chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: not feeling well; her arm was sore; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: not feeling well) and pain in arm (Verbatim: her arm was sore). The outcome of the feeling unwell was resolved and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the feeling unwell and pain in arm to be related to Shingrix.     It was unknown if the company considered the feeling unwell and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2024 The doctor herself was the patient. The age of the patient was reported as approximately 60 years. She experienced not feeling well for a couple of days after receiving Shingrix and her arm was sore.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: it made her feel ill with things such as GI symptoms-diarrhea; This non-serious case was reported by a nurse via sales rep and described the occurrence of diarrhea in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diarrhea (Verbatim: it made her feel ill with things such as GI symptoms-diarrhea). Shingrix was discontinued. The outcome of the diarrhea was not reported.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     It was unknown if the company considered the diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-NOV-2024 The patient was a nurse, and she self-reported this case for herself. The patient was approximately 65 years old. The patient took 1st dose of Shingrix and said it made her felt ill with things such as GI (gastrointestinal) symptoms like diarrhea.  She said do not recall the length of time.  Further she said that she would not return to get dose 2 of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got 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.   Concurrent medical conditions included cancer (was going through cancer treatment).   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-NOV-2024 This case was reported by a patient via interactive digital media. Patient reported that he/she had a shingles shots and still got shingles when he/she was going through cancer treatment.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of SHINGRIX approximately four years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix approximately four years ago ).   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: first dose of SHINGRIX approximately four years ago ). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2024 Consumer stated that she had the first dose of Shingrix approximately four years ago missed dose. No further information was known such as consumer demographics, DOB, date of administration, site of administration.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pateint did not received 2nd dose yet/Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01-JAN-2018).   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: pateint did not received 2nd dose yet/Late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-NOV-2024 The reporter reported that the patient had received 1st dose of Shingrix vaccine but it was when it first came out in 2018, and the reporter asked what were the recommendations, if patient whether start over or to get the 2 shots. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The HCP (Healthcare professional) mentioned that he did not know where the patient received the 1st dose, he only mentioned that it was at a pharmacy, but not knowing the specific location. Also, HCP did not have the expiry date not lot number of the 1st dose.; Sender's Comments:  US-GSK-US2024004054:same reporter
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the Twinrix second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 04-APR-2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: never received the Twinrix second dose). 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: 06-NOV-2024 The pharmacist reported that a patient received first dose of Twinrix vaccine and never received 2nd dose of Twinrix vaccine. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose of Shingrix had not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14-OCT-2023).   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: 2nd dose of Shingrix had not been administered yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2024 The pharmacist called to inform about a patient that her first dose of Shingrix was over a year ago, 11 months ago. According to reporter, at the time of the reporting, the 2nd dose of Shingrix had not been administered yet, which led to an incomplete course of vaccination. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Two doses given at the appointment for the last dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 52F7M, expiry date 15-JUN-2026) for prophylaxis.   On 04-NOV-2024, the patient received the 2nd dose of Shingrix. On 04-NOV-2024, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: Two doses given at the appointment for the last dose). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2024 The patient received first dose of Shingrix on an unknown date. The reporter reported that administration of two doses on the same day as on 04-NOV-2024, both on the day the patient was only supposed to receive their last dose (2nd dose), which led to overdose. They provided data about the vaccine, patient and event and consented to receive follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Product distribution issue
Clinical narrative: those doses were unviable and one of our patients received one of those shots; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of poor quality vaccine administered in a male patient who received Herpes zoster (Shingrix) (batch number 99Y4J, expiry date 27-OCT-2026) for prophylaxis.   On 04-NOV-2024, the patient received Shingrix. On 04-NOV-2024, an unknown time after receiving Shingrix, the patient experienced poor quality vaccine administered (Verbatim: those doses were unviable and one of our patients received one of those shots). The outcome of the poor quality vaccine administered was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2024 The reporter informed that due to a couriers mistake, a box of doses of Shingrix was delivered 2 days after the date it should have.  According to courier, those doses were unviable and asked the reporter to not administer these doses. Reporter mentioned stated that one of our patients received one of those shots. Such dose was administered to the patient on 04 november 2024.
