chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given late; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 26th July 2022, the patient received the 2nd dose of Twinrix. On 26th July 2022, the dose was an unknown dose. On 26th July 2022, the patient started Twinrix Pre-Filled Syringe Device. On 26th July 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Jul-2022 Reporter's Comments: The pharmacist reported the patient received first dose of Twinrix series on 25th May 2022 and second dose was given late on 26th July 2022.   Both doses were administered from lot number 4F3YY. The reporter consented to follow up Additional Supportive Information: The patient received 2nd dose of Twinrix on 26th July 2022, later than the recommended standard schedule, which led to lengthening of the vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't got 2nd vaccine/ greater than 6 months; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose of Shingrix on an unknown arm intramuscularly on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The patient's daughter stated that her mother had not gotten her 2nd dose of Shingrix vaccine and it had been greater than 6 months. The patient was planning on getting the vaccine. No further information about the patient or vaccine. The reporter did not consent to follow-up. This report is for 2 of 2 patients. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022112808:Same reporter
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Rash pruritic, Skin discolouration
Clinical narrative: rash that develops on his chest, sides, and arms; rash itches once in a while; red spots; rash turns white; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly in unspecified arm at same pharmacy in November 2021). Additional patient notes included Never had an allergic reaction to anything during his lifetime.   In February 2022, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced rash, itchy rash, red spotty rash and skin discoloration. On an unknown date, the outcome of the rash, itchy rash, red spotty rash and skin discoloration were not recovered/not resolved.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the itchy rash, red spotty rash and skin discoloration to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Jul-2022 Reporter's Comments: The patient self-reported this case. The patient received his second shot of Shingrix on an unknown arm at the end of February 2022, he did not have the exact date (or lot number of the Shingrix administered) but did provide his pharmacy's contact information since they should have that information on file. Since receiving the second shot, the patient had a rash that developed on his chest, sides and arms. The patient had not seen a doctor about this including his primary care doctor; he had an appointment to see a dermatologist on Monday (01st August 2022). The patient had been self-treating with an unspecified generic inexpensive cream, which had Vaseline in it. He said the rash itched once in a while but did not hurt; and it hadn't gotten any worse. The patient stated that he had to put the cream on his arms when he went out in public because the cream leaved red spots, but one could barely see them, otherwise the rash turned white. Patient was unsure if his rash would be considered hives. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Pain
Clinical narrative: pain at the injection site; body pain; generalized weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 13th October 2020, the patient received the 2nd dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain and weakness generalized. On an unknown date, the outcome of the injection site pain, general body pain and weakness generalized were unknown.   It was unknown if the reporter considered the injection site pain, general body pain and weakness generalized to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Jul-2022 Reporter's comment: The patient reported the case. The patient received a dose of Shingrix and experienced pain at the injection site, body pain and generalized weakness.  The reporter was given medical disclaimer. Referred to health care professional. Spoke per package insert (PI) and content. Provided medical information phone number for HCP reference. The reporter consented to follow up. Additional Supportive Information: The age at vaccination was auto populated in patient tab and product tab, which were different age.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received liquid portion only; received liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date February 2023) for prophylaxis.   On 25th July 2022, the patient received Menveo. On 25th July 2022, unknown after receiving Menveo, 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: 29-Jul-2022 Reporter's comment: A nurse reported that a patient received the liquid portion of Menveo only. The reporter stated the expiration date was February 2023 (she did not had an exact date). The reporter did not had the patient's details but consented to follow-up via email. Additional supportive information: The patient received the liquid portion of Menveo only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: 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 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The registered nurse reported that on the day of reporting the patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Back injury
Clinical narrative: Back injury; This case was reported by a consumer via call center representative and described the occurrence of back injury in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced back injury. On an unknown date, the outcome of the back injury was unknown.   It was unknown if the reporter considered the back injury to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: The reporter was the patient, who received his first dose of shingrix in August 2019.  The patient was stated that after his first dose had sustained a back injury.  The patient did not provide additional details about the back injury.  The patient also stated that had not yet received his second dose of Shingrix. The patient did not provide consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Pulmonary embolism, Superficial vein thrombosis, Thrombosis with thrombocytopenia syndrome, Ultrasound scan
