chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Influenza like illness, Paraesthesia
Clinical narrative: Flushing of face and chest; Tingling in lips and arms; feeling warm; Most pronounced after combination of Athletic Greens and chai latte; Numb lips; allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date, refer case US2022AMR081860).   On 29th April 2022, the patient received the 2nd dose of Shingrix. On 2nd May 2022, 3 days after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the patient experienced flushing, tingling, feeling of warmth, food interaction and numb lips. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the allergic reaction was recovered/resolved and the outcome of the flushing was recovering/resolving and the outcome of the tingling and numb lips were not recovered/not resolved and the outcome of the feeling of warmth and food interaction were unknown.   It was unknown if the reporter considered the allergic reaction, flushing, tingling, feeling of warmth, food interaction and numb lips to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR081860   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and was feeling a little tired and flu like symptoms. The patient also experienced flushing of his/her face, tingling in his/her lips and arms and feeling warm. Most pronounced was after the combination of Athletic Greens and a chai latte. However, even later in the day, his/her face and chest were flushed for no apparent reason. The patient separated out the chai from the AG, which reduced some of this, but the numb lips continue.  On 5th May 2022 the also experienced worst of the apparent allergic reaction, . It subsided after he/she took some benadryl. The patient discontinued the AG and as of today (day of reporting) the tingling/numbness in his/her lips and on his/her face persists. The patient asked for advice. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081860:Same reporter
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Diffuse large B-cell lymphoma, Pneumonitis, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Triple hit lymphoma
Clinical narrative: Triple Hit Diffuse Large B cell Lymphoma; Diffuse Large B cell Lymphoma; Pneumonitis; tested for COVID antibodies, had no antibodies; This case was reported by a consumer via call center representative and described the occurrence of triple hit lymphoma in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rituximab (Rituxan) for triple hit lymphoma and diffuse large b-cell lymphoma and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   On 7th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Rituxan at an unknown dose and frequency and COVID-19 VACCINE PFIZER. In January 2022, less than 2 months after receiving Shingrix, the patient experienced covid-19 antibody test negative. On an unknown date, the patient experienced triple hit lymphoma (serious criteria GSK medically significant), diffuse large b-cell lymphoma (serious criteria GSK medically significant) and pneumonitis. The patient was treated with cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone. The action taken with Rituxan was unknown. On an unknown date, the outcome of the triple hit lymphoma, diffuse large b-cell lymphoma, pneumonitis and covid-19 antibody test negative were unknown.   It was unknown if the reporter considered the triple hit lymphoma, diffuse large b-cell lymphoma, pneumonitis and covid-19 antibody test negative to be related to Shingrix.  Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comment: The case was reported by the patient. Last year from reporting, he/she was diagnosed with triple hit diffuse large B cell lymphoma.  The patient went through 6 rounds of chemo, 1 R-CHOP (an immuno-chemotherapy regimen consisting of Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Vincristine and Prednisone) and 2 through 6. The patient was tested in January 2022 for Covid antibodies after 3 injection of the Pfizer vaccine.  They found that, the patient had no antibodies for Covid, likely due to the Rituxan in the chemotherapy treatment. After round 4, completed on 11th May 2022, the patient developed pneumonitis, possibly related to the Rituxan in the chemotherapy treatment. The Rituxan was not used in the final two rounds of chemotherapy. Less than a month after receiving Shingrix,the patient experienced triple hit lymphoma and diffuse large b-cell lymphoma. Between 5 and 6 months after receiving Shingrix, the patient experienced pneumonitis. The patient was due for his/her second shot of Shingrix. The reporter wanted to know that, Rituxan interfere with the Shingrix vaccine. Unfortunately, there was no drug interaction (Rituxan prevented Shingrix from working) section listed in the package insert. It was unknown if the reporter considered the b-cell lymphoma, pneumonitis and covid-19 antibody test negative to be related to Covid-19 vaccine Pfizer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: not to pain, less pain due to vaccines; had my 2nd shingle shot 5/19/22, got shingles last Thursday; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Shingles vaccine. On 2nd June 2022, 14 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received 2nd shingle shot on 19th May 2022 and he/she got shingles last Thursday. The patient said the vaccine was not to painful but thinking less pain due to vaccines. Less than 3 weeks after vaccination, the patient experienced pain. Follow up would not be possible, as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Jun-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient took the vaccine and got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Musculoskeletal chest pain, Vaccination failure
