chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Cough, Dizziness, Feeling cold, Myalgia
Clinical narrative: Uncontrollable shaking, freezing, followed by fever, muscle/bone pain, ongoing bronchial cough. Have taken regular flu shots since they were available with no bad effects. What medical moron thought giving a Sr. 400% more powerful vaccine was a good idea? Oh, yes! I had shot and walked to front of store. Was overcome by a horrible dizzy spell. No longer than 2 mins. following receipt of shot.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Uncontrollable shaking, freezing, followed by fever, muscle/bone pain, ongoing bronchial cough. Have taken regular flu shots since they were available with no bad effects. What medical moron thought giving a Sr. 400% more powerful vaccine was a good idea? Oh, yes! I had shot and walked to front of store. Was overcome by a horrible dizzy spell. No longer than 2 mins. following receipt of shot.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported redness, swelling and pain at site of injection. Was seen by urgent care and given BACTRIM for possible cellulitis.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Large red swollen lump at inj site. Warm to touch. Lump is grapefruit sized.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Rash, Skin warm
Clinical narrative: Rash on arm 10/19/17, progressive redness and warmth. Cellulitis. Tx BACTRIM DS 10/20/17 one PO BID x 10 days.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Balance disorder, Cold sweat, Feeling abnormal, Headache, Insomnia
Clinical narrative: Patient felt fine until 10/16/17 - woke up with headache fever body aches off balance resolved 10/20. C/O on 10/20 blurred vision can't sleep better today, but still doesn't feel right. Able to work. Cold sweats continue. Referred to PCP for evaluation on 10/23/17.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Pain, Pyrexia, Vision blurred
Clinical narrative: Patient felt fine until 10/16/17 - woke up with headache fever body aches off balance resolved 10/20. C/O on 10/20 blurred vision can't sleep better today, but still doesn't feel right. Able to work. Cold sweats continue. Referred to PCP for evaluation on 10/23/17.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: Pt showed Red, swollen and hot left arm. Pt went to urgent care and was prescribed BENADRYL for allergic reaction. 10-23-17 Pt reported it was nearly back to normal to RPh.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Eczema
Clinical narrative: Mom called to report worsening eczema 2 days after receiving the PENTACEL vaccine. Mom did not want to try a topical steroid. She would like to try an organic moisturizer. Referred to Allergist.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Rash, Skin warm, Urticaria
Clinical narrative: Rash/whelps (hot to touch). Fever. Nausea. Vomiting.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Rash/whelps (hot to touch). Fever. Nausea. Vomiting.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt. rec'd GARDASIL-9 (#2) at annual V-up on 07/17/17. During 15 min. 'wait period' pt. with report of numbness/tingling to (LT) arm. Pt. evaluated by Dr and NP = normal strength: Rec. D/C to home for rest/monitoring. If increasing go to ER. PCN C/D next day. (Positive) pain to (LT) arm, but no numbness/tingling.
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA, MENB
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 17-year-old female patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018). Concomitant products included FLUARIX QUADRIVALENT and Hep A vaccine. On 6th October 2017, the patient received BEXSERO .5 ml. On 11th October 2017, 5 days after receiving BEXSERO, the patient experienced injection site warmth, injection site itching and injection site tenderness. On an unknown date, the outcome of the injection site warmth, injection site itching and injection site tenderness were unknown. The reporter considered the injection site warmth, injection site itching and injection site tenderness to be possibly related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. On 6th October 2017, the patient received a dose of FLUARIX QUADRIVALENT (batch number: 572KT, expiry date: 25th May 2018) in right deltoid and Hepatitis A vaccine (non GSK, batch number: N005796, expiry date: 26th May 2018) in left deltoid. The patient received a dose of BEXSERO at 4:30 in left deltoid. It was reported that the left arm was itchy and warm to the touch. The area measured at greater than 10 cc with tenderness. This case was one of the 3 cases, reported by the same reporter for the patients who experienced events after the same lot number of BEXSERO.