chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry throat, Dysphonia, Flushing, Hyperhidrosis
Clinical narrative: Pt reported vomiting, lip numbness, flushing/sweating, dizziness, throat itching, hoarse voice. Vitals: @19:05 159/98, 78, 22, 97.4F, 100% -- > @19:20 157/89, MAP 106, 78, 100% EMS called @1914.   19:27 EMS arrived and pt transported to the local Hospital  IN ED: she started experiencing a dry and itchy throat, her lips started to get swollen and numb, and she started having a rash. She was sent to the ER via 911. She was given 1 shot of epinephrine and 1 shot of Bendaryl. She stayed in the ED for 2-3 hours. She continued to feel a numb sensation in throat for 1 day after being discharged. She notes she was well prior to the vaccine and was on no new meds, supplements, diet, etc.  At follow up 5/25/22 Possible allergic reaction after first Covid vaccination 1 week ago (Pfizer). Initially throat sx, No hives. Later noted lip swelling (no pictures). No lung Or GI sx. No diffuse rash. No hx of allergic reactions to any meds except reactions to narcotics. Discussed with patient that research has shown that the majority of patients who had similar-type reaction to first dose of Covid vaccine have tolerated subsequent doses without problem. She does not desire to get vaccine, only done per her lawyer If subsequent dose needed will see about the skin test protocol, pre-treat w/ antihistamine and receive in medical facility.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Pharyngeal hypoaesthesia, Rash, Throat irritation
Clinical narrative: Pt reported vomiting, lip numbness, flushing/sweating, dizziness, throat itching, hoarse voice. Vitals: @19:05 159/98, 78, 22, 97.4F, 100% -- > @19:20 157/89, MAP 106, 78, 100% EMS called @1914.   19:27 EMS arrived and pt transported to the local Hospital  IN ED: she started experiencing a dry and itchy throat, her lips started to get swollen and numb, and she started having a rash. She was sent to the ER via 911. She was given 1 shot of epinephrine and 1 shot of Bendaryl. She stayed in the ED for 2-3 hours. She continued to feel a numb sensation in throat for 1 day after being discharged. She notes she was well prior to the vaccine and was on no new meds, supplements, diet, etc.  At follow up 5/25/22 Possible allergic reaction after first Covid vaccination 1 week ago (Pfizer). Initially throat sx, No hives. Later noted lip swelling (no pictures). No lung Or GI sx. No diffuse rash. No hx of allergic reactions to any meds except reactions to narcotics. Discussed with patient that research has shown that the majority of patients who had similar-type reaction to first dose of Covid vaccine have tolerated subsequent doses without problem. She does not desire to get vaccine, only done per her lawyer If subsequent dose needed will see about the skin test protocol, pre-treat w/ antihistamine and receive in medical facility.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Pt reported vomiting, lip numbness, flushing/sweating, dizziness, throat itching, hoarse voice. Vitals: @19:05 159/98, 78, 22, 97.4F, 100% -- > @19:20 157/89, MAP 106, 78, 100% EMS called @1914.   19:27 EMS arrived and pt transported to the local Hospital  IN ED: she started experiencing a dry and itchy throat, her lips started to get swollen and numb, and she started having a rash. She was sent to the ER via 911. She was given 1 shot of epinephrine and 1 shot of Bendaryl. She stayed in the ED for 2-3 hours. She continued to feel a numb sensation in throat for 1 day after being discharged. She notes she was well prior to the vaccine and was on no new meds, supplements, diet, etc.  At follow up 5/25/22 Possible allergic reaction after first Covid vaccination 1 week ago (Pfizer). Initially throat sx, No hives. Later noted lip swelling (no pictures). No lung Or GI sx. No diffuse rash. No hx of allergic reactions to any meds except reactions to narcotics. Discussed with patient that research has shown that the majority of patients who had similar-type reaction to first dose of Covid vaccine have tolerated subsequent doses without problem. She does not desire to get vaccine, only done per her lawyer If subsequent dose needed will see about the skin test protocol, pre-treat w/ antihistamine and receive in medical facility.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Headache, Visual impairment
Clinical narrative: blurred and fuzzy vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurred and fuzzy vision".  Additional information: Reporter stated that she had called about the Pfizer Covid vaccine, adult. It was her first vaccine. She had blurred and fuzzy vision. She agrees to complete report. Due to sound quality, she agrees for agent to call her back, to finish report. Two unsuccessful outbound calls made by agent, and voicemail obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: blurred and fuzzy vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurred and fuzzy vision".  Additional information: Reporter stated that she had called about the Pfizer Covid vaccine, adult. It was her first vaccine. She had blurred and fuzzy vision. She agrees to complete report. Due to sound quality, she agrees for agent to call her back, to finish report. Two unsuccessful outbound calls made by agent, and voicemail obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown), in left arm and on 02Dec2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 011M20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme" (unspecified if ongoing), notes: Other medical history: Lyme; "Known allergies: medications containing sulfa" (unspecified if ongoing), notes: Known allergies: medications containing sulfa; "Interchange of vaccine products" (unspecified if ongoing), notes: Dose: 1- Moderna, Dose 2 and 3- Pfizer. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown), in left arm and on 02Dec2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 011M20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme" (unspecified if ongoing), notes: Other medical history: Lyme; "Known allergies: medications containing sulfa" (unspecified if ongoing), notes: Known allergies: medications containing sulfa; "Interchange of vaccine products" (unspecified if ongoing), notes: Dose: 1- Moderna, Dose 2 and 3- Pfizer. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: patient developed tinnitus, but it got worse not horrible after the second booster dose; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (patient developed tinnitus, but it got worse not horrible after the second booster dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19. The patient had no acute and chronic past illnesses related to the adverse event at the time of vaccination. No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. The patient had no allergies to medications, food and other products except seasonal allergies.  Concurrent medical conditions included Seasonal allergy (just seasonal allergies).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced TINNITUS (patient developed tinnitus, but it got worse not horrible after the second booster dose). At the time of the report, TINNITUS (patient developed tinnitus, but it got worse not horrible after the second booster dose) outcome was unknown.            The patient takes regular medication but did not report which medication the patient takes exactly.  The patient received second dose of Moderna vaccine 28 days after the first dose.  On 27-Oct-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 11-May-2022, the patient received second booster dose of Moderna COVID-19 Vaccine.  After receiving the first booster dose, the patient developed tinnitus, but it got worsened and not horrible after the second booster dose.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-571807 (Patient Link).   Reporter did not allow further contact
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: aspiration pneumonia after testing positive for covid 5/22/22
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Pneumonia aspiration, SARS-CoV-2 test positive
Clinical narrative: aspiration pneumonia after testing positive for covid 5/22/22
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Arthralgia, Asthenia, Blood test normal, Cognitive disorder
Clinical narrative: After my second dose of Pfizer BioNTech, I have flu-like symptoms within 90 minutes and hormonal symptoms within 24 hours. These symptoms have been communicated to numerous western and functional doctors and included: fatigue, headache & severe cognitive issues, intense muscle pain (feeling like my entire body was getting paralysed), joint pain, mild fever, intense ongoing pain at the injection site, severe pelvic pain and sensations, adverse changes to my hair (greasy and straw-like), late/ missed menstrual cycle, locking of my left hand, and occasional numbness and tingling in my feet. Within 90 minutes of the vaccine on the afternoon of June 2, 2021, I was holding my head and not feeling well enough to work. The symptoms intensified around 3-8 weeks with intense muscle aches and fatigue. It has been almost 12 months and I still have severe cognitive issues, belts of intense muscle aches, fatigue and energy issues, and occasional pelvic pain. Symptoms continue to prevent me from performing my regular work, exercising, and during 'flares' from undertaking basic daily activities. The vaccine has taken a year of my life and still counting.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram pelvis, Exercise tolerance decreased, Fatigue, Hair texture abnormal, Headache
Clinical narrative: After my second dose of Pfizer BioNTech, I have flu-like symptoms within 90 minutes and hormonal symptoms within 24 hours. These symptoms have been communicated to numerous western and functional doctors and included: fatigue, headache & severe cognitive issues, intense muscle pain (feeling like my entire body was getting paralysed), joint pain, mild fever, intense ongoing pain at the injection site, severe pelvic pain and sensations, adverse changes to my hair (greasy and straw-like), late/ missed menstrual cycle, locking of my left hand, and occasional numbness and tingling in my feet. Within 90 minutes of the vaccine on the afternoon of June 2, 2021, I was holding my head and not feeling well enough to work. The symptoms intensified around 3-8 weeks with intense muscle aches and fatigue. It has been almost 12 months and I still have severe cognitive issues, belts of intense muscle aches, fatigue and energy issues, and occasional pelvic pain. Symptoms continue to prevent me from performing my regular work, exercising, and during 'flares' from undertaking basic daily activities. The vaccine has taken a year of my life and still counting.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Hypoaesthesia, Impaired work ability, Influenza like illness, Injection site pain
Clinical narrative: After my second dose of Pfizer BioNTech, I have flu-like symptoms within 90 minutes and hormonal symptoms within 24 hours. These symptoms have been communicated to numerous western and functional doctors and included: fatigue, headache & severe cognitive issues, intense muscle pain (feeling like my entire body was getting paralysed), joint pain, mild fever, intense ongoing pain at the injection site, severe pelvic pain and sensations, adverse changes to my hair (greasy and straw-like), late/ missed menstrual cycle, locking of my left hand, and occasional numbness and tingling in my feet. Within 90 minutes of the vaccine on the afternoon of June 2, 2021, I was holding my head and not feeling well enough to work. The symptoms intensified around 3-8 weeks with intense muscle aches and fatigue. It has been almost 12 months and I still have severe cognitive issues, belts of intense muscle aches, fatigue and energy issues, and occasional pelvic pain. Symptoms continue to prevent me from performing my regular work, exercising, and during 'flares' from undertaking basic daily activities. The vaccine has taken a year of my life and still counting.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Joint lock, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Malaise, Mobility decreased
