chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pruritus
Clinical narrative: Itchiness all over her body; Has not been feeling good; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2022, the patient received the 2nd dose of Shingrix. On 12th April 2022, less than a day after receiving Shingrix, the patient experienced generalized pruritus and feeling bad. On an unknown date, the outcome of the generalized pruritus and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and feeling bad to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: The patient had her second dose of Shingrix and since that time she had not been feeling good and had experienced itchiness all over her body. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Powder was reconstituted with sterile water and administered to patient; Powder was reconstituted with sterile water and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA642A, expiry date 30th November 2022) for prophylaxis.   On 3rd May 2022, the patient received Menveo. On 3rd May 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: 04-MAY-2022 Reporters comment: The patient was 16 years old at he time of reporting. Director reported that, Menveo powder was inadvertently reconstituted with sterile water and administered to the patient. The reporter consented to follow up. Additional supportive information: Menveo powder was inadvertently reconstituted with sterile water and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 81.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 81-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA520A, expiry date 30th April 2022) for prophylaxis.   On 4th May 2022, the patient received Menveo. On 4th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporters comment: A health care professional reported that, the patient received an expired dose of Menveo. The reporter consented to follow up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Age: 64.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Did not receive 3rd dose till the time of reporting; 1st dose on 6/14/2021, 2nd dose on 7/26/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 26th July 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th July 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, unknown after starting Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 4-May-2022 Reporter's comments: The pharmacist would like to know if the patient could receive the third dose of Twinrix on the date of reporting. The patient received 1st dose of Twinrix on 14th June 2021. The patient received 2nd dose of Twinrix late on 26th July 2021. During the call, the third dose was not given yet. The healthcare professional had intention to do it but at the moment of the consult by phone, the vaccine had not been administered. The consent to follow up was given by postal or email address, however the healthcare professional requested by phone Additional Supportive Information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to which led to lengthening of interval between vaccine doses. Till the time of reporting the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Patient inadvertently received a pediarix vaccine instead of dtap; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X325, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 5th May 2022, unknown after receiving Pediarix and Pediarix 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: 05-MAY-2022 Reporters comment: The patient inadvertently received Pediarix vaccine instead of dtap in left thigh. The reporter consented to follow up. Additional supportive information: The patient inadvertently received Pediarix vaccine instead of dtap, which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: 1st dose 2 years ago and did not follow up due to the pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 05-MAY-2022 Reporters comment: The patient received their 1st dose of Shingrix, 2 years ago from the date of reporting and did not follow up due to the pandemic. The reporter asked, if they need to restart the series or they could get the 2nd dose now. The reporter consented to follow up.
Age: 35.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 35 year old immunocompetent patient received shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th May 2022, the patient received Shingrix. On 5th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 5-MAY-2022 Reporter's Comment: Healthcare professional reported a 35-year-old immunocompetent patient received Shingrix. The reporter consented to follow up. Additional Supportive Information: A 35-year-old patient received Shingrix, which led to inappropriate age at vaccine administration.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a dose of Adjuvant only; received a dose of Adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NX5J, expiry date 9th June 2023) for prophylaxis.   On 5th May 2022, the patient received Shingrix. On 5th May 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: 5-MAY-2022 Reporter's Comment: The reporter was a Medical assistant. The patient received a dose of adjuvant only of Shingrix instead of the reconstituted vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 3/4/2020, not yet received second; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th March 2020).   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: 5-MAY-2022 Reporter's Comment: The reporter was a pharmacy intern. The patient had not yet received the second dose of Shingrix. The reporter consented to follow up by safety via telephone only. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received vaccine subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 5th May 2022, the patient received Boostrix. On 5th May 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient received Boostrix vaccine subcutaneously instead of intramuscular. The reporter consented to follow up. Additional supportive information: The patient received Boostrix vaccine subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix 1440) (batch number B4JL4, expiry date 21st February 2022) for prophylaxis.   On 5th May 2022, the patient received Havrix 1440. On 5th May 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 6-MAY-2022 Reporter's Comment: The patient received an expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix, which was already expired on 21st February 2022, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA46A, expiry date 20th March 2022) for prophylaxis.   