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Candida infection, Streptococcal infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of streptococcal infection in a 18-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced streptococcal infection and thrush. On an unknown date, the outcome of the streptococcal infection and thrush were unknown. It was unknown if the reporter considered the streptococcal infection and thrush to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The anonymous consumer reported that her daughter was diagnosed with thrush after receiving her 1st dose of BEXSERO. The daughter had not received the 2nd dose of BEXSERO till the time of reporting. The consumer was not willing to provide the patient name or other details. This was a chat that was transferred from MI to the GRC. The reporter stated that her daughter was due to have her 2nd dose of BEXSERO on Monday, but she had been diagnosed with strep and thrush. The reporter wanted to know if it was okay for her daughter to had the vaccine while being on those drugs.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018). Concomitant products included FLUARIX TETRA and Hep A vaccine. On 9th October 2017, the patient received BEXSERO .5 ml. On 10th October 2017, 1 days after receiving BEXSERO, the patient experienced injection site pain, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site erythema and injected limb mobility decreased were unknown. The reporter considered the injection site pain, injection site erythema and injected limb mobility decreased to be possibly related to BEXSERO. Additional details were received as follows: On 6th October 2017, the patient received a dose of FLUARIX QUADRIVALENT (batch number: 572KT, expiry date: 25th May 2018) in right deltoid and Hepatitis A vaccine (non GSK, batch number: N005796, expiry date: 26th May 2018) in left deltoid. The patient received a dose of BEXSERO at 10:30 in left deltoid. The patient experienced soreness in left arm. There was a very minimal surrounding ring of erythema on left deltoid with moderately decreased left shoulder range of motion secondary to pain. The area was tender to palpation but without swelling or induration. The concomitant Hepatitis A vaccine was considered as a non GSK vaccine considering the batch number information from the linked case US2017157942. This case was one of the 3 cases, reported by the same reporter for the patients who experienced events after the same lot number of BEXSERO.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Received flu vaccine at 3pm. By 6pm had red, swollen area approximately 3x4 inches itchy. No systemic signs/symptoms.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Decreased appetite, Fatigue, Headache, Limb discomfort, Pain in extremity
Clinical narrative: Same day- PNEUMOVAX 23 after administered left arm was hot and heavy. Severe arm pain /heaviness, headache, decreased appetite, fatigue, palpitations. Stays in bed for 3 days due to severe exhaustion.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Palpitations, Skin warm
Clinical narrative: Same day- PNEUMOVAX 23 after administered left arm was hot and heavy. Severe arm pain /heaviness, headache, decreased appetite, fatigue, palpitations. Stays in bed for 3 days due to severe exhaustion.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Limb injury
Clinical narrative: Administered high on shoulders, likely into subacromial bursae leading to likely SIRVA.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Rt arm after PNEUMOVAX is swollen and hot to the touch, pt complains also hurts to move arm- resolved by 10/17/17.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Headache, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Muscle weakness; numbness and tingling in hands and face; trouble swallowing; constant headache.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray normal, Electrocardiogram normal, Full blood count normal, Metabolic function test normal, Musculoskeletal stiffness
Clinical narrative: Seconds 20 - 30 (1/2 minute) of seizure like activity and stiffening and generalized shaking.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Seizure like phenomena, Tremor, Urine analysis normal, White blood cell count increased
Clinical narrative: Seconds 20 - 30 (1/2 minute) of seizure like activity and stiffening and generalized shaking.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, RV5
Symptoms: Staring, Tremor
Clinical narrative: 2 hours post immunizations had 30-40 seconds of shaking of head and left arm. Eyes straight ahead (no X rolled back), no LOC. After event alert and playful. Afebrile. Exam in office 30 min after event was normal. No other events.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red and hot and itchy.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Spinal pain
Clinical narrative: Pt received FLUZONE HD in left arm IM delt and is now having pain in Rt arm and spine.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Spinal pain
Clinical narrative: Pt rec'd FLUZONE HD in Lt arm and since then has pain in Rt arm and spine.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Swelling
Clinical narrative: Employee reports had flu shot on 10-17-17 and immediately after had itching, swelling, redness. Reported this on 10/19/17 was better but still itching.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Employee reports had flu shot on 10-17-17 and immediately after had itching, swelling, redness. Reported this on 10/19/17 was better but still itching.
