chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Injection site discolouration, Injection site rash, Injection site reaction
Clinical narrative: itchy area on left deltoid where she received her vaccine; redness on left deltoid where she received her vaccine; Swelling on left deltoid where she received her vaccine; very hard area on her left deltoid where she received her vaccine; hot to touch on left deltoid where she received her vaccine; left arm is still more purple in color; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchy area on left deltoid where she received her vaccine), injection site erythema (Verbatim: redness on left deltoid where she received her vaccine), injection site swelling (Verbatim: Swelling on left deltoid where she received her vaccine), injection site induration (Verbatim: very hard area on her left deltoid where she received her vaccine), injection site warmth (Verbatim: hot to touch on left deltoid where she received her vaccine) and injection site discoloration (Verbatim: left arm is still more purple in color). The outcome of the injection site itching, injection site erythema, injection site swelling and injection site discoloration were not resolved and the outcome of the injection site induration was not reported and the outcome of the injection site warmth was resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The patient is the reporter. The reporter stated that 3 days after receiving her first Shingrix vaccine she had swelling, redness, hot to touch, very hard and itchy area on her left deltoid where she received her vaccine. The patient did not have the batch lot number. Her left arm was still very itchy and more purple in color. However, heat was resolved, and the swelling had gone tremendously. Patient did have an appointment with her healthcare professional in the week of reporting. The patient asked about getting the 2nd Shingrix Vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth, Pain, Pruritus, Rash macular, Skin warm
Clinical narrative: itchy area on left deltoid where she received her vaccine; redness on left deltoid where she received her vaccine; Swelling on left deltoid where she received her vaccine; very hard area on her left deltoid where she received her vaccine; hot to touch on left deltoid where she received her vaccine; left arm is still more purple in color; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchy area on left deltoid where she received her vaccine), injection site erythema (Verbatim: redness on left deltoid where she received her vaccine), injection site swelling (Verbatim: Swelling on left deltoid where she received her vaccine), injection site induration (Verbatim: very hard area on her left deltoid where she received her vaccine), injection site warmth (Verbatim: hot to touch on left deltoid where she received her vaccine) and injection site discoloration (Verbatim: left arm is still more purple in color). The outcome of the injection site itching, injection site erythema, injection site swelling and injection site discoloration were not resolved and the outcome of the injection site induration was not reported and the outcome of the injection site warmth was resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The patient is the reporter. The reporter stated that 3 days after receiving her first Shingrix vaccine she had swelling, redness, hot to touch, very hard and itchy area on her left deltoid where she received her vaccine. The patient did not have the batch lot number. Her left arm was still very itchy and more purple in color. However, heat was resolved, and the swelling had gone tremendously. Patient did have an appointment with her healthcare professional in the week of reporting. The patient asked about getting the 2nd Shingrix Vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: itchy area on left deltoid where she received her vaccine; redness on left deltoid where she received her vaccine; Swelling on left deltoid where she received her vaccine; very hard area on her left deltoid where she received her vaccine; hot to touch on left deltoid where she received her vaccine; left arm is still more purple in color; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchy area on left deltoid where she received her vaccine), injection site erythema (Verbatim: redness on left deltoid where she received her vaccine), injection site swelling (Verbatim: Swelling on left deltoid where she received her vaccine), injection site induration (Verbatim: very hard area on her left deltoid where she received her vaccine), injection site warmth (Verbatim: hot to touch on left deltoid where she received her vaccine) and injection site discoloration (Verbatim: left arm is still more purple in color). The outcome of the injection site itching, injection site erythema, injection site swelling and injection site discoloration were not resolved and the outcome of the injection site induration was not reported and the outcome of the injection site warmth was resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The patient is the reporter. The reporter stated that 3 days after receiving her first Shingrix vaccine she had swelling, redness, hot to touch, very hard and itchy area on her left deltoid where she received her vaccine. The patient did not have the batch lot number. Her left arm was still very itchy and more purple in color. However, heat was resolved, and the swelling had gone tremendously. Patient did have an appointment with her healthcare professional in the week of reporting. The patient asked about getting the 2nd Shingrix Vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: itchy area on left deltoid where she received her vaccine; redness on left deltoid where she received her vaccine; Swelling on left deltoid where she received her vaccine; very hard area on her left deltoid where she received her vaccine; hot to touch on left deltoid where she received her vaccine; left arm is still more purple in color; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchy area on left deltoid where she received her vaccine), injection site erythema (Verbatim: redness on left deltoid where she received her vaccine), injection site swelling (Verbatim: Swelling on left deltoid where she received her vaccine), injection site induration (Verbatim: very hard area on her left deltoid where she received her vaccine), injection site warmth (Verbatim: hot to touch on left deltoid where she received her vaccine) and injection site discoloration (Verbatim: left arm is still more purple in color). The outcome of the injection site itching, injection site erythema, injection site swelling and injection site discoloration were not resolved and the outcome of the injection site induration was not reported and the outcome of the injection site warmth was resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The patient is the reporter. The reporter stated that 3 days after receiving her first Shingrix vaccine she had swelling, redness, hot to touch, very hard and itchy area on her left deltoid where she received her vaccine. The patient did not have the batch lot number. Her left arm was still very itchy and more purple in color. However, heat was resolved, and the swelling had gone tremendously. Patient did have an appointment with her healthcare professional in the week of reporting. The patient asked about getting the 2nd Shingrix Vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: itchy area on left deltoid where she received her vaccine; redness on left deltoid where she received her vaccine; Swelling on left deltoid where she received her vaccine; very hard area on her left deltoid where she received her vaccine; hot to touch on left deltoid where she received her vaccine; left arm is still more purple in color; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchy area on left deltoid where she received her vaccine), injection site erythema (Verbatim: redness on left deltoid where she received her vaccine), injection site swelling (Verbatim: Swelling on left deltoid where she received her vaccine), injection site induration (Verbatim: very hard area on her left deltoid where she received her vaccine), injection site warmth (Verbatim: hot to touch on left deltoid where she received her vaccine) and injection site discoloration (Verbatim: left arm is still more purple in color). The outcome of the injection site itching, injection site erythema, injection site swelling and injection site discoloration were not resolved and the outcome of the injection site induration was not reported and the outcome of the injection site warmth was resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The patient is the reporter. The reporter stated that 3 days after receiving her first Shingrix vaccine she had swelling, redness, hot to touch, very hard and itchy area on her left deltoid where she received her vaccine. The patient did not have the batch lot number. Her left arm was still very itchy and more purple in color. However, heat was resolved, and the swelling had gone tremendously. Patient did have an appointment with her healthcare professional in the week of reporting. The patient asked about getting the 2nd Shingrix Vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: itchy area on left deltoid where she received her vaccine; redness on left deltoid where she received her vaccine; Swelling on left deltoid where she received her vaccine; very hard area on her left deltoid where she received her vaccine; hot to touch on left deltoid where she received her vaccine; left arm is still more purple in color; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchy area on left deltoid where she received her vaccine), injection site erythema (Verbatim: redness on left deltoid where she received her vaccine), injection site swelling (Verbatim: Swelling on left deltoid where she received her vaccine), injection site induration (Verbatim: very hard area on her left deltoid where she received her vaccine), injection site warmth (Verbatim: hot to touch on left deltoid where she received her vaccine) and injection site discoloration (Verbatim: left arm is still more purple in color). The outcome of the injection site itching, injection site erythema, injection site swelling and injection site discoloration were not resolved and the outcome of the injection site induration was not reported and the outcome of the injection site warmth was resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The patient is the reporter. The reporter stated that 3 days after receiving her first Shingrix vaccine she had swelling, redness, hot to touch, very hard and itchy area on her left deltoid where she received her vaccine. The patient did not have the batch lot number. Her left arm was still very itchy and more purple in color. However, heat was resolved, and the swelling had gone tremendously. Patient did have an appointment with her healthcare professional in the week of reporting. The patient asked about getting the 2nd Shingrix Vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: itchy area on left deltoid where she received her vaccine; redness on left deltoid where she received her vaccine; Swelling on left deltoid where she received her vaccine; very hard area on her left deltoid where she received her vaccine; hot to touch on left deltoid where she received her vaccine; left arm is still more purple in color; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 3 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: itchy area on left deltoid where she received her vaccine), injection site erythema (Verbatim: redness on left deltoid where she received her vaccine), injection site swelling (Verbatim: Swelling on left deltoid where she received her vaccine), injection site induration (Verbatim: very hard area on her left deltoid where she received her vaccine), injection site warmth (Verbatim: hot to touch on left deltoid where she received her vaccine) and injection site discoloration (Verbatim: left arm is still more purple in color). The outcome of the injection site itching, injection site erythema, injection site swelling and injection site discoloration were not resolved and the outcome of the injection site induration was not reported and the outcome of the injection site warmth was resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site erythema, injection site swelling, injection site induration, injection site warmth and injection site discoloration to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The patient is the reporter. The reporter stated that 3 days after receiving her first Shingrix vaccine she had swelling, redness, hot to touch, very hard and itchy area on her left deltoid where she received her vaccine. The patient did not have the batch lot number. Her left arm was still very itchy and more purple in color. However, heat was resolved, and the swelling had gone tremendously. Patient did have an appointment with her healthcare professional in the week of reporting. The patient asked about getting the 2nd Shingrix Vaccine. The reporter consented to follow up.