Clinical narrative: After my second dose of Pfizer BioNTech, I have flu-like symptoms within 90 minutes and hormonal symptoms within 24 hours. These symptoms have been communicated to numerous western and functional doctors and included: fatigue, headache & severe cognitive issues, intense muscle pain (feeling like my entire body was getting paralysed), joint pain, mild fever, intense ongoing pain at the injection site, severe pelvic pain and sensations, adverse changes to my hair (greasy and straw-like), late/ missed menstrual cycle, locking of my left hand, and occasional numbness and tingling in my feet. Within 90 minutes of the vaccine on the afternoon of June 2, 2021, I was holding my head and not feeling well enough to work. The symptoms intensified around 3-8 weeks with intense muscle aches and fatigue. It has been almost 12 months and I still have severe cognitive issues, belts of intense muscle aches, fatigue and energy issues, and occasional pelvic pain. Symptoms continue to prevent me from performing my regular work, exercising, and during 'flares' from undertaking basic daily activities. The vaccine has taken a year of my life and still counting.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Pelvic pain, Pyrexia, Seborrhoea
Clinical narrative: After my second dose of Pfizer BioNTech, I have flu-like symptoms within 90 minutes and hormonal symptoms within 24 hours. These symptoms have been communicated to numerous western and functional doctors and included: fatigue, headache & severe cognitive issues, intense muscle pain (feeling like my entire body was getting paralysed), joint pain, mild fever, intense ongoing pain at the injection site, severe pelvic pain and sensations, adverse changes to my hair (greasy and straw-like), late/ missed menstrual cycle, locking of my left hand, and occasional numbness and tingling in my feet. Within 90 minutes of the vaccine on the afternoon of June 2, 2021, I was holding my head and not feeling well enough to work. The symptoms intensified around 3-8 weeks with intense muscle aches and fatigue. It has been almost 12 months and I still have severe cognitive issues, belts of intense muscle aches, fatigue and energy issues, and occasional pelvic pain. Symptoms continue to prevent me from performing my regular work, exercising, and during 'flares' from undertaking basic daily activities. The vaccine has taken a year of my life and still counting.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: One month after my 4th dose of Pfizer, I tested positive for COVID.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood lactic acid, Cellulitis, Full blood count, Liver function test
Clinical narrative: Second day post 3rd booster - developed fever and severe sepsis due to left lower extremity cellulitis - he is being admitted to hospital for IVF and IV ABX.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Pyrexia, Sepsis
Clinical narrative: Second day post 3rd booster - developed fever and severe sepsis due to left lower extremity cellulitis - he is being admitted to hospital for IVF and IV ABX.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID a month after dose 4 of Pfizer vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic ketoacidosis, Intensive care, Laboratory test abnormal, Type 1 diabetes mellitus
Clinical narrative: Permanent condition Diabetes Type 1 , treatment insulin injection to help to manage the diabetes
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I rarely got my period anymore, but then 2 weeks after the vaccine, I had my period for almost 2 full months.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Full body rash. Persistent mildly erythematous full body maculopapular rash, itchy. Started day of vaccine and persisted x1wk.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye irritation, Eyelid margin crusting, Meibomian gland dysfunction, Photophobia
Clinical narrative: I have had 4 COVID shots to date. About a month after the first shot I developed conjunctivitis that appeared to be related to Meibomian gland dysfunction. It was treated with steroid drops and antibiotic drops. After the 2nd, 3rd and 4th  shot I had  repeat episodes of conjunctivitis,  Eyes burning, lashes stuck together in the am, light sensitivity. Up until today I never thought the vaccine was related to the eye problem. I was reading about how to treat and prevent dry eye issues and ran across an article which correlated some eye issues with COVID cases and the COVID vaccine.  It may just be a coincidence that I developed a chronic eye problem over the 2 years I have been getting the COVID vaccines and boosters but I felt it was worth putting in a report in case you. have seen this occur in other vaccine recipients.  My last booster was a month ago and I had an eye flare up about 2 weeks after the injection. It was treated with steroid eyedrops and my eyes seem OK now. I am using fish oil, warm compresses, and 5x/day PF eyedrops.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angioedema, Chest pain, Headache, Oropharyngeal pain
