chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Patient uncooperative, Underdose
Clinical narrative: No other adverse issues or side effects were reported; The patient pulled away during administration and did not receive the full dose.; This spontaneous report has been received from a medical assistant, regarding to a 3-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 06-SEP-2024, the patient was vaccinated (at 3 years-old) with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered for prophylaxis (lot number reported as X013192, which has been verified to be valid, with an expiration date reported and established as 08-MAY-2025) (strength, dose, vaccination scheme, route of administration and anatomical site of injection were not provided); reconstituted with sterile diluent (MERCK STERILE DILUENT), solution for injection/infusion (lot number reported as W037058, which has been verified to be valid, with an expiration date reported and established as 27-JUN-2025) (strength, dose, indication, vaccination scheme, route of administration and anatomical site of injection were not provided). However, during the administration, the patient pulled away and did not receive the full dose (Incorrect dose administered). The reporter stated that 0.2 mL of the reconstituted vaccine was left in the syringe after the patient pulled away.   No other adverse issues or side effects were reported.
Age: 15.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE. No PQC.; Caller reported the patient received both PROQUAD and VARIVAX on 9/6/2024. Confirmed no other AE occurred. Case number provided. AE letter sent to caller. No other AE. No PQC.; Caller reported the patient received both PROQUAD and VARIVAX on 9/6/2024.; This spontaneous report was received from Other Health Professional regarding to a 15-year-old patient.  The patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 06-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin(rHA) (PROQUAD), injection, 1 dose (product administered to patient of inappropriate age) (lot #Y003881, which was a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date: 05-AUG-2025) and with varicella virus vaccine live (oka/merck) (VARIVAX) (overdose) injection, 1 dose (lot #Y006582, which was a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD); expiration date: 26-MAR-2026)  (dose numbers, strengths, routes of administration and anatomical locations were not provided) both administered for prophylaxis. No additional adverse event or PQC was reported, and AE letter was sent to caller.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: Suspected vaccination failure; very bad case of shingles/still contracted shingles; nerve damage; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: very bad case of shingles/still contracted shingles) and nerve damage (Verbatim: nerve damage). The outcome of the vaccination failure was not reported and the outcome of the shingles and nerve damage were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and nerve damage to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported by a patient via interactive digital media. The reporter reported that a patient received shingles vaccine and still had a very bad case of shingles or contracted shingles, so bad that it was caused a serious problem/issue with nerve damage. This case of shingles was so severe. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Injection site pain
Clinical narrative: very sore arm at injection site; Redness; weakness while exercising; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 months ago with modest side effects).   On 31-AUG-2024, the patient received the 2nd dose of Shingrix (unknown arm). On 31-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: very sore arm at injection site), erythema (Verbatim: Redness) and weakness (Verbatim: weakness while exercising). The outcome of the injection site pain, erythema and weakness were not resolved.   It was unknown if the reporter considered the injection site pain, erythema and weakness to be related to Shingrix.     It was unknown if the company considered the injection site pain, erythema and weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-SEP-2024 The reporter reported that a patient received Shingrix vaccine and experienced redness, very sore arm at injection site, weakness while exercising. The patient had his first dose of Shingrix approximately 5 months ago with modest side effects. He got his second dose with far more acute side effects including being extremely weak while attempting a weight workout. The symptoms was treated.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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 shingles (Verbatim: shingles). The outcome of the shingles was resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 28-AUG-2024 This case was reported by a patient via interactive digital media. The reporter reported that the he/she had received Shingrix vaccine and currently recovering from Shingles and reported they are miserable. The reporter mentioned that he/she had the original vaccination but the current vaccine requires a 2nd dose 6 months after initial vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: rashes on my bodyand rashes on my scalp; intense itch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acrivastine (Benadryl).