chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via other manufacturer and described the occurrence of shingles in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DUPILUMAB (DUPIXENT) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 1st dose of DUPIXENT. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: This case involved few adult patients who experienced shingles while being treated with Dupilumab (Dupixent) and Varicella Zoster vaccine (Shingrix). The patient's past medical history , medical treatment, vaccination and family history were not provided. On an unknown date, the patient started taking Dupixent (Dupilumab) of unknown formulation, strength, dosage, frequency , route batch number expiry date for unknown indication via unknown device and Shingrix ( Varicella Zoster vaccine) of unknown formulation , dosage and batch number. On an unknown date , the patient developed a non-serious event shingles ( herpes zoster) (unknown latency following the first dose intake of Dupilumab and Varicella Zoster vaccine. It was reported that, a few patients that had started on Dupixent who had developed Shingles later. The reporter enquired, with the Shingles vaccine (now been not live) when it should be administered. The medical information agent confirmed the spelling of demographic with the caller for accuracy. The reporter stated that, the patients were waiting, she did not have time to answer any questions over the phone but sated that, if paperwork were sent to her, she could provide information then. It was not reported if the patient received the corrective treatment for the event. At the time of reporting, the outcome was unknown for the event shingles. It was unknown if the reporter considered the shingles to be related to Dupixent .
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Accidentally administered a third dose; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose of Menveo received on an unknown date). Concomitant products included MENVEO.   On 28th March 2022, the patient received the 3rd dose of Menveo. On 28th March 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient received his second dose of Menveo in January 2022.  It was unknown if the patient experienced any adverse reactions from the accidental third dose of Menveo. Additional Supportive Information:the patient returned to the office for a well-child visit and was accidentally administered a third dose of Menveo,which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2-sep-2021, has not received 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd September 2021).   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: 30-MAR-2022 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix more than six months ago. The patient asked did he/she need just another booster or did he/she need to start the series again with a first shot and then a booster within 6 months. The patient also stated that GlaxoSmithKline information indicated that the booster should be given between 2-6 months after the first dose, his/her question was what should he/she did now that the six month window has passed.  Additional supportive information:  Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Epistaxis, Oral disorder, Petechiae, Rash, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Shingrix induced trombocitopenya (ITP secondary to Shingrix); petechiae; lesions in his mouth; wide spread rash; nose bleed; This case was reported by a pharmacist via sales rep and described the occurrence of thrombocytopenia in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number DP2D3, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date).   On 7th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, 5 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant), petechia (serious criteria hospitalization), oral lesion (serious criteria hospitalization), rash (serious criteria hospitalization) and epistaxis (serious criteria hospitalization). The patient was treated with prednisone and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the thrombocytopenia, petechia, oral lesion, rash and epistaxis were unknown.   The reporter considered the thrombocytopenia, petechia, oral lesion, rash and epistaxis to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's Comments: the reporter stated that unclear why patient developed symptoms post 2nd dose by not after the 1st dose. The patient developed petechiae, lesions in his mouth, widespread rash and nosebleed 5 days post 2nd dose of Shingrix.  The patient was prescribed Valtrex and prednisone. The patient was admitted to the hospital 10 days after the 2nd dose of Shingrix.  The patient was then diagnosed with Shingrix induced thrombocytopenia (ITP secondary to Shingrix) by hematologist. Due to no other source for patient presentation, pharmacist believed this could be due to Shingrix.  The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: nerver got the 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 31-MAR-2022 Reporter's Comment:The reporter reported this case via interactive digital media. The reporter asked if a patient received 1st dose of Shingles vaccine in 2019 but never got the second dose what should they do now. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination.  The follow-up would not possible, as no contact details were available.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: an 11 year old male was accidentally given a 0.5mL dose of Kinrix; the intention was to give a dtap dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FMS, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th March 2022, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On 28th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   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: 28-Mar-2022 Reporter's Comments: A medical assistant reported that the patient accidentally given Kinrix for wound management and the intention was to give a dtap dose. The healthcare professional was informed by 2nd line agent that DTaP was not recommended by Centers for Disease Control and Prevention in patients 7 years old and up. CDC recommended Tdap. The consent to follow up was given via email. Additional Supportive Information: The 11 year old patient received Kinrix instead of dtap vaccine, which led to age at vaccine administration and wrong vaccine administered.