Clinical narrative: Developed red itchy painful rash on neck about 35 hours after vaccine that lasted 3-4 days. Then exactly two weeks after vaccine I developed hives , swelling that come and go daily with red flat rash that comes and goes,headaches, intermittent upper abdominal pains ,  chest pains and throat pain.  Per Dermatology they call it  Acute Urticaria and Angioedema. Symptoms now going on 4 weeks this Friday.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Swelling, Urticaria
Clinical narrative: Developed red itchy painful rash on neck about 35 hours after vaccine that lasted 3-4 days. Then exactly two weeks after vaccine I developed hives , swelling that come and go daily with red flat rash that comes and goes,headaches, intermittent upper abdominal pains ,  chest pains and throat pain.  Per Dermatology they call it  Acute Urticaria and Angioedema. Symptoms now going on 4 weeks this Friday.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: NO adverse event reported; Patient has received Dose #1 on 1/4/2022 (T006849  6/16/2022) Dose # 2 on 3/11/2022 (T006849  6/16/2022) and a 3rd dose on 4/15/2022 (T020618  3/16/2023); This spontaneous report was received from a medical assistant referring to a 5-month-old female patient.  The patient's medical history, concurrent conditions and previous drug reactions or allergies were not reported. The patient's concomitant medications included rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX).   On 04-JAN-2022, the patient was vaccinated by a healthcare professional with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter (ml), lot: number T006849, which was determined to be valid, with expiration date: 16-JUN-2022, administered intramuscularly for prophylaxis (strength and anatomical site were not provided). On 11-MAR-2022, the patient received the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter (ml), lot number: T006849, which was determined to be valid, with expiration date: 16-JUN-2022, administered intramuscularly for prophylaxis (strength and anatomical site were not provided). On 15-APR-2022, the patient received an unscheduled dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter (ml), lot number: T020618, which was determined to be valid, with expiration date: 16-MAR-2023, administered intramuscularly for prophylaxis (strength and anatomical site were not provided) (extra dose administered). At the time of reporting, the outcome of the event extra dose administered was recovered.   There were no other adverse event or product quality complaint reported.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; patient was inadvertenly administered a GARDASIL 9 vaccine past it's expiration date; This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, drugs reactions or allergies and medical history were not provided.  On 25-APR-2022, the patient was inadvertently vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # T005928, expiration date 12-APR-2022 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).  This report was considered as non-valid due to lack of the patient's identifiers.  Follow-up information has been received from a registered nurse and updated the unspecified patient of unknown age and gender to a 33-year-old female patient. The patient had no known drug allergies (NKDA). The patient had cervical cancer.  On 25-APR-2022, the patient came for the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, and administrated in right deltoid. The type of medication checked and given. Patient waited after infection and after no adverse reaction left clinic. On checking the injection, the reporter then noted that the expiration date on laid injection was 12-APR-2022. After called the pharmacy and spoke with reporter, pharmacist, explaining what had happened. The reporter called Merck and told there would be no loss in strength of the vaccine in that time frame. A quality investigation report (QIR) was completed. The current location of vaccine/vaccine-device was disposed off. There was no prescription drug treatment for the experience required. There was no product quality complaint. At time of current moment report to pharmacy, doctor was ongoing medical assistant quality investigation report (QIR) done.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Patient received possibly improperly stored vaccines due to lack of temperature readings; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. On 29-MAR-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant human albumin-rHA) subcutaneous injection, valid lot # U015476, valid expiration date: 13-NOV-2022, administered for prophylaxis (strength, dose, and anatomical location were not provided). The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (Product storage error). There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   Causal assessment between measles, mumps, rubella and varicella (Oka Merck) virus vaccine live (PROQUAD) regarding the events was not provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000503: US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000553: US-009507513-2205USA000544: US-009507513-2205USA000545:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Varivax administered after temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-APR-2022, the patient received inappropriately stored (product storage error) live (oka/merck) (VARIVAX) with lot number U026207 and expiration date 24-AUG-2023 or with lot number U029496 and expiration date 21-SEP-2023 (route of administration and anatomical location were not reported).  