Clinical narrative: Had all the damn shots one booster then got shingles/Suspected vaccination failure; I got shingles; I feel like it's screwed up my immune system.; Spent six weeks feeling like somebody hit me in the ribs; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, immune imbalance and rib pain. On an unknown date, the outcome of the vaccination failure, shingles, immune imbalance and rib pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, immune imbalance and rib pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JUN-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient reported that he/she totally agreed. The patient had all the damn Shingle shots one booster then he/she got shingles. The patient felt like it was screwed up immune system.  The patient spent six weeks feeling like somebody hit him/her in the ribs with a baseball bat, he/she would not wish it on worst enemy Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: After both shingrix doses still got shingles/Suspected vaccination failure; shingles in both thighs and groin area; Shingles not as painful as others; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-JUN-2022  Reporter's Comments: This case was received from the patient's wife via interactive digital media. The patient had the original shingles vaccine and both Shingrix doses a few years later.  The patient still got shingles on both thighs and groin area.  Fortunately for him it only lasted a couple months and not as painful as what others experience       Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Shingles vaccination is HORRIBLE!! I GOT SOOO SICK; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient stated that shingles vaccination was horrible and got sick. The patient did not recommend it. Additional Supportive Information: Follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot 7 months and 10 days after 1st; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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: 9-JUN-2022 Reporter's Comments: The case was self reported by the patient via interactive digital media. The reporter wanted to know if he/she was protected after receiving 2nd Shingrix shot 7 months and 10 days after the 1st dose. Additional Supportive Information: The patient received 2nd Shingrix shot 7 months and 10 days after the 1st dose, which led to lengthening of vaccination schedule. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose before Covid and nowgetting 2nd; This case was reported by a consumer 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 (the patient received 1st dose on an unknown date).   On an unknown date, the patient did not 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: 09-June-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient asked what if he/she had first dose of the vaccine before Covid and he/she was just now getting his/her second. The patient wants to know whether need to take another dose. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of liquid portion of Menveo without reconstitution; Administration of liquid portion of Menveo without reconstitution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 10-JUN-2022 Reporter's comment: The reporter reported that a patient received liquid portion of Menveo without reconstitution. Additional Supportive Information: The reporter reported that a patient received liquid portion of Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case has been linked with the case US2022AMR091766 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091766:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administration of lyophilized portion of Menveo using a different diluent; Administration of lyophilized portion of Menveo using a different diluent; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 10-JUN-2022 Reporter's Comment: The reporter reported that, the patient was administered with lyophilized portion of Menveo using a different diluent. Additional Supportive Information: The patient was administered with lyophilized portion of Menveo using a different diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case had been linked to US2022AMR091748,reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091748:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: lost some diluent while drawing it up, technique issue; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.   Additional Information: GSK Receipt Date: 6-Jun-2022 Reporter's Comments: The reporter was a pharmacist who works for a retail pharmacy. One of the pharmacists lost some diluent while drawing it up for a vaccine and she had to use another diluent bottle.  So, at the time of reporting they had 1 vaccine bottle without a diluent. The pharmacist spoke to the reporter and asked her if she thought there was a quality issue with the vial. She said no. She said that she thinks that it was a technique issue. No patient involvement as they were able to prepare the full dose using a different adjuvant vial (from the same box). The vaccine administration facility was the same as primary reporter. Reporter provided limited information.  No further questions were asked because reporter was not sure if this was considered an adverse event or not.  Reporter was not aware that a report was being filed. Additional Supportive Information: Pharmacists lost some diluent while drawing it up for a vaccine and she had to use another diluent bottle, which led to Wrong technique in product usage process.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: patients have been complaining about not feeling well; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's Comment: The reporter reported that the patients had been complaining about not feeling well after the 2nd dose. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on march and missed the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (The patient was administered the first dose of Twinrix in march).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's Comment: The patient missed the second dose of Twinrix.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered on 08-JUN-2022. Vaccine expired 22-MAY-2022.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 8th June 2022, the patient received Havrix. On 8th June 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: 8-JUN-2022 Reporter's Comments: The nurse reported expired dose of Havrix administered on 8th June 2022. The nurse unable to provide patient's date of birth.  The nurse gave consent for safety to follow up. Additional Supportive Information: The patient received dose of Havrix on 8th June which was already expired on 22nd May 2020, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Patient received the 1st dose on 21-AUG- 2020. The patient has not yet received the 2nd dose, is late due to the pandemic.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 27th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 8-JUN-2022 Reporter's Comments: The pharmacist reported that a patient received the first dose of Shingrix on 27th August 2020. The patient was late due to the pandemic. The patient had not yet received the second dose. The reporter did not consent to follow-up. The pharmacist said that follow-up via phone call would be okay (declined postal or email).
