chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Vaccination failure
Clinical narrative: This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: know 4 ppl myself you got shingles FROM the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 11-JUN-2023. The case was received from the consumer interactive digital media. The reporter stated that he/she know 4 people and himself/herself who got shingles from the shot and in one instance they lasted over a year, debilitating for sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This was 2 of the 4 cases, reported by the same reporter. Sender's Comments: US-GSK-US2023AMR082854: same reporter; US-GSK-US2023AMR082853: same reporter; US-GSK-US2023AMR082797: same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Vaccination failure
Clinical narrative: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure; know 4 ppl myself you got shingles FROM the shot; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: know 4 ppl myself you got shingles FROM the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-JUN-2023 The case was received from the consumer interactive digital media. The reporter stated that he/she know 4 people and himself/herself who got shingles from the shot and in one instance they lasted over a year, debilitating for sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This was 4 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR082853:same reporter US-GSK-US2023AMR082851:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: People say get shot I did still got shingles going on 2 weeks very painful/Suspected vaccination failure; People say get shot I did still got shingles going on 2 weeks very painful; People say get shot I did still got shingles going on 2 weeks very painful; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: People say get shot I did still got shingles going on 2 weeks very painful/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: People say get shot I did still got shingles going on 2 weeks very painful) and pain (Verbatim: People say get shot I did still got shingles going on 2 weeks very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-JUN-2023 The case was received from the consumer interactive digital media. The reporter stated that people said to get shot, the patient did still got shingles going on 2 weeks very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Bradycardia, Deafness unilateral, Fatigue, Feeling abnormal, Heart rate decreased
Clinical narrative: After administration of HPV #2, patient became pale and dazed, minimally responsive to questions - on palpation of radial pulse, heart rate had become bradycardic and faint. She reported she felt very tired and couldn't hear out of her right ear. We had patient lay on the table, cool towel on back of neck, and had her smell alcohol pad. Immediately after these interventions, patient's color returned, pulse strengthened and increased to normal, and she felt back to her normal self. Hearing reportedly returned to that ear. She sat up, drank some water, ate a snack, and was feeling back to baseline so was discharged. While she did not lose consciousness, this was consistent with vasovagal response following HPV vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Hyporesponsive to stimuli, Pallor, Presyncope
Clinical narrative: After administration of HPV #2, patient became pale and dazed, minimally responsive to questions - on palpation of radial pulse, heart rate had become bradycardic and faint. She reported she felt very tired and couldn't hear out of her right ear. We had patient lay on the table, cool towel on back of neck, and had her smell alcohol pad. Immediately after these interventions, patient's color returned, pulse strengthened and increased to normal, and she felt back to her normal self. Hearing reportedly returned to that ear. She sat up, drank some water, ate a snack, and was feeling back to baseline so was discharged. While she did not lose consciousness, this was consistent with vasovagal response following HPV vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine was expired 5/2 in the refrigerator and given on 6/2
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: vaccine was expired on 5-12-23 and given on 6-2-23
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Eye swelling, Injection site rash, Injection site urticaria, Mobility decreased
Clinical narrative: VACCINE ADMINISTERED ON 06/12, PATIENT TARTED HAVING SYMPTOMS ON 06/14 TH MORNING WHEN SHE WOKE UP, SHE HAD HIVES LIKE RASH AT THE SITE OF INJECTION, SWOLLEN EYES, PAIN IN THE ARMPITS AND COULD NOT LIFT HER ARM
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Seizure
Clinical narrative: patient had a seizure the night of the vaccination with moderna bivalent booster and flu shot. Has hx of seizures, but has not had a seizure for about a year before this one.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pallor, Photophobia
Clinical narrative: Patient received vaccine. After about 3 minutes patient's face became very pale. Medical assistant asked patient if she was feeling okay. Patient reported feeling like she was going to "throw up". Emesis bag, water and apple juice were offered to patient. Staff offered for patient to lay down on exam table. Pt declined, stating she wanted to lay down on floor.  Light in room were turned off as patient reported feeling like lights were too bright.  Pt laid down on the floor for about 7 minutes and states she was feeling better. Pt was able to sit up on chair. Pt drunk apple juice and water. Blood pressure was checked.  Patient was monitored for an additional 7 minutes.  Pt reported feeling well and was discharged with mom.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Headache, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Body aches, abdomen pain, headache, nausea, sore throat, tenderness and swelling at shot site, itching at shot site initially but has gone away.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: Body aches, abdomen pain, headache, nausea, sore throat, tenderness and swelling at shot site, itching at shot site initially but has gone away.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient had already completed series and received a 3rd dose in error.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus
Clinical narrative: 5:30 PM Administered Pneumovax, 5:45pm patient stated both palms were red, left arm itched.  Kept her about 20 minutes, reported neck itchy.  10-15 minutes later no progression of symptoms.  She felt safe to drive home.  sent her home with Benadryl and she had an Epipen at home.  she stated she is well-versed in allergic reactions and knew what to do.  called her at 6:30pm when she was home.  had taken the 2 benadryl and no progession of itching or redness.