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient does not report signs/symptoms of adverse effects; Product experienced a temperature excursion and was administered; Spontaneous information has been received from a physician via a medical assistance regarding a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.   On 05-JUN-2023, Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) experienced a temperature excursion, and on an unknown date in June 2023, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (exact dose, route not reported) as prophylaxis (valid lot # W027449, with expiration date reported on 25-SEP-2024) before they were aware of the temperature excursion. The patient did not report any sign or symptom of adverse effect.; Sender's Comments:  US-009507513-2306USA003878:
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Inbound call from nurse calling to report administration of ROTATEQ to a child that is 9 months old.  HCP declined to provide full patient demographics.  Confirmed that no symptomatic adverse events were reported.  Caller stated that the administered; This spontaneous report was received from a nurse refers to a 9-month-old patient of unknown gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral, lot number 1968386, expiration date 23-MAY-2024, 2 milliliter, for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Interchange of vaccine products, No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 26-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number w029552, expiration date 14-MAR-2024 (dose and route of administration not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (interchange of vaccine products). Additionally, the vaccine underwent a temperature excursion of 8 degrees Celsius for 2280 hours (product storage error). No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP called regarding alternate dosage schedule GARDASIL 9 for adult patient who received the first two dose of the series on the following dates: dose #1: 8/29/22 and  dose #2: 12/10/2022.   No additional AE/PQC.; This spontaneous report was received from a pharmacist referring to an adult patient of unknown gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 29-AUG-2022, 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) (dose, route of administration, lot number and expiration date not reported) for prophylaxis and on 10-DEC-2022,  was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) (inappropriate schedule of product administration). No adverse event was reported.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; calling to report administration of an expired dose of MMR II to a patient. confirmed this was the first dose for the patient and no symptoms reported.  No other AE and no PQC.; This spontaneous report was received from a medical assistant referring to a 3-year-old patient of unknown gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 28-JUN-2023, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number U019290, expiration date 18-JUN-2023 (dose and route of administration not provided) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: The PROQUAD also suffered from a non supported temperature excursion; No Additional AE/PQC reported; HCP called to report that the patient was given PROQUAD instead of MMR II.; This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 27-JUN-2023, a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection that had suffered from a non-supported temperature excursion (product storage error) was administered to the patient for prophylaxis  instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (wrong product administered). (lot number w029552 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date has been established as 14-MAR-2024). No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Per, a female pregnant patient at 29 weeks of pregnancy was inadvertently administered GARDASIL-9 instead of TDAP.; Per, a female pregnant patient at 29 weeks of pregnancy was inadvertently administered GARDASIL-9 instead of TDAP.; No additional AE; This spontaneous report was received from an office manager and refers to a pregnant female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, anatomical location, and route of administration were not provided) instead of diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (Wrong product administered). At this time, she was at 29 weeks of pregnancy (Exposure during pregnancy). She sought medical attention. No additional information or adverse event was reported (No adverse event).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of menactra was inadvertently administered with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old male patient to whom an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Jul-2023, the patient received 0.5 mL expired dose 1 of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (batch number: U7190AA; Expiry date: 16-Jan-2023) via intramuscular route in the left arm for immunization, inadvertently with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event an expired dose of menactra was inadvertently administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Insomnia, Tinnitus
Clinical narrative: Tinnitus, High Pitched and Loud, Full time since two weeks after Vaccination; increased insomnia due to tinnitus.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: Tinnitus, high pitch constant tone primary in left ear at onset. Symptoms have progressed to both ears.