Age: 32.0
Sex: U
Vaccine: FLU4
Symptoms: Contusion, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Within 2 hours of receiving flu vaccine felt (in L increasing arm bruising 10/17) woke this AM and (L. arm swollen redness and was itchy) Seen in clinic.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Received flu vaccine on 10-20-17. Started to itch (L) deltoid area where FLUZONE given. At 7:00 applied hydrocortisone cream and ice. (L) delt reddened and swelling and itching.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rhinorrhoea, Skin warm, Swelling
Clinical narrative: Had flu shot 5:50 on 10-18-17. After injection site began to itch and then proceeded to get swollen then red and warm. Pt states had had the flu shot in past without any reaction. Mild reaction and runny nose.l
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient with, blood pressure and cholesterol issues. The patient's concomitant medications were unknown. The patient's had no drug Reactions or allergies. No information was provided regarding the patient's medical history or concomitant medications. On unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot number, expiration date, route of administration, lot number and expiration date were not reported). On 12-OCT-2017, due to no documented history of vaccination of this vaccination, the patient was vaccinated with PNEUMOVAX 23 lot number N013541 and expiration date of 23-JAN-2019 for prophylaxis (dose and route of administration were not reported). On the same date, the patient was vaccinated with influenza virus vaccine in his right arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported). A couple of days after vaccination, in October, the patient experienced suspected cellulitis and symptoms of redness and "warm to the touch" of his upper left arm a couple days after vaccination. On 14-OCT-2017, the patient saw his doctor who instructed the patient that it could be cellulitis and provided a prescription for antibiotic, cephalexin. The doctor instructed the patient to fill the prescription only if the symptoms got worse. On 14-OCT-2017, the patient filled the prescription for cephalexin. On an unspecified date, the patient's arm was less red but the redness spread to his forearm. The pharmacist also reported that after the vaccination on 12-OCT-2017, it was discovered that in 2013, the patient did have a previous vaccination with PNEUMOVAX 23. At the time of the report, the outcome of the event cellulitis was unknown. Additionally, the reporter did not provide causality assessment between the event and the suspect therapies PNEUMOVAX 23 and influenza virus vaccine. Upon internal review, cellulitis was determined to be medically significant.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient with, blood pressure and cholesterol issues. The patient's concomitant medications were unknown. The patient's had no drug Reactions or allergies. No information was provided regarding the patient's medical history or concomitant medications. On unknown date the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot number, expiration date, route of administration, lot number and expiration date were not reported). On 12-OCT-2017, due to no documented history of vaccination of this vaccination, the patient was vaccinated with PNEUMOVAX 23 lot number N013541 and expiration date of 23-JAN-2019 for prophylaxis (dose and route of administration were not reported). On the same date, the patient was vaccinated with influenza virus vaccine in his right arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported). A couple of days after vaccination, in October, the patient experienced suspected cellulitis and symptoms of redness and "warm to the touch" of his upper left arm a couple days after vaccination. On 14-OCT-2017, the patient saw his doctor who instructed the patient that it could be cellulitis and provided a prescription for antibiotic, cephalexin. The doctor instructed the patient to fill the prescription only if the symptoms got worse. On 14-OCT-2017, the patient filled the prescription for cephalexin. On an unspecified date, the patient's arm was less red but the redness spread to his forearm. The pharmacist also reported that after the vaccination on 12-OCT-2017, it was discovered that in 2013, the patient did have a previous vaccination with PNEUMOVAX 23. At the time of the report, the outcome of the event cellulitis was unknown. Additionally, the reporter did not provide causality assessment between the event and the suspect therapies PNEUMOVAX 23 and influenza virus vaccine. Upon internal review, cellulitis was determined to be medically significant.
