chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Swelling
Clinical narrative: subsequently developed a fever of 102 F; subsequently developed a fever of 102 F, nausea; subsequently developed a fever of 102 F, nausea, dizziness; she could not lift her arm; weakness in the arm where the vaccination was administered; This spontaneous report was received from a medical assistant concerning to a 70 year old female patient. The patient's medical history included diabetes mellitus and hypertension. The patient doesn't referred allergies. Concomitant therapies included pioglitazone hydrochloride(ACTOS), amlodipine(AMLODIPINE) and atorvastatin calcium (LIPITOR).      On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot number S005857 and expiration date 03-DEC-2020, for prophylaxis (dosage schedule, and anatomical location were not reported). And subsequently on 28-SEP-2019, the patient  developed a fever of 102 F (pyrexia), nausea, dizziness and weakness in the arm where the vaccination was administered (muscular weakness). The reporter stated the patient reported that the patient could not lift her arm (injected limb mobility decreased). Laboratory diagnostics and studied were not performed. The patient sought for medical attention.   The outcome of pyrexia, muscular weakness, injected limb mobility decreased, dizziness and nausea was unknown.  The causality between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Dizziness, Injected limb mobility decreased, Muscular weakness, Nausea, Pyrexia
Clinical narrative: subsequently developed a fever of 102 F; subsequently developed a fever of 102 F, nausea; subsequently developed a fever of 102 F, nausea, dizziness; she could not lift her arm; weakness in the arm where the vaccination was administered; This spontaneous report was received from a medical assistant concerning to a 70 year old female patient. The patient's medical history included diabetes mellitus and hypertension. The patient doesn't referred allergies. Concomitant therapies included pioglitazone hydrochloride(ACTOS), amlodipine(AMLODIPINE) and atorvastatin calcium (LIPITOR).      On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot number S005857 and expiration date 03-DEC-2020, for prophylaxis (dosage schedule, and anatomical location were not reported). And subsequently on 28-SEP-2019, the patient  developed a fever of 102 F (pyrexia), nausea, dizziness and weakness in the arm where the vaccination was administered (muscular weakness). The reporter stated the patient reported that the patient could not lift her arm (injected limb mobility decreased). Laboratory diagnostics and studied were not performed. The patient sought for medical attention.   The outcome of pyrexia, muscular weakness, injected limb mobility decreased, dizziness and nausea was unknown.  The causality between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: She received influenza vaccine at pharmacy (outside our medical system) in RUE today and no reaction in the RUE.  She had reaction of redness and swelling in LUE where she received Prevnar vaccine.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Patient received injection at 8pm, at a public health clinic held in the community. At around 9 pm she began to feel swelling of her lips and tongue. Was transported to ED at 9:35 pm, where VS were stable. Was treated with Pepsid  & Solumedrol IV, Vistaril PO.  Patients symptoms resolved and she was discharged with medications including one EPI PEN.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Fall, Loss of consciousness, Musculoskeletal stiffness, Syncope
Clinical narrative: Patient fainted and fell on the floor briefly after flu shot with stiff body and jerking movements. Patient regained consciousness after 10-15 seconds
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: numbness/tingling dullness pain radiating after shot given
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: started off with a mild sore spot, over time getting aching pains, chills, mild fever. The pain is now more accute down my arm, and I can feel overall tightness in that arm, the aches are now spread throughout my body.  Becoming tired, to the point that filling out this form I've nearly fallen asleep twice, and realize I'd typed words that are unintelligible because I was falling asleep.  The aches and pains have triggered my restless leg syndrome to shake
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Restless legs syndrome, Skin tightness, Somnolence, Tremor
Clinical narrative: started off with a mild sore spot, over time getting aching pains, chills, mild fever. The pain is now more accute down my arm, and I can feel overall tightness in that arm, the aches are now spread throughout my body.  Becoming tired, to the point that filling out this form I've nearly fallen asleep twice, and realize I'd typed words that are unintelligible because I was falling asleep.  The aches and pains have triggered my restless leg syndrome to shake
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Feeling cold, Headache, Impaired work ability
Clinical narrative: Within one hour of receiving the vaccine @ pharmacy, I was shaking, freezing cold, shivering uncontrollably, had a headache, lower back, neck & shoulders were very painful!  It was so bad I was unable to work the following day, 10/09/2019, which I CANNOT afford to do! Although I had to return to work I am still suffering from body aches & general malaise. I have NEVER had a reaction to the flu shot in the past.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Musculoskeletal pain, Neck pain, Pain, Tremor
Clinical narrative: Within one hour of receiving the vaccine @ pharmacy, I was shaking, freezing cold, shivering uncontrollably, had a headache, lower back, neck & shoulders were very painful!  It was so bad I was unable to work the following day, 10/09/2019, which I CANNOT afford to do! Although I had to return to work I am still suffering from body aches & general malaise. I have NEVER had a reaction to the flu shot in the past.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Periorbital pain, Photophobia
