chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: receiving an "adult" dose made from 2 pediatric doses / Tdap and HepB on the same syringe; Tdap and HepB on the same syringe; 20yo patient receiving 2 pediatric doses; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   On 4th March 2022, the patient received Engerix B pediatric and Boostrix. On 4th March 2022, unknown after receiving Engerix B pediatric and Boostrix, the patient experienced wrong technique in drug usage process, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong technique in drug usage process, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received an adult dose of Engerix made from 2 pediatric doses, a dose of Boostrix and a dose of Engerix. In the facility they had only pediatric doses, so they mixed two.  Healthcare professional was not sure if the patient received 1 dose of Engerix or if they mixed the vaccines, so it would have Tdap and Hepatitis B on the same syringe, which led to wrong technique in drug usage process, inappropriate dose of vaccine administere and inappropriate age at vaccine administration. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022041370:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Boostrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 28th February 2022) for prophylaxis.   On 1st March 2022, the patient received Boostrix. On 1st March 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received an expired dose of Boostrix, which led to expired vaccine used. The reporter inquired, if the patient needed to be revaccinated or not and if a dose was valid. The reporter was unable to provide vaccine and patient details. The reporter did not consent to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix administered and was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 9BC23, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Infanrix, which led to expired vaccine used. The reporter did not have any patient demographics available at time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 17Oct2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not have the lot number and expiry date of the 1st dose of Shingrix. The reporter consented to follow up via email.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product complaint, Product preparation issue
Clinical narrative: Adjuvant vial incorrectly capped; Dose was given without using the antigen; Dose was given without using the antigen; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459K, expiry date 27th May 2023) and (batch number N3545, expiry date 27th May 2023) for prophylaxis. This case was associated with a product complaint.   On 3rd March 2022, the patient received Shingrix .5 ml. On an unknown date, the dose was an unknown dose. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The reporter stated that, the office had a Shingrix adjuvant vial with a brown cap.  Two vials of adjuvant were used, and the dose was given to the patient without using the antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The GlaxoSmithKline field representative had driven out to the healthcare professional office on the date of reporting and stated that, the rest of the vials in the box were capped correctly.  He took pictures of the 2 adjuvant vials used and would be sending the picture to GlaxoSmithKline. The agent called the healthcare professional to confirm and obtain further information for the case.  As per the healthcare professional, the defect was not noticed until after the vaccine was administered. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 1 in 2019, has not received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete vaccination schedule. No reactions were reported. The reporter asked how to proceed. The reporter did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: dose that had expired on 31-Oct-2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 3rd March 2022, the patient received Menveo. On 3rd March 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 details were provided as follows: The patient received an expired dose of Menveo, which led to expired vaccine used.
Age: 39.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation error, Product preparation issue
Clinical narrative: received liquid only portion; received liquid only portion; 39 year old received Shingrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 39-year-old male patient who received Herpes zoster (Shingrix) (batch number 32KA9, expiry date 11th June 2023) for prophylaxis.   On 7th March 2022, the patient received the 1st dose of Shingrix. On 7th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The 39-year-old patient received injection of liquid AS01B only portion of the Shingrix vaccine, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration.  The vaccine was inadvertently not reconstituted prior to administration. At the time of reporting, the dose had not been repeated. The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient given pediatric dose; adult patient given pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B) (batch number 2SNM39, expiry date 16th March 2024) for prophylaxis.   On 4th March 2022, the patient received Engerix B. On 4th March 2022, unknown after receiving Engerix B, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The reporter was a pharmacy intern. The reporter reported that an adult patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter did not consent to follow-up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: dose reconstituted and not used within 6h; The vaccines was reconstituted and not used within the 6hs. Patient was vaccinated after the 6 hs period; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 5A9GE, expiry date 3rd June 2023) for prophylaxis.   On 7th March 2022, the patient received Shingrix. On 7th March 2022, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug and wrong technique in drug usage process were unknown.  Additional details were provided as follows: Clinical supervisor reported that the patient was vaccinated with a dose of Shingrix which was reconstituted and not used within the 6 hours, which led to incorrect storage of drug. The patient was vaccinated after the 6 hours period of reconstitution, which led to wrong technique in drug usage process.  