Age: 65.0
Sex: F
Vaccine: PNC13, FLUX, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the first of two reports. A 65-year-old female patient received, on 10Oct2017 at 12:50, PREVNAR 13 (Lot number S39564, Expiry date Sep2018, NDC number 00005197101) intramuscularly, in the right arm, at single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine (flu), received on 10Oct2017, for immunization. On 16Oct2017, the patient experienced redness and swelling of the right arm. This patient went to the doctor's office on 16Oct2017, and was diagnosed with a skin infection under the skin. The event was assessed as serious (medically significant). Clinical outcome of the event was unknown at time of this report. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of event cannot be excluded, considering the temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: PNC13, FLUX, PNC13
Symptoms: Erythema, Peripheral swelling, Skin infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the first of two reports. A 65-year-old female patient received, on 10Oct2017 at 12:50, PREVNAR 13 (Lot number S39564, Expiry date Sep2018, NDC number 00005197101) intramuscularly, in the right arm, at single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine (flu), received on 10Oct2017, for immunization. On 16Oct2017, the patient experienced redness and swelling of the right arm. This patient went to the doctor's office on 16Oct2017, and was diagnosed with a skin infection under the skin. The event was assessed as serious (medically significant). Clinical outcome of the event was unknown at time of this report. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of event cannot be excluded, considering the temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Right side of face Drooped. Right Eye not able to shut. Mouth crooked. Slurred speech. Physical therapy on face. Taking steroids.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Dysarthria, Electrocardiogram normal, Eyelid function disorder
Clinical narrative: Right side of face Drooped. Right Eye not able to shut. Mouth crooked. Slurred speech. Physical therapy on face. Taking steroids.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, X-ray normal
Clinical narrative: Right side of face Drooped. Right Eye not able to shut. Mouth crooked. Slurred speech. Physical therapy on face. Taking steroids.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Ocular hyperaemia, Photophobia
Clinical narrative: Pt received the vaccine in the afternoon and the following day called our pharmacy complaining of red, puffy eyes and sensitivity to light.
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Influenza, Nausea, Tremor, Vomiting
Clinical narrative: Horrible flu symptoms. Vomiting nausea shaking uncontrollably. Chills.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Blood lactic acid increased, Blood potassium decreased, Chest X-ray normal, Dyspnoea, Headache
Clinical narrative: Patient had flu shot earlier in the day and had gone to ER later that night for headache, fevers, myalgias, and shortness of breath. His VS at the ER were temperature: 101.5 F, HR 103, RR: 14, BP: 147/84, SpO2: 98% on RA. CXR normal, WBC: 4.1, lactic acid 2.3, K: 3.2. Given 1 dose of azithromycin and ceftriaxone. The next day, had no further fevers, lactic acid returned to normal. Was felt to be reaction to recent vaccination or viral URI, and discharged home. No home antibiotics written.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Platelet count decreased, Pyrexia, White blood cell count decreased
Clinical narrative: Patient had flu shot earlier in the day and had gone to ER later that night for headache, fevers, myalgias, and shortness of breath. His VS at the ER were temperature: 101.5 F, HR 103, RR: 14, BP: 147/84, SpO2: 98% on RA. CXR normal, WBC: 4.1, lactic acid 2.3, K: 3.2. Given 1 dose of azithromycin and ceftriaxone. The next day, had no further fevers, lactic acid returned to normal. Was felt to be reaction to recent vaccination or viral URI, and discharged home. No home antibiotics written.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Chest X-ray, Computerised tomogram, Electrocardiogram, Electroencephalogram
Clinical narrative: Two days after vaccine was administered, pt. began with a burning sensation near elbow on left arm. By the next morning symptoms had progressed to whole left arm and both legs, progressing to paresthesia. Pt. has been diagnosed with Guillain-Barre.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Two days after vaccine was administered, pt. began with a burning sensation near elbow on left arm. By the next morning symptoms had progressed to whole left arm and both legs, progressing to paresthesia. Pt. has been diagnosed with Guillain-Barre.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 26-SEP-2017, the patient was vaccinated with M-M-R II albumin status: recombinant human albumin (rHA), 1 dose, lot # L036853, expiration date: 24-SEP-2017, for prophylaxis (route of administration was not provided). Other suspect therapy included sterile diluent (manufacturer unknown) lot#: M033585 and expiration date: 21-APR-2019. No adverse effects were reported. The reporter also stated that the M-M-R II that was administered did not have temperature excursions.