Age: 59.0
Sex: M
Vaccine: HEPAB
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 59-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 30th March 2022, unknown after receiving Twinrix and Twinrix 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: 30-Mar-2022 Reporter's comment: On the date of reporting the patient received an expired dose of Twinrix. The consent to follow up was given. Additional Supportive Information: The patient received Twinrix which was already expired on 28th February 2022, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient 1st dose on July 2021 has not received 2nd dose; This case was reported by a nurse 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 (In July 2021 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comment: The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: DTAP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Infanrix instead of boostrix; Patient received an infanrix dose by error; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 11-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose 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: 30-Mar-2022 Reporter's Comment: The reporter reported that a patient received an Infanrix dose by error. The reporter consented to follow up. Additional Supportive Information: The patient received an Infanrix dose by error, which led to accidental overdose and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Developed some rashes, HCP discards shingles; This case was reported by a physician via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR057922   Additional Information: GSK Receipt Date: 30-March-2022 Reporter's Comments: Physician reported that a patient developed some rashes  after being administered with 2 shingrix doses in 2019.  The reporter discarded that the rashes were because the shingles disease, but the patient requested revaccination with shingrix. The reporter was not consulted to follow up, callback attempted but not successful. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR057922:Same reporter
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HBV (Engerix B) (batch number 5L27A, expiry date 11th February 2022) for prophylaxis.   On 30th March 2022, the patient received the 1st dose of Engerix B. On 30th March 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comment: The patient received an Engerix-B expired dose. The reporter consented to follow up. The reporter was working at home. Hence, requested follow-Up by fax.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered vaccine reconstituted with sterile water; administered vaccine reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA602A, expiry date 31st August 2022) for prophylaxis.   On 24th February 2022, the patient received Menveo. On 24th February 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's Comments:  Medical Assistant reported that, the patient received vaccine which was reconstituted with sterile water instead of the supplied CYW-135 liquid diluent, which led Inappropriate preparation of medication and Inappropriate dose of vaccine administered The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HAV (Havrix) (batch number 299X2, expiry date 24th January 2022) for prophylaxis.   On 17th March 2022, the patient received the 2nd dose of Havrix. On 17th March 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's comment: The nurse reported that, the patient received an expired dose of the Havrix in left deltoid and wanted to know what to do next. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Havrix and it was already expired on 24th January 2022, which led to expired vaccine used.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 31st March 2022, unknown after receiving Twinrix and Twinrix 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: 31-March-2022 Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: On 31st March 2022, the patient received dose of Twinrix that was already got expired on 08th February 2022, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HBV (Engerix B) (batch number J7H4D, expiry date 23rd March 2022) for prophylaxis.   On 31st March 2022, the patient received Engerix B. On 31st March 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: Nurse reported through webform, that patient was given accidentally expired Engerix-B vaccine in left deltoid. The reporter enquired, was this vaccine considered valid or do we need to administer again and do we need to take any other action other than following internal policies. The reporter consented to follow up. Additional Supportive Information. On 31st March 2022, patient received dose of Engerix B that was already got expired on 23rd March 2022, which led to expired vaccine used.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swelling in lymph nodes of neck; This case was reported by a consumer via call center representative and described the occurrence of lymphadenopathy cervical in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2021, 1 days after receiving Shingrix, the patient experienced lymphadenopathy cervical. Shingrix was discontinued. On an unknown date, the outcome of the lymphadenopathy cervical was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's comments: This case was reported by the patient's wife. Reporter did not have the lot or expiration date of the Shingrix vaccine administered. The patient received Shingrix in his right arm. The next day he developed swelling in the lymph nodes of his neck which was still unresolved. The patient's doctor advised patient not to get the second dose.The reporter did not consent to follow-up. The reporter did not gave consent to contact patient's healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: accidentally gave a Shingrix shot, she completed her series; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received in May 2021).   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: 1-Apr-2022 Reporter's comments: Healthcare professional accidentally gave the patient a Shingrix shot. Then the reporter found out she completed her series in May 2021. The reporter asked if they should be concerned for the patient's safety.No further details provided on form. Specialist submitting all available details. The consent to follow up was given. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the ASO1B adjuvant component of the vaccine; administered only the ASO1B adjuvant component of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 75P#7, expiry date 3rd June 2023) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 1st April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments:  The reporter administered only the ASO1B adjuvant component of the Shingrix vaccine to a husband and wife. The reporter was not sure which of them received only the diluent or the full vaccination. The reporter consented to follow up. Additional Supportive Information: The reporter administered only the ASO1B adjuvant component of the Shingrix vaccine to a patient in left arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case is linked with case US2022058812 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058812:same reporter