Clinical narrative: peri-orbital eye pain and sensitivity to light
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain  Limited ROM and function Numbness in the hand and radiating pain
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Feverish, chills, nausea, diarrhea, dull headedness, headache, deep fatigue, lethargy, injection site pain Feverish symptoms/chills broke late afternoon on October 9th. Some chill briefly overnight, but it passed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Nausea, Pyrexia
Clinical narrative: Feverish, chills, nausea, diarrhea, dull headedness, headache, deep fatigue, lethargy, injection site pain Feverish symptoms/chills broke late afternoon on October 9th. Some chill briefly overnight, but it passed.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle strain, Pain in extremity
Clinical narrative: Patient reported back to the pharmacy on 10/7/2019 after receiving and Adacel vaccine on 10/1/2019 with complaints of a torn muscle with pain up his arm and across his chest. Patient had been seen by a doctor that day for symptoms. The doctor gave the patient a prescription for lidocaine patches.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot
Clinical narrative: Localized redness and warmth
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: He developed a swollen, warm, erythematous and tender left arm after administration. It was roughing 48 hours post administration when he was evaluated by me and no  tenderness noted, no airway involvement, no evidence of abscess. He was afebrile when I saw him.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Received call from healthcare provider with Clinic on 10/9/19.  Client presented with parent with redness, swelling, and pain in right arm at site of injections.  Discussed with her, client received TDaP and Menactra in right arm.  Health care provider reported that she felt would resolve on it's own. Reports she was going to give client hydrocortisone and encourage client to use ice.  Spoke with client's father today, 10/10/2019, reports client missed school yesterday, but arm is doing better today, though not resolved, and went back to school today.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeding disorder, Headache, Nausea
Clinical narrative: Extreme headache, nausea, fatigue. Could barely get out of bed for 33mhours. Could not eat for 33 hours.  Felt much better after waking up at about 7am two days after receiving vaccine.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered an improperly stored VAQTA; no adverse events; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.     On 23-SEP-2019, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot #S007769, expiration date on 24-JUL-2020 (strength, dose, frequency, route of administration, anatomical location, and indication were not reported).  The administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (9 degrees Celsius) for 9 hours and 55 minutes. There was no previous temperature excursion reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: improperly stored doses of VAQTA were administeres to a patient; no adverse affects; This spontaneous report was received from the office manager referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  On an unknown date the patient was vaccinated with a improperly stored hepatitis a vaccine, inactivated (VAQTA) Lot No. S009562 has been verified to be a valid lot number, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019. (Strength, dose, frequency, route of administration, anatomical location, and indication were not reported).  The administered dose of vaccine experienced the temperature excursion of 35.1 degrees Fahrenheit for 5 hours. There was no previous temperature excursion reported. Data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient ws inadvertently administered a dose of PROQUAD that had been improperly stored; This spontaneous report was received from the vaccine coordinator and refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  On 24-SEP-2019, the patient was inadvertently vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R030805, expiration date on 02-AUG-2020 (Strength, dose, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent. No adverse effect reported.  The administered dose of vaccine experienced the temperature excursion of 27.1 degrees Fahrenheit 77 for 40 minutes. There was no previous temperature excursion reported. Data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects.; an improperly stored VARIVAX was administered.; Information has been received from a medical assistant referring to an unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 13-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N029632, expiration date: 23-OCT-2019, dose, frequency and route were not reported) for prophylaxis. The administered doses experienced a temperature excursion at 13.3F (6°F to 14°F)  for 30 mins; Previous temperature excursions were 15.3F (15°F to 46°F) for 8 hours. The temperature excursions were detected by a data logger (Product storage error). No adverse effects. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; One dose of an improperly stored vaccine, PROQUAD, has been administered to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not provided.   On 30-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose, route, frequency, were not provided) for prophylaxis; the Lot No. S008578 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported as 16-SEP-2020, and upon internal validation established as the same.   The nurse reported that this vaccine dose was administered on this date, but the vaccine was improperly stored (incorrect product storage). It presented a temperature excursion with a temperature of 8.5 degrees Celsius for 25 minutes. And no adverse events were reported. There were no other temperature excursions presented for this vaccine and there was a data logger.   Moreover, it was stated that the sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored (Lot# S026376 and expiration date 24-MAR-2022).
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Anaphylactic shock, Asthenia
Clinical narrative: Anaphylactic Shock; The patient looked weak; This spontaneous report was received from a pharmacist concerning to a 70 year old male patient with diabetes mellitus and prostate issues (reported as might have prostate issues). Medical history and concurrent conditions were not provided.  On 30-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form intramuscularly, lot# S018405, the expiration date of 28-MAR-2021, for prophylaxis (reported as vaccination).  Other suspect therapies included an unspecified flu vaccine (reported as flu shot); dose, route, lot# and the expiration date were not reported also for prophylaxis.      On the same date, the patient developed an anaphylactic shock right after administration of the unspecified flu vaccine and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (interval between both vaccines was about 3-4 minutes). The pharmacist stated that he gave the patient epinephrine hydrochloride (EPIPEN) as treatment right away and the patient recovered from the event right away. However, the patient looked weak (asthenia), so the pharmacist called an ambulance to take the patient to an unspecified hospital. At the time of reporting it was unknown per pharmacist if the patient would be admitted to the hospital.  By the time of the report, the outcome of asthenia was unknown. The relatedness between the events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and unspecified flu vaccine was unknown.  Upon internal review, the anaphylactic shock was determined to be medically significant.
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Anaphylactic shock, Chest discomfort, Dyspnoea, Erythema
Clinical narrative: Anaphylactic Shock; The patient looked weak; This spontaneous report was received from a pharmacist concerning to a 70 year old male patient with diabetes mellitus and prostate issues (reported as might have prostate issues). Medical history and concurrent conditions were not provided.  On 30-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form intramuscularly, lot# S018405, the expiration date of 28-MAR-2021, for prophylaxis (reported as vaccination).  Other suspect therapies included an unspecified flu vaccine (reported as flu shot); dose, route, lot# and the expiration date were not reported also for prophylaxis.      On the same date, the patient developed an anaphylactic shock right after administration of the unspecified flu vaccine and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (interval between both vaccines was about 3-4 minutes). The pharmacist stated that he gave the patient epinephrine hydrochloride (EPIPEN) as treatment right away and the patient recovered from the event right away. However, the patient looked weak (asthenia), so the pharmacist called an ambulance to take the patient to an unspecified hospital. At the time of reporting it was unknown per pharmacist if the patient would be admitted to the hospital.  By the time of the report, the outcome of asthenia was unknown. The relatedness between the events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and unspecified flu vaccine was unknown.  Upon internal review, the anaphylactic shock was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Cancer in remission, Neoplasm malignant, Pneumonia
Clinical narrative: The patient is also "a cancer patient in remission".; had pneumonia about 5 or 6 years ago; had a mild reaction; This spontaneous report as received from a patient's husband refers to a female of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date in 1992, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (manufacturer unknown) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 1992, the patient experienced mild reaction (unspecified). In approximately 2013 (reported as about 5 or 6 years ago), the patient experienced pneumonia. On an unknown date, the patient was diagnosed with a cancer (unspecified). It was reported that, the cancer was in remission, at the time of the report. The outcome of the events was not provided.  The reporter considered mild reaction to be related to pneumococcal vaccine (manufacturer unknown). The relatedness between cancer and pneumonia and pneumococcal vaccine (manufacturer unknown) was not provided.  Upon internal review, the events of cancer and pneumonia were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Patient received improperly stored VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. Concomitant therapies  included a properly stored sterile diluent to reconstitute the vaccine.  On 26-SEP-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# R018142 and expiration date 25-JUN-2020,  for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion was of -12.7Centigrade degrees (°C), during 36 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired dose administered; This spontaneous report as received from a study coordinator (Researcher) refers to a 4 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 26-SEP-2019, the patient was vaccinated with properly stored but an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R002805, Expiry date : 23-SEP-2019) for prophylaxis (expired product administered).  The patient had no adverse event.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; was administered PROQUAD./ was administered VARIVAX; was reconstituted with saline diluent; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medication or medical history.     On 01-OCT-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005079 with expiration date on 19-FEB-2019 for prophylaxis (dose and route of administration were not reported) that was reconstituted on a sterile diluent(MERCK STERILE DILUENT) and during the same office visit, the patient was also administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (dose, route of administration, lot number and expiration date were not reported), which was reconstituted with a saline diluent (manufacturer unknown). However, no adverse effects were reported.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; improperly stord dose of VAQTA; This spontaneous report was received from a medical assistant concerning to a 7-year-old female patient. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 03-OCT-2019, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot number S005725 with expiration date on 07-OCT-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 46.5 degrees Fahrenheit (F) for 5 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Hearing loss; Information has been received from a lawyer and a consumer (reported as spouse) referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 22-OCT-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient experienced hearing loss. The patient did not recover from the events. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.   The reporter considered the event were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received on 04-OCT-2019 from a lawyer and the patient, regarding a case in litigation referring a  female patient of unknown age. Concurrent conditions, medical history and concomitant medication were not reported.   On or about 18-APR-2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route, anatomical location, lot number and expiration date were not provided) for long-term prevention of shingles and zoster-related conditions. Subsequent, on unknown date, to patient's Zoster Vaccine Live (ZOSTAVAX) inoculation, patient was treated by a health care provider, at the clinic for shingles, requiring hospitalization.   As a direct and proximate result of patient's use of the Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and would 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 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 causality between Zoster Vaccine Live (ZOSTAVAX) and shingles was considered as related by reporters.
Sex: F
Vaccine: MMR
Symptoms: Skin papilloma
Clinical narrative: The consumer was vaccinated with "the measles mumps rubella vaccination as a child and has had plantar's warts for 6 years now; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were unknown. On an unknown date, during her childhood the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date (reported as: 6 years ago), the patient had experienced plantar warts. Furthermore, the patient had sought medical attention. The consumer reported that she tried every treatment. There was no product quality complaint. The outcome of the event was unknown. The relatedness between the event plantar warts and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, Parasite stool test negative
Clinical narrative: diarrhea; This spontaneous report was received from a medical assistant refers to a 4 month old male patient. The patient's concurrent condition included acid reflux. Concomitant medications and drug reactions/allergies were reported as none. On 16-JUL-2019, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter one time orally for prophylaxis (also reported as "well baby check"). On 20-SEP-2019, the patient was vaccinated with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S005874 and expiration date 31-OCT-2020, at a dose of 2 milliliter one time orally. On 21-SEP-2019 (one day later of second dose of vaccine), the patient experienced diarrhea (diarrhoea) that lasted for 12 days. The patient sought medical attention. On an unknown date in 2019, the patient's stool culture was negative for ova and parasite (O and P) and showed normal flora. No treatment was given for the event. No product quality complaint (PQC) present. The outcome of diarrhoea was reported as resolved on 02-OCT-2019.  The causality assessment was not provided by the reporter.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received improperly stored VARIVAX; No adverse event; This spontaneous report was received from medical assistant referring to a female patient of unknown age. The patient's concurrent conditions, drug allergies/reactions and medical history were not reported. On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) (strength, formulation, dose/frequency, route was not reported) lot # S011951 expiration date reported as 16-APR-2019, but upon internal validation established as 16-APR-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of minus 12.3 degree Celsius for 6.05 hours. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The physician is reporting that the patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with one dose of an improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  lot # S009757 and expiration date 27-SEP-2020 (dose, frecuency and route were not provided) for prophylaxis (product storage error). The administered dose of the vaccine was stored with a temperature of 32.5 degrees Fahrenheit for 8 hours. There was a digital data logger involved, but there was no previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine administered; This spontaneous report was received from a health care professional regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 30-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R028003 and expiry date:01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). No adverse effects were reported. There was no previous temperature excursion. The vaccine was stored above 47 °F to 53.7 °F for a time frame of 6 hours 16 minutes. Data logger was present.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Swelling; Redness covers about a 3 inch area below the injection site; Bruise; Soreness; This case was reported by a consumer and described the occurrence of swelling in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received withe 3 months spacing and experienced very little reaction, refer inked case US2019AMR178056)  On 26th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced swelling, injection site erythema, contusion and pain. On an unknown date, the outcome of the swelling, injection site erythema, contusion and pain were unknown.   It was unknown if the reporter considered the swelling, injection site erythema, contusion and pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient refused to provide patient's information. On Thursday, the patient received Shingrix. The patient experienced bruise, swelling, redness, soreness and the redness covered about a 3 inch area below the injection site. The patient asked was this in the normal range or should the patient be concerned. The patient how long should the patient expect the swelling and redness to last following the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Very little reaction; This case was reported by a consumer and described the occurrence of adverse event in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient refused to provide patient's information. The patient received 1st dose of Shingrix 3 months spacing. The patient experienced very little reaction. For tolerance to 2nd dose, refer linked case US2019AMR178052.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Felt lightheaded; Had difficulty walking; Arm was sore for weeks; Body was sore for over 1 month; This case was reported by a pharmacist and described the occurrence of light-headed feeling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced light-headed feeling, walking difficulty, pain in arm and general body pain. On an unknown date, the outcome of the light-headed feeling and walking difficulty were unknown and the outcome of the pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the light-headed feeling, walking difficulty, pain in arm and general body pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient had side effects. On the same evening at the vaccination, the patient felt lightheaded and had difficulty walking. Less than 2 years after receiving Shingrix, the patient's arm was sore for weeks and her body was sore for over 1 month. The reporter suggested to wait on the 2nd dose, until the reporter contacted Glaxosmithkline.
Sex: U
Vaccine: MENB
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced Bell's palsy. The reporter consented for follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: felt bad; tired; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced feeling bad and tiredness. On an unknown date, the outcome of the feeling bad was unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the feeling bad and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received her first dose of Shingrix in May.  The patient felt bad, and was tired with that administration but it was resolved. The emergency room visit was required. The reporter consented to follow up. This case has been linked with cases US2019172796, US2019172789 and US2019173375 reported by the same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Musculoskeletal pain
Clinical narrative: swelling at injection site; redness at injection site; itchiness at injection site; pain radiated throughout the arm / pain at injection site / could hardly touch it; pain radiated up the shoulder and back of the neck; pain radiated up the shoulder and back of the neck; could hardly touch it; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist reporting that patient received Shingrix on left arm and experienced swelling, redness, itchiness and pain at the injection site, additionally the pain radiated throughout the arm.  The caller reported that the issues did resolved after about one week's time after about one week's time. The healthcare professional stated that the pain hurt so much that the patient could hardly touch it. The pain radiated up the shoulder and to the back of the neck.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Tenderness
Clinical narrative: swelling at injection site; redness at injection site; itchiness at injection site; pain radiated throughout the arm / pain at injection site / could hardly touch it; pain radiated up the shoulder and back of the neck; pain radiated up the shoulder and back of the neck; could hardly touch it; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist reporting that patient received Shingrix on left arm and experienced swelling, redness, itchiness and pain at the injection site, additionally the pain radiated throughout the arm.  The caller reported that the issues did resolved after about one week's time after about one week's time. The healthcare professional stated that the pain hurt so much that the patient could hardly touch it. The pain radiated up the shoulder and to the back of the neck.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix .5 ml. On 12th September 2019, 14 days after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. 2 weeks after receiving Shingrix, the patient was diagnosed with shingles. On 12th September 2019, the patient started on Acyclovir. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Product administered at inappropriate site
Clinical narrative: headache; pain in the right arm; Administered the vaccine in the right arm, but lower than the deltoid / Injected the vaccine in the muscle tissue or fatty tissue; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache, pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the headache, pain in arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.  Additional details were received as follows: Caller is the patient's wife. Caller states that the patient received the 2nd dose of Shingrix yesterday. Caller states that the pharmacist adminstered the vaccine in the right arm, but lower than the deltoid, which led to vaccine administered at inappropriate site. Caller states that she is not sure if the pharmacist injected the vaccine in the muscle tissue or fatty tissue. Caller states that the patient developed pain in the right arm and also experienced a headache following the vaccine. Caller disconnected before providing patient initials, DOB, or mailing address. Caller did not provide any additional information. This case was linked to cases US2019178924 and US2019AMR179518, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: chills; fever; malaise; This case was reported by a physician via call center representative and described the occurrence of chills in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced chills, fever and malaise. On an unknown date, the outcome of the chills, fever and malaise were resolved with sequelae.   It was unknown if the reporter considered the chills, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had chills, fever, malaise, after each dose of Shingrix. The patient thought that it was due to not having chickenpox. The reporter was seeing patient and did not wish to provide patient's information. The reporter did not consent to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Age: 17.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: MA gave 17 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; MA gave 17 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse via office Staff.  This case is linked with 2019SA267186, 2019SA267187, 2019SA267188 (same reporter)  This case involves a 17 years old male patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccine included Menactra (MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX))   On 18 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE Frequency : once, lot QFAA1918, exp date: 30 June 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the 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  List of documents held by the sender: none
Age: 14.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 years old Flublok instead of prescribed Fluzone Quadrivalent, No adverse events; 14 years old Flublok instead of prescribed Fluzone Quadrivalent, No adverse events; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse via office Staff.  This case is linked with 2019SA267180, 2019SA267187, 2019SA267186 (same reporter)  This case involves a 14 years old female patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccine was given.   On 11 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1903 , exp date: 19 May 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the 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  List of documents held by the sender: none