On 6th May 2022, the patient received Menveo. On 6th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 6-MAY-2022 Reporter's Comment: The pharmacist reported that an expired dose of Menveo was administered by error. The reporter consented to follow up by email. Additional Supportive Information: The patient received Menveo, which was already expired on 20th March 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: given to immunocompetent 25 yo patient; Shingrix given by mistake, Varicella vaccine was intended; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 6-MAY-2022 Reporter's Comment: The physician reported that Shingrix was given 2 weeks prior to reporting date to a 25-year-old immunocompetent patient by mistake when Varicella vaccine was intended to be given.  The physician asked was there any safety information, timing of Varicella vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: A 25-year-old immunocompetent patient received Shingrix by mistake instead of Varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 48 year old male. Initial information was processed along with the additional information received on 06-MAY-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-AUG-2021 to right arm for prophylactic vaccination. The age at time of vaccination was 48 years old. No concomitant medications were reported. On 04-JAN-2022, the patient experienced headache and mild fever of 99.3 degree Fahrenheit. On the same day, the patient had tested positive for covid-19 in a Binax rapid antigen test which indicated suspected covid-19 infection and suspected clinical vaccination failure. On 06-JAN-2022, the patient recovered from headache and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000229574.; Sender's Comments: V0:20220509386  -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: 8 DAYS AND COUNTING AND STILL POSITIVE; This spontaneous report received from a patient via a social media (Twitter) and by a company representative concerned a patient of an 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 was previously 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 and 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 covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (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 not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-APR-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient was covid-19 test positive (Dose number in series: 2). Laboratory data included: COVID-19 virus test (NR: not provided) positive. It was reported that "I got my booster 8 days and counting & still positive". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Sunburn
Clinical narrative: LIMBS BURNING; FEELING OF AN INVISIBLE SUNBURN ACROSS ARMS, LEGS AND FACE; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced limbs burning, and feeling of an invisible sunburn across arms, legs and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from limbs burning, and feeling of an invisible sunburn across arms, legs and face. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-FEB-2022, the patient passed away from unknown cause of death. It was unknown if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220513819 - Covid-19 vaccine ad26.cov2.s -Passed away. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy, Skin laceration, Vaccination site mass, Vaccination site pain, Vaccination site scab
Clinical narrative: SCARRING AT VACCINATION SITE; INDENTATION AT VACCINATION SITE; MASS AT THE VACCINATION SITE; LOSS OF SOME MUSCLE MASS; CUT IN ARM THAT GOES TO BONE; PAIN/TENDERNESS AT VACCINATION SITE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: car accident, lacunar stroke, and hysterectomy, and concurrent conditions included: low blood pressure, cigarette smoker (average 1pack/3days), alcohol use, chronic back pain from car accident (uses marijuana), seasonal allergies, allergy to penicillin, drug allergy (Heparin, Lovenox, Lasix, IV Gentimicin), allergic to bee sting and marijuana use for pain (rarely, average 1/month). Also patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 18-JUN-2021 at left arm for prophylactic vaccination. It was unknown whether patient experienced any adverse reactions following vaccination with covid-19 vaccine ad26.cov2.s. Caller stated that she had no issue with the initial vaccination The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-FEB-2022 at left arm for prophylactic vaccination. Age at time of vaccination 47 years old. No concomitant medications were reported. On an unspecified date in 2022, within a month post the booster shot, the patient experienced loss of muscle mass so severe that she has skin on bones for which the patient was told to fix it with plastic surgery but plastic surgery was elective, also patient had the side effect of pain/ tenderness, scarring and indentation at the site on her Left arm in which she received the booster Janssen Covid-19 Vaccine and also had loss of some muscle mass with cut in her arm that goes to bone(Dose number in series 2). The patient had seen the nurse for the scarring, indentation and pain/tenderness at vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from scarring at vaccination site, indentation at vaccination site, and pain/tenderness at vaccination site, and the outcome of mass at the vaccination site, loss of some muscle mass and cut in arm that goes to bone was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site scar
