chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bladder pain, Chills, Extra dose administered, Fatigue
Clinical narrative: This does not give the option to say that each vaccine I received caused symptoms.  I have now had my second booster as well.  I had the common symptoms of high fever above 102, headache, nausea, abdominal pain including bladder, fatigue, ache all over, extreme shivering chills for about 12 hours.  Then was left with fatigue and achiness for three weeks.  The side-effect worth noting is a recurrence of leg weakness causing an inability to walk right.  This happened in 2005-2006.  No diagnosis was ever given and it went away on its own.  It did recur until about a week after my first vaccine.  It settled down until the boosters I received on 11/02/.2021 and the second on 05/26/2022.  This last time it was more severe, but strength returned mostly after five days.  Too soon to tell if it is completely gone, but my past experience is that it no longer goes away completely, but shows up especially when I'm fatigued.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Muscular weakness, Nausea, Pain
Clinical narrative: This does not give the option to say that each vaccine I received caused symptoms.  I have now had my second booster as well.  I had the common symptoms of high fever above 102, headache, nausea, abdominal pain including bladder, fatigue, ache all over, extreme shivering chills for about 12 hours.  Then was left with fatigue and achiness for three weeks.  The side-effect worth noting is a recurrence of leg weakness causing an inability to walk right.  This happened in 2005-2006.  No diagnosis was ever given and it went away on its own.  It did recur until about a week after my first vaccine.  It settled down until the boosters I received on 11/02/.2021 and the second on 05/26/2022.  This last time it was more severe, but strength returned mostly after five days.  Too soon to tell if it is completely gone, but my past experience is that it no longer goes away completely, but shows up especially when I'm fatigued.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This does not give the option to say that each vaccine I received caused symptoms.  I have now had my second booster as well.  I had the common symptoms of high fever above 102, headache, nausea, abdominal pain including bladder, fatigue, ache all over, extreme shivering chills for about 12 hours.  Then was left with fatigue and achiness for three weeks.  The side-effect worth noting is a recurrence of leg weakness causing an inability to walk right.  This happened in 2005-2006.  No diagnosis was ever given and it went away on its own.  It did recur until about a week after my first vaccine.  It settled down until the boosters I received on 11/02/.2021 and the second on 05/26/2022.  This last time it was more severe, but strength returned mostly after five days.  Too soon to tell if it is completely gone, but my past experience is that it no longer goes away completely, but shows up especially when I'm fatigued.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Rash pruritic, Skin warm, Urticaria
Clinical narrative: About a week after I started to break out in hives / dermatographia. It?s been a daily occurrence since January and it is now June. Antihistamines help slightly but don?t make them go away. Constant hot itching and rashes daily.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria chronic
Clinical narrative: About a week after I started to break out in hives / dermatographia. It?s been a daily occurrence since January and it is now June. Antihistamines help slightly but don?t make them go away. Constant hot itching and rashes daily.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest discomfort, Fatigue, Feeling hot, Hypersomnia
Clinical narrative: 1. Heart area felt tied up and as if it would explode 2. Fatigue, could barely move out of bed and felt hot 3. Pain at injection site after both doses 4. Symptoms resolved after one day, including sleep of 8+ hours
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: 1. Heart area felt tied up and as if it would explode 2. Fatigue, could barely move out of bed and felt hot 3. Pain at injection site after both doses 4. Symptoms resolved after one day, including sleep of 8+ hours
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Burning sensation, Dental operation, Face injury, Fine motor skill dysfunction
Clinical narrative: Within 15 minutes of receiving the first dose of the Pfizer vaccine, my body began to go into shock. I started to lose vision and motor skills. I felt an intense burning sensation going through my entire body. There were no medical professionals present in the waiting area. Out of pure desperation, I got up to go alert someone. I made it to the door where the vaccine was being administered, but I fainted before I could alert a medical professional. I landed directly on my face, resulting in 4 fractured teeth. I required two surgeries to repair the damages, all of which I was forced to pay out of pocket for. One surgery was to remove the fractured teeth that were not salvageable, and the other was to put support posts into my gums for my new teeth (caps). Soon after the accident, I began to suffer from trauma induced panic attacks that I have never had in my life. I am now forced to take medication to ensure that I do not have these panic attacks anymore. I also have to go to therapy because of this incident. I was assured beforehand by the vaccine screeners that I would be safe, and that there would be professionals there to help me should I go into shock. There was no one to help me in the waiting area once I went into shock.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injury, Panic attack, Shock, Syncope, Tooth fracture