Sex: U
Vaccine: VARZOS
Symptoms: Blood phosphorus increased, Renal disorder
Clinical narrative: phosphorus is high; Something to do with kidney; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blood phosphorus increased 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 blood phosphorus increased (Verbatim: phosphorus is high) and renal disorder (Verbatim: Something to do with kidney). The outcome of the blood phosphorus increased and renal disorder were not reported.   The reporter considered the blood phosphorus increased and renal disorder to be possibly related to Shingles vaccine.     The company considered the blood phosphorus increased and renal disorder to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had no pain and got shingles shot. The patient thought that it had something to do with his/her kidney or his/her phosphorus is high. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the adjuvant only that was not reconstituted with the antigen; received the adjuvant only that was not reconstituted with the antigen; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 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 inappropriate dose of vaccine administered (Verbatim: received the adjuvant only that was not reconstituted with the antigen) and inappropriate preparation of medication (Verbatim: received the adjuvant only that was not reconstituted with the antigen). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 29 Jun 2023 The nurse reported that they had 2 vials of antigen left in a box of Shingrix so they believed that most likely 2 patients were given The adjuvant only that was not reconstituted with the antigen.  The reporter consented to follow up. The patient only received adjuvant that was not reconstituted with the antigen which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This case has been linked with case US2023AMR091993 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR091993:Same reporter, different patient
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Began soreness in left shoulder down to elbow. Daily, got worse as the day went on. Weeks, months, went to my doctor on April 26th because pain would not go away. She gave me a steroid shot and it was better for 4 weeks, then started to get pain back. Lifting difficult with (L) arm.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Confusional state, Encephalopathy, Tachycardia
Clinical narrative: Reported Symptoms: Confusion; Encephalopathy; Tachycardia; Narrative: Patient received three doses of Pfizer and one dose of Moderna COVID 19 vaccine. The patient presented to the ED on 6 November 2022 with confusion and tachycardia. The patient was admitted with COVID 19. The patient was treated with diltiazem. The patient was discharged on 16 November 2022 in stable condition. Reported per EUA. Other Relevant Hx: Other: covid encephalopathy
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B Vaccine (09-AUG-2002, 10-JAN-2003, 11-APR-2003); Hepatitis B Vaccine (09-AUG-2002, 10-JAN-2003, 11-APR-2003); This spontaneous report has been received from a health care professional via medical records from a case in litigation for 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) (MARRS# 2207USA008600), concerning to a 5-month-old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 09-AUG-2002, 10-JAN-2003 and 11-APR-2003, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown), respectively, all for prophylaxis (inappropriate schedule of product administration). The dose, strength, route, lot number and expiration date were unknown.   This is one of three cases concerning the same patient.; Sender's Comments:  US-009507513-2207USA008600: US-009507513-2305USA008516:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; an adult patient was administered PROQUAD; This spontaneous report was received from licensed practical nurse (LPN) and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 mls/once, lot #X004372 (lot # X004372 has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date: 07-AUG-2024 (anatomical location, route of administration, and indication were not provided). It was reported that an adult patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Product administered to patient of inappropriate age). There were no adverse events reported (no adverse event).
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Neuropathy peripheral, Symptom recurrence
Clinical narrative: NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Drug screen, Full blood count, Human chorionic gonadotropin, Injection site urticaria, Lip swelling
Clinical narrative: developed hive at injection sit 6/29 and then uritcaria over whole body with facial and lip swelling seen in ER 7/1
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Metabolic function test, Swelling face, Urticaria
Clinical narrative: developed hive at injection sit 6/29 and then uritcaria over whole body with facial and lip swelling seen in ER 7/1
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in the arm severe enough he cannot lift it. Recommended icing it periodically and taking 600-800mg of ibuprofen as needed.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Angioplasty, Breast mass, Magnetic resonance imaging, Myocardial infarction
Clinical narrative: Heart attack, parkinson's symptoms,lung nodules,throat tumor,breast masses bilateral
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom, Pharyngeal neoplasm, Pulmonary mass