Clinical narrative: SCARRING AT VACCINATION SITE; INDENTATION AT VACCINATION SITE; MASS AT THE VACCINATION SITE; LOSS OF SOME MUSCLE MASS; CUT IN ARM THAT GOES TO BONE; PAIN/TENDERNESS AT VACCINATION SITE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: car accident, lacunar stroke, and hysterectomy, and concurrent conditions included: low blood pressure, cigarette smoker (average 1pack/3days), alcohol use, chronic back pain from car accident (uses marijuana), seasonal allergies, allergy to penicillin, drug allergy (Heparin, Lovenox, Lasix, IV Gentimicin), allergic to bee sting and marijuana use for pain (rarely, average 1/month). Also patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 18-JUN-2021 at left arm for prophylactic vaccination. It was unknown whether patient experienced any adverse reactions following vaccination with covid-19 vaccine ad26.cov2.s. Caller stated that she had no issue with the initial vaccination The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-FEB-2022 at left arm for prophylactic vaccination. Age at time of vaccination 47 years old. No concomitant medications were reported. On an unspecified date in 2022, within a month post the booster shot, the patient experienced loss of muscle mass so severe that she has skin on bones for which the patient was told to fix it with plastic surgery but plastic surgery was elective, also patient had the side effect of pain/ tenderness, scarring and indentation at the site on her Left arm in which she received the booster Janssen Covid-19 Vaccine and also had loss of some muscle mass with cut in her arm that goes to bone(Dose number in series 2). The patient had seen the nurse for the scarring, indentation and pain/tenderness at vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from scarring at vaccination site, indentation at vaccination site, and pain/tenderness at vaccination site, and the outcome of mass at the vaccination site, loss of some muscle mass and cut in arm that goes to bone was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Haematoma, Skin disorder, Thrombosis
Clinical narrative: BLOOD CLOT ON RIGHT CALF; HEMATOMA; BUMP ON SKIN; This spontaneous report received from a patient concerned a female of an 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, first six months post vaccination, the patient experienced a hematoma. The patient had visited the emergency department, where CAT (computerized axial tomography) scan test was done to confirm blood clot in her leg (right calf). The patient's healthcare professional was aware. At the time of this report, the patient experienced a bump coming up on the skin which would come and go and felt anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on skin, and the outcome of hematoma and blood clot on right calf was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220513946-covid-19 vaccine ad26.cov2.s- Blood clot on right calf . 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: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative concerned multiple patients. The patients' height and weight were not reported.  No past medical histories or concurrent conditions were reported. The patients previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination.  It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patients received additional dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total 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 patients experienced covid-19 (Dose number in series 2). It was reported as "that people who are getting booster are getting it".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple patients with covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000229796. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this report indicates medical adverse events, there is no product quality issue described in the information reported and this does not meet the criteria for lack of effect for the vaccine) based on the PQC evaluation/investigation performed.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Dry skin, Dyspnoea, Flushing, Movement disorder
Clinical narrative: REDNESS ACROSS JOINTS, IT DECREASES RANGE OF MOTION IN THE JOINT BUT WITHOUT PAIN, FEELS TIGHT AND HOT. MAIN JOINTS THAT ARE AFFECTED ARE KNEES, ELBOWS, AND WRISTS, AND LESS COMMONLY ANKLES; BENDING AT THE WAIST IS DIFFICULT; DIFFICULTY BREATHING; FULL BODY HIVES; FLUSHING; EXTREME DRYNESS; This spontaneous report received from a patient via a company representative concerned a 25 year old male. The patient's weight was 185 kilograms, and height was 67 inches. The patient's concurrent conditions included: high blood pressure, chronic migraines, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. Non-company suspect drugs included: nortriptyline (form of admin unknown, oral, batch number was not reported) 25 mg, every 1 day, from 30-AUG-2021, frequency was not reported, 50 mg, every 1 day, frequency, and therapy dates were not reported, and 25 mg, every 1 day from 09-NOV-2021 to MAR-2022, frequency was not reported for an unspecified indication. Age at time of vaccination 25 years old. No concomitant medications were reported. On 09-NOV-2021, the patient experienced extreme dryness. On 13-NOV-2021, the patient experienced flushing, and full body hives. On an unspecified date, the patient experienced redness across joints, it decreases range of motion in the joint but without pain, feels tight and hot. main joints that are affected are knees, elbows, and wrists, and less commonly ankles, bending at the waist is difficult, and difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with nortriptyline was withdrawn on MAR-2022. The patient had not recovered from flushing, and full body hives, and the outcome of difficulty breathing, redness across joints, it decreases range of motion in the joint but without pain, feels tight and hot. main joints that are affected are knees, elbows, and wrists, and less commonly ankles, bending at the waist is difficult and extreme dryness was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: REDNESS ACROSS JOINTS, IT DECREASES RANGE OF MOTION IN THE JOINT BUT WITHOUT PAIN, FEELS TIGHT AND HOT. MAIN JOINTS THAT ARE AFFECTED ARE KNEES, ELBOWS, AND WRISTS, AND LESS COMMONLY ANKLES; BENDING AT THE WAIST IS DIFFICULT; DIFFICULTY BREATHING; FULL BODY HIVES; FLUSHING; EXTREME DRYNESS; This spontaneous report received from a patient via a company representative concerned a 25 year old male. The patient's weight was 185 kilograms, and height was 67 inches. The patient's concurrent conditions included: high blood pressure, chronic migraines, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. Non-company suspect drugs included: nortriptyline (form of admin unknown, oral, batch number was not reported) 25 mg, every 1 day, from 30-AUG-2021, frequency was not reported, 50 mg, every 1 day, frequency, and therapy dates were not reported, and 25 mg, every 1 day from 09-NOV-2021 to MAR-2022, frequency was not reported for an unspecified indication. Age at time of vaccination 25 years old. No concomitant medications were reported. On 09-NOV-2021, the patient experienced extreme dryness. On 13-NOV-2021, the patient experienced flushing, and full body hives. On an unspecified date, the patient experienced redness across joints, it decreases range of motion in the joint but without pain, feels tight and hot. main joints that are affected are knees, elbows, and wrists, and less commonly ankles, bending at the waist is difficult, and difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with nortriptyline was withdrawn on MAR-2022. The patient had not recovered from flushing, and full body hives, and the outcome of difficulty breathing, redness across joints, it decreases range of motion in the joint but without pain, feels tight and hot. main joints that are affected are knees, elbows, and wrists, and less commonly ankles, bending at the waist is difficult and extreme dryness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling abnormal, Platelet transfusion, Weight increased
