chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Mammogram normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: had left back pain; had left shoulder pain; pain radiated down left arm; hard lump on side of chest between armpit and breast; ingrown hair; tingling in fingers and palm; pain at the injection site; swelling lymph nodes in armpits; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and axillary lymph nodes enlarged. In September 2022, the patient experienced tingling. On an unknown date, the patient experienced back pain, shoulder pain, pain in arm, breast lump and ingrown hair. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the injection site pain, back pain, shoulder pain and pain in arm were recovered/resolved and the outcome of the axillary lymph nodes enlarged and ingrown hair were unknown and the outcome of the breast lump and tingling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary lymph nodes enlarged, back pain, shoulder pain, pain in arm, breast lump, ingrown hair and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Oct-2022 Reporter's Comments: The reporter was the patient.  The patient received Shingrix dose in her left deltoid.  The patient initially had pain at the injection site and within the first week she noticed swelling to the lymph nodes in both armpits (swollen lymph nodes, unclear if resolved). The patient had left back and shoulder pain that radiated down her left arm.  The patient went to the ER (Emergency room) due to the pain and lymph node swelling. The patient developed a hard lump on the left side of her chest between her armpit and breast. The patient had regular mammograms. She saw her primary doctor who thought the lump might be an ingrown hair and prescribed an antibiotic.  The antibiotic did not resolve the lump. The patient was referred to a specialist who scheduled a mammogram.  About 3 to 5 weeks ago she experienced tingling in two fingers that was now progressing to her left palm. The patient did not have anything else to report. The reporter consent to follow up.
Age: 73.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Confusional state, Diarrhoea, Magnetic resonance imaging, Nausea, Transient global amnesia
Clinical narrative: Partial loss of memory for three days/total loss of memory for 24 hours; fever; diarrhea; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, on 12Sep2022 as dose 1, single. Vaccination history included: Covid-19 vaccine (DOSE 4,SINGLE), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (DOSE 3,SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 1,SINGLE), for Covid-19 immunization.  The following information was reported: AMNESIA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering", described as "Partial loss of memory for three days/total loss of memory for 24 hours"; DIARRHOEA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering", described as "diarrhea"; PYREXIA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering". The events "partial loss of memory for three days/total loss of memory for 24 hours", "fever", "diarrhea" and "nausea" required physician office visit. Therapeutic measures were taken as a result of amnesia, pyrexia, diarrhoea, nausea.
Age: 73.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Amnesia, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Partial loss of memory for three days/total loss of memory for 24 hours; fever; diarrhea; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, on 12Sep2022 as dose 1, single. Vaccination history included: Covid-19 vaccine (DOSE 4,SINGLE), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (DOSE 3,SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 1,SINGLE), for Covid-19 immunization.  The following information was reported: AMNESIA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering", described as "Partial loss of memory for three days/total loss of memory for 24 hours"; DIARRHOEA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering", described as "diarrhea"; PYREXIA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 08Oct2022 at 19:00, outcome "recovering". The events "partial loss of memory for three days/total loss of memory for 24 hours", "fever", "diarrhea" and "nausea" required physician office visit. Therapeutic measures were taken as a result of amnesia, pyrexia, diarrhoea, nausea.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Laboratory test, Mobility decreased, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Began to experience pain in shoulders, then in knees, then in hands over several weeks which increased rapidly, until 2+ months later, I could barely sleep or move for pain. My RH levels skyrocketed. Eventually I was diagnosed with "sudden onset severe RA" never having had any indication of that condition, nor any in my family. No doubt it was underlying, but I couldnt believe how fast it happened, relatively speaking. Now I am not sure whether I should get any more boosters.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid factor increased, Sleep disorder, X-ray
Clinical narrative: Began to experience pain in shoulders, then in knees, then in hands over several weeks which increased rapidly, until 2+ months later, I could barely sleep or move for pain. My RH levels skyrocketed. Eventually I was diagnosed with "sudden onset severe RA" never having had any indication of that condition, nor any in my family. No doubt it was underlying, but I couldnt believe how fast it happened, relatively speaking. Now I am not sure whether I should get any more boosters.