Clinical narrative: Heart attack, parkinson's symptoms,lung nodules,throat tumor,breast masses bilateral
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: nausea, fatigue, headache
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient presents with complaints of feeling lethargic, and with low energy after getting the Bexsero vaccine on 07/03/2023.  Within hours she developed pain and redness at the site of the injection.  Cool compresses were applies.  She does take Xyzal nightly.  Ibuprofen was taken for a headache that developed.  She does have a history of Migraines and Imitrex was given even though she didn't feel it was consistent with her typical migraine.  The Imitrex wasn't effective.  She proceeded with alternating Tylenol and Ibuprofen.   The headache has improved.  She take Benadryl which didn't change the erythema, in fact it's now migrating to the axilla.  A fever developed today.  Tmax was 102 degrees F.      She did not have a reaction or similar symptoms after getting Bexsero #1 on 06/24/2022.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Lethargy, Pyrexia
Clinical narrative: Patient presents with complaints of feeling lethargic, and with low energy after getting the Bexsero vaccine on 07/03/2023.  Within hours she developed pain and redness at the site of the injection.  Cool compresses were applies.  She does take Xyzal nightly.  Ibuprofen was taken for a headache that developed.  She does have a history of Migraines and Imitrex was given even though she didn't feel it was consistent with her typical migraine.  The Imitrex wasn't effective.  She proceeded with alternating Tylenol and Ibuprofen.   The headache has improved.  She take Benadryl which didn't change the erythema, in fact it's now migrating to the axilla.  A fever developed today.  Tmax was 102 degrees F.      She did not have a reaction or similar symptoms after getting Bexsero #1 on 06/24/2022.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received the incorrect formulation of the COVID 19 Moderna Bivalent Vaccine. Patient received the 10ug concentration for infants 6mo to 5 years. No symptoms reported.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Diarrhoea, Infant irritability, Vomiting, Vomiting projectile
Clinical narrative: Vomiting after every feed since vaccines were given. Emesis is NBNB but is projectile at times and is usually at least 1/4 to 1/2 of her feed. Also having loose, watery stools. Fussy. No fevers.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Death, Dyspnoea, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: Presented to the ER with a chief complaint of progressively worsening shortness of breath that acutely worsened 4 days prior to admission as well a cough; pt required ventilator; poor diagnosis d/t worsening FiO2 and development of renal failure resulted in family electing for comfort measures and pt expired 1/19.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: Presented to the ER with a chief complaint of progressively worsening shortness of breath that acutely worsened 4 days prior to admission as well a cough; pt required ventilator; poor diagnosis d/t worsening FiO2 and development of renal failure resulted in family electing for comfort measures and pt expired 1/19.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Diabetic ketoacidosis, SARS-CoV-2 test positive
Clinical narrative: Admitted with DKA, resolved now, also tested positive for COVID-19; had acute respiratory failure with hypoxia and required high-flow oxygen, steroids and abx; received Actemra on 01/19; DC home on RA.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea
Clinical narrative: Presented to the emergency room with complaints of shortness of breath; dx w/ pneumonia due to COVID 19 virus; tx w/02, zinc, steroids, abx; Home w/O2
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea
Clinical narrative: Presented to ED w/SOB; adnitted for COVID-19 pna; tx w/abx, steroids, O2, remdesivir, zinc, Vit-C; weaned to RA, dc'd home
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Malaise
Clinical narrative: Presented to ED w/COVID-like symptoms; admitted for COVID-pna; tx w/ abx, Vit-C, zinc, Singulair, bronchodilators; did not need O2 therapy; discharged home w/ HHC.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: Presented to ED w/SOB; admitted for COPD acute exacerbatin and COVID-19; tx with O2, steroids, DuoNeb, Brovana, Pulmicort Respules, mucolytic and antitussives; all symptoms resolved and pt returned to baseline 3L O2 for home
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Encephalopathy, Mental status changes
Clinical narrative: Presented to ED w/AMS, admitted for encephalopathy d/t COVID-19; tx w/O2 therapy; discharged on home O2
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Appx 10-12 hours after vaccine, developed redness, warmth, and swelling in the left thigh around site of injection. Fever the next day 101F.  Redness spread the following day to about 7 cm x 5 cm and persisted to today.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/ cough; +COVID home test; admitted for COVID-19; tx w/abx, steroids, remdesivir; did not require O2; symptoms resolved and dc'd home
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest pain, Cough, Dyspnoea, Oropharyngeal pain
Clinical narrative: Presented to ED w/cp and persistent cough, sore throat & SOB; admitted for COVID-19 pna; tx w/ abx, remdesivir, steroids, pepcid, Singulair, zinc; pt did not require O2 therapy; symptoms resolved & pt dc'd home
