chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HEPAB, VARCEL
Symptoms: Chest discomfort, Dizziness
Clinical narrative: Lightheaded, tightness in center of chest.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction  expired vaccine was administered. Lot expired on 7/12/2020 and was administered 8/13/2020  contacted Merck to report and was given following case number and asked to record on VAERS: 01679927
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and selling at location of vaccine and was treated with Hydrocortisone 2.5mg
Age: 72.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction reported  expired vaccine was administered to patient. Lot expired 7/12/2020 and vaccine was administered 8/13/2020.  Reported to Merck and was given a case number and asked to include in VAERS.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Red at site of Immunization
Age: 17.0
Sex: F
Vaccine: HEP, IPV, TD
Symptoms: Pain in extremity
Clinical narrative: Phone call from Mother of Child stating "Thigh soreness while climbing stairs"
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Influenza like illness, Myalgia
Clinical narrative: The morning after the vaccine I felt like I had the flu.  Aching muscles, headache, no fever or chills though.  Loss of appetite for a day, flu like symptoms lasted 2 days.  I had the same reaction with the second vaccination starting later the same day, but took acetaminophen which knocked down the symptoms  fairly well.
Age: 62.0
Sex: M
Vaccine: HEP, HEPA, MENB
Symptoms: Extra dose administered
Clinical narrative: Called and left message for patient, unaware currently if there are any signs or symptoms. Found error of duplicated vaccine by doing weekly inventory of vaccines.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt has broken out with chicken pox outbreak
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient reported that a few hours after getting HPV9 vaccine she broke out in Hives on her back and  both arms
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Mouth swelling, Pharyngeal swelling
Clinical narrative: patient came in next day to pick up rx for Medrol and cetirizine from doctor stating she had swelled mouth and throat and thinks its from flu shot - patient gets a flu shot every year and this is first time she reacted to it
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dyskinesia, Hypotonia, Loss of consciousness, Memory impairment, Unresponsive to stimuli
Clinical narrative: -HPV/Menactra vaccines given to pt on exam table; pt stated he felt fine in that moment after receiving vaccine/had no adverse reactions to any previous vaccines in the past. Pt stated he was ok to move to bench right next to table so brother could sit on table to receive his vaccines next. 2 mins later, dad of pt states, "he passed out." Pt had gone limp against dad w/ his head down; would not respond to name/stimulation- pt was still breathing/pulse was felt. Pt began to have intermittent jerking motions for about 8 seconds, still unconscious. After I went to get the provider, CPNP, for help and we returned to the room, the pt was alert/oriented, stated he felt fine, but didn't remember losing consciousness. Pt was brought back up to table to lie back after clarifying he felt ok to do so, and provider checked him over. Water was provided, w/ a cold compress on the back of his neck. Orthostatic BPs were checked- WNL. Per CPNP, pt waited an additional 30 mins and had orthostatic BPs rechecked again (WNL) before being discharged. No further fainting episodes occurred. RN.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: low-grade fever, chills,  muscle ache, stomach ache, nausea.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin irritation
Clinical narrative: Rash, skin irritation, treatment with keflex
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Headache, Influenza like illness, Insomnia
Clinical narrative: My left arm was a little sore during the day but I was fine.  After dinner by 8:00 pm I started with a headache, chills, some nausea and general body aches. It felt like I had the flu.   This continued all through the night.   I was not able to get comfortable and got very little sleep.  About 4:30 am I did take 2 ibuprofen and finally fell asleep.  I was a little groggy at first but by about 10:00 am I was able to get myself together for work.  As the day wore on I was fine.    My co worker reminded me that I actually had a reaction to the first shingles shot I had gotten on 12/9/2019.   I did remember the reaction being the same.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Somnolence
Clinical narrative: My left arm was a little sore during the day but I was fine.  After dinner by 8:00 pm I started with a headache, chills, some nausea and general body aches. It felt like I had the flu.   This continued all through the night.   I was not able to get comfortable and got very little sleep.  About 4:30 am I did take 2 ibuprofen and finally fell asleep.  I was a little groggy at first but by about 10:00 am I was able to get myself together for work.  As the day wore on I was fine.    My co worker reminded me that I actually had a reaction to the first shingles shot I had gotten on 12/9/2019.   I did remember the reaction being the same.