The temperature excursion was at a temperature of -9 degree Celsius for a timeframe of 1 hour and 45 minutes, without previous excursions. No PQC (product quality complaint) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA006728: US-009507513-2205USA006727: US-009507513-2205USA006726: US-009507513-2205USA006725: US-009507513-2205USA006729: US-009507513-2205USA006724:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; Proquad got administered to a patient via intramuscular route instead of subcutaneous route; This spontaneous report was received from an office manager on behalf of a healthcare professional, concerning a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot number U026795 with expiration date reported as 24-FEB-2023 but internally validated as 26-FEB-2023, administered intramuscularly instead of subcutaneously (incorrect route of product administration) for prophylaxis (dose and anatomical location were not reported).  No adverse events or product quality complaints (PQC) were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; dose of PROQUAD which was administered past it's expiration date; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies details, drug reactions or allergies, and concurrent conditions were not reported.  On 05-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #T036738, expiration date: 28-APR-2022 (strength, route of administration, and indication were not provided) (Expired product administered) that was reconstituted in a sterile diluent (lot#U011647, expiration date: 28-AUG-2023). No additional adverse event or product quality complaint were reported.
Sex: M
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 a healthcare worker referring to a currently 8-year-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored dose of Hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (dose, route of administration, and vaccine scheme were not reported; lot number U026782 is an invalid lot for Hepatitis A vaccine, inactivated (VAQTA) as confirmed by Lot Verification team; expiration date reported as 28-OCT-2022).  It was reported that the vaccine was exposed to a temperature excursion of 49.6 degrees Fahrenheit during a time frame of 32 minutes (product storage error).  There was no previous temperature excursion, and no additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic AEs reported; an expired MMR-II vaccine was in advertently administered to a patient; This spontaneous report was received from a health care professional (HCP) and refers to a patient.  The patient's medical history, concurrent conditions were not reported, and concomitant therapies were not reported.  On 09-MAY-2022, an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T006165, expiration date: 19-FEB-2022 (strength, route of administration, and indication were not provided), was in advertently administered to a patient. There were no symptomatic adverse events (AEs) reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; Caller reported expired GARDASIL 9 was administered; This spontaneous report was received from Pharmacist and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-MAY-2022, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #S028738, expiration date: 03-APR-2022, administered for prophylaxis (strength, dosage, and anatomical location of administration were not provided). No additional adverse events (AEs) were reported. No other information provided
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects or symptoms following administration; Caller is a medical assistant who reports administration of VARIVAX following temperature excursion.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 10-MAY-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose of 0.5 milliliter (ml) once (vaccination scheme frequency, route of administration and anatomical site of injection were not reported; lot number U024221 that was verified to be a valid lot number with an expiration date reported and established as 08-APR-2023) for prophylaxis, following a temperature excursion  of 12 degrees Fahrenheit (F) with a time frame of 22 hours (product storage error). It was reported that there was no previous temperature excursion.  There were no adverse effects or symptoms following the administration (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature excursion on 20JAN2022.; No adverse event; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender  The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin - rHA) (PROQUAD) subcutaneous injection, lot #U017138, expiration date: 28-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) that was improperly stored and on 20-JAN-2022 had a temperature excursion in -14C during 7 hours.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997: US-009507513-2205USA005067:02167746
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Urticaria
Clinical narrative: Had experienced localized injection site redness, warmness and hives in injection site lower extremities; Had experienced localized injection site redness, warmness and hives in injection site lower extremities; Had experienced localized injection site redness, warmness and hives in injection site lower extremities; This spontaneous report was received from a nurse concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unknown date (when the patient was 15 years old), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).         On an unknown date, the patient had experienced localized injection site redness (vaccination site erythema), warmness (vaccination site warmth) and hives in injection site lower extremities (vaccination site urticaria).      The outcome of the events was unknown.     The reporter considered vaccination site erythema, vaccination site urticaria and vaccination site warmth to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's reported; HBP reporting AE for improperly stored administered vaccine.; This spontaneous report has been received from a office manager and refers to a 4-week-old patient of unknown gender.  The patient's pertinent medical history, previous drugs reactions or allergies, and concomitant medications were not reported.  On 16-MAY-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number U032668, which was confirmed to be valid, and expiration date: 24-APR-2023) (dose, vaccination scheme frequency, anatomical location and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 28 degrees Fahrenheit for 96 hours (product storage error). No previous temperature excursion was reported. No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA005673:case number 02168906 US-009507513-2205USA005621:case number 02168912