Age: 19.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Dizziness, Ear pain, Hypoacusis, Visual impairment
Clinical narrative: 2 hours after vaccines: dizziness and impaired vision. Went to sleep, woke up with decreased symptoms. 36-48 hours after vaccines: Intense earache and impaired hearing in the left ear. Phenylephrine & acetaminophen, symptoms decreased within an hour
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anosmia, Bedridden, Cough, Discomfort, Dyspnoea
Clinical narrative: At about 9:30 pm10/11/22, I began experiencing extreme aches throughout my entire body. I became very cold and was unable to breathe through my nose. I was unable to sleep comfortably and woke up with continuous, persistent coughing, a fever and significant amount of phlegm that oven been trying to expel as often as possible but can?t seem  keep up.  In addition, I cannot smell and can only taste only strong  flavors. That next day, I felt like I had the COVID virus ( I had a mildly severe  case of the second variant in Mar 2021) or the worst flu I?ve had in years.      This feels very similar to having the virus despite being  fully vaccinated and boosted. Other vaccines/booster shots only affected my sleep and  fatigue. I didn?t have such a significant flu-like, COVID-like  after the  three other shots (all Pfizer vaccines and first booster)  In addition, the knee that I had surgery on five months ago has swollen up and I?m  in excruciating pain despite being bed ridden for three 1/2 days.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling cold, Influenza like illness, Insomnia, Joint swelling, Malaise
Clinical narrative: At about 9:30 pm10/11/22, I began experiencing extreme aches throughout my entire body. I became very cold and was unable to breathe through my nose. I was unable to sleep comfortably and woke up with continuous, persistent coughing, a fever and significant amount of phlegm that oven been trying to expel as often as possible but can?t seem  keep up.  In addition, I cannot smell and can only taste only strong  flavors. That next day, I felt like I had the COVID virus ( I had a mildly severe  case of the second variant in Mar 2021) or the worst flu I?ve had in years.      This feels very similar to having the virus despite being  fully vaccinated and boosted. Other vaccines/booster shots only affected my sleep and  fatigue. I didn?t have such a significant flu-like, COVID-like  after the  three other shots (all Pfizer vaccines and first booster)  In addition, the knee that I had surgery on five months ago has swollen up and I?m  in excruciating pain despite being bed ridden for three 1/2 days.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Productive cough, Pyrexia, Taste disorder
Clinical narrative: At about 9:30 pm10/11/22, I began experiencing extreme aches throughout my entire body. I became very cold and was unable to breathe through my nose. I was unable to sleep comfortably and woke up with continuous, persistent coughing, a fever and significant amount of phlegm that oven been trying to expel as often as possible but can?t seem  keep up.  In addition, I cannot smell and can only taste only strong  flavors. That next day, I felt like I had the COVID virus ( I had a mildly severe  case of the second variant in Mar 2021) or the worst flu I?ve had in years.      This feels very similar to having the virus despite being  fully vaccinated and boosted. Other vaccines/booster shots only affected my sleep and  fatigue. I didn?t have such a significant flu-like, COVID-like  after the  three other shots (all Pfizer vaccines and first booster)  In addition, the knee that I had surgery on five months ago has swollen up and I?m  in excruciating pain despite being bed ridden for three 1/2 days.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pallor, Poor peripheral circulation, Raynaud's phenomenon, Skin texture abnormal
Clinical narrative: Marked decrease in circulation of L and R 2nd and 3rd toes when exposed to cool temperature that did not previously cause same Sx.  Experienced waxy white digits that resembled Raynauds like Sx that was initially refractory to worming and lasted 15 min or longer.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Diarrhoea
Clinical narrative: Lot number, dose in series not definite; pt has memory issues, spouse is POA & states patient had two boosters before the Bivalent Covid Pfizer immunization; rec'd flu shot concurrently. Spouse reported severe diarrhea (liquid stools x5 starting 2-3 hours after injections with generalized weakness). Spouse administered Pepto-Bismol then Immodium w eventual control of sx; Today patient is w/o symptoms, spouse reports no further diarrhea, physical exam unremarkable. Pt taking food/ fluids w/o difficulty; will f/u w PCP  within a week.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Agitation, Anxiety, Cold sweat, Feeling cold, Nausea
Clinical narrative: Patient exhibited mild signs of nausea, cool, clammy skin, anxiety approximately two minutes after immunization. PT was examined immediately by a nurse with no signs of adverse reaction, anaphylaxis, or any allergic reaction. It was noted that the PT was nervous/agitated during the administration of the vaccine and was demonstrating signs of anxiety. PT was further monitored for approximately 45 minutes successfully tolerating the immunization.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Nervousness
Clinical narrative: Patient exhibited mild signs of nausea, cool, clammy skin, anxiety approximately two minutes after immunization. PT was examined immediately by a nurse with no signs of adverse reaction, anaphylaxis, or any allergic reaction. It was noted that the PT was nervous/agitated during the administration of the vaccine and was demonstrating signs of anxiety. PT was further monitored for approximately 45 minutes successfully tolerating the immunization.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Face oedema, Lymphadenopathy, Nasal oedema