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: received a pediatric dose of Engerix B; received a pediatric dose of Engerix B instead of the correspondent adult dose.; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 43-year-old male patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 31st March 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   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: 01-APR-2022 Reporter's Comments:  The reporter reported that patient received a pediatric dose of Engerix B instead of the correspondent adult dose, which led to underdose and adult use of child product. The reporter did not consent to follow up.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix was given after the expiration date; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 43-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 28th March 2022, unknown after receiving Twinrix and Twinrix 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: 01-APR-2022 Reporter's comment: The nurse practitioner reported that, Twinrix was inadvertently given to a patient after the expiry date of 28th February 2022.  The reporter consented to follow up via email.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: bipolar disorder, attention deficit hyperactivity disorder, insomnia, and pain, and other pre-existing medical conditions included: Patient had no past medical history (PMHx) of headaches prior to vaccine, however he mentioned his father had a history of headaches and ultimately died of a brain tumor. Patient was veteran. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 20-DEC-2021) dose was not reported, 1 total, administered on 18-MAY-2021 for prophylactic vaccination.  On 18-MAY-2021, the patient experienced flu like symptoms/bad cold type symptoms/feverish (dose number in series 1). On an unspecified date, the patient experienced severe headache (intensity like migraines) following administration of covid-19 vaccine ad26.cov2.s vaccine (dose number in series 1). The headache frequency was every other day or random. He had not yet gotten any official diagnosis, testing, or treatment for his headaches. The patient recovered from flu like symptoms/bad cold type symptoms/headache/feverish on 19-MAY-2021, and had not recovered from severe headaches (intensity like migraines).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 15-AUG-2021 for prophylactic vaccination which was off label use and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included oxcarbazepine for bipolar disorder, and attention deficit hyperactivity disorder, quetiapine fumarate for insomnia, and gabapentin for pain. Treatment medications (dates unspecified) included: naproxen sodium for severe headaches (intensity like migraines). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220327423 (dose number in series 1 case).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER BETWEEN 102 TO 104F; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 08:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 08-MAR-2021, the patient experienced chills, fever between 102 to 104f, and headache. Laboratory data included: Body temperature (NR: not provided) 102 to 104 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever between 102 to 104f, chills, and headache. This report was non-serious. This case, involving the same patient is linked to 20210329954.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic vascular thrombosis, Splenic haemorrhage, Thrombosis
Clinical narrative: MASSIVE CLOTS IN LIVER; BLEEDING FROM SPLEEN; MASSIVE CLOTS IN LEGS, STOMACH; This spontaneous report received from a consumer via a company representative via social media (JNJNews account ) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the patient experienced massive clots in legs, stomach and liver and bleeding from spleen. The patient was hospitalized on unspecified date. Number of days hospitalized was unspecified. The reporter stated that, "My sisters boyfriend is in the hospital with massive clots in his legs, stomach, and liver after taking JNJNews vax. Bleeding from spleen. At best blood thinners & dialysis the rest of his life." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive clots in legs, stomach, and massive clots in liver, and the outcome of bleeding from spleen was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220404326- covid-19 vaccine ad26.cov2.s- Massive clots in liver, bleeding from spleen, massive clots in legs, stomach. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Dry throat, Feeling abnormal, Feeling hot
Clinical narrative: LOWER RIGHT QUADRANT PAIN WHEN BREATHING IN; DRY THROAT; FELT AS IF HE IS ABOUT TO BE SICK; FELT WARM; This spontaneous report received from a patient concerned a 29 year old male. The patient's weight was 240 pounds, and height was 69 inches. 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: 211D21A expiry: 10-JUL-2022) dose was not reported, administered on 02-APR-2022 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2022, the patient experienced lower right quadrant pain when breathing in, dry throat, felt as if he is about to be sick, and felt warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry throat on 02-APR-2022, and had not recovered from lower right quadrant pain when breathing in, felt as if he is about to be sick, and felt warm. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vein rupture
Clinical narrative: VEIN BURST IN LEG; This spontaneous report received from a patient concerned a 71 year old white female. The patient's height, and weight were not reported. The patient's past medical history included: 2 bowel surgeries/resection and 3 heart stents and concurrent conditions included: heart problem, bladder problem and allergies. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, batch number and expiry not reported) dose was not reported, 1 total administered on 07-MAR-2021 on right arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s  (Dose number in series 1). The patient additionally received booster of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of administration not reported, batch number: 211D21A and expiry: 10-JUL-2022) dose was not reported, 1 total administered at right arm on 29-OCT-2021 for prophylactic vaccination.  Concomitant medications included acetylsalicylic acid for drug used for unknown indication, amlodipine for drug used for unknown indication, metoprolol tartrate for drug used for unknown indication, potassium for drug used for unknown indication, rosuvastatin for drug used for unknown indication, and glyceryl trinitrate for heart problem. The patient also takes bladder medication. On an unspecified date in DEC-2021, about one and half months after the booster dose, the patient started having a vein issue (a vein burst in her right leg, on the outer side of her leg, behind the kneecap), in late November or early December (Dose number in series 2). The patient went to the emergency room on a weekend. She underwent an ultrasound to make sure it was not a blood clot passing and the results were fine. She was told to relax, take it easy, and to prop up her feet. When she sat for too long the vein did hurt and she had to get up and move. Once the vein burst, the pain went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vein burst in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220404440-Covid-19 vaccine ad26.CoV-2.s-Vein burst in leg. 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: Feeling abnormal, Malaise
Clinical narrative: This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced just did not feel right, and feeling of malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from just did not feel right, and feeling of malaise. This report was non-serious.
