMITY (Got a sore arm) and BACK PAIN (Back is hurting, but that is happening since the baby was born.) outcome was unknown and CHILLS (Got chills/is still having chills and stuff) and HEADACHE (Headache) had not resolved.            No concomitant information were reported by the reporter.  Patient received second dose of the Moderna covid19 vaccine on the 10-Jun-2022, and on the 11-Jun-2022 they got a sore arm and on the 13-Jun-2022 they got chills, headache and was still having chills and stuff. Also their back was hurting, but that was happening since the baby was born.  Patient did not have any allergies (medications, food and other products). It was reported as patient no medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient could not provided information about their first dose also reporter reported that symptoms was just starting but AE did not required patient to seek medical care (office visit, Urgent care, ER, hospitalized) and patient did not experienced a similar event in the past.  No treatment information were reported by the reporter.   Reporter did not allow further contact
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) and CHEST PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (First booster dose) on 01-Oct-2021, Pfizer (Second primary dose) and Pfizer (First primary dose). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Sulfonamide allergy (Sulfamethazine), Allergy to antibiotic (Amoxicillin) and Allergy to antibiotic (Cefalexin). Concomitant products included HYDROCODONE for Pain, ASPIRIN [ACETYLSALICYLIC ACID] for Prophylaxis.    On 09-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) and CHEST PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart). At the time of the report, PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) and CHEST PAIN (different aches and pains in different parts of body, mainly in upper left side that sometimes goes to the front, and it seems to be above heart) had not resolved.            Patient height was reported as 5 feet 9 inches. It was reported that patient had been vaccinated with the primary doses, first booster dose from Pfizer and did not experienced any side effects.  Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not experienced similar event in the past. Patient had no COVID positive test or diagnosis. No treatment medications were provided.   Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fall, Malaise, Pyrexia, Skin abrasion, Skin haemorrhage
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FALL (Elbow abrasion with bleeding suffered after fell while standing on boat), SKIN ABRASION (Elbow abrasion with bleeding suffered after fell while standing on boat), SKIN HAEMORRHAGE (Elbow abrasion with bleeding suffered after fell while standing on boat), MALAISE (fever with malaise) and PYREXIA (Fever with malaise) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphoid leukemia. Concurrent medical conditions included Chronic lymphoid leukemia. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2022, the patient experienced MALAISE (fever with malaise) and PYREXIA (Fever with malaise). On an unknown date, the patient experienced FALL (Elbow abrasion with bleeding suffered after fell while standing on boat), SKIN ABRASION (Elbow abrasion with bleeding suffered after fell while standing on boat) and SKIN HAEMORRHAGE (Elbow abrasion with bleeding suffered after fell while standing on boat). In 2022, MALAISE (fever with malaise) and PYREXIA (Fever with malaise) had resolved. At the time of the report, FALL (Elbow abrasion with bleeding suffered after fell while standing on boat) outcome was unknown, SKIN ABRASION (Elbow abrasion with bleeding suffered after fell while standing on boat) was resolving and SKIN HAEMORRHAGE (Elbow abrasion with bleeding suffered after fell while standing on boat) had resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication was not provided by the reporter.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Booster dose administered to a 15 year old patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to a 15 year old patient) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer shot (1st dose, with intramuscular route and Lot number was EWO151 with expiration date of 23-Jul-2021.) on 21-May-2021; for Product used for unknown indication: Pfizer shot (2nd dose and Lot number was EWO151 with expiration date of 23-Jul-2021.) on 14-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer shot and Pfizer shot.    On 23-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to a 15 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to a 15 year old patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's date of birth was reported as March 2007.  No concomitant medications information was reported. No treatment was given, as no AEs were reported.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Protein albumin ratio, Pruritus, Swollen tongue, Troponin
Clinical narrative: Facial Itching; My tongue has been swollen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: FJ6369), in left arm for COVID-19 immunization; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Facial Itching"; SWOLLEN TONGUE (non-serious), outcome "unknown", described as "My tongue has been swollen". The patient underwent the following laboratory tests and procedures: Protein albumin ratio: Normal, notes: I did have a lab test to look at my blood protein values to test for allergic reaction and that all back normal; Troponin: Unknown Results.Therapeutic measures were taken as a result of pruritus, swollen tongue.  Additional information: Patient reported of taking Pfizer COVID vaccine on January 18. The side effect that patient had were facial itching which started immediately after reporter got the vaccine and also had tongue swelling ever since got the vaccine. Patient got it on January 18 and tongue has been swollen a couple of time a week ever since then. Expiration date was not written on patient's card. Patient did not have any other medical conditions and medications. Whenever the tongue swelling started doctor prescribed hydroxyzine hcl to help with the swelling (Later clarified as treatment). Patient saw an allergist as well but they did not find anything in the test. Patient never did see an allergist as well but they did not find anything in the test. Patient never had any other side effect from any other vaccine. Had Flu vaccine(confirmed later as Influenza vaccine, Unknown manufacturer and captured) a few days before I got the Pfizer vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: My arm hurting; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jun2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm hurting"; PAIN (non-serious), outcome "unknown".  