Clinical narrative: Within 15 minutes of receiving the first dose of the Pfizer vaccine, my body began to go into shock. I started to lose vision and motor skills. I felt an intense burning sensation going through my entire body. There were no medical professionals present in the waiting area. Out of pure desperation, I got up to go alert someone. I made it to the door where the vaccine was being administered, but I fainted before I could alert a medical professional. I landed directly on my face, resulting in 4 fractured teeth. I required two surgeries to repair the damages, all of which I was forced to pay out of pocket for. One surgery was to remove the fractured teeth that were not salvageable, and the other was to put support posts into my gums for my new teeth (caps). Soon after the accident, I began to suffer from trauma induced panic attacks that I have never had in my life. I am now forced to take medication to ensure that I do not have these panic attacks anymore. I also have to go to therapy because of this incident. I was assured beforehand by the vaccine screeners that I would be safe, and that there would be professionals there to help me should I go into shock. There was no one to help me in the waiting area once I went into shock.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EH9889), in left arm, on 05Jan2021 as dose 2, single (Lot number: EL3214), in left arm and on 28Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive, notes: + COVID Ag test d8 post COVID. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2 weeks. No Known allergies. Patient received Anti-viral treatment for COVID-19 with Paxlovid from 17May2022 to 21May2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events covid 19 , vaccination failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE details; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range were administered to patients.   Names of vaccines involved (including lot/exp) PROQUAD; U039258; 6/9/2023        ?    Temperature 6°F; This spontaneous report was received from an administrator concerning a 5-years-old male patient.   The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 22-APR-2022, the patient was vaccinated with an improperly store (stored outside of recommended range) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin [rHA]) lot # U039258, expiration date: 09-JUN-2023, (dose, route and anatomical location were not reported) for prophylaxis. The vaccine was reconstituting with a sterile diluent (DILUENT MERCK)  (product storage error).  The storage temperature was 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (7.9 F) for 4 hours 8 minutes 0 seconds. No previous temperature excursions reported. On 09-MAY-2022, it was reported the office was unaware of the temperature excursion until she completed a data logger download (on 02-MAY-2022). No adverse events have been reported to the office at the time of the report.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA000973: US-009507513-2205USA001061: US-009507513-2205USA001202: US-009507513-2205USA001272: US-009507513-2205USA001205: US-009507513-2205USA001271:
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: had no adverse effects or symptoms from administration; Patient is now 18 years old and got her second dose of HPV vaccine today, GARDASIL 9; the vaccine was expired; This spontaneous report was received from a pharmacist and referred to an 18-year-old female patient. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in 2015, when patient was 12 years old, she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis at clinic (strength, lot #, expiry date, and route of administration were not provided; 0.5ml/once). The patient had no adverse effects with that.  On 05-MAY-2022, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, and route of administration were not provided; 0.5ml/once, lot #S022599, expiration date was reported as February 2022, upon internal validation, it was established as 25-FEB-2022) (inappropriate schedule of product administration and expired product administered). After administration, the staff realized the vaccine was expired. The reporter did not have exact expiration date as vial had been discarded and expiration date was documented only as February 2022. The patient had no adverse effects or symptoms from administration. Dose had no prior temperature excursions and was supported per post-expiry memo.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: VAQTA that had undergone temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from an other health professional, referring to a female patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were unknown.     On an unknown date, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (strength, dose, dose number and route were not provided; lot number U026782 is not valid for hepatitis A vaccine, inactivated (VAQTA) with expiration date reported as 28-OCT-2022) that had undergone temperature excursion for prophylaxis (product storage error). No additional adverse event (AE) reported.       The storage temperature of the vaccine was 49.6 degrees Fahrenheit for a time frame of 32 minutes. There is no previous temperature excursion.