Age: 60.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: PATIENT RECIVED 2 DOSES OF SHINGRIX . 1 DOSE IN EACH ARM.    SORE ARM IS ONLY SYMPTOM AT THIS TIME  AFTER A FOLLOW UP 6 HOURS AFTER DOSE.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Crying, Headache, Impaired work ability, Insomnia
Clinical narrative: I (the patient) found it significantly harder to go about my day to day activities and experienced increased insomnia as well. My ability to think through work diminished to the point where I could not complete any meaningful amount of work or university activities for the next seven months. My brain hurt, and in December 2021, it was stinging to the point that I was crying and dry heaving.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mental impairment, Pain, Retching
Clinical narrative: I (the patient) found it significantly harder to go about my day to day activities and experienced increased insomnia as well. My ability to think through work diminished to the point where I could not complete any meaningful amount of work or university activities for the next seven months. My brain hurt, and in December 2021, it was stinging to the point that I was crying and dry heaving.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Erythema, Immediate post-injection reaction, Rash
Clinical narrative: Rash to R lower ext. noted almost immediately after administering vaccines. Grandmother pointed out that patient was starting to get more red spots to face, arms, and abdomen. Provider notified immediately. As per provider, to give 4ml prednisolone and 5ml of Benadryl. Patient did vomit after administering medication. Provider notified. Patient seen by provider 15 minutes after medication. Patient ok to leave. Reaction noted to be going away. Mother advised to give patient 5ml Benadryl OTC every 6 hrs as needed if the rash returns. Verbalized understanding.
Age: 2.75
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Neck mass, Rash
Clinical narrative: Reported rash on face and on groin. Also on arms, "lump" on back/side of neck.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMRV
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: 05/01/23 - Vaccine doses given as above. 05/04/23 - Seen in UC for left thigh - possible injection site inf. Cephalexin monohydrate prescribed. (I noted appt on 5/23/23)05/08/2023 - F/U call not answered - 0 return call. 05/22/2023 - While preparing to complete inventory, I noted a discrepancy - I contacted nurse to verify doses given/incorrect documentation - She confirmed given as documented.  Parents notified.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one Janssen dose
Sex: U
Vaccine: PNC15, PPV
Symptoms: Drug eruption, Drug hypersensitivity, Rash
Clinical narrative: Drug allergy (Rash); This spontaneous report was received from an unspecified type of reporter via Pfizer concerning a patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient was vaccinated with a pneumococcal vaccine (pneumococcal Vaccine, Polyvalent (23-valent) or pneumococcal 15v conj vaccine (CRM197)) (manufacturer unknown) (as prophylaxis, no more vaccination details were provided).   On an unspecified date, the patient presented a drug allergy presented as a rash (drug eruption). The outcome of the event was not provided.  The causality assessment between the event and the suspect vaccine was related.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Ill-defined disorder
Clinical narrative: she is experiencing a number of the issues listed online concerning the settlement; This spontaneous report was received from a consumer referring to herself, a currently 31-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date when the patient was about 13-15 years old, the patient was vaccinated with the company unidentified HPV vaccine (strength, dose, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis. The patient was unsure whether she received Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  On an unknown date, the patient experienced a number of the issues listed online concerning the settlement (ill-defined disorder). The outcome of the ill-defined disorder, and the causal relationship between the ill-defined disorder and the unidentified company HPV vaccine were not reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP calling to report patient received GARDASIL 9 earlier than recommended; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 14-FEB-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 17-APR-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 12-JUN-2023, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: W030851, expiration date: 08-JAN-2025; strength, dose, and route of administration were not reported) for prophylaxis. The third dose was administered earlier than recommended (inappropriate schedule of product administration). No additional adverse events (AE) were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccination last year and I have a mild case of shingles/ suspected vaccination failure; Shingles; This serious 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, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had vaccination last year and I have a mild case of shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that because you receive vaccination does not mean that you will still experience shingles. The patient stated that he or she received Shingles vaccine last year and still have mild case of Shingles right now. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Tired; flu-like symptoms; This non-serious case was reported by a consumer and described the occurrence of tiredness in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: Tired) and influenza-like symptoms (Verbatim: flu-like symptoms). The outcome of the tiredness and influenza-like symptoms were resolving.   The reporter considered the tiredness and influenza-like symptoms to be related to Shingrix.     The company considered the tiredness and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 The case was reported for patient's friend. The reporter reported of feeling tired and flu like symptoms after 2nd dose of Shingrix and felt better within 12 hours.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Regurgitation