Clinical narrative: THROMBOSIS WITH THROMBOCYTOPENIA (VENOUS); PULMONARY EMBOLISM; THROMBUS WITHIN THE PROXIMAL PORTION OF THE GREATER SAPHENOUS VEIN; This solicited report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient initiated treatment with 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, administered on an unspecified date in on JUL-2022 (reported as approximately 6 days ago) for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in JUL-2022, the patient was hospitalized due to headaches, chest pain and back pain which were ongoing six days prior to presentation and developed 1 day after receiving the vaccine. Laboratory data (dates unspecified) included: CT angiography Bilateral small PEs (pulmonary embolism), and Diagnostic ultrasound demonstrated thrombus within the proximal portion of the greater saphenous vein in the left thigh. It was reported that, patient did not present with thrombocytopenia, but there would, of course, be some concern for vaccination related thrombosis. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombosis with thrombocytopenia (venous), pulmonary embolism, and thrombus within the proximal portion of the greater saphenous vein. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and thrombosis with thrombocytopenia (venous) as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and pulmonary embolism, and thrombus within the proximal portion of the greater saphenous vein. Company causality between covid-19 vaccine ad26.cov2.s, and pulmonary embolism, and thrombus within the proximal portion of the greater saphenous vein was related.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220754730-covid-19 vaccine ad26.cov2.s - thrombosis with thrombocytopenia , pulmonary embolism, thrombus within the proximal portion of the greater saphenous vein. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 13-APR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 18 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 13-APR-2022, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759113, 20220759160, 20220759219 and 20220759222.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTERED VACCINE FROM A BATCH TO BE DISCARDED; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 03-MAY-2022 for covid-19 prophylaxis. Age at time of vaccination 32 years old. No concomitant medications were reported. On 03-MAY-2022, the patient experienced administered vaccine from a batch to be discarded. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine from a batch to be discarded and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759052, 20220759222, 20220761815, 20220759113 and 20220759219.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 39 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 31-MAY-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 39 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 31-MAY-2022, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759052, 20220759222, 20220759160 and 20220759113.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: RECEIVED VACCINE DOSE THAT WAS IN A TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 26-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 26-JUL-2022, the patient experienced received vaccine dose that was in a temperature excursion, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine dose that was in a temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220758989. This report was associated with a product quality complaint: 90000244073.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 40 years old. No concomitant medications were reported. On 07-JUN-2022, the patient experienced out of specification product use. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759052, 20220759113, 20220759160, 20220759219, 20220759222, 20220759337 and 20220761815.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED VACCINE FROM A BATCH TO BE DISCARDED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 03-MAY-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 47 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 03-MAY-2022, the patient experienced administered vaccine from a batch to be discarded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administered vaccine from a batch to be discarded was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759052, 20220759113, 20220759160, 20220759219, 20220759222 and 20220761815.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: CAN NOT FUNCTION; VERY TIRED AND EXTREMELY WORN OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 21-AUG-2021, the patient experienced can not function, and very tired and extremely worn out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very tired and extremely worn out and can not function was not reported. This report was non-serious. This case, from the same reporter is linked to 20220803123.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Wheezing
Clinical narrative: WHEEZING; FELT UNWELL; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-JUL-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2022, the patient experienced wheezing, and felt unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wheezing and felt unwell was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinus congestion, Sneezing, Suspected COVID-19
Clinical narrative: COVID-19 SYMPTOMS; STUFFY HEAD; STUFFY NOSE; SNEEZING; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 15-FEB-2022) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 36 years old. No concomitant medications were reported. On 01-AUG-2022, the patient experienced stuffy head, stuffy nose, and sneezing. On an unspecified date, the patient experienced covid-19 symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection, stuffy head, stuffy nose and sneezing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: 102 fever; aching arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 fever) and PAIN IN EXTREMITY (aching arm) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced PYREXIA (102 fever) and PAIN IN EXTREMITY (aching arm). At the time of the report, PYREXIA (102 fever) and PAIN IN EXTREMITY (aching arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. It was reported that patient had the vaccine yesterday and now had a 102 fever and aching, further asked about contiguous as patient work with pregnant women. No treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: started losing my muscle mass; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE ATROPHY (started losing my muscle mass) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MUSCLE ATROPHY (started losing my muscle mass). At the time of the report, MUSCLE ATROPHY (started losing my muscle mass) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had reactions to the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had reactions to the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had reactions to the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (had reactions to the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.  The reporter reported that the reporter knew of a patient who had reactions to the Moderna Covid-19 vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product colour issue
