chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The third dose was inadvertently administered sooner than recommended dosing schedule; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 43-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 7th December 2022). Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 06-APR-2023, the patient received the 3rd dose of Twinrix. On 06-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: The third dose was inadvertently administered sooner than recommended dosing schedule). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient received the 3rd dose of Twinrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received pediarix instead of Infanrix/ had gotten 3 doses and received Pediarix as 4th dose; patient received pediarix instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4n2pm, expiry date 28-MAR-2025) for prophylaxis.   Previously administered products included Pediarix (had gotten 3 doses on an unknown date).   On 14-JUL-2023, the patient received the 4th dose of Pediarix. On 14-JUL-2023, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: patient received pediarix instead of Infanrix/ had gotten 3 doses and received Pediarix as 4th dose) and wrong vaccine administered (Verbatim: patient received pediarix instead of Infanrix). The outcome of the extra dose administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jul-2023 The reporter consented to follow-up. The patient was meant to be Infanrix (4th dose) but Pediarix was given instead, which led to extra dose administered and wrong vaccine administered.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero was accidentally given instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 3YB52, expiry date 30-APR-2024) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Bexsero. On 17-JUL-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero was accidentally given instead of Menveo). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jul-2023 A medical assistant called in to asked that wished to know how to proceed. Information about the vaccine, patient and event were collected. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient accidentally received a dose of Bexsero instead of Menveo, which led to wrong vaccine administered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix unapproved diluent administered; Shingrix unapproved diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   On 17-JUL-2023, the patient received Shingrix. On 17-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix unapproved diluent administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix unapproved diluent administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter consented to follow up via email.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter reported that an unapproved diluent was used to reconstitute Shingrix and it was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: received a vaccine for shingles about 2 years ago and received the SHINGRIX vaccine 6 weeks ago due to covid pandemic; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose about 2 years ago).   In JUN-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: received a vaccine for shingles about 2 years ago and received the SHINGRIX vaccine 6 weeks ago due to covid pandemic). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 17-JUL-2023 The patient received a vaccine for shingles about 2 years ago. The reporter stated that he/she did not go back for any more vaccines because of the Covid pandemic. Currently, she received the Shingrix vaccine 6 weeks ago. She called to ask if she should get another dose Shingrix vaccine.  The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPA, MENB
Symptoms: Product storage error
Clinical narrative: Bexsero, Havrix low temperature excursion: 31.5F Time: 2hrs 45 min; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Havrix and Bexsero. On an unknown date, an unknown time after receiving Havrix and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero, Havrix low temperature excursion: 31.5F Time: 2hrs 45 min). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter was a licensed practical nurse. The Bexsero, Havrix low temperature excursion: 31.5F Time: 2hrs 45 min.  The reporter did not know which vaccine was administered, if in fact it was.  No patient's information was reported.  No vaccine data (lot number, expiration date) were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that Bexsero and/or Havrix might be administered after a temperature excursion where the vaccines were determined to be unstable, which led to incorrect storage of vaccine.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received a dose of Hep B vaccine in 2015 and never had administered a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 1st dose on 30th December 2015).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Hep B vaccine in 2015 and never had administered a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter reported that a patient received a dose of Hepatitis B vaccine in 2015 and never had administered a second dose. The reporter mentioned was not sure if vaccine given in first dose was Engerix-B no lot number available. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis B vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Assisted suicide, Illness
Clinical narrative: DEBILITATING ILLNESS; ASSISTED SUICIDE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, 1 total administered start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced debilitating illness (dose number in series 2). On JUN-2023, the patient died by assisted suicide (dose number in series 2). It was unknown whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the debilitating illness was not reported. This report was serious (Death).; Sender's Comments: V0: 20230723101- assisted suicide. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: ASSISTED SUICIDE
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: BRUISE GOT WORSE; KNOT; SORE SPOT ON HER ARM; This spontaneous report received from a patient concerned a 61 year old. The patient's weight was 164 pounds, and height was 65 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. There was no drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 22-MAR-2021 at right arm for covid-19 prophylaxis. On 22-MAR-2021, the patient had a sore spot on her arm and her arm stayed a little bruised but she did not pay much attention to it. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-NOV-2021 at right arm for covid-19 prophylaxis. Age at time of vaccination 61 years old. No concomitant medications were reported.  On 12-NOV-2021 she got the booster shot on the same arm and the spot did not get better, it had progressively gotten worse. After the booster shot, it just got worse and felt even more bruised. It was swollen for quite a while and it had progressively gotten worse. It was like there was a knot under there. It hurts to rub finger across it. She states that it was the size of an egg on her right arm. It was extremely painful to touch and it hurts when she was laying on it while sleeping. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore spot on her arm, bruise got worse, and knot. This report was non-serious. This case, involving the same patient is linked to 20230644295 (Dose number in series 1).