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 8th June 2022, the patient received the 3rd dose of Havrix. On 8th June 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: 08-JUN-2022 Reporter's Comment: The reporter reported that, a patient was administered an expired dose of the Havrix vaccine in right deltoid. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of the Havrix vaccine, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment: The registered nurse reported that the patient received an expired dose of Infanrix. The reporter consented to follow up. Additional supportive information: The patient received Infanrix which was already expired, which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose Bexsero, 2nd dose was accidentally given Trumenba; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   Concomitant products included meningococcal B vaccine (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th June 2022, the patient received TRUMENBA. On 6th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 08-JUN-2022 Reporter's Comment: The reporter was a clinic manager. The patient received her 1st dose of Bexsero and instead of getting a 2nd dose of Bexsero, she was accidentally given a dose of Trumenba. The reporter consented to follow up via email. Additional Supportive Information: The patient received her 1st dose of Bexsero and instead of getting a 2nd dose of Bexsero she was accidentally given a dose of Trumenba, which led to interchange of vaccine products.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn't receive 2nd dose, first was given two years ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   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: 8-JUN-2022 Reporter's comment:The reporter stated that that a male patient did not received the 2nd dose of shingrix and first dose was given two years ago. The consent to follow up was given. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which lead to Incomplete course of vaccination.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Underdose
Clinical narrative: Administered an underdose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 21-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5277J, expiry date 12th November 2023) for prophylaxis.   On 8th June 2022, the patient received Boostrix. On 8th June 2022, unknown after receiving Boostrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comments: The patient received Boostrix on right arm. This case has been linked to US2022078374, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022078374:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not received dose up to the moment, date of start drug: (24-JUN-2019); This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose on 24th June 2019,Batch number:7457P,Expiry date:23rd June 2020).   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: 09-JUN-2022  Reporter's Comment: The patient had not received second dose of Shingrix up to the moment of this report. The reporter consented 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: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 11/16/2021 received Engerix-B first dose, has not received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 41-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 16th November 2021 for batch no 9AXEP and expiry date 23rd November 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 09-JUN-2022  Reporter's comment: The pharmacist reported that a female patient received Engerix-B first dose and had not received dose 2. The reporter consented to follow up by email please. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on OCT-2021 and did not receive his 2nd dose until 8-JUN-22; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in October 2021).   On 8th June 2022, the patient received the 2nd dose of Shingrix. On 8th June 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: 09-JUN-2022 Reporter's Comments: The reporter was patient who called in for information on Shingrix.  The patient did not receive his second dose until 8th June 2022 (approximately 8 months after).  The patient refused to provide mailing address. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a patient via a company representative concerned multiple patients. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terrible side effects. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220609828.
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 female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: COPD (chronic obstructive pulmonary disease). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in DEC-2021, the patient got covid even after receiving the primary vaccination (confirmed covid-19 infection and had confirmed clinical vaccination failure). The patient got a positive test from hospital (Laboratory data included: COVID-19 virus test Positive). The patient was in close contact with the positive case of covid (intimate relationship) that hot hospitalized because of his previous condition. The patients COPD was not worse since the infection and she was doing fine. The patient also experienced headache, lost sense of smell, lost sense of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000234344.; Sender's Comments: V0: 20220610230-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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood cholesterol, Blood pressure measurement, Decreased appetite, Nausea