Sex: U
Vaccine: MMR
Symptoms: Labelled drug-drug interaction medication error
Clinical narrative: A patient came on March 20, 2024 to receive a dose of Varivax and then the patient came back on March 29, 2024 to receive a dose of Priorix (Drug interaction).; This non-serious case was reported by a nurse via call center representative and described the occurrence of labeled drug-drug interaction medication error in a patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis.   On 29-MAR-2024, the patient received Priorix. On 20-MAR-2024, the patient received Varivax. On 29-MAR-2024, an unknown time after receiving Priorix, the patient experienced labeled drug-drug interaction medication error (Verbatim: A patient came on March 20, 2024 to receive a dose of Varivax and then the patient came back on March 29, 2024 to receive a dose of Priorix (Drug interaction).). The outcome of the labeled drug-drug interaction medication error 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: 06-NOV-2024 The patient received Varivax and within one month received Priorix, which led labeled drug-drug interaction medication error. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: can patient return in 8 months for dose 2; This non-serious case was reported by a pharmacist via sales rep 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 of Shingrix on an unknown date).   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: can patient return in 8 months for dose 2). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2024  The pharmacist asked about dosing interval for 2nd dose. The pharmacist asked was there guidance on that.  The pharmacist reported that specifically can patient return in 8 months for dose 2. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received MMR (Priorix) (batch number 47A32, expiry date 01-NOV-2024) for prophylaxis.   On 07-NOV-2024, the patient received Priorix. On 07-NOV-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). 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: 07-NOV-2024 A nurse called to inform that they gave a dose of MMR that expired on the first. The dose was administered on 07th November 2024 and expired on 01st November 2024 which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: MENB
Symptoms: Syringe issue, Underdose
Clinical narrative: Administered underdose to 3 different patients; pre-filled syringes have a large bubble that cannot be expelled; 3 Pre-filled syringes were administered to patient with only 0.3-0.4 ml of medication.; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Men B NVS (Bexsero) (batch number B4J4B, expiry date 31-OCT-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: Administered underdose to 3 different patients), poor quality vaccine administered (Verbatim: pre-filled syringes have a large bubble that cannot be expelled) and pharmaceutical product complaint (Verbatim: 3 Pre-filled syringes were administered to patient with only 0.3-0.4 ml of medication.). The outcome of the accidental underdose, poor quality vaccine administered and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2024 The caller was the healthcare professional and was reporting a Bexsero PFS appearance issue. The 3 pre-filled syringes have a large bubble that cannot be expelled, however the Bexsero was administered which led to poor quality of vaccine administered. Administered underdose to 3 different patients. The reporter confirmed all preparation procedures were followed before the defect was discovered. Pre-filled syringes were administered to patient with only 0.3 to 0.4 milliliter of medication. The reporter asked at what step was this discovered. After administration, the reporter was transferred to medical information after this PQC was placed to see if MI may have any further information on this subject. A single, clear, large (approximately 0.1 ml) bubble that takes up the width of the syringe. The reporter asked what was different from other syringes, large bubble that was not dissipate or cannot be expelled.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Infanrix instead of a Tdap vaccine; 7 year-old male patient received Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 7-year-old male patient who received DTPa (Infanrix) (batch number 73SX2, expiry date 24-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 04-NOV-2024, the patient received Infanrix. On an unknown date, the patient did not receive Tdap Vaccine. On 04-NOV-2024, an unknown time after receiving Infanrix and not applicable after receiving Tdap Vaccine, the patient experienced wrong vaccine administered (Verbatim: Received Infanrix instead of a Tdap vaccine) and inappropriate age at vaccine administration (Verbatim: 7 year-old male patient received Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2024 The office manager reported that on 04th November 2024, a 7 year old patient received Infanrix instead of a Tdap vaccine for catch up which led to wrong vaccine used. This was patient third Dtap dose. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Extra dose administered
