chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: received pediatric dose of Engerix-B; received pediatric dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 60-year-old patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 1st March 2024) for prophylaxis.   On 9th May 2022, the patient received the 3rd dose of Engerix B pediatric. On 9th May 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The health care professional reported that adult patient received dose of pediatric Engerix B. No other details of patient could be provided. The reporter consented to follow up. Additional Supportive Information: An adult patient received dose of pediatric Engerix B at inappropriate age, which led to underdose and inappropriate age at vaccine administration. This case is linked with case US2022076268 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076268:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: She got a sore arm; 1st dose on March 2020  hasn't gotten her 2nd; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The reporter was the patient stating that she got her first shingrix vaccine March 2020, but had not gotten her second. The patient had plan on getting the second vaccine. She also stated that she got a sore arm from the injection that lasted several days. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired Menveo administered; 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 Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 31st March 2022) for prophylaxis.   On 9th May 2022, the patient received Menveo. On 9th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporters comment: Medical assistant reporting, expired Menveo administered to the patient. Healthcare professional declined to provide any adverse event information. Additional supportive information: The patient received expired dose of Menveo, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered 2nd dose of shingrix  in 2.5 week from the first 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 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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: 10-MAY-2022 Reporters comment: Pharmacist reported that, the patient was administered 2nd dose of Shingrix in 2.5 week from the first dose for immunocompetent patient. Consent of follow up was not asked since healthcare professional released the call before having the opportunity to be asked for.  Healthcare professional did not provide any other detail.  Additional supportive information: The patient received 2nd dose of Shingrix, earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on May 2019, did not remember if he received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 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 Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: The patient self-reported the case. The patient was not immunocompromised. After receiving 1st dose of Shingrix, the patient did not remember if he received the 2nd dose. He was looking information about taking a third Shingrix dose. Permission for follow-up was not asked as well as no other information because member of public was looking only for an answer. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. This case had been linked with case US2022076981, reported by the same reporter for the patient's wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076981:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on May 2019 , second dose on August 14th (no data about year).; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: The patient received 1st dose of Shingrix in May 2019 and 2nd dose on 14th August, no data about year was provided. Permission for follow-up was not asked as well as no other information because member of public was looking only for an answer.  Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. This case had been linked with case US2022076977, reported by the same reporter for the patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076977:same reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: Nurse reported that, the patient was administered an expired dose of Kinrix.  The reporter consented to follow up via email.  The Vaccine Administration Facility is the same as Primary Reporter. Additional supportive information: The patient was administered an expired dose of Kinrix, which led to expired vaccine used.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on back; This case was reported by a consumer via call center representative and described the occurrence of rash in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK receipt date: 11-MAY-2022 Reporter's comment: The patient had her first dose of Shingrix and she was now experiencing a rash on her back.  Gave medical disclaimer.  Referred to health care professional (HCP).  Spoke per package insert (PI) and content.  Provided phone number for HCP reference.  Offered after call survey. Did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2019, 2nd dose 09MAY2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th October 2019).   On 9th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 9th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: The patient self-reported the case.  The patient received first dose of Shingrix dose on 16th October 2019 and second dose on 09th May 2022 in an unknown arm. She had nothing else to report. Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient has received a 3rd dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number 347S9, expiry date 2nd June 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 07th July 2021) and Shingrix (received 2nd dose on 15th November 2021).   On 11th May 2022, the patient received the 3rd dose of Shingrix. On 11th May 2021, an unknown time after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the extra dose administered to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: The patient received 3rd dose of Shingrix. The reporter enquired, if there were any concerns if the patient received 3rd dose of Shingrix 6 months after 2nd dose. Healthcare professional declined to provide patient's demographics.  The reporter consented to follow up via email per healthcare professional's request. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix below recommended temperature, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 6th April 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Medical Assistant reported that, Boostrix went below recommended temperature range on 21st March 2022. The lowest temperature was 30.2F. The readings were then ranging from 32.9F to 41.8F. The duration was 7 hr. 45 min. A dose was subsequently administered. The reporter did not have lot number, expiration date, or patient information aside from initials. Till the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077005:Same reporter US-GLAXOSMITHKLINE-US2022077009:Same reporter US-GLAXOSMITHKLINE-US2022077007:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix below recommended temperature, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number J39HG, expiry date unknown) for prophylaxis.   On 27th April 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Medical Assistant reported that, Boostrix went below recommended temperature range on 21st March 2022.  The lowest temperature was 30.2F.  The readings were then ranging from 32.9F to 41.8F.  The duration was 7 hr. 45 min.  A dose was subsequently administered. The reporter did not have expiration date, or patient information aside from initials.  Till the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077006:Same reporter US-GLAXOSMITHKLINE-US2022077005:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter US-GLAXOSMITHKLINE-US2022077009:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Engerix B below recommended temperature, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HBV (Engerix B) for prophylaxis.   On 22nd April 2022, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Engerix-B vaccines went below recommended temperature range on 21st March 2022.  The lowest temperature was 30.2F.  The readings were then ranging from 32.9F to 41.8F.  The duration was 7 hr. 45 min.  A dose was subsequently administered.  