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a 62 year old female of race white and not Hispanic or Latino. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer, high blood pressure, high cholesterol, bactrim allergy, and codeine allergy. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1802068 expiry: unknown) dose was not reported, 1 in 1 total, administered on right arm on 08-MAR-2021 at 02:00 hours for prophylactic vaccination. Age at time of vaccination 60 years old. Concomitant medications reported as Sulfamethoxazole or Bactrim treatment received as change in antibiotic and nausea medicine. It was unknown whether patient had any adverse events following vaccination with Covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received non-company Spikevax Covid-19 vaccine (Elasomeran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 071F21A, expiry: unknown) dose was not reported, administered on the right arm on 22-NOV-2021 at 01:00 hours for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Spikevax Covid-19 vaccine (dose number in series 2). The patient additionally received two doses of non-company suspect Pfizer BioNTech Covid-19 vaccine (Tozinameran) (dose number in series 3) (form of admin, route of admin were not reported, batch number: 300691085301, expiry: unknown) dose was not reported, administered first dose on 25-MAY-2022 and date of last administration dose was 28-May-2022 for prophylactic vaccination. On 28-MAY-2022, the patient experienced nausea, weakness, and loss of appetite for food or drink (dose number in series 3). The action taken with Covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient was recovering from nausea, weakness, and loss of appetite for food or drink (dose number in series 3). This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 61 year old not Hispanic or Latino, Caucasian male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy. The patient previously received first dose of Spikevax (elasomeran) (dose 1 of dose number in series 1) (form, route of administration, batch number, dose was not reported and expiry: unknown) administered on left arm on 11-FEB-2021 for prophylactic vaccination. The patient additionally received second dose of Spikevax (elasomeran) (dose 2 of dose number in series 1) (form, route of administration, batch number, dose was not reported and expiry: unknown) administered on left arm on 11-MAR-2021 for prophylactic vaccination. The patient additionally received third dose of Spikevax (elasomeran) (dose 3 of dose number in series 1) (form, route of administration, batch number, dose were not reported and expiry: unknown) administered on left arm on 28-SEP-2021 for prophylactic vaccination. It was unknown whether the patient experienced any adverse events after three doses of Spikevax (elasomeran) (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose was not reported, administered on left arm on 05-APR-2022 for prophylactic vaccination (which was Off label dosing frequency). The batch number was not reported and has been requested. Age at time of vaccination was 61 years. No concomitant medications were reported. On 16-APR-2022, patient experienced symptoms (confirmed Covid-19 infection) (dose number in series 2). Patient started Paxlovid on same day (16-APR-2022) for Covid-19 treatment, when she experienced symptoms and tested positive on RAT (Rapid antigen test) and PCR test. Patient took Paxlovid from 16-APR-2022 to 21-APR-2022. Patient experienced Paxlovid "rebound" on Day 10 (25-APR-2022). RAT cleared on 01-MAY-2022 (Day 16). Patient was currently experiencing long Covid symptoms 6 weeks after first symptoms. He received acupuncture for the treatment of the adverse event. It was reported that the patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed Covid-19 infection, and long Covid symptoms, and the outcome of off label dosing frequency was not reported. This report was non-serious. This report was associated with product quality complaint. 90000234531. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Laboratory test, Weight decreased
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced irritable bowel syndrome. On JAN-2022, Laboratory data included: Laboratory test Negative, Negative, Negative. Laboratory data (dates unspecified) included: Weight loss losing 20 LBS. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritable bowel syndrome. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. 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: unknown, expiry: unknown) dose not reported, 01 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died. The patients died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "I know too many people that died after those covid shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20220612688-covid-19 vaccine ad26.cov2.s- Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: This spontaneous report received from a parent 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced eyesight went downhill / in less than 48 hours after taking the shot had trouble with her sight. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eyesight went downhill / in less than 48 hours after taking the shot had trouble with her sight was not reported. This report was non-serious. This case, from the same reporter is linked to 20220615899.
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: BLIND WHILE DRIVING; This spontaneous report received from a consumer via a company representative via social media concerned a male.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, administered 1 total 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 blind while driving. It was reported that "Well my daughters eye sight went downhill after taking your shot. Against her will, Less than 48 hours after taking that poison she is having trouble with her sight, It crushes my soul if the hospital makes her take another one will the next one make her go blind. And my brother in law who has every vaccine offered went blind while driving. His wife had to steer the car off the road to avoid killing them. Bastards. I hate every single one of you liars. The love of money is the root of all evils. May you all burn in hell." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blind while driving was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220615827.; Sender's Comments: V0: 20220615899 -Covid-19 vaccine ad26.cov2.s -BLINDNESS. 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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: BLURRED VISION; FEVER; HEADACHE; EXHAUSTION; MUSCLE ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a Nurse (HCP), reported for herself. 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 03-JUN-2021 for prophylactic vaccination. Age at time of vaccination 43 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced fever, headache, exhaustion, muscle aches, and injection site pain. On 10-JUN-2022, the patient experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, exhaustion, muscle aches, injection site pain, and blurred vision. This report was non-serious.