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site pain, Joint lock, Lymphadenopathy, Pain
Clinical narrative: patient with severe pain at injection site, shoulder pain, enlarged lymph nodes, locked shoulder; pain with rotation, abduction and adduction
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Brain injury, COVID-19, COVID-19 pneumonia, Cerebral ischaemia
Clinical narrative: Presented to ED for worsening SOB, COVID+ x 2 wks; admitted for COVID-19 pna and acute resp failure; tx w/O2, abx, steroids, zinc, Vit-C; pt developed hypoxic ischemic brain injury; he maintained his saturations off ventilatory support with no improvement in his mental status and was discharged to hospice
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Presented to ED for worsening SOB, COVID+ x 2 wks; admitted for COVID-19 pna and acute resp failure; tx w/O2, abx, steroids, zinc, Vit-C; pt developed hypoxic ischemic brain injury; he maintained his saturations off ventilatory support with no improvement in his mental status and was discharged to hospice
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Dyspnoea, Pyrexia
Clinical narrative: Presented w/ cough, SOB, & fever x 3 days; admitted for COVID-19 pna, tx w/ abx, remdesivir, steroids, & zinc; did not need O2 therapy; dc to home
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cerebrovascular accident, Gastrostomy, Neurological symptom
Clinical narrative: Presented to ED w/ stroke-like symptoms dx w/sub acute CVA; tested positive for COVID-19 pna; admitted for COVID-19 pna w/ acute hypoxemic resp failure; tx w/abx, remdesivir, steroids, pepcid, zinc; prolonged hospital stay requiring trach and peg; tx to a HCF
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Tracheostomy
Clinical narrative: Presented to ED w/ stroke-like symptoms dx w/sub acute CVA; tested positive for COVID-19 pna; admitted for COVID-19 pna w/ acute hypoxemic resp failure; tx w/abx, remdesivir, steroids, pepcid, zinc; prolonged hospital stay requiring trach and peg; tx to a HCF
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Dermatitis contact, Food allergy
Clinical narrative: Suspect pt reaction due to egg consumption with an egg contact allergy; pt given benedryl in clinic and transported via EMS to the hospital
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, COVID-19 pneumonia, Cough, Death
Clinical narrative: Presented to ED w/chief c/o vomiting; tested COVID positive 4 days prior to arrival w/ symptoms of cough, hypoxia, SOB; admitted for PNA d/t COVID-19; tx w/abx, remdesivir, ascorbic acid, steroids, zinc; pt remained in afib despite being on IV cardizem t/o stay w/worsening kidney function; pt made DNR d/t poor prognosis and expired 1/19.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Renal impairment, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Presented to ED w/chief c/o vomiting; tested COVID positive 4 days prior to arrival w/ symptoms of cough, hypoxia, SOB; admitted for PNA d/t COVID-19; tx w/abx, remdesivir, ascorbic acid, steroids, zinc; pt remained in afib despite being on IV cardizem t/o stay w/worsening kidney function; pt made DNR d/t poor prognosis and expired 1/19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Flank pain, Pneumonia
Clinical narrative: Presented to ED w/ fever, flank pain, dx w/UTI 2 days prior; COVID+ on 12/16, cxray showed multifocal pna; pt admitted for tx of pyelonephritis and COVID-19 pna; tx w/ abx, steroid, and O2 therapy; cold ot wean off of O2; Pt DC on home O2
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyelonephritis, Pyrexia, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Presented to ED w/ fever, flank pain, dx w/UTI 2 days prior; COVID+ on 12/16, cxray showed multifocal pna; pt admitted for tx of pyelonephritis and COVID-19 pna; tx w/ abx, steroid, and O2 therapy; cold ot wean off of O2; Pt DC on home O2
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, Physical deconditioning
Clinical narrative: Presented to ED w/SOB d/t unresolved COVID infection dx 1/4/2022; admitted for COVID-19 pna; tx w/abx, remdesivir, steroids, Vit-C, zinc, O2 therapy; discharged on O2 & to acute rehab d/t phsyical deconditioning
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/ SOB; COVID +, admitted for COVID-19 pna w/ acute resp failure; tx w/O2 therapy, abx, steroids, thiamine, zinc; dc'd home on RA.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Androgen deficiency, Attention deficit hyperactivity disorder, Blood testosterone decreased, Disability
Clinical narrative: Doctor has deemed me disabled. Short term memory recall, ADHD,  fainting and falling, pre-fainting, testosterone depletion, unemployed and unable to get a job or financial assistance. Please help!!
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Economic problem, Fall, Presyncope, Syncope
Clinical narrative: Doctor has deemed me disabled. Short term memory recall, ADHD,  fainting and falling, pre-fainting, testosterone depletion, unemployed and unable to get a job or financial assistance. Please help!!
Age: 34.0
Sex: M
Vaccine: HPV9
Symptoms: Muscular weakness
Clinical narrative: he has been having an increase in weakness in his legs for the last 2 to 3 weeks. He needs to be interviewed. He was having some back and chest pain prior to the vaccine
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines ; Pfizer 4/10/21 Lot# Ew0162;  Pfizer 5/1/21 lot# Ew0172