Clinical narrative: received an extra dose of Havrix; 5th dose of Infanrix in a wrong dosing schedule.; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received HAV (Havrix) (batch number 5JA57, expiry date 24-APR-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 5ST5M, expiry date 24-MAR-2026) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date), Havrix (received 2nd dose on 17-JUL-2024), Infanrix (received 3 doses on an unknown date) and Infanrix (received 4th dose on 17-JUL-2024).   On 07-NOV-2024, the patient received the 3rd dose of Havrix and the 5th dose of Infanrix. On 07-NOV-2024, an unknown time after receiving Havrix and not applicable after receiving Infanrix, the patient experienced extra dose administered (Verbatim: received an extra dose of Havrix) and inappropriate age at vaccine administration (Verbatim: 5th dose of Infanrix in a wrong dosing schedule.). The outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2024 The nurse reported that a patient already completed 2 doses series of Havrix vaccine and on the day of reporting received the extra dose of the Havrix, which led to extra dose administered. For Infanrix already received 4 doses , she was not really due to receive the 5th dose it until 4 years old, but it  was received at 2 years of age, which led to inappropriate age at vaccine administration. The reporter was ask what need do to be in compliance with this.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Product Storage Error / Medication error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 99Y4J, expiry date 27-OCT-2026) for prophylaxis.   On 08-NOV-2024, the patient received the 1st dose of Shingrix (injection, unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong technique in drug usage process (Verbatim: Product Storage Error / Medication error). The outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2024  The reporter was an healthcare professional. The healthcare professional reported on an adverse event for Shingrix vaccine. The healthcare professional reported that a Shingrix vaccine was mixed and prepared a day before day of reporting for a patient. The healthcare professional reported that after the vaccine had been mixed and labeled, the patient changed its mind and the vaccine was placed back in the refrigerator. The healthcare professional reported that the mixed vaccine was administered on the day of reporting to a 74-year-old female. This was the 1st dose of Shingrix vaccine for this new patient. The Shingrix should be discarded if reconstituted vaccine not used within 6 hours. It is unknown in which arm the vaccine was administered.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: also received another this year unknowingly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7P27X, expiry date 30-JUN-2025) for prophylaxis.   Previously administered products included Arexvy (received Arexvy in September 2023 with batch number HL594 and expiration date 19th October 2024).   On 07-NOV-2024, the patient received the 2nd dose of Arexvy. On 07-NOV-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: also received another this year unknowingly). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2024 The pharmacist had a patient who received the Arexvy vaccine last year and also received another this year unknowingly which led to extra dose administered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased activity, Pain in extremity
Clinical narrative: she couldn't get dressed by herself; pain in her hands; This spontaneous report received from a patient concerned a female patient in their 70's. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816022) dose and frequency not reported, administered on 11-May-2021, for covid-19 prophylaxis.  No concomitant medications were reported.  On an unspecified date, the patient experienced she couldn't get dressed by herself and pain in her hands. Consumer called stating she got a Janssen Covid vaccine about 3.5 years ago and stated "it is still affecting me but not as bad". Consumer requested to speak with someone in the compensation department. This agent provided the consumer with J&J mailing address and instructed her to send the request via mail on official letterhead. Consumer stated that the vaccine affected her really badly. Consumer stated that she couldn't get dressed by herself. Consumer stated that she had to start taking pain pills. She stated that the vaccine affected her hands and feet and that she had pain in her hands (covid dose series 1 ). Consumer stated that at first her doctor said the symptoms were not due to the Covid vaccine, but later he said they were. Consumer stated she had bad side effects for almost a year. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of she couldn't get dressed by herself and pain in her hands was not reported.  This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: I had long covid last year, like fatigue and brain fog; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I had long covid last year, like fatigue and brain fog) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient received third dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In 2023, the patient experienced POST-ACUTE COVID-19 SYNDROME (I had long covid last year, like fatigue and brain fog). In 2023, POST-ACUTE COVID-19 SYNDROME (I had long covid last year, like fatigue and brain fog) had resolved.            Concomitant medication was not reported. Patient was younger than 65 years old. Patient had long covid last year, like fatigue and brain fog. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: left shoulder is still hurting; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (left shoulder is still hurting) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (left shoulder is still hurting). At the time of the report, ARTHRALGIA (left shoulder is still hurting) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient received the COVID vaccine shot, and his left shoulder was still hurting.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Nov-2024: Live follow up received is significant. Case was upgraded from invalid to valid. Suspect product was updated and reference numbers were added.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue
Clinical narrative: patient states he experienced fatigue shortly after a recent flu vaccination; Initial information received on 03-Dec-2024 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 82 years old male patient who experienced fatigue shortly after a recent flu vaccination with influenza vaccine.  The patient's past medical history included COVID-19. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.   On an unknown date, the patient experienced fatigue shortly after a recent flu vaccination (fatigue) (unknown latency) influenza vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Erythema, Induration, Neck pain, Pain
Clinical narrative: intense pain that radiates from the elbow into their neck as well as large; localized reactions with large induration and redness; localized reactions with large induration and redness; Initial information received on 27-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA359501 and US-SA-2024SA359516.             This case involves an unknown age male patient who experienced intense pain that radiates from the elbow into their neck as well as large, localized reactions with large induration and redness after receiving vaccine INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2024, the patient received Influenza Trivalent Recombinant Vaccine Solution for injection dose 0.5 ml 1x(once) via unknown route in unknown administration site for Immunization (strength, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  In 2024 the patient developed a non-serious intense pain that radiates from the elbow into their neck as well as large (pain),  localized reactions with large induration and redness (vaccination site induration) (vaccination site erythema) (latency unknown).  Reportedly: 2 people wound up with swollen lymph nodes and one had moderate swelling in his armpit  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for all the events; Sender's Comments:  US-SA-2024SA359501: US-SA-2024SA359516:
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Erythema, Induration, Lymphadenopathy, Neck pain
Clinical narrative: swollen lymph nodes; intense pain that radiates from the elbow into their neck; large, localized reactions with large induration and redness; large, localized reactions with large induration and redness; Initial information received on 27-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA359501 and US-SA-2024SA353552                        This case involves an unknown age female patient who had swollen lymph nodes, intense pain that radiates from the elbow into their neck, large, localized reactions with large induration and redness after receiving Influenza Trivalent Recombinant Vaccine [FlublokTIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2024, the patient received Influenza Trivalent Recombinant Vaccine Solution for injection dose 0.5 ml 1x(once) via unknown route in unknown administration site for Immunization (strength, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date in 2024 the patient had swollen lymph nodes (lymphadenopathy), intense pain that radiates from the elbow into their neck (pain), large, localized reactions with large induration and redness (vaccination site induration) (vaccination site erythema) (unknown latency).  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for all the events; Sender's Comments:  US-SA-2024SA353552: US-SA-2024SA359501:
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: swollen lymph nodes; intense pain that radiates from the elbow into their neck; large, localized reactions with large induration and redness; large, localized reactions with large induration and redness; Initial information received on 27-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA359501 and US-SA-2024SA353552                        This case involves an unknown age female patient who had swollen lymph nodes, intense pain that radiates from the elbow into their neck, large, localized reactions with large induration and redness after receiving Influenza Trivalent Recombinant Vaccine [FlublokTIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2024, the patient received Influenza Trivalent Recombinant Vaccine Solution for injection dose 0.5 ml 1x(once) via unknown route in unknown administration site for Immunization (strength, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date in 2024 the patient had swollen lymph nodes (lymphadenopathy), intense pain that radiates from the elbow into their neck (pain), large, localized reactions with large induration and redness (vaccination site induration) (vaccination site erythema) (unknown latency).  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for all the events; Sender's Comments:  US-SA-2024SA353552: US-SA-2024SA359501:
Sex: U