Clinical narrative: PLATELET TRANSFUSIONS; BRUISES ALL OVER BODY; GAINED WEIGHT; FELT MISERABLE; This spontaneous report received from a consumer concerned a female of unspecified age The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included eltrombopag olamine. On an unspecified date, the patient developed bruises all over her body, she did not look healthy and was hospitalized with platelet transfusions. She was in the hospitals for 7 days or so after getting the shot and had to stop working. It was unknown if the patient was discharged from the hospital. At the time of the report, she was also on Promecta and had gained weight and was just miserable, The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruises all over body, platelet transfusions, gained weight and felt miserable was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20220514980-covid-19 vaccine ad26.cov2.s-Bruises all over body, Platelet transfusion. 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: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient via a company representative via social media 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 (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot. As per reporter it was reported that, "I think I have a blood clot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220515002-covid-19 vaccine ad26.cov2.s- Blood clot . 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.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer via other manufacturer (Abbvie) concerned a 3 decade old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe hidradenitis suppurativa. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered, on an unspecified date in AUG-2021 for prophylactic vaccination.  On an unspecified date, the patient experienced occasional hidradenitis suppuritiva flares, sick, and bruises easily (dose number in series 1). The patient received booster dose of Moderna COVID-19 vaccine (spikevax, elasomeran) (dose number in series 2) (form of admin was not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination.  It was unknown whether the patient had any adverse events following vaccination with Moderna COVID-19 vaccine (elasomeran) (dose number in series 2). The patient received third dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administered (Dose number in series 3). Age at time of vaccination 3 decade old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received non-company suspect drug: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) citrate free, dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220512914.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Rash
Clinical narrative: RASH LEFT LEG; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: Epstein-Barr syndrome, and drug allergy, and other pre-existing medical conditions included: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 (coronavirus disease) treatment. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 12- AUG-2021 at 14:00 in right arm for prophylactic vaccination. It was unknown if patient experienced any adverse reactions following administration covid-19 vaccine ad26.cov2.s vaccine (dose number in series 1). The patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on AUG-2021 for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administered (dose number in series 2). Age at time of vaccination 48 years old. No concomitant medications were reported.  On 26-APR-2022, at 18:00 the patient experienced rash left leg (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash left leg, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: LIMITATIONS IN LEFT SHOULDER RANGE OF MOTION; LEFT SHOULDER PAIN INITIATED THE DAY AFTER VACCINATION; This spontaneous report received from a patient concerned a 38 year old female. 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, intramuscular, batch number: 203A28A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Age at time of vaccination 38 years old. No concomitant medications were reported.  On 08-MAY-2021, the patient experienced left shoulder pain initiated the day after vaccination. On 14-MAY-2021, the patient experienced limitations in left shoulder range of motion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left shoulder pain initiated the day after vaccination, and limitations in left shoulder range of motion. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration; Expired dose was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (first dose) on 07-May-2021 and Pfizer (second dose) on 28-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  The vial was initially stored in the refrigerator on 06-Apr-2022.  The patient received first booster dose of Moderna vaccine on 07-Apr-2022.  The healthcare provider had a lot number of the vial which they thought expired at a different time. However, when the healthcare provider entered the lot number on Moderna's online expiration tool look up, it was found that the lot had expired on 02-Apr-2022.  The healthcare provider reported that each patient was administered with a dose from a different vial and each of the vial was stored in the refrigerator on the day before administration.  The vial did not undergo any temperature excursion. It was reported that the patient had not reported of experiencing any adverse reactions to this expired dose.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Significant follow up contains : Added reporter, updated suspect product dose details, and updated narrative. On 05-May-2022: Follow-up received and reporter's email address updated.