Age: 54.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: pain and swelling in arm
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Hypertension, Pruritus
Clinical narrative: ITCHING IN FACE AND ARMS, FEW COUGH , HIGH BLOOD PRESSURE.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chiropractic, Pain in extremity
Clinical narrative: I had completed my sciatica (left leg) physical therapy series the morning of June 16, 2020 and was well.  That afternoon I opted to take my second shingle vaccine at Drugstore. That evening  experienced excruciating pain in my left leg.  After two days, my wife drove me to Urgent Care.  I received a shot and was advised to take pain pills.  The pain was so intense that  the following day, my wife again drove me to urgent care where I received a prescription of cyclobenzaprine and a nine day series of prednisone.  After the nine days the pain was so intense that I sought other pain relief.  I called Dr. who in a vertual  meeting prescribed Tramadol, which turned out to be too strong.  The next day I had an in person meeting with Dr. who prescribed meloxicam.  This worked.  I am  still in some pain after seeking aide from a chiropractor.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness moving down the arm, patients states it started the day after receiving the shot and by the time she came to see me it was down to her elbow. she states no pain or discomfort.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient received the vaccine on Friday and called the next day to ask if mild pain in the shoulder was a normal reaction to the vaccine. Pt was advised to wait until Monday to see if the pain subsides because mild pain at the site of injection is a normal reaction. Patient returned on Wednesday with a prescription for an anti-inflammatory medication and said although her symptoms were slowly subsiding, her pain was intolerable and decided to see her doctor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Mother calls in on telehealth visit in regards to some concern regarding the area where child got some Immunizations on 8-10-20. Patient received his 4 year old shots and he did fine. Mother states went home and there were no issues. No fever, cough. Asymtomatic. However on 8-11-20 she noticed he had redness and a bit of fussiness in the area of the left thigh. Mother notes the redness is not getting any bigger however does Feel a little bit swollen. Mother states hers never had any type of reactions in the past. Patient is walking around fine without any issues. Polio, MMR, DTAP, Varicella in the past; Kinnrix, ProQuad,1st done.
Age: 3.17
Sex: M
Vaccine: MMR, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. Patient asked for meningitis vaccine and was given MMR by mistake. Patient is ok
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Electrocardiogram, Pruritus, Urticaria
Clinical narrative: Itchiness, started around 1300 8/6/2020.  Hives appeared on arms around 1400 Still itchy took Benadryl and a shower. went to ER. Hives were on arms, torso, got med to help. next day hives got worse spread to legs, arms, thighs, chest. went to ER due to  chest tightness. given Benadryl IM, steroids
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt administered expired vaccine.  0 side effects
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Injection site pain, Pain, X-ray limb normal
Clinical narrative: Pain in (L) shoulder while going through ROM PAiN IN LEFT SHOULDER JoinT 1 DAY AFTER INJECTION -? CAUSE AND EFFECT
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt was given Proquad and Varivax which makes 2 doses of Varicella.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of right upper extremity
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Blood glucose normal, Feeling cold, Heart rate decreased, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Patient presents in our office today for a Trumenba  vaccine. Under the direct supervision of Dr. ; Trumenba was administered IM in the patient's Right Deltoid. Consent signed by the patient.VIS given to the patient. Advised patient to watch for signs and symptoms. Patient did not tolerate vaccine well.  Patient was sitting in room while writer administered vaccine into WIR so he could take an updated copy of vaccine form home and patients mom came out of room yelling somebody help.  When PCP and writer got to room, mother stated that she saw patient look like what was a seizure.  Patient stiffed up body and body started shaking momentarily.  Patient began to sweat and pulse was low around 45, PCP was in room taking pulse and advised writer to get an orange juice and glucose machine to check sugar.  Patients glucose was 90.  Patient given ice pack.  Patient then reported being cold so was moved to bed to lie down and given blanket to warm up.  Patient laid on bed for an additional 20 minutes and reported filling better there after.  Pulse was up to 60 and patient drank 4 cans of orange juice, patient left clinic with no further questions.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: Patient presents in our office today for a Trumenba  vaccine. Under the direct supervision of Dr. ; Trumenba was administered IM in the patient's Right Deltoid. Consent signed by the patient.VIS given to the patient. Advised patient to watch for signs and symptoms. Patient did not tolerate vaccine well.  Patient was sitting in room while writer administered vaccine into WIR so he could take an updated copy of vaccine form home and patients mom came out of room yelling somebody help.  When PCP and writer got to room, mother stated that she saw patient look like what was a seizure.  Patient stiffed up body and body started shaking momentarily.  Patient began to sweat and pulse was low around 45, PCP was in room taking pulse and advised writer to get an orange juice and glucose machine to check sugar.  Patients glucose was 90.  Patient given ice pack.  Patient then reported being cold so was moved to bed to lie down and given blanket to warm up.  Patient laid on bed for an additional 20 minutes and reported filling better there after.  Pulse was up to 60 and patient drank 4 cans of orange juice, patient left clinic with no further questions.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Rotator cuff syndrome, Ultrasound scan abnormal