Sex: F
Vaccine: PNC15
Symptoms: Vaccination site erythema
Clinical narrative: Caller reports that a 70 year old female patient developed a circular erythema at the injection site 10 days after immunization with VAXNUVANCE.; This spontaneous report was received from a nurse practitioner via company representative concerning a 70-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not reported.  On an unspecified day, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNUVANCE) (dosage regimen, lot number, expiration date, route of administration, and anatomical location were not reported) administered as prophylaxis.  Afterwards, she developed a circular erythema at the injection site (vaccination site erythema) 10 days after the immunization. No additional information was reported. At the reporting time, the outcome of the event was not provided.  The causality assessment between the event of vaccination site erythema and pneumococcal 15v conj vaccine (CRM197) (VAXNUVANCE) was unknown.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Poor quality product administered, Product container seal issue
Clinical narrative: she has a box of ROTATEQ in which the foil pouches containing ROTATEQ are unsealed; Caller reports that patient did not have any adverse effects or symptoms following administration of the ROTATEQ.; three doses have been given out of that box /caller reports the dose of ROTATEQ was administered on 27-APR-2022; This spontaneous report has been received from a Registered Nurse referring to a 3-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.   On 27-APR-2022, the patient was vaccinated with a possibly unsealed rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter (ml) orally (strength and vaccination scheme frequency were not provided; lot number 1742077 has been verified to be a valid lot number with and expiration date reported and established as 12-SEP-2022) as prophylaxis (poor quality product administered).   The reporter stated that she had a box of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) in which the foil pouches containing the vaccine were unsealed (product container seal issue ), and that three doses had been administered out of that box. However, this was noticed until 11-MAY-2022; therefore, the reporter did not know whether the foil pouches containing the administered doses were also unsealed.  It was reported that the patient did not have any adverse effects or symptoms following the administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003440: US-009507513-2205USA003247:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to an 1-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 24-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On 23-MAR-2022, the vaccine underwent temperature excursion from -14 Celsius degrees (C) to -10C for 3 hours and from -10C to 8C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: still experiencing swelling at the injection site.; This spontaneous report has been received from a nurse referring to a non-pregnant 43-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided.      On 21-APR-2022 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters (ml) in the right deltoid, lot number U008316 has been verified to be a valid lot number, expiry date 15-AUG-2023 (strength and vaccination scheme were not provided) for prophylaxis.     On the same date,was experiencing swelling at the injection site. The patient sought medical attention; however, no treatment was given for the adverse event.   At the time of reporting, the patient was not recovered from injection site swelling. The causal relationship between the aforementioned event and the suspect vaccine was not provided.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Patient was administered expired VARIVAX; This spontaneous report was received from a certified medical assistant, referring to a 13-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided.  On 13-MAY-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T015999, expiration date 08-MAY-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events or product quality complaints were reported (no advere event).
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: he received MMR II when he was a kid but his titers were low so he went to get re-vaccinated.; a dose of MMR II given IM in the deltoid instead of SQ.; This spontaneous report has been received from a male patient of unknown age, reporting on himself. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date (reported as "when he was a kid"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot #, expiration date, route of administration and anatomical location were not provided) as prophylaxis.  On an unknown date, his titers were low (unspecified test) (antibody test abnormal), due to this, he went to get revaccinated, and on an unknown date, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered intramuscularly (IM) (incorrect route of product administration) (conflicting information, also reported as "subcutaneous [SQ] instead of IM") in the deltoid region (unspecified side) (dose, lot # and expiration date were not provided) as prophylaxis. The reporter stated the titers would be check again post vaccination. At the time of the report, the outcome for antibody test abnormal was not reported.  The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and antibody test abnormal was not reported.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported at time of call; a labeled expiry of 5/12/2022 was administered to a patient on 5/13/2022.; This spontaneous report has been received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 13-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 mL, lot # T016352, expiration date 12-MAY-2022 (route of administration and anatomical location were not provided) as prophylaxis (expired product administered). There was no report of temperature excursions. No additional events were reported (no adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: she started to have unspecififed itching; localised erythema; This spontaneous report has been received from a pharmacist, who was also the patient, a female patient of unknown age referring to herself. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were reported as none.     On 24-JAN-2022, the patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) on an unspecified arm, and on 21-FEB-2022, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) in her left arm; both vaccines with route of administration reported as injection, also the same lot number U025205 that has been verified to be a valid lot number with expiry date on 13-AUG-2023, indicated for varicella (strength, dose, and frequency were not provided).       On an unspecified date in February 2022 (also reported as a couple of days after the second dose), the patient started to have an unspecified itching that comes and goes predominantly on her arms, but can also be anywhere on her body (pruritus). The patient did not report a rash but did state that after she started itching and began to scratch, the are she scracted became red. Additionally, the patient reached out for medical attention with her health care professional (HCP) and was prescribed prednisone which she started on an unknown date in May 2022 (also reported as earlier this week).. Furthermore, on an unknown date, unspecified lab work was performed and came out with normal results.   