Age: 47.0
Sex: M
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 48 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for influenza. On 03-APR-2022, the patient started experiencing symptoms of covid-19 infection and on the same day tested positive for COVID 19 using an home test. On 04-APR-2022, he went to the doctor's office and performed another antigen test at the office which also came back positive (confirmed covid-19 infection) which led to confirmed clinical vaccination failure. He was officially diagnosed with COVID 19 by his doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000224613. This case, from the same reporter is linked to 20220406100.; Sender's Comments: V0: 20220406167-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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain in extremity
Clinical narrative: Sore arm; She got a little sick/Following the second dose she was a little sick for a few days; A little nauseous/ Nausea lasted for 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ILLNESS (She got a little sick/Following the second dose she was a little sick for a few days) and NAUSEA (A little nauseous/ Nausea lasted for 2 days) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Blood pressure high, Diabetes and Obesity.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ILLNESS (She got a little sick/Following the second dose she was a little sick for a few days) and NAUSEA (A little nauseous/ Nausea lasted for 2 days). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and ILLNESS (She got a little sick/Following the second dose she was a little sick for a few days) and NAUSEA (A little nauseous/ Nausea lasted for 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2022-494417, MOD-2022-494503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Reporter's type and Outcome of event Illness were updated.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Neuropathy peripheral, Vaccination site dysaesthesia
Clinical narrative: Neuropathy in his arm/feet; Arm kept getting weaker.; Nerves are rippling down from the spot he received the shot; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in his arm/feet), MUSCULAR WEAKNESS (Arm kept getting weaker.) and VACCINATION SITE DYSAESTHESIA (Nerves are rippling down from the spot he received the shot) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027620A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer, Lymphoma (Years ago), Spinal operation (Had surgery in his neck for his left arm (spinal stenosis surgery)) and Chemotherapy. Concurrent medical conditions included Diabetes (After chemo he had diabetes), Drug allergy (Benadryl) and Neuropathy (Neuropathy in his feet).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in his arm/feet), MUSCULAR WEAKNESS (Arm kept getting weaker.) and VACCINATION SITE DYSAESTHESIA (Nerves are rippling down from the spot he received the shot). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in his arm/feet), MUSCULAR WEAKNESS (Arm kept getting weaker.) and VACCINATION SITE DYSAESTHESIA (Nerves are rippling down from the spot he received the shot) had not resolved.            No concomitant medication was reported.  Patient was never being tested or diagnosed for COVID.  Caregiver stated that her husband who has received 3 doses of the Moderna COVID 19 vaccine is having some symptoms she is not sure is related to the vaccine. In early part of February, he said to her that his nerves are rippling down from the spot he received the shot; then for several weeks the arm kept getting weaker. By the end of February into the first part of March, he had to start using his left arm to pick up his left arm. Her husband who is diabetic has neuropathy in his feet. The neurosurgeon says he has neuropathy in his arm.   No treatment medication was reported.   This case was linked to MOD-2022-527070 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Non immunocompromised patient got full third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Non immunocompromised patient got full third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Non immunocompromised patient got full third dose). At the time of the report, ACCIDENTAL OVERDOSE (Non immunocompromised patient got full third dose) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  The patient was non-immunocompromised. The patient had received 3 full doses of Moderna vaccine.  The patient wanted to know whether the fourth booster dose would be the same as the first 3 doses or not.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients given expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients given expired vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     The patient did not have any immediate allergies reaction to any vaccine, injection or shot or to any component of the COVID-19 vaccine, or a severe allergic reaction (anaphylaxis). The patient never diagnosed with cancer, leukemia, HIV/AIDS or any other condition that weakens the immune system, bleeding disorder, blood clots, myocarditis or pericarditis. .    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients given expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No temperature excursions were noted at any time during the administration of the vaccine. No treatment medication were provided.   This case was linked to MOD-2022-530317, MOD-2022-531901 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document received contains significant information: patient details and vaccine details updated.