Clinical narrative: Her arm is killing her; The vaccine that she received looked orange brown in the syringe; The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is killing her), POOR QUALITY PRODUCT ADMINISTERED (The vaccine that she received looked orange brown in the syringe) and PRODUCT COLOUR ISSUE (The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included COVID-19 (Yes, tested positive for COVID-19) in January 2022.    On 28-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced PAIN IN EXTREMITY (Her arm is killing her), POOR QUALITY PRODUCT ADMINISTERED (The vaccine that she received looked orange brown in the syringe) and PRODUCT COLOUR ISSUE (The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up). At the time of the report, PAIN IN EXTREMITY (Her arm is killing her), POOR QUALITY PRODUCT ADMINISTERED (The vaccine that she received looked orange brown in the syringe) and PRODUCT COLOUR ISSUE (The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated that before vaccination she saw the vial which had a pink cap and said 12 years and up. The Pharmacist filled up the syringe and kept pushing back the syringe. Then pharmacist administrated the vaccine. Patient started getting suspicious because her arm was killing her. The caller explained that she wanted to know what was injected to her, but did not want to start a commotion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2022: Follow up received contains QE number updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 01-Jul-2022 past the BUD date 23-Jun-2022/ administration error) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination. It was unknown if the patient was ever diagnosed with or tested COVID-19 positive. It was also unknown if there was any acute illness at the time of vaccination or any chronic or long-standing health conditions of the patient. On 01-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 01-Jul-2022 past the BUD date 23-Jun-2022/ administration error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 01-Jul-2022 past the BUD date 23-Jun-2022/ administration error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 01-Jul-2022 past the BUD date 23-Jun-2022/ administration error). Concomitant medications details were not reported. It was reported vaccine was administered 8 day past the BUD of 23 Jun 2022. Reporter further reported that as per Moderna, the product was still active and patient need not to be re-vaccinated. The event did not cause patient to seek the medical care. There was no other potential caused. It was unknown if patient same event in past. The treatment details were not reported. This case was linked to US-MODERNATX, INC.-MOD-2022-599989 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-599989: Master case.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a reaction). At the time of the report, IMMUNISATION REACTION (Patient had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm swollen up/ It looks like a big lump on the top of his arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm swollen up/ It looks like a big lump on the top of his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  No Medical History information was reported. On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced PERIPHERAL SWELLING (Arm swollen up/ It looks like a big lump on the top of his arm). At the time of the report, PERIPHERAL SWELLING (Arm swollen up/ It looks like a big lump on the top of his arm) outcome was unknown. Concomitant medication information was not provided by the reporter. It was reported that patient received booster dose. Treatment information was not provided by the reporter. Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Aggression, Compulsive hoarding, Disturbance in attention, Impaired quality of life
Clinical narrative: First he focused more,To point where it got bad; became more obsessive; became more aggressive; Hoarding everything; started behaving worse; Irreverably change his mental state; life is worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DISTURBANCE IN ATTENTION (First he focused more,To point where it got bad), OBSESSIVE THOUGHTS (became more obsessive), AGGRESSION (became more aggressive), COMPULSIVE HOARDING (Hoarding everything) and ABNORMAL BEHAVIOUR (started behaving worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autistic disorder (autistic).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (First he focused more,To point where it got bad), OBSESSIVE THOUGHTS (became more obsessive), AGGRESSION (became more aggressive), COMPULSIVE HOARDING (Hoarding everything), ABNORMAL BEHAVIOUR (started behaving worse), MENTAL DISORDER (Irreverably change his mental state) and IMPAIRED QUALITY OF LIFE (life is worse). At the time of the report, DISTURBANCE IN ATTENTION (First he focused more,To point where it got bad), OBSESSIVE THOUGHTS (became more obsessive), AGGRESSION (became more aggressive), COMPULSIVE HOARDING (Hoarding everything), ABNORMAL BEHAVIOUR (started behaving worse), MENTAL DISORDER (Irreverably change his mental state) and IMPAIRED QUALITY OF LIFE (life is worse) outcome was unknown.            No concomitant medications were reported.  It was reported that patient refused taking medicines.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Mental disorder, Obsessive thoughts