The outcome of pruritus and erythema was reported as not recovered.  The causal relationship between varicella virus vaccine live (oka/merck) (VARIVAX) with pruritus and erythema was not reported.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report has been received from a medical assistant, concerning a 5-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 05-APR-2022, the patient was vaccinated with improperly stored second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022 (Product storage error). No previous temperature excursion was reported. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008105: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008066: US-009507513-2205USA008069: US-009507513-2205USA008100: US-009507513-2205USA008189: US-009507513-2205USA007739: US-009507513-2204USA009330:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Improperly stored VARIVAX administered; This spontaneous report has been received from a certified medical assistant, concerning a 4-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. The patient's birth weight was reported as 6 pounds and 11 oz.  On 14-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (second dose) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis.   The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022. No previous temperature excursion was reported. No additional adverse events were reported. It was also mentioned that the patient experienced a "device or device component malfunction" (Discrepant information).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004:
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a health professional and refers to a 6-year-old female patient. The patients' pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 31-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number U025790, expiration date reported as 19-AUG-2023, and lot number U029496, expiration date reported as 21-SEP-2023, administered for prophylaxis (strength were not provided) (product storage error). The temperature excursion was -14 degrees Celsius (°C) up to -10°C for 3 hours 0 minutes, and  -10°C up to 8°C for 1 hour 30 minutes 0 seconds. No previous temperature excursion was reported. No adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008004:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX has been administered to a total of 13 patients. Temperature excursion; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.   On an unspecified date between 11-MAY-2022 and 24-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX)  subcutaneous injection, lot #U039949, expiration date: 16-DEC-2023 (dose, route, vaccination scheme frequency and anatomical location were not provided); along with an sterile diluent, for prophylaxis.  The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 2 hours (h), 5 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 25 min, 0 sec. The involved vaccine had a previous temperature excursion of -14°C up to-10°C (-12C) for 50 minutes 0 seconds. No additional adverse events were reported.
Age: 48.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Patient received VAXNEUVANCE and had injection site swelling and muscle aches following administration of VAXNEUVANCE.; Patient received VAXNEUVANCE and had injection site swelling and muscle aches following administration of VAXNEUVANCE.; This spontaneous report has been received from a physician, regarding herself, a 48 years-old non pregnant female patient. The patient's medical history included asthma as current condition. Previous drug reaction included injection site swelling and muscle aches after the administration of a COVID vaccines (manufacturer unknown). Allergies and concomitant medications were not reported.  On 26-MAY-2022, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) intramuscularly as prevention of invasive pneumococcal disease (strength, dose, scheme, lot number and expiration date were not reported.  On the same day, the patient experienced injection site swelling and muscle aches (myalgia) following administration of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). The patient did not received treatment. The outcome of the events was reported as recovering.   The causal relationship between injection site swelling and (myalgia) and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) was not reported.
Sex: U
Vaccine: HEP, HEPAB, UNK
Symptoms: Expired product administered
Clinical narrative: patient received expired dose; This case was reported by a other health professional via other manufacturer and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hepatitis B vaccine for prophylaxis and benzathine benzylpenicillin (Bicillin La) unknown for product used for unknown indication.   On an unknown date, the patient received Twinrix, Twinrix Pre-Filled Syringe Device, Hepatitis B vaccine and Bicillin La at an unknown dose and frequency. On an unknown date, unknown after receiving Twinrix, Twinrix Pre-Filled Syringe Device and Hepatitis B vaccine, the patient experienced expired vaccine used. The action taken with Bicillin La was unknown. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comments: The pharmacy intern called from a health system regarding Bicillin LA. The reporter's supervisor informed her that, they had a patient that received an expired product and were trying to get more information. The pharmacist was working with the patient. The reporter believed that, they gave expired dose of Twinrix to the patient. The patient might have received expired dose of Hepatitis B vaccine as well. She did not have a lot number or expiration date of product. On an unknown date, unknown after receiving Bicillin LA, the patient experienced expired product used. No further details were provided. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, Hepatitis B vaccine,which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Localized redness from first dose; This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR084938   Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The patient was over 50 years at the time of reporting. Patient received first dose of Shingrix back in January, 2022 and went in a month before reporting for second dose. Patient received both doses at local pharmacy. Patient had localized redness after the first dose. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose refer linked case US2022AMR084938, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084938:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS, pt is apprehensive about other vx; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-Feb-2022 Reporter's Comments: The reporter had a patient who developed GBS (Guillain Barre syndrome) after a dose of Shingrix within 42 days. The patient was due for a Flu shot and COVID-19 booster shot, but was apprehensive about receiving any more vaccinations. The reporter requested any information GlaxoSmithKline could provide. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR086239:same reporter, case deleted