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: 8 or 9 year old who had been fully vaccinated developed chickenpox approximately 2 weeks ago; This spontaneous report was received from a physician via company representative and refers to a child patient (reported as between 8 or 9 year) of unknown gender.   The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date in 2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection administered as prophylaxis (strength, dose, frequency, patient route of administration, anatomical location, lot number and expiration date were not provided).  On an unknown day in November 2024, after the patient was fully vaccinated, developed chickenpox approximately 2 weeks ago (varicella post vaccine). It was unknown by the reporter if the patient sought medical attention, if any treatment was administered, or if any diagnostic or study procedures were performed. The outcome was not provided.   Causality assessment between the event and suspect vaccine was not provided.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP called to state that the patient was inadvertently administered PROQUAD and VARIVAX in the same day. The HCP confirms no symptomatic AE and states that they checked on the patient and they are "fine". The DILUENT used to reconstitute the vaccines; This spontaneous report was received from a other health professional and refers to a 12-months-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.  On 03-DEC-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection 0.5ml/series (lot# x021282 is a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX); expiration date was reported and validated as 20-AUG-2025) administered for prophylaxis (strength, lot #, expiry date, anatomical location and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection 0.5ml/dose (lot # x021129 is a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD); expiration date was reported and validated as 12-FEB-2025) administered for prophylaxis (strength, lot #, expiry date, anatomical location and route of administration were not provided). Both were reconstituted with  sterile diluent (BAXTER STERILE DILUENT) Solution for injection/infusion (lot # 1946080 is a valid lot number for sterile diluent (BAXTER STERILE DILUENT); expiration date was reported and validated as 01-DEC-2025; strength, indication, dose, frequency, route of administration, lot number and expiration date were not reported). No additional adverse event.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects or symptoms reported; HCP called to report TE where PNEUMOVAX 23 was administered to one patient; This spontaneous report has been received from a consumer referring a 64-year-old female patient.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 03-DEC-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, at a dose of 0.5 milliliter (mL), administered for prophylaxis (strength, route and anatomical location of administration were not provided; lot # reported as x027348, which has been determined to be a valid lot # for this vaccine, expiration date provided and validated to be on 24-JAN-2026). It was reported that this vaccine experienced a temperature excursion (TE) and then was administered to one patient (product storage error). The temperatures reported were: 47.4f (prior) during a timeframe of 1 hour 0 minutes 0 seconds; 47.9f (prior) during a timeframe of 1 hour 50 minutes 0 seconds; and 47.4f (current) during a timeframe of 1 hour 0 minutes 0 seconds. No side effects or symptoms reported (no adverse event). No Additional information provided. No Additional adverse event (AE)/ No product quality complaint (PQC).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rashes on my body, thighs, groin, back.; This is a spontaneous report received from a Pharmacist.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 at 12:00 as dose 2, single (Lot number: EW0151) at the age of 47 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 31May2021, outcome "not recovered", described as "red rashes on my body, thighs, groin, back." Therapeutic measures were taken as a result of rash erythematous.  Additional information: Patient had no drug allergy. Patient did not receive any other vaccines on the same date as/ within 4 weeks prior to the vaccine. Patient received betamethasone lotion and predinisone tablets for the adverse event.
Sex: U
Vaccine: COVID19
Symptoms: Embolism venous
Clinical narrative: an increase in VTE post-Covid vaccination; This is a spontaneous report received from a Physician from a sales representative.  An elderly patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EMBOLISM VENOUS (hospitalization, medically significant), outcome "unknown", described as "an increase in VTE post-Covid vaccination". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event embolism venous and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: took a self-test and was tested Covid 19; took a self-test and was tested Covid 19; This is a spontaneous report received from a consumer, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose number unknown, single (lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "took a self-test and was tested Covid 19". The patient took a self-test and was tested Covid 19. She said that she was up to date for her booster shot and she had a history of being immunocompromised. She wanted to get Paxlovid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) positive, notes: took a self-test and was tested Covid 19.  Batch/lot number is not provided, and it cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: there was no adverse effect, by mistake we gave expired vaccine  exp 10/24, already talked to the manufacture, they told the only thing that the patient needs to do is that she can gat another covid vaccine since maybe it is not effective, and talked to the patient, she told that I will get another one.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient got Arexvy vaccine in 2023 and 2024