Clinical narrative: Pain and swelling in left arm ~12hrs after shot Swelling of left armpit and lymph nodes in left arm put ~ 36hrs after shot Mild Asthma  symptoms (use of prosit inhaler required ~67hrs after shot Mild Edema -right side of face and nose; right palm, right forearm
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Pain and swelling in left arm ~12hrs after shot Swelling of left armpit and lymph nodes in left arm put ~ 36hrs after shot Mild Asthma  symptoms (use of prosit inhaler required ~67hrs after shot Mild Edema -right side of face and nose; right palm, right forearm
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Dysgeusia, Headache, Hyperventilation, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: metal taste in mouth-Medium, Systemic: Headache-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out for about a minute or 2 after receiving a flu and a covid booster vaccines. paramedics were called in and checked vitals. all vitals were normal. patient left home with parent afterwards
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    The concomitant and treatment medication was not reported.  This case contains information for the 15th of 15 adult patients described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 15
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site induration, Injection site pruritus, Pain in extremity
Clinical narrative: swelling of the arm; itching at the injection site; redness of the arm; hardness as the injections site; arm soreness; warm feeling in her right arm; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 17-SEP-2022 between 13:35 and 14:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). At approximately 16:00, the patient began experiencing swelling of the arm (vaccination site swelling), itching at the injection site (vaccination site pruritus), redness of the arm (vaccination site erythema), hardness at the injection site (vaccination site induration), arm soreness (vaccination site pain), and a warm feeling in her right arm (vaccination site warmth). The patient did not believe that these symptoms were getting worse. This was all the information that was given regarding this case. At the time of reporting, the patient had not recovered from the events (reported as "How long will these symptoms last?").  The causal relationship between the reported events and polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: swelling of the arm; itching at the injection site; redness of the arm; hardness as the injections site; arm soreness; warm feeling in her right arm; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 17-SEP-2022 between 13:35 and 14:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). At approximately 16:00, the patient began experiencing swelling of the arm (vaccination site swelling), itching at the injection site (vaccination site pruritus), redness of the arm (vaccination site erythema), hardness at the injection site (vaccination site induration), arm soreness (vaccination site pain), and a warm feeling in her right arm (vaccination site warmth). The patient did not believe that these symptoms were getting worse. This was all the information that was given regarding this case. At the time of reporting, the patient had not recovered from the events (reported as "How long will these symptoms last?").  The causal relationship between the reported events and polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: swelling of the arm; itching at the injection site; redness of the arm; hardness as the injections site; arm soreness; warm feeling in her right arm; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 17-SEP-2022 between 13:35 and 14:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). At approximately 16:00, the patient began experiencing swelling of the arm (vaccination site swelling), itching at the injection site (vaccination site pruritus), redness of the arm (vaccination site erythema), hardness at the injection site (vaccination site induration), arm soreness (vaccination site pain), and a warm feeling in her right arm (vaccination site warmth). The patient did not believe that these symptoms were getting worse. This was all the information that was given regarding this case. At the time of reporting, the patient had not recovered from the events (reported as "How long will these symptoms last?").  The causal relationship between the reported events and polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: U
Vaccine: HEP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Caller is a pharmacist calling to report that improperly stored doses of RECOMBIVAX HB and VARIVAX were administered to the patient on 12AUG2022. No additional information provided. No additional AE reported. No PQC reported.     RECOMBIVAX HB- lot U; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient{s medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 12-AUG-2022, the patient was vaccinated with an improperly stored hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (lot number U008328 has been verified to be valid; expiration date reported and established as 16-DEC-2022), and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U028164 has been verified to be valid; expiration date reported and established as 09-SEP-2023) for prophylaxis (doses, vaccination schemes, routes of administration, and anatomical locations were not provided).    The administered dose of hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) was stored at a temperature of 48.79 degrees Fahrenheit  (F), during a time frame of 2 hours and 43 minutes (conflicting information also reported as 22.87 F during a time frame of 3 hours and 36 minutes), and for varicella virus vaccine live (Oka/Merck) (VARIVAX) a temperature of 33.13 F was reported during a time frame of 14 hours and 55 minutes. No additional temperature excursion were reported for neither of the vaccines. No additional adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Nurse reported that PNEUMOVAX 23 was administered to a couple twice. This AE is for the wife. Please see AE case 02256651 for the husband. Patient received one dose of PNEUMOVAX 23 on 9/19/2022 and was accidently given a dose again of PNEUMOVAX 23 on; Information has been received from a nurse, referring to a 88 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, lot number, expiration date and administration route was not provided) for prophylaxis. Later on 27-SEP-2022, the patient was accidently given an additional dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 ml, lot # U027357 and expiration date 25-MAR-2023 (administration route was not provided) for prophylaxis. No additional adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse regarding a 12-month-old patient of an unspecified gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002601, expiration date: 24-JAN-2024, product quantity 1, (dose, injection anatomical location, and route of administration were not provided) administered as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion for 1 hour and 45 minutes with previous excursions. No adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional adverse events reported; Caller reported VARIVAX that had undergone temperature excursion was administered to a patient.; Product administered to patient of inappropriate age; This spontaneous report was received from a nurse regarding a 1-day-old patient of unknown gender.     There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 01-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot number W002601, which had been verified to be valid, expiration date reported and validated as 24-JAN-2024), as prophylaxis (Improper storage of product in use) (Inappropriate age at vaccine administration). The vaccine administered was stored with an unknown temperature for a time frame of 1 hour and 45 minutes. There was a previous temperature excursion. No additional AE were reported. It was not reported if a data logger was used.; Sender's Comments:  US-009507513-2210USA001538: US-009507513-2210USA001524: US-009507513-2210USA001533:
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: No additional AE.; some of the MMR II dripped out and down the patient's arm.; This spontaneous report was received from a nurse concerning an 18-month-old child (also reported as baby) patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 12-AUG-2022, the patient may have been vaccinated with less than the recommended dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered subcutaneously as prophylaxis, lot number U025199 with expiration date 13-AUG-2023 (dosage regimen was not reported). The nurse reported that when the child received the vaccine, some of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) dripped out and down the patient's arm, and the child's parents were concerned the patient did not get the full dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) (Vaccine underdose). No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional ae reported; MMR II was administered to 2 patient's; This spontaneous report was received from a nurse referring to a 13-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T029549 with an expiration date on 10-SEP-2022), administered for prophylaxis (strength, and route of administration were not provided) (expired product administered).  No additional adverse events were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA001505:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was inadvertently administered PNEUMOVAX 23 via PNEUMOVAX 23 Prefilled Syringe on 10/10/2022. Expired on 07/01/2022; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-OCT-2022, the patient was vaccinated with a dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #T036820, expiration date: 01-JUL-2022, administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered).  There was no adverse event reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; potential temperautre excursion/but could not confirm if a temperautre excursion had occurred prior to the administration; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not provided.  The nurse reported that her data logger did not record temperatures for about a week. Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was "assumed to be in normal storage range", but could not confirm if a temperature excursion had occurred prior to the administration.   On 05-OCT-2022, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5ml, lot #U029144, expiration date: 31-MAR-2024, (strength, site and route of vaccination were not provided) for prophylaxis. No additional adverse event (AE) was reported (no adverse event). The temperature excursion for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was unknown. It was unknown if the previous temperature excursion occurred.
Age: 19.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; Caller reports that MMR II lot expired on 10/08/22 and was administered on 10/11/22; This spontaneous report was received from an administrator and refers to a 19-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 11-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin  (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T034391, expiration date: 08-OCT-2022, (strength, dose number, route and site of vaccination were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) was reported (no adverse event).  .
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Arrhythmia, Chest pain, Heart rate increased, Supraventricular tachycardia
Clinical narrative: CARDIAC ARRHYTHMIA (INTERMITTENT) 24 HOUR POST INJECTION; HIGH HEART RATES (SVT) INTERMITTENT WITH INTERMITTENT CHEST PAIN; A spontaneous report has been received from a consumer concerning a female patient of Caucasian ethnic origin (age 7 years, height 52 in, weight 98 lb).    No medical history was reported. No concomitant products were reported.    The following demography was reported for the patient's parent: Sex: Unknown    On an unknown date, the patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route. The patient received 1 dose(s).    No malfunction has been reported for FLUMIST QUADRIVALENT.    On 02-Oct-2022, the patient experienced cardiac arrhythmia (intermittent) 24 hour post injection (preferred term: Arrhythmia). On an unknown date, the patient experienced high heart rates (svt) intermittent with intermittent chest pain (preferred term: Chest pain).     At the time of reporting, the event of cardiac arrhythmia (intermittent) 24 hour post injection was improving. The outcome of the event of high heart rates (svt) intermittent with intermittent chest pain was unknown.     The reporter assessed the event of cardiac arrhythmia (intermittent) 24 hour post injection to be serious due to seriousness criteria of hospitalised.     The reporter assessed the event of  high heart rates (svt) intermittent with intermittent chest pain as non-serious.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Follow-up of insignificant information received by AstraZeneca/MedImmune on 07-Oct-2022 from consumer via spontaneous source: Patient initials updated. Reporter case id added. Narrative updated.; Sender's Comments: Arrhythmia is not listed in the company core data sheet of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Due to limited information on diagnosis confirmation, circumstances leading to event, clinical course and treatment provided, predisposing /triggering risk factors, relevant medical and cardiovascular history, concurrent conditions, concomitant medications, detailed diagnostic and etiologic workup, the evaluation did not find the evidence to suggest a causal relationship between the event and Quadrivalent live attenuated influenza vaccine (Q/LAIV).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/received vaccine, contracted shingles, joined 10% club; shingles//received vaccine, contracted shingles, joined 10% club; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The reporter reported that the he/she apparently joined the 10 percent club as Shingrix as advertised as 90 percent effective. The reporter really would like to talk to an expert on Shingrix to get their perspective from any clinical data that was available. The reporter consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary of vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2022AMR144944, reported by same reporter for himself/herself. The case was kept valid considering that the unspecified number of patients received vaccine and had shingles.; Sender's Comments:  US-GSK-US2022AMR144944:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got a shot 1 year, got shingles next year; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot 1 year ago and got shingles the next year. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/I had the shot, get a mild case of Shingles a couple of years later; Mild case of Shingles (annoying ); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and had no side effects.  The patient did get a mild case of shingles a couple of years later.  The patient stated that annoying but nothing like you described. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both vaccines, then got shingles/Suspected vaccination failure; shingles/ then got shingles/ last episode was very minor; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had similar experiences. The patient had both vaccines and then got shingles. The patient stated that last episode was very minor. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the shingles shot and got shingles/suspected vaccination failure; shingles/Got the shingles shot and got shingles; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shot and got shingles.  The patient stated that yup, very painful.  The patient mentioned that the people that have had chicken pox beware. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had shingrex 3 yrs ago, diagnosed shingles; shingles, lower side and stomach; This 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.   Previously administered products included Shingles vaccine  (received a dose of Shingles shot 7 years ago ).   On an unknown date, the patient received Shingrix. On 6th October 2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had a Shingrix shot 3 years ago and was just diagnosed Thursday with shingles.  The physician put him/her on a anti viral (Valtrex) to be taken for 7 days.  The patient had them on his/her lower left side and wraps around to the middle of his/her stomach and lower.  The patient stated that hopefully because of the vaccines and was asking that would have a milder case. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was reported that the patient was diagnosed thurs with shingles, considering that onset date was captured as 6th October 2022.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and then shingles/suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (a friend of reporter's daughter's) got the shot and then got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, Chills, Headache, Insomnia, Pain
Clinical narrative: Headaches; Body aches; Chills; Ringing in the ear; Unable to sleep; This case was reported by a consumer via patient support programs and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Shingrix. On 3rd October 2022, less than a day after receiving Shingrix, the patient experienced headache, general body pain, chills, ringing in ears and sleeplessness. On an unknown date, the outcome of the headache, general body pain, chills, ringing in ears and sleeplessness were resolved with sequelae.   It was unknown if the reporter considered the headache, general body pain, chills, ringing in ears and sleeplessness to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments:  The patient  stated that she received the 1st vaccine on Monday and she had headaches, body aches and chills, ringing in the ear, and unable to sleep been up since 4am from 3rd October 2022. The reporter seriousness for patient stated events were unspecified The reporter stated verbatim event relatedness were unknown. The reporter had given consent to contact.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Headaches; Body aches; Chills; Ringing in the ear; Unable to sleep; This case was reported by a consumer via patient support programs and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Shingrix. On 3rd October 2022, less than a day after receiving Shingrix, the patient experienced headache, general body pain, chills, ringing in ears and sleeplessness. On an unknown date, the outcome of the headache, general body pain, chills, ringing in ears and sleeplessness were resolved with sequelae.   It was unknown if the reporter considered the headache, general body pain, chills, ringing in ears and sleeplessness to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments:  The patient  stated that she received the 1st vaccine on Monday and she had headaches, body aches and chills, ringing in the ear, and unable to sleep been up since 4am from 3rd October 2022. The reporter seriousness for patient stated events were unspecified The reporter stated verbatim event relatedness were unknown. The reporter had given consent to contact.