Clinical narrative: infant spits out or regurgitates; infant spits out or regurgitates; This non-serious case was reported by a other health professional via sales rep and described the occurrence of regurgitation of medication in a infant patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: infant spits out or regurgitates) and accidental underdose (Verbatim: infant spits out or regurgitates). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 13-JUN-2023 The patient spitted out or regurgitated most of the Rotarix dose, a single replacement dose might be considered at the same vaccine visit. The reporter asked if this was only within the first 15 minutes. The patient spitted out or regurgitated most of the Rotarix dose, which led to accidental underdose.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Illness, Rash
Clinical narrative: rashes on both thigh; feel sick (tired; feel sick (tired); This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11-JUN-2023, the patient received the 1st dose of Shingles vaccine. In JUN-2023, less than a week after receiving Shingles vaccine, the patient experienced rash (Verbatim: rashes on both thigh), sickness (Verbatim: feel sick (tired) and tiredness (Verbatim: feel sick (tired)). The outcome of the rash was resolved and the outcome of the sickness and tiredness were not reported.   It was unknown if the reporter considered the rash, sickness and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the rash, sickness and tiredness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Jun-2023 The case was received from the patient via interactive digital media. The patient took a shot last sunday and there was minimal reaction and had rashes on both thigh and felt sick (tired). The patient stated that on the day of reporting, the rashes were subsided. The patient was afraid to take 2nd dose.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: tingling and numbness started going down into her arm; tingling and numbness started going down into her arm; soreness at the injection site; numbness where the injection site was on her arm; Tingling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site numbness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-APR-2023, the patient received the 2nd dose of Shingrix (left arm). On 12-APR-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site). In APR-2023, the patient experienced injection site numbness (Verbatim: numbness where the injection site was on her arm) and injection site tingling (Verbatim: Tingling). On an unknown date, the patient experienced tingling (Verbatim: tingling and numbness started going down into her arm) and numbness (Verbatim: tingling and numbness started going down into her arm). The outcome of the injection site numbness, injection site tingling, injection site pain, tingling and numbness were not resolved.   It was unknown if the reporter considered the injection site numbness, injection site tingling, injection site pain, tingling and numbness to be related to Shingrix.   It was unknown if the company considered the injection site numbness, injection site tingling, injection site pain, tingling and numbness to be related to Shingrix.   Additional Information: GSK Receipt date: 05-JUN-2023 The reporter reported that from the time of her injection, and for several weeks after the injection (no exact date provided), she had soreness at the injection site. About 2 weeks after the injection (may be longer she said as no exact date provided), she was still experiencing the soreness at the injection site, and also started having tingling and numbness where the injection site was on her arm. This tingling and numbness started going down into her arm and hand a few days after it started at the injection site (no exact date provided). The patient did not have any exact dates for any of her adverse reactions. Consent to follow up with HCP was obtained.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Chills, Headache, Malaise
Clinical narrative: chills; severe headache; malaise; being confined to bed for the first and second days; receiving first dose of Shingrix 7-8 months ago and the second dose today, 6-9-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 09-JUN-2023, the patient received the 2nd dose of Shingrix. On 09-JUN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: receiving first dose of Shingrix 7-8 months ago and the second dose today, 6-9-2023). On an unknown date, the patient experienced chills (Verbatim: chills), headache (Verbatim: severe headache), malaise (Verbatim: malaise) and bedridden (Verbatim: being confined to bed for the first and second days). The outcome of the chills, headache, malaise and bedridden were resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills, headache, malaise and bedridden to be related to Shingrix.     It was unknown if the company considered the chills, headache, malaise and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUN-2023 The patient reported that he received first dose of shingrix 7 to 8 months ago and second dose on 09th June 2023 just 30-45 minutes prior to filing report. After the administration of first dose of Shingrix patient experienced chills, severe headache, malaise and was confined to bed for the first and second days. The symptoms resolved after second day.  The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 10-JUN-2023, the patient received Boostrix. On 10-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter called to inquire if the patient should be revaccinated with Boostrix. The reporter did not consent to follow-up. A patient was inadvertently administered an expired vaccine of Boostrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix - Second dose at Less than Minimum Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 12-JUN-2023, the patient received the 2nd dose of Shingrix. On 12-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix - Second dose at Less than Minimum Interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 12-Jun-2023 A pharmacist called in to report the administration of the second dose of Shingrix at less than minimum interval. The reporter asked how to proceed with patient vaccination. During the call permission for follow up was not requested. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a other health professional 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 (received first dose in November 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-Jun-2023 The patient never receive second dose. No data available regarding patient´s date of birth, gender, or lot number. The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a first dose of Menveo on 6-11-2020 and received second dose of Menveo on 6-12-2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (On 11th June 2020, received first dose (0.5 ml) intramuscularly on unknown arm).   On 12-JUN-2023, the patient received the 2nd dose of Menveo (intramuscular, unknown arm) .5 ml. On 12-JUN-2023, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too long (Verbatim: Patient received a first dose of Menveo on 6-11-2020 and received second dose of Menveo on 6-12-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter did consent to follow up. The patient received 2nd dose of Menveo late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid component of Menveo; Administered only the liquid component of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 15-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva768a, expiry date 31-DEC-2023) for prophylaxis.   On 09-JUN-2023, the patient received Menveo. On 09-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administered only the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: Administered only the liquid component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter reported that the patient likely received only liquid component of Menveo due to there being an extra powder component. The reporter did consent to follow up via  The reporter gave by error Menveo liquid portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: mixed Shingrix reconstituted with unproved sterile diluent; mixed Shingrix reconstituted with unproved sterile diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 97LJ7, expiry date 06-AUG-2024) for prophylaxis.   On 12-JUN-2023, the patient received Shingrix. On 12-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: mixed Shingrix reconstituted with unproved sterile diluent) and inappropriate dose of vaccine administered (Verbatim: mixed Shingrix reconstituted with unproved sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter was administrative assistant. No patient details were available. The reporter consented to follow up. The reporter called in behalf of healthcare professional and stated that a medical assistant mixed Shingrix reconstituted with unproved sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 08-APR-2021 for covid-19 prophylaxis. The patient received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 005C21A expiry: UNKNOWN) dose was not reported, administered on 22-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2). The patient received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: 014B22A expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). No concomitant medications were reported. On an unspecified date in 2023, the patient experienced covid-19 infection (confirmed covid-19 infection) (Dose number in series 3) which led to confirmed clinical vaccination failure (Dose number in series 1) and received non-company treatment drug Paxlovid (nirmatrelvir/ritonavir) from 26-MAY-2023 to 31-MAY-2023 for covid-19 treatment. Original positive test on 26-MAY-2023 with negative testing (2023) following completion of Paxlovid. Patient experienced worsening of symptoms (had improved but never fully resolved) with new positive covid test on 09-JUN-2023.  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230629512-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Haemochromatosis, Neuropathy peripheral
Clinical narrative: her doctor reported to her that another female patient also had neuropathy in the feet; "hemochromatosis" 2 weeks after she received her 2nd moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 (her doctor reported to her that another female patient also had neuropathy in the feet) (seriousness criterion medically significant) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose). At the time of the report, NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose) outcome was unknown.            Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Neuropathy peripheral, and the unexpected and non-serious event of Hemochromatosis. Neuropathy peripheral occurred on an unknown date related to the second dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests, performed, clinical course or treatments received. Hemochromatosis could be a risk factor for Neuropathy peripheral. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant medication details provided. No treatment medication details provided.  The reporter stated that her doctor reported to her that another female patient also had neuropathy in the feet and hemochromatosis 2 weeks after she received her 2nd moderna dose as she stated that same thing happened to the other patient.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Upon internal review on 13-Jun-2023, significant correction was performed to upgrade the event neuropathy peripheral to serious medically significant. On 13-Dec-2021: Follow-up received on 13-Dec-2021 included no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema; urticarial rash; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Multiple sclerosis (stable multiple sclerosis, not on therapy).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant) and URTICARIA (urticarial rash). The patient was treated with DIPHENHYDRAMINE (oral) for Angioedema, at a dose of UNK, one time dose. At the time of the report, ANGIOEDEMA (Angioedema) and URTICARIA (urticarial rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Angioedema) and URTICARIA (urticarial rash) to be related.    