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient got vaccine in 2023 and 2024
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever (38C) for about a day, chills for a few hours, headache and muscle aches for about two days.  All of these resolved
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Blood glucose decreased, Condition aggravated, Diabetes mellitus, Headache
Clinical narrative: I am a stable and well controlled type 1 diabetic. I work in healthcare and have received the flu vaccine every year and have never had any issues. However, about 30 minutes after receiving this dose of the flu vaccine this year I noticed my blood sugar started to drop (I wear a continuous glucose monitor so I always know what my blood sugar is). I didn't think anything about it at the time but proceeded to use my hypoglycemia protocol to fix the problem because I was scheduled to work that night. But what I was noticing was that no matter how much I was intaking to correct the low blood sugar, it continued to drop. I had not taken any insulin that day so that was not part of the problem.  While at work all night my monitor kept alerting me that my blood sugar was LOW which is critical and below 40. I even checked my blood sugar with a finger stick glucometer to make sure my was accurate and it was. I was still continuing to treat this because having a blood sugar that low can lead to coma or death. During this whole time I was experiencing hypoglycemic symptoms of shaking, sweating, severe headaches, anxiety, irritability, and tingling in my mouth.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Irritability, Paraesthesia oral, Tremor
Clinical narrative: I am a stable and well controlled type 1 diabetic. I work in healthcare and have received the flu vaccine every year and have never had any issues. However, about 30 minutes after receiving this dose of the flu vaccine this year I noticed my blood sugar started to drop (I wear a continuous glucose monitor so I always know what my blood sugar is). I didn't think anything about it at the time but proceeded to use my hypoglycemia protocol to fix the problem because I was scheduled to work that night. But what I was noticing was that no matter how much I was intaking to correct the low blood sugar, it continued to drop. I had not taken any insulin that day so that was not part of the problem.  While at work all night my monitor kept alerting me that my blood sugar was LOW which is critical and below 40. I even checked my blood sugar with a finger stick glucometer to make sure my was accurate and it was. I was still continuing to treat this because having a blood sugar that low can lead to coma or death. During this whole time I was experiencing hypoglycemic symptoms of shaking, sweating, severe headaches, anxiety, irritability, and tingling in my mouth.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Blood pressure increased, Incoherent, Pain, Pyrexia, Seizure
Clinical narrative: According to patient's spouse, the morning of 12/3 patient was feverish (102.4), achy, incoherent and had elevated blood pressure (158/110). He called EMS and she was transported to hospital. The morning of 12/4 patient had a seizure at hospital and is still hospitalized.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: PATIENT SAID HE STARTED EXPERIENCING BACK AND SOME CHEST MUSCLE SPASMS AFTER FLU SHOT, NO SHORTNESS OF BREATH REPORTED
Age: 62.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: Pt received the RSV vaccine on 12/3/24 -- but has also received it on 09/17/23
Age: 62.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Pt received the RSV vaccine on 12/3/24 -- but has also received it on 09/17/23
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Anxiety, Malaise, Palpitations
Clinical narrative: after receiving vaccinations, patient returned to work and within the hour felt very anxious, palpitations, not feeling well at all.
Age: 31.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was recommended Typhim vaccine and instead received polio. Spoke to patient and they were not experiencing and side effects, no harm to patient. Patient will return for Typhim vaccine next business day.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Extrasystoles
Clinical narrative: Lightheadedness & heart palpitations, no treatment, still occurring
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Supraventricular extrasystoles, Ultrasound Doppler normal
Clinical narrative: Lightheadedness & heart palpitations, no treatment, still occurring
Age: 26.0
Sex: M
Vaccine: ANTH, MMR, MNQ, UNK
Symptoms: Chronic gastritis, Gastrooesophageal reflux disease
Clinical narrative: Sudden onset GERD with no previous history or risk factor. I thought I was drowning at night before I started sleeping sitting up, still unresolved 8 years on, now have chronic gastritis.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain
Clinical narrative: PATIENT HAD T-dap VACCINE ON FRIDAY 11/29/2024 EVENING ; SHE DID NOT EXPERIENCE SORENESS AT TIME OF INJECTION BUT LATER FELT SORENESS UNTIL REPORTING DATE 12/6/2024. SHE ALSO REPORTED INJECTION SITE AND SURROUNDING AREA IS HARDEN. PATIENT STATE SHE DID NOT TAKE ANY MEDICATION FOR SORENESS EXCEPT USING HEATING PAD. RECOMMENDED PATIENT TO SEEK MEDICAL HELP FOR THIS ADVERSE REACTION.