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced generalized rash (Verbatim: rashes on my bodyand rashes on my scalp) and generalized pruritus (Verbatim: intense itch). The outcome of the generalized rash and generalized pruritus were not resolved.   It was unknown if the reporter considered the generalized rash and generalized pruritus to be related to Shingrix.     It was unknown if the company considered the generalized rash and generalized pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported by a patient via interactive digital media. The patient had the double shots and had a reaction rashes on his/her body and scalp, intense itch. The patient have had 2 steroid shots since February and taken Benadryl and recommend others to moisturize.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: The fourth Dtap and IPV dose was at 1 year of age; a 7 year and 6 months male patient received Kinrix as a fifth dose in the Dtap series and fifth dose in the IPV series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for an unknown indication.   Previously administered products included Dtap (received fourth dose at 1 year of age) and IPV (received fourth dose at 1 year of age).   On 15-AUG-2024, the patient received Kinrix. On 15-AUG-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 7 year and 6 months male patient received Kinrix as a fifth dose in the Dtap series and fifth dose in the IPV series). On an unknown date, the patient experienced inappropriate schedule of vaccine administered (Verbatim: The fourth Dtap and IPV dose was at 1 year of age). The outcome of the inappropriate age at vaccine administration was unknown and the outcome of the inappropriate schedule of vaccine administered was not reported.   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: 27-AUG-2024 The nurse reported that the patient of an inappropriate age received Kinrix as a fifth dose in the Dtap series and fifth dose in the IPV series, which led to inappropriate age at vaccine administration. The fourth Dtap and IPV dose was at 1 year of age, which led to inappropriate schedule of vaccine administered
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Fatigue, Hyperacusis, Pyrexia
Clinical narrative: she had vertigo; tiredness; a fever; falling down; dizziness; noise bothered; This non-serious case was reported by a consumer via call center representative and described the occurrence of vertigo in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-AUG-2024, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced vertigo (Verbatim: she had vertigo), tiredness (Verbatim: tiredness), fever (Verbatim: a fever), fall (Verbatim: falling down), dizziness (Verbatim: dizziness) and sound sensitivity increased (Verbatim: noise bothered). The outcome of the vertigo, tiredness, fall, dizziness and sound sensitivity increased were not resolved and the outcome of the fever was resolved.   It was unknown if the reporter considered the vertigo, tiredness, fever, fall, dizziness and sound sensitivity increased to be related to Shingrix.     It was unknown if the company considered the vertigo, tiredness, fever, fall, dizziness and sound sensitivity increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-SEP-2024 This case was reported by patient itself. The patient was a spanish speaking patient and spanish interpreter was utilized.  On the second day, she had vertigo, a fever, tiredness, and was falling down. She also had dizziness and noise bothered her.  All symptoms were still present except the fever which has resolved. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: she had vertigo; tiredness; a fever; falling down; dizziness; noise bothered; This non-serious case was reported by a consumer via call center representative and described the occurrence of vertigo in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-AUG-2024, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced vertigo (Verbatim: she had vertigo), tiredness (Verbatim: tiredness), fever (Verbatim: a fever), fall (Verbatim: falling down), dizziness (Verbatim: dizziness) and sound sensitivity increased (Verbatim: noise bothered). The outcome of the vertigo, tiredness, fall, dizziness and sound sensitivity increased were not resolved and the outcome of the fever was resolved.   It was unknown if the reporter considered the vertigo, tiredness, fever, fall, dizziness and sound sensitivity increased to be related to Shingrix.     It was unknown if the company considered the vertigo, tiredness, fever, fall, dizziness and sound sensitivity increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-SEP-2024 This case was reported by patient itself. The patient was a spanish speaking patient and spanish interpreter was utilized.  On the second day, she had vertigo, a fever, tiredness, and was falling down. She also had dizziness and noise bothered her.  