Clinical narrative: First he focused more,To point where it got bad; became more obsessive; became more aggressive; Hoarding everything; started behaving worse; Irreverably change his mental state; life is worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DISTURBANCE IN ATTENTION (First he focused more,To point where it got bad), OBSESSIVE THOUGHTS (became more obsessive), AGGRESSION (became more aggressive), COMPULSIVE HOARDING (Hoarding everything) and ABNORMAL BEHAVIOUR (started behaving worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autistic disorder (autistic).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (First he focused more,To point where it got bad), OBSESSIVE THOUGHTS (became more obsessive), AGGRESSION (became more aggressive), COMPULSIVE HOARDING (Hoarding everything), ABNORMAL BEHAVIOUR (started behaving worse), MENTAL DISORDER (Irreverably change his mental state) and IMPAIRED QUALITY OF LIFE (life is worse). At the time of the report, DISTURBANCE IN ATTENTION (First he focused more,To point where it got bad), OBSESSIVE THOUGHTS (became more obsessive), AGGRESSION (became more aggressive), COMPULSIVE HOARDING (Hoarding everything), ABNORMAL BEHAVIOUR (started behaving worse), MENTAL DISORDER (Irreverably change his mental state) and IMPAIRED QUALITY OF LIFE (life is worse) outcome was unknown.            No concomitant medications were reported.  It was reported that patient refused taking medicines.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL).    No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Coronary artery thrombosis
Clinical narrative: 2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well; The initial case previously was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on 29Jul2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: CORONARY ARTERY THROMBOSIS (death, medically significant), outcome "fatal", described as "2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well". The patient date of death was unknown. Reported cause of death: "2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well (Further not clarified)". It was not reported if an autopsy was performed. Clinical course: 2 other people that I used to catch the bus with, they died. They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201004865 same reporter/drug/event, different patient;; Reported Cause(s) of Death: 2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well (Further not clarified)
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, C-reactive protein, Hepatitis B virus test, Hepatitis C virus test, Red blood cell sedimentation rate
Clinical narrative: Rheumatoid arthritis; This is a literature report for the following literature source(s): "Progression from palindromic rheumatism to rheumatoid arthritis after COVID-19 vaccination", Rheumatology, 2022; Vol:1, pgs:100-101.  A 40-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for palindromic rheumatism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Anti-cyclic citrullinated peptide antibody: >250 IU/ml; >250 IU/ml; C-reactive protein: normal; 17.2 mg/dl, notes: elevated; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; Red blood cell sedimentation rate: normal; Rheumatoid factor: 28 IU/ml; Ultrasound scan: effusion and synovitis in the radiocarpal joints; X-ray: normal; normal. Therapeutic measures were taken as a result of rheumatoid arthritis.; Sender's Comments: Based on available information in the case the reported event Rheumatoid arthritis assessed as unrelated to suspect drug  and more likely related to intercurrent/ underlying medical condition The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor, Ultrasound scan, X-ray
Clinical narrative: Rheumatoid arthritis; This is a literature report for the following literature source(s): "Progression from palindromic rheumatism to rheumatoid arthritis after COVID-19 vaccination", Rheumatology, 2022; Vol:1, pgs:100-101.  A 40-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for palindromic rheumatism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Anti-cyclic citrullinated peptide antibody: >250 IU/ml; >250 IU/ml; C-reactive protein: normal; 17.2 mg/dl, notes: elevated; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; Red blood cell sedimentation rate: normal; Rheumatoid factor: 28 IU/ml; Ultrasound scan: effusion and synovitis in the radiocarpal joints; X-ray: normal; normal. Therapeutic measures were taken as a result of rheumatoid arthritis.; Sender's Comments: Based on available information in the case the reported event Rheumatoid arthritis assessed as unrelated to suspect drug  and more likely related to intercurrent/ underlying medical condition The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 31Oct2021 at 11:00 as dose 2, (booster)single (Lot number: 3203080) at the age of 35 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Mar2021 at 08:00 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "COPD" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "HSV2" (unspecified if ongoing); "ADD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "insomnia" (unspecified if ongoing). Concomitant medication(s) included: AMPHETAMINE; ADDERALL, start date: 01Jul2022, stop date: 19Jul2022; DEXTROAMPHETAMINE HYDROCHLORIDE, start date: 01Jul2022, stop date: 19Jul2022; LUNESTA, start date: 01Jul2022, stop date: 19Jul2022. Past drug history included: Prednisone, reaction(s): "known allergies: Prednisone", notes: known allergies: Prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (28Jul2022) 101. 5, notes: I had a fever of 101. 5; SARS-CoV-2 test: (2022) Unknown results, notes: I took Paxlovid to prevent developing severe Covid; (2022) Negative, notes: The medication made me very I'll immediately upon taking it but completed the full course and was Covid negative after 3 days; (2022) Positive, notes: However on the last date of taking the treatment, my Covid test came back positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received COVID 19 Treatment with Paxlovid start date was 19Jul2022 and stop date was 24Jul2022 indication was treatment of COVID-19. The patient now starting to feel nasal congestion, headaches, fatigue, brain fog, lethargic, hot/cold feeling inside, dizziness, nausea and cough is returning. I had a fever of 101. 5 today after going 4 days without one and not taking fever reducing Medicine. I am afraid I have rebound Covid and unsure how to address the symptoms or that I will not be able to fight this virus on my own. I'm feeling as sick as I felt on day one. My kids are also sick but we're not treated with Paxlovid. I am concerned over these symptoms and unsure what I can do.  No follow-up attempts are required. No further information is expected.