Clinical narrative: Left upper arm pain
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Bradycardia, Hypotension, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: complete blackout; an episode of syncope; Initial information received on 03-Aug-2020 regarding an unsolicited valid serious case received from a other health professional.  This case is linked to cases 2020SA202835 and 2020SA202427 via same reporter.  This case involves a 11 years old female patient who experienced an episode of syncope (syncope) and had complete blackout (loss of consciousness), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination  On 03-Aug-2020, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6596AB and expiry date 24-May-2021) via unknown route in the right arm for prophylactic vaccination  On 03-Aug-2020, the patient developed serious episode of syncope (syncope) and had complete blackout (loss of consciousness) immediately (exact latency was not reported) after receiving the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  Final diagnosis was Loss of consciousness.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient had recovered from the event (The patient had a complete blackout for less than a minute and was doing better).; Sender's Comments: This case involves a 11 years old female patient who experienced syncope with blackout on same day after vaccination with MENACTRA. The time to onset was compatible. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: complete blackout; an episode of syncope; Initial information received on 03-Aug-2020 regarding an unsolicited valid serious case received from a other health professional.  This case is linked to cases 2020SA202835 and 2020SA202427 via same reporter.  This case involves a 11 years old female patient who experienced an episode of syncope (syncope) and had complete blackout (loss of consciousness), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination  On 03-Aug-2020, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6596AB and expiry date 24-May-2021) via unknown route in the right arm for prophylactic vaccination  On 03-Aug-2020, the patient developed serious episode of syncope (syncope) and had complete blackout (loss of consciousness) immediately (exact latency was not reported) after receiving the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  Final diagnosis was Loss of consciousness.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient had recovered from the event (The patient had a complete blackout for less than a minute and was doing better).; Sender's Comments: This case involves a 11 years old female patient who experienced syncope with blackout on same day after vaccination with MENACTRA. The time to onset was compatible. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: complete blackout; an episode of syncope; Initial information received on 03-Aug-2020 regarding an unsolicited valid serious case received from a other health professional.  This case is linked to cases 2020SA202835 and 2020SA202427 via same reporter.  This case involves a 11 years old female patient who experienced an episode of syncope (syncope) and had complete blackout (loss of consciousness), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination  On 03-Aug-2020, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6596AB and expiry date 24-May-2021) via unknown route in the right arm for prophylactic vaccination  On 03-Aug-2020, the patient developed serious episode of syncope (syncope) and had complete blackout (loss of consciousness) immediately (exact latency was not reported) after receiving the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  Final diagnosis was Loss of consciousness.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient had recovered from the event (The patient had a complete blackout for less than a minute and was doing better).; Sender's Comments: This case involves a 11 years old female patient who experienced syncope with blackout on same day after vaccination with MENACTRA. The time to onset was compatible. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise, Product administered at inappropriate site
Clinical narrative: subcutaneously instead of intramuscularly.; welt appeared that was 3 inches by 3 inches; where the welt was was also red; The area where the welt was was / warm; where the welt was was / hard to the touch; This case was reported by a nurse via call center representative and described the occurrence of welts in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 7th August 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In August 2020, the patient experienced welts, erythema, feeling of warmth and induration. On an unknown date, the outcome of the welts, erythema, feeling of warmth, induration and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the welts, erythema, feeling of warmth and induration to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, the patient received Shingrix by subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. Less than a week after vaccination, the patient had welt that was 3 inches by 3 inches, also the area where the welt was, was red, warm, and hard to the touch. The reporter consented to followup.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Incorrect route of product administration, Induration, Urticaria
Clinical narrative: subcutaneously instead of intramuscularly.; welt appeared that was 3 inches by 3 inches; where the welt was was also red; The area where the welt was was / warm; where the welt was was / hard to the touch; This case was reported by a nurse via call center representative and described the occurrence of welts in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 7th August 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In August 2020, the patient experienced welts, erythema, feeling of warmth and induration. On an unknown date, the outcome of the welts, erythema, feeling of warmth, induration and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the welts, erythema, feeling of warmth and induration to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, the patient received Shingrix by subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. Less than a week after vaccination, the patient had welt that was 3 inches by 3 inches, also the area where the welt was, was red, warm, and hard to the touch. The reporter consented to followup.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm, 102 fever, body aches, nausea, lethargy
Age: 0.58
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No other AE was reported; A 7-month-old patient was mistakenly vaccinated with GARDASIL 9; This spontaneous report was received from an office manager concerning a 7-month-old male patient. The patient had no concurrent conditions and medical history, as well as concomitant medications.  On 29-JUL-2020, the patient was mistakenly vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Lot No. R027946, expiration date 27-APR-2021) intramuscularly, once for prophylaxis (strength and dose were not provided).  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: GARDASIL 9 was stored improperly and administered; No Adverse event; This spontaneous report as received from a license practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date, the patient was vaccinated with an improperly stored does of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637651, expiration date 09-JUN-2022, for prophylaxis (strength, dose, route, anatomical site and vaccination schedule were not reported), which had a temperature excursion of 50 F for 1 hour and 46 minutes. The temperature excursion was detected by a data logger and had no previous temperature excursion.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: patient received an improperly stored dose of V ARIV AX; This spontaneous report was received from an office manager referring to a patient of unknown age and gender.   The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 03-AUG-2020, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S028920 has been verified to be valid, expiration date 16-SEP-2021) (dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored diluent (manufacturer unknown).     The temperature excursion was: 22 Fahrenheit (F) degrees for 1 hour. No previous temperature excursions. The excursion call was made by a data logger.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: MMR II was administered to a patient that was improperly stored; no additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  On 05-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S015427 and expiration date 20-MAY-2021, for prophylaxis (dose, strength, frequency and route of administration were not reported).  It was reported that the vaccine had a temperature excursion of -4.1C during 45 minutes. No previous temperature excursions were reported. Digital data logger was involved.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Her son was a few days late receiving his 3rd GARDASIL-9 vaccination; This spontaneous report as received from a patient's mother regarding a male patient of unknown age. The patient's medical history, concomitant medications and drug reactiosn or allergies were not provided.  On an unspecified date, the patient was a few days late to be vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route, lot # and expiration date were not provided).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 29-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; The patient was administered expired VAQTA; This spontaneous report was received from an office manager, concerning a 22-years-old male patient. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On 23-JUL-2020, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) vial formulation, via intramuscular as prophylaxis; lot number S018419 with an expiration date on 12-JUL-2020 (expired product administrated) (strength, dose, and anatomical location were not provided). No adverse effects reported, nor product quality complain involved.
Sex: F
Vaccine: PPV, UNK
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash, Tenderness
Clinical narrative: unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow; This spontaneous report was received from a nurse referring to a female patient of unknown age with drug reactions/allergies to nonsteroidal anti-inflammatory drug (NSAIDS), penicillin and sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA). There was no concomitant medication.     On 04-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength and dose were unknown; lot # S036495, expiration date 13-SEP-2021) via intramuscular route for prophylaxis.        A few hours later, the patient experienced an unspecified rash, redness, pain, tenderness and swelling from the deltoid to the elbow. Symptoms worsened overnight. On 05-AUG-2020, the patient had a telehealth visit with physician and was prescribed acetaminophen (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). No lab diagnostics/studies were performed. Symptoms were not resolved. The causality assessment was not provided.  The reporter requested a lot check for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  lot S036495, expiration date 13-SEP-2021. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.     On 06-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# S020962, expiration date 07-JUL-2021, dose reported as 1 (unit not provided); strength and route were not provided), and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S038175, expiration date 26-NOV-2021, dose reported as 1 (unit not provided); strength and route were not provided) both for prophylaxis (product storage error). The temperature excursions included -6 fahrenheit degree to 14 fahrenheit degree (10 fahrenheit degree) for 1 hour and 15 minutes, 15 fahrenheit degree to 46 fahrenheit degree (44.8 fahrenheit degree) for 1 hour and 30 minutes and 47 fahrenheit degree to 77 fahrenheit degree (50 fahrenheit degree) for 2 hours and 30 minutes. There was no previously temperature excursion. There was a data logger involved.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 03-AUG-2020, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# S020160, expiration date 30-JUN-2021, 1 (units not provided); strength, dose detail and route were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot# S038175, expiration date 26-NOV-2021, 1 (units not provided); strength, dose detail and route were not reported) for prophylaxis.    The temperature excursion was of -50 Fahrenheit degrees, time frame was -6 Fahrenheit degrees to 14 Fahrenheit degrees (10 Fahrenheit degrees) for 1 hour and 15 minutes; 15 Fahrenheit degrees to 46 Fahrenheit degrees (44.8 Fahrenheit degrees) for 1 hour and 30 minutes; 47 Fahrenheit degrees to 77 Fahrenheit degrees (50 Fahrenheit degrees) for 2 hours and 30 minutes. There were no previous excursions reported. The digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no adverse effects from vaccine per nurse.; Nurse reported expired PROQUAD vaccine given to a patient today.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 11-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliters (ml) given once (lot number S003865 which has been verified to be valid, expiration date reported and validated as 08-AUG-2020) (vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis (expired product administered). The nurse reported that, the patient had no adverse effects from the vaccine.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; expired but properly stored dose of VAQTA was administered; This spontaneous report was received from a medical assistant, concerning a 2 year old patient of unknown gender. Information regarding pertinent medical history, concomitant medications and drug reactions/allergies was not reported.      On 11-AUG-2020, the patient was vaccinated with an expired but properly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S005724, expiration date 10-JUL-2020) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse effect were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: expired vaccine of VARIVAX was given to a patient today; This spontaneous report was received from the medical assistant, referring to a  currently 38 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX)  0.5 milliliter once, subcutaneously (lot # R018932 expiration date 02-JUL-2020) for prophylaxis (expired product administered).
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; It gave me the damn flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that the patient received flu shot once. It gave the flu never ever again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for influenza was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness in the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 7th April 2022) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix. On 1st August 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and experienced injection site erythema. The reporter stated that, the patient still experiences injection site erythema, with no pain. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: passed out after receiving a dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of passed out in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) for prophylaxis.   The patient's past medical history included suture insertion.   On 29th June 2020, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After receiving a dose of Bexsero, the patient passed out  The patient had to go to the Emergency Room to get stitches, following her passing out.  The reporter was consented for follow up. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158058:same reporter US-GLAXOSMITHKLINE-US2020158060:same reporter
Sex: U
Vaccine: MENB
Symptoms: Headache, Viral infection
Clinical narrative: severe headache; viral type symptoms; This is a spontaneous report from a contactable other HCP via Pfizer sales representative.   A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA) at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  Four-five days after receiving the vaccine, the patient went back into the office with severe headache and viral type symptoms on an unspecified date. The outcome of events was unknown. The reporter was not sure if it was a viral infection or if symptoms resulted from Trumenba.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines were exposed at minus 1.25 degree Celsius and administered to patient after excursion, No AE; Initial information received on 03-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case is linked to cases 2020SA203233, 2020SA203126, 2020SA203423, 2020SA202350, 2020SA202831, 2020SA202832, 2020SA203422 and 2020SA207050 via same reporter.  This case involves a 11 years old female patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and 0.5 mL dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was exposed at minus 1.25 degree Celsius (batch number and expiry date not reported) via unknown route (in the left arm and site not reported for Adacel) on 31-Jul-2020 for prophylactic vaccination(product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degrees Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203233, 2020SA202232, 2020SA202350, 2020SA203126, 2020SA202832, 2020SA203422, 2020SA202831 and 2020SA207050 (same reporter).  This case involves an 11 years old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date not reported) in the right arm on an unknown date for prophylactic vaccination after a temperature excursion (product storage error).  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  The patient did not receive any other vaccines or medications on that visit.  This was an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 11 year old female patient received Daptacel instead of Adacel vaccine, No AE; a 11 year old female patient received Daptacel, No AE; Initial information received on 04-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional.   This case involves a 11-year-old female patient who vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for  prophylactic vaccination.  On 03-Aug-2020, the patient received a 0.5 ml sixth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE  [DAPTACEL] (lot number: C5643CA and expiry date: 17-Jul-2021) via an intramuscular route the right deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was also reported that therapy date was 04-AUG-2020.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.