chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inadvertently reconstituted with sterile water; Inadvertently reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 4th May 2022, the patient received Menveo. On 4th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-MAY-2022 Reporters comment: Pharmacist reported that, Menveo powder was inadvertently reconstituted with sterile water and administered to the patient.  The reporter consented to follow up. Additional supportive information: Menveo powder was inadvertently reconstituted with sterile water and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she got her 1st dose about a year ago, but has not gotten the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received  0.5ml, intramuscularly, in left arm one year prior to the reporting date).   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 Information: GSK Receipt Date: 05-MAY-2022 Reporter's comment: Caller was the patient and stated that she had not gotten the second vaccine but intends to get it. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 67.0
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Blister, Emotional distress, Herpes zoster, Injection site pain, Poor quality sleep
Clinical narrative: Itching on Monday/ some itching on left arm; Hasn't been sleeping well; he is upset because he received SHINGRIX; Blister; Shingles today after SHINGRIX x2 in 2019/suspected vaccination failure; Today diagnosed with shingles; Injections were painful going in,dose 2; Injections were painful going in, dose 1; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis.   On 26th November 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, the patient received the 1st dose of Shingrix. On 30th April 2022, the patient received the 4th dose of COVID-19 VACCINE MODERNA. On 22nd August 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 26th November 2019, the patient experienced injection site pain. On 5th May 2022, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pruritus, poor sleep, emotional distress and blister. On an unknown date, the outcome of the vaccination failure, injection site pain, injection site pain, pruritus, emotional distress and blister were unknown and the outcome of the shingles and poor sleep were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, pruritus, poor sleep, emotional distress and blister to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, pruritus, poor sleep, emotional distress and blister to be related to Shingrix.     Additional Information: GSK receipt date: 05-May-2022 Reporter's comment: The patient reported that he went to his dermatologist on the day of reporting and was diagnosed with shingles after receiving both the Shingrix doses. Immediately after receiving the doses, the patient stated that the injections were painful and was going in and he paid for them, could he get a refund. More than 2 years after 1st and 2nd dose and less than a week after Moderna Covid booster dose, on Monday the patient started itching and noticed a few small blisters all down right arm and some itching on left hand. The patient also said that he has had not been sleeping well and the patient was upset because he received Shingrix doses. The reporter consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. It was unknown if the reporter considered the shingles, pruritus, poor sleep to be related to COVID-19 Vaccine Moderna.  Note: For Moderna Covid suspect, dose number was captured as per narrative.
Age: 67.0
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Pruritus, Vaccination failure
Clinical narrative: Itching on Monday/ some itching on left arm; Hasn't been sleeping well; he is upset because he received SHINGRIX; Blister; Shingles today after SHINGRIX x2 in 2019/suspected vaccination failure; Today diagnosed with shingles; Injections were painful going in,dose 2; Injections were painful going in, dose 1; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis.   On 26th November 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, the patient received the 1st dose of Shingrix. On 30th April 2022, the patient received the 4th dose of COVID-19 VACCINE MODERNA. On 22nd August 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 26th November 2019, the patient experienced injection site pain. On 5th May 2022, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pruritus, poor sleep, emotional distress and blister. On an unknown date, the outcome of the vaccination failure, injection site pain, injection site pain, pruritus, emotional distress and blister were unknown and the outcome of the shingles and poor sleep were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, pruritus, poor sleep, emotional distress and blister to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, pruritus, poor sleep, emotional distress and blister to be related to Shingrix.     Additional Information: GSK receipt date: 05-May-2022 Reporter's comment: The patient reported that he went to his dermatologist on the day of reporting and was diagnosed with shingles after receiving both the Shingrix doses. Immediately after receiving the doses, the patient stated that the injections were painful and was going in and he paid for them, could he get a refund. More than 2 years after 1st and 2nd dose and less than a week after Moderna Covid booster dose, on Monday the patient started itching and noticed a few small blisters all down right arm and some itching on left hand. The patient also said that he has had not been sleeping well and the patient was upset because he received Shingrix doses. The reporter consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. It was unknown if the reporter considered the shingles, pruritus, poor sleep to be related to COVID-19 Vaccine Moderna.  Note: For Moderna Covid suspect, dose number was captured as per narrative.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on 30th November 2021) and Bexsero (2nd dose received on 2nd February 2022).   On 5th May 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 5th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAY-2022 Reporter's comment: The registered nurse reports patient received extra dose of Bexsero.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient received 3rd dose of Shingrix. Healthcare professional was unable to provide any adverse event details.  The reporter consented to follow up. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose instead of the adult dose; pediatric dose instead of the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a male patient who received HBV (Engerix B pediatric) (batch number LN992, expiry date 13th December 2022) for prophylaxis.   On 3rd May 2022, the patient received Engerix B pediatric. On 3rd May 2022, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient was administered a pediatric dose of the Engerix-B vaccine inadvertently instead of the adult dose. The reporter consented to follow up. Additional supportive information: The patient was administered a pediatric dose of the Engerix-B vaccine inadvertently instead of the adult dose, which led to adult use of a child product and underdose.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient got a 4th dose of pediarix Vs the infarix; Patient got a 4th dose of pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 21-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9Pz, expiry date 24th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2022, the patient received the 4th dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 5th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient received Pediarix in Left Vastus Lateralis. Nurse reported that, the patient got a 4th dose of Pediarix versus the Infanrix.   The nurse stated that, the patient was not exhibiting any adverse reactions. The reported consented to follow up. Additional supportive information: The patient got a 4th dose of Pediarix versus the Infanrix, which led to wrong vaccine administered and extra dose administered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient mistakenly given expired Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number XH2DF, expiry date 7th May 2022) for prophylaxis.   On 9th May 2022, the patient received Shingrix (intramuscular). On 9th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  The reporter is the Healthcare professional (practice administrator). He reported that a 60 year old female patient was mistakenly given Shingrix two days after the expiry date. The reporter had nothing else to report. Might follow up with prescriber at reporter's address/email/phone. The reporter consented to follow up. Additional Supportive Information:  The patient was mistakenly given Shingrix in unknown arm two days after the expiry date, which led to expired vaccine used.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: 1st dose on 07Oct2021, 2nd dose on 06May2022; Only received one dose, then had shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number H2PE2, expiry date 19th May 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number T29Y2, expiry date 8th April 2023) for prophylaxis.   On 6th May 2022, the patient received the 2nd dose of Shingrix. On 7th October 2021, the patient received the 1st dose of Shingrix. On 18th April 2022, not applicable after receiving Shingrix and 193 days after receiving Shingrix, the patient experienced shingles. On 6th May 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 9-May-2022 Reporter's Comment: The patient self-reported this case. Member of public stated that she was not aware that two doses were needed for Shingrix, so she only received one dose and then had a shingles outbreak. The shingles outbreak occurred approximately 18th April 2022. After shingles cleared, she received second dose. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered hiberix without the diluent; Administered hiberix without the diluent; 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 Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   On 26th April 2022, the patient received Hiberix. On 26th April 2022, unknown after receiving Hiberix, 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: 09-May-2022 Reporter's Comments:  Registered nurse reported that, there were 3 vaccines that were administered hiberix without the diluent. She was unaware of how these vaccines were reconstituted so were unable to give any information. The reporter consented to follow up. Additional Supportive Information:  The patient received Hiberix without the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076035:Same reporter. US-GLAXOSMITHKLINE-US2022AMR076036:Same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Patient received Shingrix subcutaneously; Patient received Shingrix in the back of the arm; This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2022, the patient received Shingrix (subcutaneous). On 3rd May 2022, unknown after receiving Shingrix, the patient experienced wrong route of administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the wrong route of administration and vaccine administered at inappropriate site were unknown.    Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Nurse reported a patient received Shingrix subcutaneously, in the back of the arm on 5th May 2022. AE report had all details provided by Healthcare professional at this time. Additional Supportive Information:  The patient received Shingrix in unknown arm. The patient received Shingrix subcutaneously, in the back of the arm, which led to wrong route of administration and vaccine administered at inappropriate site.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of Kinrix instead of Infanrix; Administration of Kinrix to a 24 month old patient; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 24-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  The Healthcare professional called to report the administration of Kinrix to a child but had intended to give Infanrix. AE filed. Provided Medical information phone number for reporter's reference and a warm transfer to Medical information. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received Kinrix vaccine instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered about 3 weeks after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 2nd June 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th May 2022, the patient received the 2nd dose of Shingrix. On 9th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Pharmacist stated that the first dose of Shingrix was administered about 3 weeks ago (13th April 2022) and the patient came back on the day of reporting, requesting the 2nd dose, which was administered. The reporter consented to follow up via postal. Additional Supportive Information: The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: LOSS OF EFFECT; COVID-19 PCR TEST POSITIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 04-MAY-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: Unknown) dose was not reported, 1 total administered at left arm on an unspecified date in JAN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient tested positive for COVID-19 on PCR, and experienced loss of effect. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the COVID-19 PCR test positive and loss of effect was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000229106.; Sender's Comments: V0:20220502894-Covid-19 vaccine ad26.cov2.s-Loss of effect. 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Since 12 January he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affected soles, and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Initially he felt hot showers were also a trigger but episodes not currently associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 5 January, 7 days prior to onset of symptoms. He has used oral antihistamines with limited benefit. He denies constitutional symptoms. UCT score today is 8 (0, 1, 0, 2, 0, 3, 1, 1). No history of adverse reactions to prior vaccines.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Scratch, Skin lesion, Urticaria
Clinical narrative: Since 12 January he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affected soles, and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Initially he felt hot showers were also a trigger but episodes not currently associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 5 January, 7 days prior to onset of symptoms. He has used oral antihistamines with limited benefit. He denies constitutional symptoms. UCT score today is 8 (0, 1, 0, 2, 0, 3, 1, 1). No history of adverse reactions to prior vaccines.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Injection site pain, Scan thyroid gland, Vocal cord inflammation
Clinical narrative: The spot where I got the shot remains tender. But the biggest issue has been my throat. Around the area where my vocal cords feel inflamed and while not in constant pain, I've been having terrible swallowing issues, especially with solid foods. Sometimes I need to drink water to push the food to pass through.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This spontaneous report received from a patient via a company representative via a social media concerned a patient of an 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 and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, after 10 days of vaccination, the patient experienced clot. It was reported that "JNJ contact me if you'd like to discuss the clot I developed 10 days after your vaccine". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clot was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: vaccine ad26.cov2.s-Clot. 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
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose and start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the patient died from an unknown cause of death. The reporter stated that, "The covid vaccine killed my mother. Can I finally post this without being ostracized. I needed my mother more than she needed that shot". It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220515166-covid-19 vaccine ad26.cov2.s-Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Lip swelling, Lip ulceration, Oral herpes, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; COLD SORES; LIP SWELLING WITHOUT BREATHING INVOLVEMENT MORE PRONOUNCED ON THE BOTTOM LIP; LIP ULCER; This spontaneous report received from a pharmacist concerned a 37 year old male patient. Initial information was processed along with the additional information received on 10-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 DM (diabetes mellitus) without longterm use of insulin (The reporter stated controlled with A1c 6% on 16-FEB-2022, down from 8% on 21-DEC-2021), and autistic disorder of childhood onset, and other pre-existing medical conditions included: The reporter stated that patient had no known drug allergies. On 15-DEC-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 01 total, administered to right arm for prophylactic vaccination. The patient age at time of vaccination was 37 years old. Concomitant medications included dextromethorphan hydrobromide/quinidine sulfate, famotidine, hyoscyamine, lorazepam, metformin, omeprazole, ondansetron, propranolol, and risperidone. On 21-DEC-2021, Laboratory data included: HbA1C (Haemoglobin A1C)(NR: not provided) 8 %. On 16-FEB-2022, Laboratory data included: HbA1C (Haemoglobin A1C) (NR: not provided) 6 %. On an unspecified date, the patient had suspected covid- 19 infection and suspected clinical vaccination failure. On 27-APR-2022, the patient was treated for covid-19 with non-company suspect drug Paxlovid (oral route of administration, batch number and expiry were not reported) dose and frequency were not reported.  On 01-MAY-2022, on 3 day of medication the patient started lip swelling without breathing involvement, more pronounced on the bottom lip. 01-MAY-2022, the patient had lip ulcer.  On an unspecified date, the patient experienced cold sores and improving by using Lysine and (LLT) Abreva on day 4 post non-company suspect drug (Paxlovid) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lip swelling without breathing involvement more pronounced on the bottom lip, lip ulcer, and cold sores, and the outcome of suspected clinical vaccination failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230266.; Sender's Comments: V0-20220516356- 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; COLD SORES; LIP SWELLING WITHOUT BREATHING INVOLVEMENT MORE PRONOUNCED ON THE BOTTOM LIP; LIP ULCER; This spontaneous report received from a pharmacist concerned a 37 year old male patient. Initial information was processed along with the additional information received on 10-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 DM (diabetes mellitus) without longterm use of insulin (The reporter stated controlled with A1c 6% on 16-FEB-2022, down from 8% on 21-DEC-2021), and autistic disorder of childhood onset, and other pre-existing medical conditions included: The reporter stated that patient had no known drug allergies. On 15-DEC-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 01 total, administered to right arm for prophylactic vaccination. The patient age at time of vaccination was 37 years old. Concomitant medications included dextromethorphan hydrobromide/quinidine sulfate, famotidine, hyoscyamine, lorazepam, metformin, omeprazole, ondansetron, propranolol, and risperidone. On 21-DEC-2021, Laboratory data included: HbA1C (Haemoglobin A1C)(NR: not provided) 8 %. On 16-FEB-2022, Laboratory data included: HbA1C (Haemoglobin A1C) (NR: not provided) 6 %. On an unspecified date, the patient had suspected covid- 19 infection and suspected clinical vaccination failure. On 27-APR-2022, the patient was treated for covid-19 with non-company suspect drug Paxlovid (oral route of administration, batch number and expiry were not reported) dose and frequency were not reported.  On 01-MAY-2022, on 3 day of medication the patient started lip swelling without breathing involvement, more pronounced on the bottom lip. 01-MAY-2022, the patient had lip ulcer.  On an unspecified date, the patient experienced cold sores and improving by using Lysine and (LLT) Abreva on day 4 post non-company suspect drug (Paxlovid) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lip swelling without breathing involvement more pronounced on the bottom lip, lip ulcer, and cold sores, and the outcome of suspected clinical vaccination failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230266.; Sender's Comments: V0-20220516356- 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 29-APR-2022, the patient experienced suspected covid-19 infection along with bad headache and had suspected clinical vaccination failure. The patient slept well enough. Laboratory data included: COVID-19 rapid POC (rapid antigen) test (NR: not provided) positive. The patient was treated with the physician. Treatment medications (dates unspecified) included: ascorbic acid, magnesium, diphenhydramine hydrochloride, zinc, and ergocalciferol. The symptom bad headache was resolved on 30-APR-2022. The patient had not taken any booster shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 02-MAY-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229988.; Sender's Comments: V0: 20220516398-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Malaise, Movement disorder
Clinical narrative: This spontaneous report received from a patient 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 received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included vitamin B12 NOS. On 11-APR-2021, the patient experienced very long, could not move body, sweating like came out of a pool, suddenly started feeling very ill, and numbness of both legs and both hands for 8 weeks (2 months). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suddenly started feeling very ill, sweating like came out of a pool, and very long, could not move body, and the outcome of numbness of both legs and both hands for 8 weeks (2 months) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional 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 was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, dose number 1, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date in APR-2022, patient initially was tested negative for covid but had covid symptoms (confirmed covid-19 infection) and started on Paxlovid. The patient additionally received non-company co-suspect Paxlovid (form of admin not reported, oral, batch number: unknown, expiry: unknown) dose was not reported, administered from 23-APR-2022 to 28-APR-2022 for treatment of COVID-19. No concomitant medications were reported. On 02-MAY-2022, 5 days after finishing the treatment with Paxlovid patient experienced tiredness, fatigue, covid positive and confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0.20220518635-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related..
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Myalgia
Clinical narrative: This spontaneous report received from a patient concerned a White male of unspecified age and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in SEP-2021, 4 to 6 months after primary vaccination, the patient started experiencing severe muscle soreness, about one inch under the skin of the injection site, felt like someone hit in that area and felt like there was a bruise inside the skin, but could not physically see it (all events with dose number in series 1). Patient stated at the time of reporting that it was little worse. The patient had not recovered from severe muscle soreness under the skin about one inch at vaccination site, and felt like bruising inside the skin. The patient received additional booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number and expiry date were not reported) dose was not reported, 1 total, administered on  11-NOV-2021 for prophylactic vaccination. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that dose were stored in the freezer before administration. One dose was administered on 22-Nov-2021. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 10-March-2022 and was stored in the freezer before administration; Doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-March-2022 and was stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 10-March-2022 and was stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-March-2022 and was stored in the freezer before administration) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Taste disorder, Vomiting
Clinical narrative: COVID-19; Vomiting; Horrible taste is mouth; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Horrible taste is mouth), COVID-19 (COVID-19) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced TASTE DISORDER (Horrible taste is mouth) and VOMITING (Vomiting). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 02-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, TASTE DISORDER (Horrible taste is mouth), COVID-19 (COVID-19) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency to the third dose of mRNA-1273 vaccine cannot be assessed. No SARS- CoV-2 test was reported. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 02-May-2022 for COVID-19, at an unspecified dose and frequency. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency to the third dose of mRNA-1273 vaccine cannot be assessed. No SARS- CoV-2 test was reported. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 02-May-2022 for COVID-19, at an unspecified dose and frequency. The benefit-risk relationship of the mRNA-1273 is not affected by this report.