Additional information: This report was not related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills; Headache; Muscle aches; Intense fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician). An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Not available/provided to reporter at the time of report completion) administration date: Aug2021 for COVID-19 Immunisation, reaction(s): "Chills", "intense fatigue", "headache", "muscle aches", Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown, Not available/provided to reporter at the time of report completion) administration date: Sep2021 for COVID-19 Immunisation, reaction(s): "Chills", "intense fatigue", "Headache", "muscle aches". The following information was reported: CHILLS (non-serious) with onset May2022, outcome "recovered" (2022), HEADACHE (non-serious) with onset May2022, outcome "recovered" (2022), FATIGUE (non-serious) with onset May2022, outcome "recovered" (2022), described as "Intense fatigue", MYALGIA (non-serious) with onset May2022, outcome "recovered" (2022), described as "Muscle aches". It was unknown if therapeutic measures were taken as a result of chills, headache, myalgia, fatigue.  Additional information: It was reported that patient experiencing 1 day of chills and 5 days of headache, muscle aches and intense fatigue beginning the day after receiving her first booster (3rd Pfizer vaccine shot), 8 months after completing her primary vaccination course of two doses of the Pfizer COVID-19 vaccine. On the sixth day after receiving her booster shot, she awoke feeling normal with all symptoms resolved. She had experienced similar symptoms 1 day after each of the two doses of Pfizer vaccine that lasted only for 1 day each during her primary vaccination sequence of dosing. Facility type vaccine was unknown. It was unknown if patient received other vaccine in four weeks. It was unknown if patient has taken other medication in two weeks. She was not tested COVID positive prior to CIVID vaccination and was not tested positive post vaccination. It was unknown whether patient had any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP, also reported as office manager) and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-APR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot number: U022819, expiration date: 14-JAN-2023, administered for prophylaxis (dose, strength, and route of administration were not provided). Vaccine was improperly stored in temperature of 70 F for 96 hours (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fatigue; fever; body aches; headaches; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 2nd dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced fatigue, fever, general body pain and headache. On an unknown date, the outcome of the fatigue, fever, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, fever, general body pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingrix and had severe fatigue like fever body aches and headaches cents.  The patient wanted to know about how long should this last. The reporter started to get concerned. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Got 2nd shot on Tuesday my arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 11-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got shingles shot on Tuesday. The patient arm was still sore. The reporter stated that, it was better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever stayed under 102; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient was vaccinated with shingles vaccine on Tuesday (from the day of reporting) and started running a fever which stayed under 102 degree F. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incomplete course of vaccination, Incorrect dose administered, Needle issue
Clinical narrative: majority of  vaccine leaked onto the patients arm; vaccine leaked onto the patients arm; vaccine leaked onto the patients arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: The reporter stated that, she had a patient that was administered Shingrix, but the reporter had a needle malfunction, and the majority of the vaccine leaked onto the patients arm.  The reporter believed complete dose was not received by the patient adverse event filed. The reporter provided limited information. Additional Supportive Information: A patient that was administered Shingrix, but the reporter had a needle malfunction, and the majority of the vaccine leaked onto the patients arm and reporter believed complete dose was not received by the patient, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix December 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st December 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-Jun-2022 Reporter's comment: The health care professional reported that patient received 1st dose of Shingrix in December 2019.  No reactions reported.  Consented to follow up was granted. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant component; administered only the adjuvant component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Shingrix. On 14th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The reporter stated that, the patient was administered only the adjuvant component of the Shingrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with case US2022093076, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093076:Same Reporter
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administered only the adjuvant component; Patient was administered only the adjuvant component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Shingrix. On 14th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The reporter stated that, the patient was administered only the adjuvant component of the Shingrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with case US2022093075, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093075:Same Reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Off label use