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Dizziness, Fatigue, Headache, Hypotension
Clinical narrative: Pain in injected arm and light headache starting 3-4 hours later. The next day I woke up with low blood pressure, dizziness, mild headache, mild fatigue and a low fever. It subsided with ibuprofen. 2 days later my armpit on same side of injection was mildly painful with movement and quite swollen.  3rd day my armpit remains equally or more swollen. Mild fatigue.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain in injected arm and light headache starting 3-4 hours later. The next day I woke up with low blood pressure, dizziness, mild headache, mild fatigue and a low fever. It subsided with ibuprofen. 2 days later my armpit on same side of injection was mildly painful with movement and quite swollen.  3rd day my armpit remains equally or more swollen. Mild fatigue.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Joint stiffness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: I had neck stiffness, Shoulder (both) pain and weakness, Elbow (both) stiffness and pain, sharp pains in both arms. I had my 2nd and last Moderna booster on Nov 17 2022. I had almost never ending symptoms that just went totally  away on May 16th 2023. I changed nothing in my daily meds, diet or  anything else to make my symptoms go away.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Asthenia, Blood creatine phosphokinase increased, Blood creatinine, Chromaturia
Clinical narrative: Patient developed progressive stiffness and soreness in her legs, generalized weakness, dark urine, increased thirst, and nausea. She called me with these symptoms and I evaluated her and ultimately diagnosed her with rhabdomyolysis with acute renal injury. She was hospitalized for IV fluids and serial lab assessments. The rhabdomyolysis resolved and she was discharged home after 48 hours.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness, Nausea, Pain in extremity, Red blood cell sedimentation rate increased, Rhabdomyolysis
Clinical narrative: Patient developed progressive stiffness and soreness in her legs, generalized weakness, dark urine, increased thirst, and nausea. She called me with these symptoms and I evaluated her and ultimately diagnosed her with rhabdomyolysis with acute renal injury. She was hospitalized for IV fluids and serial lab assessments. The rhabdomyolysis resolved and she was discharged home after 48 hours.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Thirst
Clinical narrative: Patient developed progressive stiffness and soreness in her legs, generalized weakness, dark urine, increased thirst, and nausea. She called me with these symptoms and I evaluated her and ultimately diagnosed her with rhabdomyolysis with acute renal injury. She was hospitalized for IV fluids and serial lab assessments. The rhabdomyolysis resolved and she was discharged home after 48 hours.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 14 yr old received 5y-11y bivalent booster, no side effects.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Eczema, Rash, Urticaria
Clinical narrative: A few days after IM injection, I had blisters on my left foot, focused on the toe area. These progressed into an excema reaction to follow. Never having been diagnosed with excema prior. This situation took weeks to reside. Followed by multiple more breakouts on my left foot and also urticaria reactions now all over my torso, abdomen, thighs, and neck at times. These giant hives will surface and last several hours, after residing they will then appear in another area the next day on my body.  Most softball size in nature.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Aspartate aminotransferase increased, Ataxia, Blood lead normal, Full blood count abnormal, Gliosis
Clinical narrative: Developed ataxia on 01/22/2023
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Magnetic resonance imaging head abnormal, Metabolic function test abnormal, Neutrophil count decreased
Clinical narrative: Developed ataxia on 01/22/2023
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Urticarial rash - the day of vaccine had a transient rash on his arm.   was itchy all night and woke next morning with hives all over his stomach, later that day there were hives on his legs as well.  By the next day(2d after the vaccine), it was fully resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Influenza virus test negative, Pyrexia
Clinical narrative: None before   After vaccines later that day had fever high to 102 F for next three days, cough, congestion, and vomiting and 1 episode of diarrhea, ongoing stomach ache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, Vomiting
Clinical narrative: None before   After vaccines later that day had fever high to 102 F for next three days, cough, congestion, and vomiting and 1 episode of diarrhea, ongoing stomach ache.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  No known health complications for patient.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  Pt contacted, no known health complications.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given a 0.5ml dose of the Moderna Bivalent dose 6 days after expiration
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given 0.5ml injection of the vaccine 14 days after Beyond use date
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient was given 0.5ml injection of the vaccine 14 days after the beyond use date .