Patient experienced an urticarial rash distributed on the trunk and upper and lower extremities, followed by angioedema of the lips and other soft tissues of the face within 48 hours of the first dose of her Moderna vaccine.  Treatment included  patient-initiated baking soda baths for  urticarial rash that persisted for 3 days and resolved  The patient did not have a known COVID-19 infection prior to vaccine administration. Additionally, she had no prior history of skin disease, no prior history of cutaneous reactions after other vaccines, nor known allergies to injectable medications.  The patient was advised against obtaining the second Moderna vaccine dose due to the risk of airway obstruction with fatal asphyxiation and/or systemic circulatory symptoms.  Company Comment - This literature non-study concerns a 68 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of angioedema and unexpected non serious event of urticaria. The events occurred within 48hrs after first dose of mRNA-1273 vaccine. As reported, the patient presented with angioedema of the lips and other soft tissues of the face within 48 hours of the first dose of mRNA-1273. The angioedema was short-lived, persisting for several hours before resolving with a patient-initiated one-time dose of oral diphenhydramine. The patient was advised against obtaining the second Moderna vaccine dose due to the risk of airway obstruction with fatal asphyxiation and/or systemic circulatory symptoms. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-491407, MOD-2022-491408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Upon internal review on 12-Jun-2023, significant correction was performed to upgrade the event Angioedema to serious medically significant.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got covid in december; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got covid in december) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19: Paxlovid (Last dose in the evening. Taken for 5 days Patient was again covid positive on 23-jul-2022, and this time symptoms were different congestion, cold like and tired.) from 17-Jul-2022 to 21-Jul-2022; for Product used for unknown indication: PRAVASTATIN (stopped taking and Tablet 20 mg for I believe 7 days once on meds.). Past adverse reactions to the above products included COVID-19 with Paxlovid; and No adverse event with PRAVASTATIN. Concurrent medical conditions included Asthma, Penicillin allergy and Allergy to antibiotic (erythrocin 500 mg tablets, erythrocin 500mg injection, 1 vial). Concomitant products included ALBUTEROL [SALBUTAMOL] and BECLOMETHASONE DIPROPIONATE for Asthma, OMEPRAZOLE, LORATADINE, VITAMIN D3 and ASCORBIC ACID, ROSA CANINA (VITAMIN C PLUS ROSE HIPS) for an unknown indication.    In November 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022, the patient experienced COVID-19 (got covid in december). On 21-Dec-2022, COVID-19 (got covid in december) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2022, SARS-CoV-2 test: Negative. On 23-Jul-2022, SARS-CoV-2 test: Positive. On 17-Dec-2022, SARS-CoV-2 test: Positive. On 21-Dec-2022, SARS-CoV-2 test: Negative. On an unknown date, SARS-CoV-2 test: Positive.         Patient had received two Moderna vaccines and two boosters, from which the last dose was taken at the end of November 2022. Patient was on trip in Dec-2022 and had again got Covid. Patient had not even realized it as she thought that it was just cold. Patient had cold symptoms, she walked touring about 40 miles and ate normally. Symptoms were started on Monday 12-Dec-2022. Patient was tested positive on 17-Dec-2022 and once tested negative on 21-Dec-2022, patient just felt very tired for a couple of weeks and mentioned that it was too late to take paxlovid. Patient took Losartan potassium 25 milligram beginning of 2023 and cranberry extract 500 milligram since May-2023 and was still taking.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Thrombosis
Clinical narrative: NVAF; Two weeks after getting third vaccine I developed blood clot in my leg; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (NVAF) and THROMBOSIS (Two weeks after getting third vaccine I developed blood clot in my leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic fatigue (She had chronic fatigue probably all her life and had to always sleep for 10-12 hours a day. This started to become a problem in 2020.). Concomitant products included APIXABAN (ELIQUIS) from 03-Jan-2021 to an unknown date for an unknown indication.   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. In 2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (Two weeks after getting third vaccine I developed blood clot in my leg) (seriousness criterion medically significant). On an unknown date, the patient experienced ATRIAL FIBRILLATION (NVAF) (seriousness criterion medically significant). The patient was treated with Surgery (Two different surgeries to remove blood clot) for Thrombosis. At the time of the report, ATRIAL FIBRILLATION (NVAF) and THROMBOSIS (Two weeks after getting third vaccine I developed blood clot in my leg) outcome was unknown.            Concomitant medication was not provided. Patient reported that, Eliquis was working great to her and she did not know what her life would be if she did not had it.  Company comment: This is a spontaneous case regarding a female patient of an unknown age in treatment with Apixaban for an unknown indication, who experienced unexpected and medically significant event of Thrombosis leg (AESI) 2 weeks after receiving third dose of mRNA-1273 vaccine. In addition, on an unknown date, patient experienced unexpected and medically significant event of atrial fibrillation (AESI). Treatment included two different surgeries to remove blood clot. At the time of the report, outcome was unknown.  No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Apixaban remains a confounding factor.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.