Sex: U
Vaccine: COVID19, COVID19, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: Got singles, has Shingrix shots/suspected vaccination failure; got Covid in Dec after 3rd Pfizer; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID 19 VACCINE MODERNA) for prophylaxis and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   The patient's past medical history included shingles (in 2011). Previously administered products included Pfizer Covid-19 vaccine (received 2 dose of Pfizer on an unknown date).   On an unknown date, the patient received Shingrix. In May 2022, the patient received the 4th dose of COVID 19 VACCINE MODERNA. On an unknown date, the patient received the 3rd dose of COVID-19 VACCINE PFIZER. In May 2022, more than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria medically significant) and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix.     Additional Information: receipt date: 29-May-2022 Reporter's comment: The case was received from the patient via social media interactive digital media. The patient had received 3 Pfizer with negative effects. The patient had Shingrix shots and 2 weeks before the reporting day, the patient got shingles right after the 4th shot of Covid vaccine (Moderna). Less than 2 years after the Shingrix shots and unknown after 3rd dose of Pfizer, the patient got Covid in December. It unknown if the reporter considered the Covid-19 to be related to Covid-19 Vaccine Pfizer. It unknown if the reporter considered the vaccination failure, shingles to be related to Moderna Covid-19.  Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot about a year ago, never got second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got first Shingrix shot about a year ago (would be confirmed) but definitely more than 6 months).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAY-2022 Reporter's Comment: The patient never got his/her second shot of Shingrix.  The reporter wanted to know how did they go about getting this finished. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Vaccine underwent temperature excursions administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, 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: 31-MAY-2022 Reporter's Comment: The patient administered with Infanrix that underwent temperature excursions. Additional Supportive Information: The patient administered with Infanrix that underwent temperature excursions, which led to incorrect storage of drug. The case had been linked to US2022AMR086945,reported by the same reporter, for a different product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR086945:Same Reporter
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine underwent temperature excursions administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect product storage in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA642A, expiry date 30th November 2022) for prophylaxis.   On 31st May 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 31-May-2022 Reporter's Comments: Menveo underwent temperature excursions was administered on 31st May 2022. Additional Supportive Information: The patient received dose of Menveo that underwent temperature excursions, which led to incorrect storage of drug. This case had been linked with case US2022AMR086924, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR086924:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administration of a Third dose; This case was reported by a physician and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th June 2018) and Shingrix (2nd dose received on 3rd September 2018). Concomitant products included PNEUMOCOCCAL VACCINE (PREVENAR).   On 1st June 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 1st June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: The patient self-reported the case. The patient was administered with varicella zoster 50 yrs plus (shingrix - shingles) 0.5 ml intramuscular and pnucn20 (Prevenar 20) (pneumococcal conjugate, 20 valent). The patient's intention was to receive Prevnar 20, however, the patient was informed by his/her provider that he/she only had a single prior dose of Shingrix and required a second dose to complete his/her immunization for shingles. After receiving both Shingrix, and Prevenar vaccines, the patient later discovered that he/she previously had two prior Shingrix vaccines. The reporter asked what were the complications or risks of receiving a 3rd dose of Shingrix vaccination after completed series of 2 doses. The reporter also asked if there were any issues associated with concomitant administration of Prevnar 20 on same day. Additional Supportive Information: The patient inadvertently administered with third dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 05-may-2022 patient is late for the 2nd dose 1st dose was administrated on 2019/Only first dose was administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's comment: The pharmacist reported that the patient was late for second dose of Shingrix. No LOT number and expiration date provided. No vaccination date provided and dob (date of birth) was provided. VAERS details were reported for 1st dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HAV (Havrix adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 31st May 2022, the patient received Havrix adult. On 31st May 2022, unknown after receiving Havrix adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022086481   Additional Information: Additional Information: GSK Receipt Date: 31-May-2022 Reporter's Comments: Medical Assistant reported a patient was administered an expired dose of Havrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix adult vaccine which was already expired. Case US2022086481 was identified as duplicate of US2022086483. The case US2022086481was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: administered to a patient 3 days after the expiration date; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 1st May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 4th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: The registered nurse stated that Rotarix was administered to a patient 3 days after the expiration date. The reporter consented to follow up via posta. Initials of patient and lot number not available at the time of the reporting.  Additional Supportive Information: The patient received Rotarix which was already expired, which led to expired vaccine used.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received dose reconstituted by using saline; received dose reconstituted by using saline; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 3G33K, expiry date 10th July 2023) for prophylaxis.   On 27th May 2022, the patient received the 2nd dose of Shingrix. On 27th May 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: The pharmacist reported that the patient had received (not completely sure if that was the date) a 2nd dose of Shingrix that was reconstituted by using normal saline. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email. Additional Supportive Information: The patient had received a 2nd dose of Shingrix that was reconstituted by using normal saline which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.