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reports vaccine administered after temperature excursion.; This spontaneous report has been received from a nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies, and concomitant medications were not provided.  On 18-MAY-2022, the patient was administered vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) 0.5 milliliters (ml) subcutaneously (valid lot number U031560 [expiration date 06-APR-2023]) for prophylaxis, after a temperature excursion of 10 degrees Fahrenheit (F) for 14 minutes (min) (product storage error) (dose number, vaccination scheme frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
Sex: M
Vaccine: PPV
Symptoms: Product dispensing issue
Clinical narrative: Caller states that his nephew was taken to a local Health Department to try to get vaccine but both would not give him the vaccine. Per caller, the reason was that "it was only indicated for children under 4 and adults over 65."; This spontaneous report was received from a physical therapist referring to his 8 year-old nephew. The patient's concurrent conditions included immunodeficiency. Information about patient's concomitant medications, pertinent medical history and drug reactions/ allergies was not provided.  On an unknown date, the patient was prescribed pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, strength, route of administration, anatomical location, expiration date and lot number was not provided) for prophylaxis.   The reporter stated that, on an unknown date, the vaccine could not have been given to the patient. The reporter stated that the reason was that it was only indicated for children under 4 and adults over 65 (product dispensing issue).
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: 3 pts received a dose during the excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter informed that their facility had a medication refrigerator excursion occur and patient received the Boostrix dose during excursion. The temperature range was from 35 degree F to 9.5 degree F and total duration was 11 hours. The reporter asked was this Boostrix vaccine was still viable. The vaccine was not a part of a prior temperature excursion. Additional Supportive Information: The patient received the Boostrix dose during excursion, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081064:Same Reporter US-GLAXOSMITHKLINE-US2022AMR081065:Same Reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: 3 pts received a dose during the excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter informed that their facility had a medication refrigerator excursion occur and patient received the Boostrix dose during excursion. The temperature range was from 35 degree F to 9.5 degree F and total duration was 11 hours. The reporter asked was this Boostrix vaccine was still viable. The vaccine was not a part of a prior temperature excursion. Additional Supportive Information: The patient received the Boostrix dose during excursion, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081064:Same Reporter US-GLAXOSMITHKLINE-US2022AMR080983:Same Reporter
Sex: U
Vaccine: FLUX
Symptoms: Dysstasia, Gait disturbance, Guillain-Barre syndrome, Intensive care, Loss of personal independence in daily activities
Clinical narrative: Guillain Barre, ICU for 2 weeks, rehab 3 months; Still have issues with walking; Still have issues with standing a long period of time; Had to learn how to walk,write, eat,and all the basic things in life; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), walking difficulty, difficulty in standing and activities of daily living impaired. On an unknown date, the outcome of the guillain barre syndrome and activities of daily living impaired were unknown and the outcome of the walking difficulty and difficulty in standing were not recovered/not resolved.   The reporter considered the guillain barre syndrome to be related to Flu vaccine. It was unknown if the reporter considered the walking difficulty, difficulty in standing and activities of daily living impaired to be related to Flu vaccine.     Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got Guillain Barre from get the flu shot.  The patient ended up in ICU (intensive care unit) for 2 weeks and then ended up in a rehabilitation for 3 months.  The patient had to learn how to walk, write, eat and all the basic things in life.  2 years later, the patient still had issues with walking and standing a long period of time. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose later than six months after the first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter enquired, what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose. Additional Supportive Information:The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. 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 18 months ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 18 months before reporting).   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: 19-May-2022 Reporter's Comments: The patient self-reported this case. The patient had first shot of Shingrix 18 months before reporting and wanted to know if he/she needed to start all over with 2 shots or would 2nd shot only still be effective. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the day of reporting, which led to incomplete course of vaccination.