All symptoms were still present except the fever which has resolved. The reporter did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered a dose of MENVEO which expired 8/31/2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA960A, expiry date 31-AUG-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administered a dose of MENVEO which expired 8/31/2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-SEP-2024 The health care professional reports that they administered a expired dose of Menveo, which led expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after Shingrix administration; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles after Shingrix administration). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-SEP-2024 The reporter reported that got the Shingrix vaccine and got shingles immediately following the vaccine last month. The reporter stated it was unknown if the shingles occurred after the 1st dose or after the series was completed. This case has been linked to the case US2024109538 reported by the same reporter.; Sender's Comments:  US-GSK-US2024109538:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Contracted COVID-19 infection; she was in bed for two days sweating through her shirt; this seemed to worsen with each subsequent injection over the past few years; mild cold; flu-like symptoms; nausea; Headache; she had a "COVID arm" where there was a rash down her arm; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted COVID-19 infection), HYPERHIDROSIS (she was in bed for two days sweating through her shirt), CONDITION AGGRAVATED (this seemed to worsen with each subsequent injection over the past few years), NASOPHARYNGITIS (mild cold) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 COVID-19 (Contracted COVID-19 infection), HYPERHIDROSIS (she was in bed for two days sweating through her shirt), CONDITION AGGRAVATED (this seemed to worsen with each subsequent injection over the past few years), NASOPHARYNGITIS (mild cold), INFLUENZA LIKE ILLNESS (flu-like symptoms), NAUSEA (nausea), HEADACHE (Headache) and RASH (she had a "COVID arm" where there was a rash down her arm). At the time of the report, COVID-19 (Contracted COVID-19 infection), HYPERHIDROSIS (she was in bed for two days sweating through her shirt), CONDITION AGGRAVATED (this seemed to worsen with each subsequent injection over the past few years), NASOPHARYNGITIS (mild cold), INFLUENZA LIKE ILLNESS (flu-like symptoms), NAUSEA (nausea), HEADACHE (Headache) and RASH (she had a "COVID arm" where there was a rash down her arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773480 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773480:Same reporter/ different patient (Patient's mother case)
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Rash
Clinical narrative: Contracted COVID-19 infection; she was in bed for two days sweating through her shirt; this seemed to worsen with each subsequent injection over the past few years; mild cold; flu-like symptoms; nausea; Headache; she had a "COVID arm" where there was a rash down her arm; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted COVID-19 infection), HYPERHIDROSIS (she was in bed for two days sweating through her shirt), CONDITION AGGRAVATED (this seemed to worsen with each subsequent injection over the past few years), NASOPHARYNGITIS (mild cold) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 COVID-19 (Contracted COVID-19 infection), HYPERHIDROSIS (she was in bed for two days sweating through her shirt), CONDITION AGGRAVATED (this seemed to worsen with each subsequent injection over the past few years), NASOPHARYNGITIS (mild cold), INFLUENZA LIKE ILLNESS (flu-like symptoms), NAUSEA (nausea), HEADACHE (Headache) and RASH (she had a "COVID arm" where there was a rash down her arm). At the time of the report, COVID-19 (Contracted COVID-19 infection), HYPERHIDROSIS (she was in bed for two days sweating through her shirt), CONDITION AGGRAVATED (this seemed to worsen with each subsequent injection over the past few years), NASOPHARYNGITIS (mild cold), INFLUENZA LIKE ILLNESS (flu-like symptoms), NAUSEA (nausea), HEADACHE (Headache) and RASH (she had a "COVID arm" where there was a rash down her arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773480 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773480:Same reporter/ different patient (Patient's mother case)
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Feeling hot, Headache, Nausea
Clinical narrative: felt very hot; feeling tired; headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (felt very hot), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (feeling tired) in a 79-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 VACCINE (Dose 1 LOT  029L20A) on 14-Jan-2021 and Moderna COVID-19 VACCINE (Dose 2 LOT  029L20A) on 11-Feb-2021; for Product used for unknown indication: Covid-19 vaccine (Dose 3 LOT 989903) on 27-Oct-2021, Covid-19 vaccine (Dose 4) on 31-Mar-2022, Covid-19 vaccine (Dose 5) on 12-Sep-2022, Pfizer (Dose 6) on 27-Sep-2023 and Covid-19 vaccine (Dose 7) on 13-Mar-2024. Past adverse reactions to the above products included No adverse effect with Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine, Moderna COVID-19 VACCINE, Moderna COVID-19 VACCINE and Pfizer. Concurrent medical conditions included Thyroid disorder (Patient had slow thyroid and was taking medicine for it.) and High cholesterol (Patient Had high cholesterol and was taking medicine.).   On 03-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 03-Sep-2024, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced FEELING HOT (felt very hot) and FATIGUE (feeling tired). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, FEELING HOT (felt very hot) and HEADACHE (headache) had not resolved and NAUSEA (nausea) and FATIGUE (feeling tired) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported.  Patient had received other vaccines in the 4 weeks prior to COVID-19  Patient had Moderna for the last couple of years and have been taking the 4-month recommended interval religiously.   This case was linked to US-MODERNATX, INC.-MOD-2024-773440 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2024: Live follow up received contains non-significant information. Reference IDs were added. On 06-Sep-2024: Live significant follow up received. Updated outcome of the event nausea to recovering. Added new event fatigue.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773440:Patient 2 (wife case)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Concussion, Dizziness, Headache, Vomiting
Clinical narrative: light headedness; cool sweat; constant vomiting of bile for 12 hours; severe headache on the day after the vaccine; Light sensitivity as with a concussion; This spontaneous case was reported by a patient and describes the occurrence of CONCUSSION (Light sensitivity as with a concussion), DIZZINESS (light headedness), COLD SWEAT (cool sweat), VOMITING (constant vomiting of bile for 12 hours) and HEADACHE (severe headache on the day after the vaccine) in a 63-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 03-Sep-2024, the patient experienced CONCUSSION (Light sensitivity as with a concussion) and VOMITING (constant vomiting of bile for 12 hours). 03-Sep-2024, the patient experienced HEADACHE (severe headache on the day after the vaccine). On 04-Sep-2024, the patient experienced DIZZINESS (light headedness) and COLD SWEAT (cool sweat). At the time of the report, CONCUSSION (Light sensitivity as with a concussion), DIZZINESS (light headedness), COLD SWEAT (cool sweat), VOMITING (constant vomiting of bile for 12 hours) and HEADACHE (severe headache on the day after the vaccine) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. Patient took fluids and electrolytes to her diet as treatment for symptom.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Headache, Nausea, Pyrexia
Clinical narrative: he could hardly stand up; feeling chills; fever; headache; felt nauseous; This spontaneous case was reported by a patient and describes the occurrence of DYSSTASIA (he could hardly stand up), CHILLS (feeling chills), PYREXIA (fever), HEADACHE (headache) and NAUSEA (felt nauseous) in an 89-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza (Influenza 4 days before) on 31-Aug-2024; for Drug use for unknown indication: Codeine, Sulfa drug and Penicillin. Past adverse reactions to the above products included No adverse effect with Codeine, Influenza, Penicillin and Sulfa drug. Concurrent medical conditions included Drug allergy, Penicillin allergy, Sulfonamide allergy (sulfur drugs) and Drug allergy (Codeine).    On 04-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 05-Sep-2024, the patient experienced DYSSTASIA (he could hardly stand up), CHILLS (feeling chills), PYREXIA (fever), HEADACHE (headache) and NAUSEA (felt nauseous). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 Tylenol. At the time of the report, DYSSTASIA (he could hardly stand up), CHILLS (feeling chills), PYREXIA (fever), HEADACHE (headache) and NAUSEA (felt nauseous) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. Patient stated that he could hardly stand up or get out of bed. He stated he ate one thing and felt nauseous, so he did not eat anything else. Patient took 2 Tylenol. It was reported that today patient was feeling normal. He stated that when he got up this morning, he did not have that feeling (nauseous) and he got up and made some breakfast, ate it and didn't get sick.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura
Clinical narrative: red circular elevated skin patch / bump; This spontaneous case was reported by a consumer and describes the occurrence of PURPURA (red circular elevated skin patch / bump) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042914) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PURPURA (red circular elevated skin patch / bump). At the time of the report, PURPURA (red circular elevated skin patch / bump) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported.  Patient had red circular elevated skin patch / bump which was not painful or itchy. The patient did not experience any additional symptoms/events.  Patient had no concomitant disease or risk factor. Treatment medications were not provided.
Sex: U
Vaccine: PNC20
Symptoms: Device connection issue
Clinical narrative: Needle screw has broken one of the vaccine/no patient; The initial case was missing the following minimum criteria: only product complaint. Upon receipt of follow-up information on 29Aug2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose numbe unknown, single (Lot number: LC1279, Expiration Date: 31Dec2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious), outcome "unknown", described as "Needle screw has broken one of the vaccine/no patient".  The reporter considered "needle screw has broken one of the vaccine/no patient" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "needle screw has broken one of the vaccine/no patient" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: The reporter wanted to file a product complaint so she can get a credit. She wanted to replace one of the syringe because one of their nurses uncapped the needle and the needle screw has broken one of the vaccine. They have already experienced it twice.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: Prevnar 20 vaccine broke in half prior to vaccination; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 03Sep2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from a sales representative and product quality group.  An infant patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Prevnar 20 vaccine broke in half prior to vaccination". Therapeutic measures were not taken as a result of device breakage.  Causality for "prevnar 20 vaccine broke in half prior to vaccination" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: When they were about to mix the vaccine the vial exploded; This is a spontaneous report received from a nurse.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HG1756, Expiration Date: May2025) for immunisation, Device Lot Number: H759, Device Expiration Date: 01May2028. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "When they were about to mix the vaccine the vial exploded".  Causality for "when they were about to mix the vaccine the vial exploded" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional Information: When they were about to mix the vaccine, the vial exploded, and the nurse would like to have this product replaced. The vaccine was not administered to any patient as it has been prepared before they entered in the patient room. The medicine was everywhere. Syringe details (Lot Number: HG1756, Expiration Date: May2025, NDC Number: 0069025001, UPC Number: 300690344058). Diluent details (Lot Number: HN3790, Expiration Date: 04Apr2025, NDC Number: 0069020701). Adapter details (Lot Number: H759, Expiration Date: 01May2028).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site was just a little sore , which is typical from previous Covid shots; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3(booster),single (Lot number: FH8027) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot number: EN6203, Location: RT Arm), administration date: 01Mar2021, for COVID-19 immunization, reaction(s): "Vaccination site pain"; comirnaty (DOSE 2, SINGLE, Lot number: ER8727), administration date: 23Mar2021, for COVID-19 immunization, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site was just a little sore , which is typical from previous Covid shots".
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site was just a little sore, which is typical from previous Covid shots; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer", start date: 1999 (unspecified if ongoing), notes: 25 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot number: EN6203, in right arm), administration date: 01Mar2021, when the patient was 79-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, Lot number: ER8727, in right arm), administration date: 23Mar2021, when the patient was 79-year-old, for COVID-19 immunisation; BNT162b2 (Dose 3, Lot number: FH8027, in right arm), administration date: 09Nov2021, when the patient was 80-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site was just a little sore, which is typical from previous Covid shots".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400252152 same patient and drug, similar event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost my being able to small or taste; lost my being able to small or taste; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, 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: AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2022, outcome "unknown" and all described as "lost my being able to small or taste".  Additional information: the patient lost small and taste. This has been since the patient got the vaccine  2 years ago.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash spots; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Sep2024 as dose 1, single (Lot number: LM2222) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset Sep2024, outcome "unknown", described as "Rash spots".  Additional information: the patient had the rash spots showing. She had rash, couple of rash spots.