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: 7/14 high fever began at 2:00pm of 102.5. Treated with alternating tylenol and motrin per dr. instruction. Fever lasted until 7/16. On 7/18 hives began all over her body. Two welts on lower calf, also one on face near eye. Noticed around 11:00am upon returning from outside. Took her to see Dr same day at 3:00pm.. Dr advised to treat with 5 ml of Zyrtec daily.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Death, Myocarditis, Syncope
Clinical narrative: Patient suddenly collapsed while jogging. He was 33 y/o healthy, fit, active male with no cardiac issues, Autopsy diagnosis is Myocarditis.
Sex: U
Vaccine: COVID19-2
Symptoms: Pain in extremity, Rash erythematous, Rash pruritic, Sluggishness
Clinical narrative: Itchy red bumpy rashes appear randomly on body and disperse after about 30 minutes.   They have occurred on torso, hands, feet, legs, arms, neck and scalp.   Started on 7/1 and continue to appear.  First occurrence was on underside of left forearm.  Most frequent occurrences have been on lower torso (hips), neck and scalp.  Changes to temperature and humidity do not seem to impact when and where they occur.   Exercise and diet do not appear to have any impact on occurrences.   There do not seem to be any other side effects.  The day after the injection, there were no different side-effects than previous doses (all Moderna), sore arm and slight sluggishness.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: 24 hours after injection pain started in arm, within 48 hours pain radiated down the arm, into the neck, chills, and still present a week later. Pain getting worse.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Maternal exposure during pregnancy, No adverse event
Clinical narrative: HBP calling to report administering a fourth dose of the GARDASIL 9 vaccine to a pregnant women.  HBP confirmed there are no symptoms to report and the patient already received 3 doses of GARDASIL 9 previously.  No other AE and no PQC; HBP calling to report administering a fourth dose of the GARDASIL 9 vaccine to a pregnant women.  HBP confirmed there are no symptoms to report and the patient already received 3 doses of GARDASIL 9 previously.  No other AE and no PQC; HBP calling to report administering a fourth dose of the GARDASIL 9 vaccine to a pregnant women.  HBP confirmed there are no symptoms to report and the patient already received 3 doses of GARDASIL 9 previously.  No other AE and no PQC; This spontaneous report was received from a medical assistant and refers to a pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical vaccinations included 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On 10-JUL-2023, the patient was vaccinated with a fourth dose (extra dose administered) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered as prophylaxis (maternal exposure during pregnancy) (strength, lot #, expiry date, and route of administration were not provided). No adverse events were reported.