The reporter did not have lot number, expiration date, or patient information aside from initials. Till the time of reporting, a repeat dose had not been administered. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077006:Same reporter US-GLAXOSMITHKLINE-US2022077007:Same reporter US-GLAXOSMITHKLINE-US2022077005:Same reporter US-GLAXOSMITHKLINE-US2022077009:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Engerix B below recommended temperature, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HBV (Engerix B) (batch number N4GA4, expiry date unknown) for prophylaxis.   On 3rd May 2022, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Engerix-B vaccines went below recommended temperature range on 21st March 2022. The lowest temperature was 30.2F. The readings were then ranging from 32.9F to 41.8F. The duration was 7 hr. 45 min.  A dose was subsequently administered. The reporter did not have expiration date, or patient information aside from initials. Till the time of reporting, a repeat dose had not been administered. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077006:Same reporter US-GLAXOSMITHKLINE-US2022077007:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter US-GLAXOSMITHKLINE-US2022077005:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st on 05/2021, 2nd on 01/2022 but pharmacy has no record of it; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2021).   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: The patient reported that, she received a late second dose of Shingrix. She asked if another dose was needed and would it be first dose of series again or should she wait for another year to make sure. The pharmacy told her that, they had no record of 2nd dose. Additional Supportive Information: The patients received 2nd dose 8 months apart, which led to lengthening of vaccination schedule.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number ms5hc, expiry date 8th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 25th March 2019).   On 12th May 2022, the patient received the 3rd dose of Shingrix. On 12th May 2022, 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: 12-May-2022 Reporter's Comments: The pharmacist reported that the patient received a 3rd dose of Shingrix . No adverse event was reported . The reporter consented to follow up.  Additional Supportive Information: The patient received 3rd dose of shingrix which led to extra dose administered.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAV (Havrix) (batch number ek59b, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-May-2022 Reporter's Comments: The pharmacist reported that a female patient received an expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patient; 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 Men B NVS (Bexsero) (batch number unknown, expiry date January 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.   In April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-May-2022 Reporter's Comments: The health care professional reported an expired dose of bexsero was administered to patient on April 2022. The reporter consented to follow up. No other information available. Additional Supportive Information: The patient received Bexsero which was already expired which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: gave Menveo with sterile diluent; gave Menveo with sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 12th May 2022, the patient received Menveo. On 12th 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: 12-May-2022 Reporter's Comments: It was stated that practice manager gave Menveo powder with a sterile diluent. The health care professional unable to provide any other adverse event details at the time of reporting. The reporter consented to follow up.  Additional Supportive Information: The patient received Menveo powder with a sterile diluent 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: first Shingrix in 2019, never received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first Shingrix vaccine in 2019, in an unknown arm Intramuscular).   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: 12-May-2022 Reporter's Comments: The pharmacist reported that her patient received her first Shingrix vaccine in 2019, and  never received the second Shingrix vaccine (Inappropriate Schedule of Vaccine). The reporter did not consent to follow-up.  Additional Supportive Information: The patient did not received 2nd dose till the time of reporting which led to incomplete course of vaccination.
Sex: F
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 patient concerned a 45 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 total, administered on 23-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient received additional dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021 for prophylactic vaccination.  Sometime the week of 09-NOV-2021, patient contracted covid-19 (Dose number in series 1). On 12-NOV-2021, the symptoms started like runny nose, sinus pressure behind cheeks, ears bothering her, hence confirmed covid-19 infection and had confirmed clinical vaccination failure (Dose number in series 1). Patient went to urgent care on 17-NOV-2021, and on same day confirmed to be covid-19 positive (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. 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 product quality complaint: 90000229929.; Sender's Comments: V0:20220516327-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: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: ANAPHYLACTIC SHOCK; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: blood clots. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, intramuscular and batch number and expiry date were not reported) dose was not reported, 1 total administered on 04-MAY-2021 for a prophylactic vaccination. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 22-OCT-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 anaphylactic shock (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic shock was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220524087-covid-19 vaccine ad26.cov2.s-Anaphylactic shock. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. 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: Pulmonary embolism
Clinical narrative: BILATERAL PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative via social media concerned a female of unspecified age, race 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 (suspension for injection, route of admin, and batch number and expiry date were not reported) dose and start therapy date were not reported, 01 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 had bilateral pulmonary embolism after Covid injection. Treatment medications (dates unspecified) included: rivaroxaban (Xarelto). The reporter stated that, "What say you to the bilateral pulmonary embolism I had after your Covid injection BS paying for your blood thinner dollor400/mo of Xeralto. Coincidence I think not." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220525470-COVID-19 VACCINE AD26.COV2.S-Bilateral pulmonary embolism. 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: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Headache
Clinical narrative: GUILLAIN BARRE SYNDROME/ AIDP; HEADACHE; This spontaneous report received from a patient concerned a 50 year old male of unspecified 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 was not reported, 1 total, administered on 03-APR-2022 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In APR-2022 (a few days after the vaccination), the patient first experienced some headaches. On an unspecified date (currently), the patient suffered from a guillain barre syndrome. The patient experienced arm and face numbness (symptoms of acute inflammatory demyelinating polyneuropathy (AIDP) and was just diagnosed with acute inflammatory demyelinating polyneuropathy (AIDP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome/ aidp, and the outcome of headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220525640 -Covid-19 vaccine ad26.cov2.s -GUILLAIN BARRE SYNDROME. This event(s) is labeled per authority and is therefore considered potentially related.
Age: 40.0
Sex: F
Vaccine: COVID19, 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 (company employee) concerned a 41 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, alcohol use (1-2 glasses per month), non-smoker, seasonal allergies, and keflex allergy (hives), and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 20-JAN-2022) dose was not reported, 1 total, administered on left arm on 03-APR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 14-FEB-2022, Laboratory data included: COVID-19 rapid POC test (NR: not provided) positive which led to suspected clinical vaccination failure (dose number in series 1). The outcome of suspected clinical vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect moderna covid-19 vaccine as a booster (dose number in series 2) (form of admin not reported, route of admin not reported, and batch number: 034F21A expiry: UNKNOWN) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination.  On 14-FEB-2022, the patient was really sick and had bad symptoms such as really bad fatigue, fever for 3-4 days and lost taste and smell for 3 weeks, tested positive for covid and experienced suspected covid-19 infection (dose number in series 2). The patient recovered from suspected covid-19 infection on 24-FEB-2022. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000230748.; Sender's Comments: V0: 20220525852- covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FOR MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE (VIALS STORED IN THE FRIDGE AFTER PUNCTURE) (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use), and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use) and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220528115, 20220528178, 20220528223 and 20220528196.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022; they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The number of doses/vials was reported as 4 doses at 1 vial.  The vial does not undergone any temperature excursions.  No treatment medications was reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: positive SARS-CoV 2 antibody test after second dose; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive SARS-CoV 2 antibody test after second dose), PYREXIA (fever) and CHILLS (chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced COVID-19 (positive SARS-CoV 2 antibody test after second dose). At the time of the report, COVID-19 (positive SARS-CoV 2 antibody test after second dose), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) patient had a positive SARS-CoV 2 antibody test after his second dose.         No Concomitant product use was reported.  The patient received their second dose of Moderna Covid-19 vaccine in Mar-2021 and had a fever and chills after their second dose vaccine. It was also reported that the patient had a positive SARS-CoV 2 antibody test after their second dose in the primary series of the Moderna Covid-19 vaccine.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 32-year-old male patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI) and the expected events of Pyrexia and Chills. The events occurred on the same month after receiving the second dose of mRNA-1273 Vaccine. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-563510, MOD-2021-040897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow-up received contains non significant information.; Sender's Comments: This spontaneous case concerns a 32-year-old male patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI) and the expected events of Pyrexia and Chills. The events occurred on the same month after receiving the second dose of mRNA-1273 Vaccine. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient tested positive for COVID-19 in Feb2022; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (patient tested positive for COVID-19 in Feb2022) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history included multiple orthopedic problems. The patient had no allergies to medications, food, and other products.  Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced COVID-19 (patient tested positive for COVID-19 in Feb2022). At the time of the report, COVID-19 (patient tested positive for COVID-19 in Feb2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning an 87-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (tested positive for COVID-19), after receiving a dose of mRNA-1273 vaccine. Date of vaccinations, clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-564774 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an 87-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (tested positive for COVID-19), after receiving a dose of mRNA-1273 vaccine. Date of vaccinations, clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Headache, Influenza like illness, Nasal congestion
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion) and COUGH (Cough mostly in the afternoon or when she exercises) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery in October 2021. Concurrent medical conditions included Pollen allergy, Allergy to molds and Blood cholesterol abnormal. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion), COUGH (Cough mostly in the afternoon or when she exercises), SINONASAL OBSTRUCTION (sinus are blocked), HEADACHE (Slight headache) and PAIN IN EXTREMITY (Patient felt her arm sore/Achy arm/sometimes it still hurts). At the time of the report, ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion), COUGH (Cough mostly in the afternoon or when she exercises), SINONASAL OBSTRUCTION (sinus are blocked), HEADACHE (Slight headache) and PAIN IN EXTREMITY (Patient felt her arm sore/Achy arm/sometimes it still hurts) had not resolved. Concomitant medication included unspecified medication for her cholesterol. Patient never had COVID positive test or diagnosis. No vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was stated that symptoms were worse the last 3 days. Patient had not experienced a similar event in the past. No treatment was given for the events.