Sex: F
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy, Condition aggravated
Clinical narrative: Flare of Sweet Syndrome After COVID-19 Vaccination; Flare of Sweet Syndrome After COVID-19 Vaccination; This is a literature report for the following literature source(s).  A 21-year-old woman with history of ulcerative colitis presented with worsening lesions on the face, neck, and bilateral hands with associated edema. Additionally, she also reported joint pain, nausea, emesis, and hematochezia. The patient received her first dose of the Pfizer-BioNTech COVID-19 vaccine 3 weeks prior to the flare. No other triggering factors, medications, or exposures were noted. She reported similar lesions in the past that self-resolved one year ago. Initial biopsy demonstrated superficial perivascular and interstitial mixed cell infiltrate with features suggestive of evolving vasculitis, papillary dermal edema, mild epidermal hyperplasia, and spongiosis. Given suspicion for a neutrophilic dermatosis, patient was started on methylprednisolone with rapid improvement and resolution of her cutaneous findings; however, her lesions recurred after discontinuation of the systemic corticosteroids. Repeat biopsy demonstrated similar findings. Patient was started on dapsone and has remained well controlled with no abnormal lab findings or issues with tolerability. Sweet syndrome is an acute febrile neutrophilic dermatosis. Neutrophilic dermatoses can be idiopathic or secondary to an underlying disorder and may present with extracutaneous manifestations. Many cases of cutaneous adverse effects following COVID-19 vaccination have been described. To our knowledge, only a few cases of Sweet syndrome following COVID-19 vaccination have been reported to date, but none regarding reactivation of the condition. Given continued discovery of new contagious COVID-19 variants, the need for additional booster doses may be necessary; thus, discussion of potential reactivation of neutrophilic dermatoses is warranted in affected patients to weigh the risks and benefits of the vaccine.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Off label use
Clinical narrative: patient was recommended to take Adacel due to history of Alpha Gal  with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid non-serious case received from a patient and live follow up received on 28-Aug-2024 both were processed together  This case involves a 66 years old female patient who was recommended to take DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] due to history of Alpha Gal with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy.   On an unknown date, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date unknown) was recommended due to history of Alpha Gal with no reported adverse event (Off label use) (same day latency). Information on batch number corresponding to the one at time of event occurrence could not be requested
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: A dose of Adacel was given intravenously as a booster for wound prophylaxis with no reported Adverse Event; Initial information received on 28-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult female patient (under 65-year-old) to whom a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was given intravenously as a booster for wound prophylaxis with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Aug-2024, the patient received booster dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection, 1X (one time) via intravenous route in unknown administration site for wound prophylaxis (Prophylaxis) (strength, dose, batch number and expiry date unknown) with no reported adverse event (incorrect route of product administration) (latency same day).  Information on batch number corresponding to the one at time of event occurrence was requested.  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: 16.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 years old patient received flublok with no reported adverse event; Initial information received on 03-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse practitioner.   This case involves a 16 years old male patient who received Influenza Trivalent Recombinant Vaccine [Flublok Tiv] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination and family history were not provided.   Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunization.   On 03-Sep-2024, the 16 years old male patient received a Standard dose 0.5 ml once (dose 1) Influenza Trivalent Recombinant Vaccine Solution for injection (batch number- TFAA2407, Expiry date: 31-MAY-2025) via intramuscular route in the left deltoid for Influenza with no reported adverse event (product administered to patient of inappropriate age) (latency same day).   Reportedly, no treatment was received.   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: 41.0
Sex: F
Vaccine: RAB
Symptoms: Dysgeusia
Clinical narrative: had reported a metallic taste after administration; Initial information received on 03-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to other case 2024SA257799  This case involves a 41-year-old female patient who had reported metallic taste after administration rabies (HDC) vaccine [Imovax rabies].  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 29-Jul-2024, the patient received a standard dose 1 ml of suspect rabies (HDC) vaccine powder and solvent for suspension for injection (unknown batch and expiry date) via intramuscular route in right arm site for Immunisation.  On an unknown date in 2024 the patient had reported a metallic taste after administration (dysgeusia) (unknown latency) following the administration of rabies (HDC) vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, the patient were supposed to obtain the next dose on 05aug2024, but the product was backordered.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events Dysgeusia.  At time of reporting, the outcome was Unknown for the event Dysgeusia.  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.  Senders comment: Reporter can be contacted by Sanofi:Yes; Sender's Comments:  US-SA-2024SA257799:02206806
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: fluzone high dose that leaked and sprayed out on patient arm from the syringe when attempting administration with no adverse event; fluzone high dose that leaked and sprayed out on patient arm from the syringe when attempting administration with no adverse event; Initial information received on 03-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who while receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that leaked and sprayed out on patient arm from the syringe when attempting administration with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2024, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot UT8409EA and expiry 30-Jun-2025) (route, dose and strength: unknown) in unknown administration site for prophylactic administration.  On 30-AUG-2024 the patient while receiving fluzone high dose that leaked and sprayed out on patient arm from the syringe when attempting administration with no adverse event (accidental exposure to product) (exposure via skin contact) (latency same day).  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.