The reporter gave consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STOMACH ACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: unknown expiry: unknown) dose was not reported, (Dose number in series 01), 01 in total was administered on an unspecified date for prophylactic vaccination.  No adverse events were reported following vaccination covid-19 vaccine ad26. cov2.s (Dose number in series 01). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, (Dose number in series 02) 01 in total was administered on 14-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 23-FEB-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient started to experience fever, head and chest congestion, coughing which resulted in suspected COVID-19 (Coronavirus disease-19) infection. On the same day, the patient experienced stomach ache (Dose number in series 02). On 26-FEB-2022, the patient tested positive for COVID-19 virus test (NR: not provided) (using the iHealth rapid take home antigen provided by the federal government) which resulted in suspected clinical vaccination failure (Dose number in series 02). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected COVID-19 infection and stomach ache was not reported. This report was serious (Other Medically Important Condition). The case was associated with product quality complaint (RA): 90000219343.; Sender's Comments: V0: 20220260810-COVID-19 VACCINE AD26.COV2.S-Suspected Clinical Vaccination Failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered not related.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Cough, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: SWEATING; ORAL INTAKE REDUCED; DIZZINESS; EYE NUMBNESS; INFECTION; COUGHING; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to DEC-2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating, oral intake reduced, dizziness, eye numbness, infection, coughing, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib was withdrawn on DEC-2021. The patient recovered from eye numbness, had not recovered from weakness, dizziness, and infection, and the outcome of sweating, oral intake reduced, tiredness and coughing was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hypoaesthesia eye, Hypophagia, Infection
Clinical narrative: SWEATING; ORAL INTAKE REDUCED; DIZZINESS; EYE NUMBNESS; INFECTION; COUGHING; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to DEC-2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating, oral intake reduced, dizziness, eye numbness, infection, coughing, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib was withdrawn on DEC-2021. The patient recovered from eye numbness, had not recovered from weakness, dizziness, and infection, and the outcome of sweating, oral intake reduced, tiredness and coughing was not reported. This report was non-serious.
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 patient concerned an elderly female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: stiff, and hurting. The patient was previously treated with adalimumab for moderate to severe rheumatoid arthritis. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose umber in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. Following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced feeling unwell, pain and stiffness (Dose umber in series: 1). The patient recovered from feeling unwell, pain and stiffness. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose umber in series: 2) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (Dose umber in series: 2). The patient received covid-19 vaccine ad26.cov2.s (Dose umber in series: 3) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered (Dose umber in series: 3). 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 action taken with covid-19 vaccine ad26.cov2.s was not applicable. 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 20220304173 (Dose umber in series: 1).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site mass, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: SMALL LUMP AT INJECTION SITE; COVID-19; SWOLLEN LYMPH NODES/LITTLE SWOLLEN GLAND; This spontaneous report received from a patient concerned a 7 decade 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, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced small lump at injection site, covid-19, and swollen lymph nodes/little swollen gland. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small lump at injection site, and swollen lymph nodes/little swollen gland, and the outcome of covid-19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year adult male. 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, and expiry: 11-DEC-2021) dose was not reported, 1 total, administered on left arm on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient reported having symptoms of covid after receiving the JnJ/Janssen Covid 19 vaccine(Suspected COVID-19) and hence experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220310221- 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.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 20 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309987, 20220309972, 20220310306, 20220310363, 20220309858, 20220310590 and 20220310631.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Investigation, Loss of personal independence in daily activities
Clinical narrative: GUILLAIN-BARRE SYNDROME/UNABLE TO WALK; COULD NOT FUNCTION PROPERLY; This spontaneous report received from a consumer via Social media concerned a 28 year old female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2. (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "my 28 year old daughter received j&j shot, she woke up in the morning and was unable to walk. The patient visited emergency room during a pandemic and she waited 14 hours before she could be seen. After 2 days of invasive tests (unspecified) they narrowed it down to either multiple sclerosis or Guillain-Barre syndrome. On an unspecified date, more tests (unspecified) were performed and there was no finding of any lesions on her brain. The patient was diagnosed with Guillain-Barre syndrome and was hospitalized (dates unspecified). The patient received hemoglobin treatment for 2 months in hospitals and a rehabilitation hospitals. The patient was finally able to come home and continued physical therapy for another couple of months. Still patient could not function properly". The duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from could not function properly, and the outcome of guillain-barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20220311045-covid-19 vaccine ad26.cov2.s -Guillain barre syndrome . This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiovascular disorder
Clinical narrative: CARDIOVASCULAR EVENT; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cardiovascular event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiovascular event was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Reactive angioendotheliomatosis
Clinical narrative: REACTIVE ANGIOENDOTHELIOMATOSIS RASH; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced reactive angioendotheliomatosis rash. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) angioendotheliomatosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reactive angioendotheliomatosis rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shortness of breath was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PASS OUT; This spontaneous report received from a patient 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, and batch number: unknown, expiry: unknown) dose, 1 total, 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, following vaccination with Covid-19 vaccine Ad26.Cov2.s, patient passed out. Reason not specified. Reporter reported as "Yalls vaccine made me pass out in a rite aid". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pass out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20220313494-covid-19 vaccine ad26.cov2.s -pass out. 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: TROUBLES WITH BLOOD CLOTS; This spontaneous report received from a consumer 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 administration, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date was 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 had troubles with blood clots. As per reporter, "my brother and my friend were now having troubles with blood clots. My friends daughter now was suffering with an autoimmune disease and the list goes on. Makes me sick what was happening to people now" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220313555 and 20220313665.; Sender's Comments: V0-20220313549-COVID-19 VACCINE AD26.COV2.S- troubles with blood clots. The event(s) has a 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: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: TROUBLES WITH BLOOD CLOTS; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, 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 had troubles with blood clots. As per reporter, "My birther and my friend are now having troubles with blood clots. My friends daughter now is suffering with an Auto amune disease and the list goes on. Makes me sick what is happening to people now" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of troubles with blood clots was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220313549, 20220313665, 20211245023 and 20211245964.; Sender's Comments: V0- 20220313555 -COVID-19 VACCINE AD26.COV2.S- Troubles with blood clots. The event(s) has a 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: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: AUTOIMMUNE DISEASE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 autoimmune disease. It was reported that, "My friends' daughter now is suffering with an Auto immune disease." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of autoimmune disease was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220313555 and 20220313549.; Sender's Comments: V0:20220313665-COVID-19 VACCINE AD26.COV2.S-Autoimmune disease. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hyperaesthesia, Injection site bruising, Injection site scar
Clinical narrative: INJECTION SITE SCAR/SCAR TISSUE ABOVE THE BELLY; HYPERAESTHESIA/PHYSICALLY FELT MORE SENSITIVE INTERNALLY; INJECTION SITE BRUISING; This spontaneous report received from a patient via other company concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced injection site scar/scar tissue above the belly, hyperaesthesia/physically felt more sensitive internally, and injection site bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from injection site scar/scar tissue above the belly, and hyperaesthesia/physically felt more sensitive internally, and the outcome of injection site bruising was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Allergy to antibiotics). Concomitant products included VITAMINS NOS and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  It was reported that the patient had not taken any other vaccines within 1 month prior to receiving the Moderna COVID-19 vaccine.  It was reported that the patient had no medical history related to the adverse event and both acute and chronic illnesses at the time of vaccination.  Company Comment. This spontaneous case concerns a 62 year old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 11 months and 3 days after receiving first dose of mRNA-1273.  She received first dose of mRNA-1273 on 3-Feb-2021 followed by a second dose on an unknown date.  She tested positive for COVID-19 on 06-Jan-2022.  Clinical course and treatment for COVID-19 were not reported.  At the time of reporting, the outcome of the event was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.     This case was linked to MOD-2022-500852 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62 year old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 11 months and 3 days after receiving first dose of mRNA-1273.  She received first dose of mRNA-1273 on 3-Feb-2021 followed by a second dose on an unknown date.  She tested positive for COVID-19 on 06-Jan-2022.  Clinical course and treatment for COVID-19 were not reported.  At the time of reporting, the outcome of the event was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was moved to refrigerator on 06/Oct/21. Total duration of temperature excursion is 4 hours.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 1-Dec-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C.