Clinical narrative: COVID-19; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient from other company (Pfizer) concerned a 75 year old female of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, high cholesterol issue, polyethylene glycol allergy, heart condition, thyroid and had 3 stents in aortic arteries. On 01-FEB-2021, patient received first dose of tozinameran (Pfizer vaccine) (dose number in series 1) (form of admin, route of admin not reported, batch number: EL9264 and expiry: Unknown) 1 total, dose was not reported, administered for prophylactic vaccination.  On an unspecified date, the patient had a bad allergic reaction (dose number in series 1). The patient went to the emergency as her tongue was swollen and she couldn't swallow (dose number in series 1). Treatment medications (dates unspecified) included: IV Benadryl, and epinephrine. As the patient couldn't take Pfizer vaccine due to allergy to PEG (Polyethylene glycol) so took Johnson and Johnson as second dose. On 25-AUG-2021, the patient received second 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 was not reported, 1 total administered for prophylactic vaccination which was an off label dosing frequency (dose number in series 2). The drug was associated with Off label use. The batch number was not reported and has been requested. Age at time of vaccination 75 years old. Concomitant medications included acetylsalicylic acid, captopril, hydrochlorothiazide, levothyroxine sodium for thyroid, pantoprazole sodium sesquihydrate, pravastatin and vitamin.  On 31-DEC-2021, the patient had covid-19 and her antibodies were pretty high (dose number in series 2) and the patient was unsure if they are still high or not. Laboratory data included: Antibody test pretty very high. The patient was exposed to COVID last week but was not tested positive yet so enquired about administering Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and off label dosing frequency was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: CALLER KNOW PEOPLE WHO HAVE EXPERIENCED AE AFTER RECEIVING THE VACCINE/SIDE EFFECTS; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 caller know people who have experienced ae after receiving the vaccine/side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of caller know people who have experienced ae after receiving the vaccine/side effects was not reported. This report was non-serious.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K212A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were given.  Reporter stated that on 24-May-2022, 1 vial was placed in the refrigerator from which 1 dose (0.25 mL booster dose) was given. No temperature excursions were reported.  No treatment information were given.   This case was linked to MOD-2022-589616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2022: Follow up contains significant information: Patient demographics (age) added.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms which included chills, body ache, Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms which included chills, body ache, Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for RA, Plaque psoriasis and Ulcerative colitis.    No Medical History information was reported.   On 25-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms which included chills, body ache, Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms which included chills, body ache, Fatigue) had not resolved.            No concomitant medications were reported. Patient experienced flu-like symptoms which included chills, body aches and  fatigue. The reporter's causality for the event of flu like symptoms with Rinvoq (upadacitinib) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Patient visited hospital and received urgent care and medication. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Pfizer / BioNTech / COVID 19 Treatment; Pfizer / BioNTech / COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "Pfizer / BioNTech / COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient took Paxlovid for COVID 19 Treatment. Colleague reported that Paxlovid makes you feel like you are having morning breath all the time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site injury
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220554543(0). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE INJURY (non-serious), outcome "unknown", described as "vaccine injury". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. Other Case identifier(s): 20220560492(0) (Janssen Research & Development, LLC).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medical included Lisadexmefaine and Trandazaole hydrochloride. The following information was reported: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Patient reported as she was taking other medications within 2 weeks of starting of COVID-19, her con current condition included Auto immune disease and drug allergy. She t received covid-19 vaccine ad-26 cov2 dose was not reported 01 in total was administration on 11Mar2021 14:00 to left arm for prophylactic vaccination at the age of 53-Years old. She received non-company suspect vaccine included tozinameran (Pfizer biotechcovid-19 vaccine) (dose number in series 2) dose was not reported total on ad mistered on 09Dec2021 16:00 to right arm for prophylactic vaccination. On an unspecified date the she experienced covid-19 and was hospitalized (dose number in series) which led to suspect cynical vaccination failure. On 09May2022 she received paxlovid (form of admin. Route of admin were not reported, batch: FY0461 and expiry: Jan2023) does not reported for treatment of covid-19. The she received the course of 4 days of paxlovid treatment and discontinued on 12May2022.  Company Remark (sender's comment): Covid-19 vaccine AD26, cov2. suspected clinical vaccination failure. The event has a compatible /suggestive temporal relationship is unlabeled had unknown. They are other factors more likely to be associated with the events than the drug specifically: special situation. Therefore this event is considered not related.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Citric acid, reaction(s): "Known allergies: Citric acid". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23May2022, outcome "recovered" (27May2022) and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective included PAXLOVID.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.