Age: 1.0
Sex: M
Vaccine: PNC15
Symptoms: Product storage error
Clinical narrative: No adverse side effects were reported with the administration of the vaccine.; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes); This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's concurrent conditions, pertinent medical history,  drug reactions or allergies, and concomitant therapies were not reported.  On 19-JUN-2023, the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 ml once via injection in right thigh, lot #W039033, expiration date 01-OCT-2024, for prophylaxis (route of administration was not provided). It was reported that the vaccine underwent a current temperature excursion at 49.1 degree Fahrenheit (F) for 34 minutes, and also underwent two previous temperature excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes. The user of the device was a health care professional (HCP) and product was not available to obtain. No adverse side effects were reported with the administration of the vaccine. No additional AE information was provided and no PQC.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2307USA004472
Sex: M
Vaccine: MMRV
Symptoms: Hand-foot-and-mouth disease, Headache, Pruritus, Pyrexia, Rash
Clinical narrative: pain with his teeth; Headache; Hand, foot and mouth disease: mouth sores, headache and low grade fever, body-wide itchy chicken-pox like rash on his elbows, wrists fingers, ankles, knees and buttocks and also complaining of pain with his teeth.; This spontaneous report was received from a consumer and refers to a male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUL-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliters, lot #X004370, expiration date: 07-AUG-2024, administered as prophylaxis (strength, vaccination scheme, and route of administration were not provided).  On 09-JUL-2023, the patient developed a headache, fever, then body-wide itchy chickenpox-like rash on his elbows, wrists, fingers, ankles, knees, and buttocks, on 10-JUL-2023, the patient complained of pain with his teeth, progressed rash, and developed mouth sores; due the symptoms, the patient was taken to the doctor's office and was diagnosed with hand-foot-mouth virus. The outcome of the events was not reported.   The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Sex: M
Vaccine: MMRV
Symptoms: Stomatitis, Toothache
Clinical narrative: pain with his teeth; Headache; Hand, foot and mouth disease: mouth sores, headache and low grade fever, body-wide itchy chicken-pox like rash on his elbows, wrists fingers, ankles, knees and buttocks and also complaining of pain with his teeth.; This spontaneous report was received from a consumer and refers to a male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUL-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliters, lot #X004370, expiration date: 07-AUG-2024, administered as prophylaxis (strength, vaccination scheme, and route of administration were not provided).  On 09-JUL-2023, the patient developed a headache, fever, then body-wide itchy chickenpox-like rash on his elbows, wrists, fingers, ankles, knees, and buttocks, on 10-JUL-2023, the patient complained of pain with his teeth, progressed rash, and developed mouth sores; due the symptoms, the patient was taken to the doctor's office and was diagnosed with hand-foot-mouth virus. The outcome of the events was not reported.   The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 6/30/2023, af; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injection, 1 dose, administered for prophylaxis, lot number W039699 verified as valid, expiration date upon internal review established as 25-MAY-2024 (strength and route of administration were not provided) after a temperature excursion (product storage error) with a temperature of 48.8 degree Fahrenheits. No adverse event reported.
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Patient received PNEUMOVAX 23 on 12-JUL-2023 and reported left upper extremity paresthesia on 14-JUL-2023.; This spontaneous report was received from a physician and refers to a 67-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 12-JUL-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, administered for pneumonia vaccination (prophylaxis) (strength, dose, lot #, expiry date, and route of administration were not provided).  On 14-JUL-2023, the patient experienced left upper extremity paresthesia (paresthesia). At the time of reporting, the patient had not recovered from the event.   The reporter considered the event paresthesia to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 3rd patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up significant information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 4th patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up significant information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 5th patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up significant information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant medication was not reported. The vial was initially thawed on 10-Jun-2023. Treatment medication was not reported.  This case is for 6th patient out of 30 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine administration date was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant medication was not reported. The vial was initially thawed on 10-Jun-2023. Treatment medication was not reported.  The case was created for 7th patient out of 30 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine administration date was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug was reported.  On 10-Jun-2023, the vial was initially thawed.  On 14-Jun-2023, the vial was administered.  No treatment drug was reported.   The case corresponds to 8th out of 30 patients who had received expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up received: Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug was reported.  On 10-Jun-2023, the vial was initially thawed.  No treatment drug was reported.   The case corresponds to 9th out of 30 patients who had received expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up received: Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug was reported.  On 10-Jun-2023, the vial was initially thawed.  No treatment drug was reported.   The case corresponds to 10th out of 30 patients who had received expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up received: Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645: