chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Blister
Clinical narrative: This literature marketed report as received from an other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced chest blisters and potential toxicity. The outcome of chest blisters and potential toxicity was unknown. The reporter considered chest blisters and potential toxicity to be related to PNEUMOVAX 23. This is one of several reports derived from the same literature (linked reports MARRS # 1709USA000317, 1709USA000318, 1709USA000319). Sender's Comments: US-009507513-1709USA000317: US-009507513-1709USA000318: US-009507513-1709USA000319.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a 48 year old patient. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. On an unknown date the patient experienced drug administered to patient of inappropriate age and no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to PROQUAD.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63 year old male patient. The patient's medical history was not provided. The patient did not have any known drug reactions or allergies. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD). His concomitant therapies included BREO, PROAIR and NEXIUM. On 29-AUG-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX 23 lot # N003993, expiration date 20-OCT-2018 (dose was not reported) for prophylaxis. On approximately 29-AUG-2017, the patient experienced hives on arms, back and chest which did not itch and was seen by the reporter on 30-AUG-2017. He took one dose of BENADRYL)on 30-AUG-2017 that provided relief. No lab diagnostic studies were performed. The outcome of urticaria was reported as not recovered/not resolved. The relatedness between the event and the suspect drug was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age. On 29-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M001747, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On 29-AUG-2017, the patient experienced expired product administered. No adverse effects were reported. The outcome of expired product administered was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age and gender, with no concurrent conditions and medical history reported. On 02-AUG-2017, the patient was vaccinated with improperly stored (18 hours in temperature -12 Celsius degrees) PROQUAD lot # M041083, therapy type RHA, expiration date 04-APR-2018 (route of administration was not reported). Other suspect therapy included sterile diluent lot # K019027, expiration date 07-AUG-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. No adverse effects were reported. This is one of four reports from the same reporter. Sender's Comments: US-009507513-1708USA002682: US-009507513-1709USA000307: US-009507513-1709USA000306.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age and gender, with no concurrent conditions and medical history reported. On 05-AUG-2017, the patient was vaccinated with improperly stored (18 hours in temperature -12 Celsius degrees) PROQUAD lot # M041083, therapy type RHA, expiration date 04-APR-2018 (route of administration was not reported), for prophylaxis. Other suspect therapy included sterile diluent lot # K019027, expiration date 07-AUG-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of four reports from the same reporter. Sender's Comments: US-009507513-1709USA000305: US-009507513-1709USA000307: US-009507513-1708USA002682.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age and gender, with no concurrent conditions and medical history reported. On 17-JUL-2017, the patient was vaccinated with improperly stored (18 hours in temperature -12 Celsius degrees) PROQUAD lot # M041083, therapy type RHA, expiration date 04-APR-2018 (route of administration was not reported), for prophylaxis. Other suspect therapy included sterile diluent lot # K019027, expiration date 07-AUG-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of four reports from the smae reporter. Sender's Comments: US-009507513-1709USA000305: US-009507513-1709USA000306: US-009507513-1708USA002682.
Sex: U
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This literature marketed report as received from an other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with measles, mumps, and rubella virus vaccine (manufacturer unknown) for prophylaxis. On an unknown date the patient experienced adverse event. The outcome of adverse event was unknown. The reporter considered adverse event to be related to measles, mumps, and rubella virus vaccine (manufacturer unknown). This is one of several reports derived from the same literature (linked reports MARRS # 1709USA000317, 1709USA000318, 1708USA012768). Sender's Comments: US-009507513-1708USA012768: US-009507513-1709USA000317: US-009507513-1709USA000318.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Pt experienced right arm pain, high fever, flu like symptoms. Ice, Tylenol.
Age: 28.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Bruxism, Loss of consciousness, Muscle tightness, Neck pain, Seizure like phenomena
Clinical narrative: After given 2 hepatitis vaccines, within 1 minute, pt said 'oh no' and placed his head on table, then back on head of chair. He seemed to 'fall asleep', with snoring. He then started tensing up his arms, we laid him flat on the floor and supported his head. We kept calm and kept saying 'it's ok' and rubbing his hands. Tensed arms, straight and then to his side. Made a strained face and sound while tensing arms.  Got an ice pack to place on his head, to try to bring him about. Finally did 'wake up' within a couple minutes. He first asked 'where am I'. We all said at work. He seemed fine, while still laying, he knew he had received shots and felt nervous about them, he knew his friend who was in the room and that he was there. He felt embarressed, but said he bite his tongue and neck was a little sore. Pt thinks he 'blacked out', said he had this happen during an accident where he cut himself and also when he had his lip pierced. As a medical professional, this appeared to look like a seizure. His tensed body, mainly arms, snoring, clenched jaw. Very strange. Pt has no history of seizures, although they seem to run in his family. He has not had any vaccines as an adult. I advised him to get a family doctor and to get checked out. Advised him to not get any vaccines until check out by md. Md may call our pharmacy for details on this reaction.
Age: 28.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Snoring, Tongue biting
Clinical narrative: After given 2 hepatitis vaccines, within 1 minute, pt said 'oh no' and placed his head on table, then back on head of chair. He seemed to 'fall asleep', with snoring. He then started tensing up his arms, we laid him flat on the floor and supported his head. We kept calm and kept saying 'it's ok' and rubbing his hands. Tensed arms, straight and then to his side. Made a strained face and sound while tensing arms.  Got an ice pack to place on his head, to try to bring him about. Finally did 'wake up' within a couple minutes. He first asked 'where am I'. We all said at work. He seemed fine, while still laying, he knew he had received shots and felt nervous about them, he knew his friend who was in the room and that he was there. He felt embarressed, but said he bite his tongue and neck was a little sore. Pt thinks he 'blacked out', said he had this happen during an accident where he cut himself and also when he had his lip pierced. As a medical professional, this appeared to look like a seizure. His tensed body, mainly arms, snoring, clenched jaw. Very strange. Pt has no history of seizures, although they seem to run in his family. He has not had any vaccines as an adult. I advised him to get a family doctor and to get checked out. Advised him to not get any vaccines until check out by md. Md may call our pharmacy for details on this reaction.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called with extreme fatigue and pain in her right arm. Patient claimed that she could not move her right arm. Counseled the patient to ice her arm and take ibuprofen and to seek medical help if condition worsens.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: 8/29/17 at MD visit- Itchy rash all over, first noted at 1:30. Wheal and flare, currently groin, thighs, underarms, some on torso. Moving around. No meds tried. Got QUADRACEL yesterday. No other new meds, foods.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Rash macular
Clinical narrative: Pt developed redness and itching on left deltoid at the site of the injection. He called PCP who advised him to apply ice. Itching worsened and the redness spread over the entire deltoid. After 6 days he presented at urgent care after developing a macular rash on groin and thighs.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: Severe pain at injection site at time of injection. Patient returned to the office two days later with large, red, erythematous area over site of injection. Unable to move left arm due to pain. Hand tingling. Fever up to 102.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dysarthria, Inappropriate affect, Speech disorder
Clinical narrative: Suddenly crying for no reason followed by uncontrolled laughing. Slurred words and unusual speech. Symptoms lasted for about 24 hours.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site edema in a 18-year-old female patient who received BEXSERO. On 10th August 2017, the patient received the 1st dose of BEXSERO. In August 2017, less than a month after receiving BEXSERO, the patient experienced injection site edema, injection site erythema and injection site tenderness. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the injection site edema, injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site edema, injection site erythema and injection site tenderness to be related to BEXSERO. Additional details were reported as follows: The patient experienced subcutaneous edema, erythema and tenderness of the deltoid at the injection site. The patient was advised to apply ice and take BENADRYL. No further medical intervention was required. The exact injection site was not reported. The lot number was unknown.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Dizziness, Erythema, Presyncope
Clinical narrative: In about 5 minutes after getting FLUZONE HD and PNEUMOVAX, patient returned to the pharmacy and complained of extreme dizziness and almost fainted. Her face and neck were very red in color. The patient sat down in the pharmacy waiting room to rest and while sitting, she was complaining of chest pain and almost extreme lower back pain. Patient did not have any facial swelling, throat constriction, or hives/rashes. An ambulance was called due to the chest pain complaint. Once the paramedics came, patient's symptoms subsided and she returned to normal. Upon further check up by the paramedics, blood pressure and vitals were normal/stable. Patient was fine the rest of the day and haven't had any further events due to the vaccines.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypotonia, Pyrexia, Swelling face, Vomiting
Clinical narrative: Fever starting @ 8pm and vomiting, the next day in the morning his face was swollen. The facial swelling was improving within 24 hours. Child was "limp" for the first 12 hours of "reaction", but slowly improved each day.
Sex: M
Vaccine: HEP
Symptoms: Eczema
Clinical narrative: Eczema on arms , legs, back and face.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse and refers to multiple patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, and drug reactions or allergies. On unknown dates, the patients were vaccinated with multiple doses of improperly stored PROQUAD (rHA) (lot number reported as N002916, expiration date 24-JUL-2018) (dose, frequency, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature of -14 to -10 Celsius for 24 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse effects were reported. There was no product quality complaint involved. No further information provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA012618.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse and refers to multiple patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, and drug reactions or allergies. On unknown dates, the patients were vaccinated with multiple doses of improperly stored VARIVAX (lot number M034583, expiration date 27-JUL-20180 and (lot number M047661, expiration date 02-DEC-2018]) (dose, frequency, route of administration, and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent. Sterile diluent used for reconstitution of vaccines was properly stored. The vaccine was exposed to a temperature of -14 C to -10 Celsius for time frame of 24 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA012558.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to herself of an unknown age. The patient's medical history and concomitant medication were not reported. On an unspecified date the patient received her first dose of GARDASIL (dose, frequency, route and lot# were unknown) for prophylaxis and then on another unspecified date she received GARDASIL 9 (dose, frequency, route and lot# were unknown) for prophylaxis which was other than indicated in the prescribing information. No adverse events was reported at the time of the class.
Age: 0.33
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-AUG-2017 four months of age, inadvertently received PNEUMOVAX 23 (0.5ml/once, intramuscular with a lot number M043424 and expiry date 06-JUN-2018 instead of PREVNAR 13. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 DF, subcutaneous for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of over 65 years of age. In August 2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. In August 2017, the patient experienced injection site pruritus and injection site erythema. The outcome of injection site pruritus and injection site erythema was reported as recovered/resolved. Sender's Comments: US-009507513-1708USA013436.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This literature marketed report as received from an other health professional refers to four patients of unknown age. On an unknown date the patients were vaccinated with pneumococcal vaccine (manufacturer unknown) for prophylaxis. On an unknown date the patients experienced adverse event. The outcome of adverse event was unknown. The reporter considered adverse event to be related to pneumococcal vaccine (manufacturer unknown). This is one of several reports derived from the same literature (linked reports MARRS # 1709USA000318, 1709USA000319, 1708USA012768). Sender's Comments: US-009507513-1709USA000319: US-009507513-1708USA012768: US-009507513-1709USA000318.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This literature marketed report as received from an other health professional refers to 2 patients of unknown age. On an unknown date the patients were vaccinated with human papillomavirus vaccine (manufacturer unknown) for prophylaxis. On an unknown date the patients experienced adverse event. The outcome of adverse event was unknown. The reporter considered adverse event to be related to human papillomavirus vaccine (manufacturer unknown). This is one of several reports derived from the same literature (MARRS # 1709USA000317, 1709USA000319, 1708USA012768). Sender's Comments: US-009507513-1709USA000317: US-009507513-1709USA000319: US-009507513-1708USA012768.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient. On an unknown date, the patient was vaccinated with ROTATEQ dose 4, oral for prophylaxis (extra dose administered).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a healthcare professional refers to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412 for prophylaxis.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable a physician. This physician reported similar events for two brothers. This is the first of two reports. A 15 year-old male patient of an unspecified ethnicity received the first dose of TRUMENBA (lot R4510, expiry date 01Jul2018) on 17Jul2017 at 0.5 ml single intramuscular in the left deltoid for routine vaccination. The patient medical history was none, concomitant medications were not reported. The patient experienced severe redness, swelling, and tenderness at the site of injection on 18Jul2017. Therapeutic measures were taken in response to the events and included the administration of BENADRYL and ibuprofen. The patient recovered after several days on an unspecified date in Jul2017. The events were considered non serious by the reporter. Sender's Comments: Linked Report(s): US-PFIZER INC-2017378572 same reporter/product/events, different patient; US-PFIZER INC-2017378572 same reporter/product/events, different patient.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for two brothers. This is the second of two reports. A 17 year-old male patient of an unspecified ethnicity received a dose of TRUMENBA (lot R4510, expiry date 01Jul2018) on 17Jul2017 at 0.5 ml single intramuscular in the left deltoid for routine vaccination. The patient medical history was none, concomitant medications were not reported. The patient experienced severe redness, swelling, and tenderness at the site of injection on 18Jul2017. Therapeutic measures were taken in response to the events and included the administration of BENADRYL and ibuprofen. The patient recovered after several days on an unspecified date in Jul2017. The events were considered non serious by the reporter. Sender's Comments: Linked Report(s): US-PFIZER INC-2017378481 same reporter/product/events, different patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of injection site erythema in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The office manager reported that 5 patients recently experienced severe injection site reactions as redness and swelling at the injection site. A few of the patients returned to the office for evaluation. This was reported to the field rep off the cuff and the reporter provided very little information but said she would compile all the patient's information for follow up. An registered nurse was also present at the time of the report. This case has been linked with 4 cases, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature, Dizziness, Dysphonia, Fatigue
Clinical narrative: No energy, fatigue, hoarse voice, tightness of the throat, temperature, and dizziness.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: No energy, fatigue, hoarse voice, tightness of the throat, temperature, and dizziness.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of injection site erythema in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The office manager reported that 5 patients recently experienced injection site reactions as redness and swelling at the injection site. A few of the patients returned to the office for evaluation This was reported to the field rep off the cuff and the reporter provided very little information but said she would compile all the patient's information for follow up. An registered nurse was also present at the time of the report. This case has been linked with 4 cases, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of drug administration, Injection site induration, Injection site mass, Injection site nodule
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 18-year-old female patient who received BEXSERO (batch number 158701, expiry date 29th September 2017). On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not provided. The reporter stated that, the patient received BEXSERO through subcutaneous route instead of intramuscular route, which led to inappropriate route of vaccination. No further information was provided. Follow up information was received from a nurse on 24th August 2017: The patient's demographic details were updated. On an unknown date, unknown after BEXSERO, the patient undeveloped hard know to back of left arm where vaccine was administered. The outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to BEXSERO. The VAERS details were updated. This was medication error associated with adverse event.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: Site rxn red welt 2-3" x 2" raised welt itchy, felt like bee sting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Pt came into the office and received his KINRIX IM in his Rt. leg and received his PROQUAD, subq in his Rt. leg also. On the side of his right leg is where it was really red, swollen and had blisters. The site where his PROQUAD was given.
Sex: U
Vaccine: RV1
Symptoms: Immediate post-injection reaction, Laceration, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of laceration in a adult patient who received ROTARIX lyophilized formulation (batch number A41CB558A, expiry date 5th September 2017) and (batch number A41CB573A, expiry date 17th October 2017). This case was associated with a product complaint. On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced laceration and pharmaceutical product complaint. On an unknown date, the outcome of the laceration and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration to be related to ROTARIX lyophilized formulation. Additional details were reported as follows: The age at vaccination was not reported. The first incidence involves vial breaking when transfer adaptor attached (during preparation of vial). The other three incidences involve vials snapping at the neck when cap is removed (during preparation of vials). It was confirmed that no product given to the patients. As per GlaxoSmithKline employee, package condition not damaged or open. It was unknown who opened the box. Medical Assistants administered product, unknown if experienced. It was unknown how stored. It was unknown if purchased directly from GlaxoSmithKline. It was unknown if carton was damaged, unknown if leakage was there in carton, unknown if glass pieces were till in vial, unknown if holes or pieces missing from vial and it was unknown if med still in vial. It was attempted to reach out to health care professional for further details. Voicemail was left with serial number. It was unknown if product was available for return, unknown if credit needed. It was unable to verify lot numbers. One of the staff members experienced the product exploding in face and got into eyes. It was unknown which of the four incidences is related to this adverse event. This case was linked to case US2017130511 and US2017130509, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Silver dollar raised red knot tender to the touch on back of arm. Itchy very tender.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient received the wrong vaccine. Patient wanted Serotype B vaccine, instead got ACWY vaccine. No reaction was noted, and patient received the correct vaccine shortly afterwards.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Left arm redness, raised area approx. 9 cm in diameter, warm to touch, non-tender, itching. Instructed to take BENADRYL for localized reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pain
Clinical narrative: Patient with raised erythematous area measuring on left deltoid area 8.0 cm (length) x 7.5 cm (width). Patient given Ibuprofen 100mg/5mL oral suspension for pain and told to ice area to decrease inflammation. Patient's family informed when to call back clinic or seek emergency care.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: Patient with short (approximately 1 minute) febrile seizure (temperature 101F as measured by mother) approximately 1 hour after vaccine administration while on the way home from clinic. Patient with known history of complex febrile seizures.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Approx 5 cm, round, slightly pink area at injections site. No redness, no swelling, tender to touch. Pt reports he noticed this 8/28/17. Instructed to apply ice and use ibuprofen. Go to Urgent care for any new/worsening symptoms.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient complained of pain in right arm and redness at injection location. No swelling, no drainage, no other symptoms. Pain began this morning, just noted redness about 2:00pm.
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Headache, Hyperhidrosis, Nausea, Thinking abnormal, Urinary tract infection
Clinical narrative: Patient called today stating that last night she had headache, nausea and sweating and her family told her that she is not thinking clearly. She states is on macrobid for UTI treatment. She has an appointment to see her doctor in 2 hours. I encouraged her to keep that appointment and that I would report to VAERS since she had YF vaccine 15 days ago.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Asthenia, Grip strength decreased, Injection site erythema, Loss of personal independence in daily activities
Clinical narrative: Mother reports patient was complaining of pain which started around 6 PM the day of the vaccines. He kept saying it was pain like his "bone was broken".  She gave him motrin and he stopped complaining. However, the next day she started to notice the muscle function slowly decreasing. She reports she didn't notice until she gave him a glass of milk in his left hand that he dropped. Earlier in the day he also asked her to peel his banana, which he usually can do on his own. That morning he also asked her to button his shirt and help pull on his pants which she thought was just related to the local reaction in the arm. Mom reports that later that afternoon she noticed weakness in the flexion of the elbow, then  no longer moving fingers, and then dropping of the wrist. He complained of pain in the wrist and the forearm only. She reports she gave another dose of motrin and massaged the areas with olive oil.  His mom reports that he had total resolution of symptoms over about 6 hours or so, by 4 AM 9/1/2017 muscle function was all normal again. She reports that her niece had a similar reaction to Hep B vaccine and that she had no use of her arm for 6 weeks. She reports that she had to undergo physical and occupational therapy and required a brace for her hand and writ. She does not have any effects that have lingered. Patient's mother asking me to report this event to the VAERS in case it returns or he has additional issues in the future.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Mobility decreased, Muscle disorder, Pain, Pain in extremity
Clinical narrative: Mother reports patient was complaining of pain which started around 6 PM the day of the vaccines. He kept saying it was pain like his "bone was broken".  She gave him motrin and he stopped complaining. However, the next day she started to notice the muscle function slowly decreasing. She reports she didn't notice until she gave him a glass of milk in his left hand that he dropped. Earlier in the day he also asked her to peel his banana, which he usually can do on his own. That morning he also asked her to button his shirt and help pull on his pants which she thought was just related to the local reaction in the arm. Mom reports that later that afternoon she noticed weakness in the flexion of the elbow, then  no longer moving fingers, and then dropping of the wrist. He complained of pain in the wrist and the forearm only. She reports she gave another dose of motrin and massaged the areas with olive oil.  His mom reports that he had total resolution of symptoms over about 6 hours or so, by 4 AM 9/1/2017 muscle function was all normal again. She reports that her niece had a similar reaction to Hep B vaccine and that she had no use of her arm for 6 weeks. She reports that she had to undergo physical and occupational therapy and required a brace for her hand and writ. She does not have any effects that have lingered. Patient's mother asking me to report this event to the VAERS in case it returns or he has additional issues in the future.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received PNEUMOVAX on 8/29 in the evening at his appt. He went to bed that night and noticed pain in his right arm through the night, then on 8/30/17 he awoke with swelling in upper arm, pain had worsened and by 8/31/17 when patient awoke the pain an swelling were worse, edema from mid biceps to medial epicondyle of right arm, warm to touch as well. Patient was seen by Dr. at the office 8/31/17, advised to use cold compresses, Ibuprofen prn, if not improving over next 1-2 days to start Prednisone 20mg 3 for 3 days, 2 for 3 days, 1 for 3 days. Spoke with patient today 9/1/17 and some improvement, he did not start Prednisone and swelling and redness have decreased, he is using cold compresses, Ibuprofen, pain continues when touches bicep area. Patient to call if symptoms worsen or do not continue to improve.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year old female patient. There were no drug reactions/allergies, pertinent medical history, and concomitant therapies for the patient. On 04-AUG-2017, the patient was vaccinated with a second dose of GARDASIL 9 (lot # M017083; expiry: 01-JUN-2019) via intramuscular route in the left arm, to prevent human papilloma virus (HPV). Since receiving the vaccine on the same day, the patient experienced pain. She required medical attention. Physician reported that the patient's mother called in to the office and was told to give Ibuprofen and apply warm compresses to the injection site. No lab diagnostics/studies performed. Outcome of the event was reported as not resolved. Causality assessment was not reported. Lot # M017083 is an invalid lot number for GARDASIL 9.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown demographics. Information regarding patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX, injection (dose, frequency, route, lot and expiry details unspecified) reconstituted with properly stored sterile diluent for prophylaxis (incorrect product storage). The vaccines were exposed to a temperature excursion of 6 to 14 degree Fahrenheit for a time frame of 7 hours and 30 minutes. There were no previous temperature excursion. Data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX for prophylaxis.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Headache, Nausea, Nodule
Clinical narrative: Arm was swollen to the elbow and had a hard knot. She said she was nauseated and dizzy and had a headache. She said she had no energy and couldn't get off the couch for 2 days.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm was swollen to the elbow and had a hard knot. She said she was nauseated and dizzy and had a headache. She said she had no energy and couldn't get off the couch for 2 days.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given Tdap, polio, MMR, and var when not needed.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Drug administered at inappropriate site, Injection site pain, Injection site reaction, Local reaction, Neck pain
Clinical narrative: Patient presented 9/1/17 with whelps on left shoulder and collarbone, soreness down left shoulder and neck, and swollen neck on left side. Patient said she received Flu and Pneumonia both 8/30/17 in the same arm. Patient said she was going to the doctor to let them check her out and make sure it was a reaction to the shot and nothing else. Patient called and let us know that the doctor decided it was just a localized reaction and gave her a TORADOL injection along with another injection she didn't know the name of. The doctor said it was given high in the arm.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling, Urticaria
Clinical narrative: Patient presented 9/1/17 with whelps on left shoulder and collarbone, soreness down left shoulder and neck, and swollen neck on left side. Patient said she received Flu and Pneumonia both 8/30/17 in the same arm. Patient said she was going to the doctor to let them check her out and make sure it was a reaction to the shot and nothing else. Patient called and let us know that the doctor decided it was just a localized reaction and gave her a TORADOL injection along with another injection she didn't know the name of. The doctor said it was given high in the arm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 17-year-old female patient who received MENVEO. Co-suspect products included MENVEO (batch number M16172, expiry date unknown). Previously administered products included MENVEO (received in 2012). In November 2016, the patient received the 2nd dose of MENVEO. On 23rd August 2017, the patient received the 3rd dose of MENVEO. In November 2016, unknown after receiving MENVEO and not applicable after receiving MENVEO, the patient experienced extra dose administered. On 23rd August 2017, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered, extra dose administered and wrong vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. In November 2016, the patient received 2nd dose of MENVEO, which led to extra dose administered. On 23rd August 2017, the patient received 3rd dose of MENVEO instead of giving BEXSERO, which led to extra dose administered and wrong vaccine administered.
Sex: U
Vaccine: RV1
Symptoms: Immediate post-injection reaction, Laceration, Product container issue, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of laceration in a adult patient who received ROTARIX (batch number A41CB558A, expiry date 5th September 2017) and (batch number A41CB573A, expiry date 17th October 2017). This case was associated with a product complaint. On an unknown date, the patient received ROTARIX. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving ROTARIX, the patient experienced laceration and pharmaceutical product complaint. On an unknown date, the outcome of the laceration and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration to be related to ROTARIX. Additional details were reported as follows: The age at vaccination was not reported. The first incidence involving vial breaking when transfer adaptor attached (during preparation of vial). The other three incidences involve vials snapping' at the neck when cap is removed (during preparation of vials). It was confirmed that no product given to the patients. As per GlaxoSmithKline employee, package condition not damaged or open. It was unknown who opened the box. Medical Assistants administered product, unknown if experienced. It was unknown how stored. It was unknown if purchased directly from GlaxoSmithKline. It was unknown if carton was damaged, unknown if leakage was there in carton, unknown if glass pieces were still in vial, unknown if holes or pieces missing from vial and it was unknown if med still in vial. It was attempted to reach out to health care professional for further details. Voicemail was left with serial number. It was unknown if product was available for return, unknown if credit needed. It was unable to verify lot numbers. One of the staff members experienced the product exploding in face and got into eyes. It was unknown which of the four incidences is related to this adverse event. This case was linked to case US2017130511, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Inflammation, Pain, Pruritus
Clinical narrative: Approx. 1 hr after vaccination started getting very itchy then became hard and ring of red around the hardness then became very inflamed for couple of days and very sore by 3rd day redness started to go away.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Approx. 1 hr after vaccination started getting very itchy then became hard and ring of red around the hardness then became very inflamed for couple of days and very sore by 3rd day redness started to go away.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pruritus
Clinical narrative: Approx. 1 hr after vaccination started getting very itchy then became hard and ring of red around the hardness then became very inflamed for couple of days and very sore by 3rd day redness started to go away.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Injection site reaction, Local reaction, Mass
Clinical narrative: Localized injection site reaction. Several hours after administration of vaccine small area of bruising and golf ball sized lump hot to the touch. The following day swelling spread with redness and heat throughout the upper arm. Signs of possible infection.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Localized injection site reaction. Several hours after administration of vaccine small area of bruising and golf ball sized lump hot to the touch. The following day swelling spread with redness and heat throughout the upper arm. Signs of possible infection.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Bone pain, Cough, Eye pain, Hyperhidrosis, Malaise
Clinical narrative: Pt reported "bone pain",  pain behind eyes, sore throat, malaise, severe dry cough, sweating. Pt was advised to take acetaminophen, but declined. Pt asked about epsom soaks, and was told they would be ok.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain
Clinical narrative: Pt reported "bone pain",  pain behind eyes, sore throat, malaise, severe dry cough, sweating. Pt was advised to take acetaminophen, but declined. Pt asked about epsom soaks, and was told they would be ok.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Pain
Clinical narrative: Redness heat, swelling at site. Extreme muscle pain persists. Painful to abduct greater than 75 degrees. Improving.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Noticed next morning upper arm (shoulder to elbow) red and swollen. Not a noticeable reaction at specific injection site. Swelling was more towards inner arm and elbow than on site of immunization.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild/moderate localize swelling with some erythema at injection site. No pain or signs of infection noted. No other s/s of allergic rx. Recommend pt tried cool compress and take benadryl x 1 day along with naproxen for edema.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Myalgia
Clinical narrative: The patient is having trouble walking and experiencing pain in his muscles.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blister, Diarrhoea, Erythema, Pyrexia, Rash
Clinical narrative: Developed erythematous swelling with small surface bullae ~2-3cm irregular borders, mildly tender - this developed prior to child being seen for h/o fever and had defervesced at time of clinic appt. Also 4 episodes watery diarrhea 7 days post vaccination, sneezing without other URI symptoms. fever to 103 on 8/29, fever trend down when he was seen on 9/1. Exposed to +Ill sibling with URI symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Sneezing, Swelling, Tenderness
Clinical narrative: Developed erythematous swelling with small surface bullae ~2-3cm irregular borders, mildly tender - this developed prior to child being seen for h/o fever and had defervesced at time of clinic appt. Also 4 episodes watery diarrhea 7 days post vaccination, sneezing without other URI symptoms. fever to 103 on 8/29, fever trend down when he was seen on 9/1. Exposed to +Ill sibling with URI symptoms.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: PT STATES THAT SHE WAS ITCHING TODAY WHILE IN CLASS AT SCHOOL. ON HER WAY HOME TODAY AT APPX 4:00PM SHE NOTICED HIVES. WHEN SHE GOT HOME SHE NOTICED HIVES ALL OVER BODY BUT NOT FACE. MOSTLY ON HER BACK AND STOMACH AREAS. I ADVISED THAT SHE TAKE BENADRYL OTC AND TO CONTACT HER PRIMARY CARE PHYSICIAN. PT ASKED HOW LONG TO EXPECT HIVES I SAID I'M NOT CERTAIN, BUT WOULD EXPECT 24-48 HOURS. CONTACT HER MD TO BE SURE. PT DENIED ANY DIFFICULTY BREATHING. STATED RASH NOT ON FACE. DENIED ALLERGY TO EGGS. STATED HAS HAD PREVIOUS FLU SHOTS AND RECALLS HAVING THE H1N1 VACCINE A FEW YEARS AGO WITH NO ADVERSE EVENTS.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Sore, red, swollen, warm to touch at injection site.