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Local reaction, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old female patient. The patient had no pre-existing diagnosed allergies, birth defects or medical conditions. On 12-NOV-2012, 14-JAN-2013 and 03-JUL-2013, the patient was vaccinated with respectively the first, second and third dose of human papillomavirus vaccine (manufacturer unknown) for prophylaxis (lot#, expiry date, dose and route of administration not provided). The patient forgot that she had been vaccinated, reported to a physician that she had not received any of human papillomavirus vaccine, signed consent and on 26-SEP-2017 she was vaccinated with a dose of GARDASIL 9 lot # N015087, expiry date 20-OCT-2019, intramuscularly for prophylaxis. She was not ill during the vaccination. There were no other vaccinations within 4 weeks prior this date. Then she spoke to her mother and returned to tell that she had already completed the series (in the other office). On an unknown date, the patient experienced localized reaction only (not specified after which dose of vaccine). The outcome of  localized reaction was recovered. On an unknown date after the injection (unspecified which injection), the patient experienced hives, which resolved on an unknown date with diphenhydramine. The reporter did not assess causality between the events and suspect therapies.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist, who is also the patient's mother, referring to her son, a child male patient of unknown age. No information was provided regarding the patient's medical drug and allergy history, concurrent conditions or concomitant therapies. On unknown dates, the patient was vaccinated with PNEUMOVAX 23 and with PREVNAR 13 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis, every 2 years; at age 2 years, 4 years, and 6 years, for both vaccines. The reporter stated that the patient had received 3 doses of both vaccines so far. The patient, had had "no antibodies to pneumococcal disease" since an unspecified age (it was unable to clarify whether this issue had been present since birth), which was detected by a bloodwork on an unknown date. As a result, the patient had been vaccinated using the schedule mentioned above. Then, the patient had an additional bloodwork on an unknown date, which showed that he still had not developed "antibodies to pneumococcal disease". It was unknown how many doses were administered when the bloodwork was drawn and how many times the bloodwork had been done since initiation of vaccination. The outcome of the patient for no antibodies to pneumococcal disease was unknown and the causality assessment between PNEUMOVAX 23 and the event was unknown. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1710USA011787.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report was received from  a healthcare worker (via company representative) reported on her niece, a 19 year old female patient. The patient's medical history, drug reactions, concomitant medication and allergies were not reported. On 22-SEP-2017 the patient was vaccinated with GARDASIL 9 (lot #, expiration date, concentration and dose were not provided), intramuscular for prophylaxis. On 23-SEP-2017, the next evening; the patient experienced high fever of 103F and elevated white blood cell count of 17000 (unespecified units). The patient went to an unspecified urgent care facility on the evening of the same date, where she was treated by an unspecified provider and prescribed an unspecified medication for the fever and also given an unspecified antibiotic. The healthcare worker reported that the patient did fully recover on 24-SEP-2017. The causal relationship between, GARDASIL 9, and the events was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous, non-valid report was received from a medical assistant and refers to unspecified patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date, reported as "in the past, unable to clarify further", the patient was vaccinated with PEDVAXHIB for prophylaxis. On 04-OCT-2017, the patient was vaccinated with PEDVAXHIB lot # N007751, expiration date: 13-NOV-2019, intramuscularly (dosage was unknown) instead of influenza virus vaccine inactivated (unspecified) (lot#, expiration date, dosage, route of administration were unknown), reported as "flu shot". No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-OCT-2017, the patient was vaccinated with an improperly stored and expired dose of GARDASIL 9 lot number M004116 and expiration date of 12-OCT-2017, intramuscularly for prophylaxis (dose was not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of  9°C to 24°C with a time frame of 64 hours and 24 minutes.There was no previous temperature excursion neigther "data logger" involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 19-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N019825 with expiration date 09-JAN-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter also stated that the temperature excursion occurred in between 15 Fahrenheit degrees (°F) and 46 Fahrenheit degrees (°F) with a time frame of 45 minutes. The call was because of a data logger and there was no previous temperature excursions.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot # N005619, expiration date 29-OCT-2018, orally, for prophylaxis (strength, dose and frequency  were not reported) and RECOMBIVAX HB lot # N020613, expiration date 05-MAY-2020, for prophylaxis (strength, dose, route and frequency were not reported). The temperature/Time frame was 34.8°F for 8 hours 23 minutes and 34.8°F for 8 hours 15 minutes. The previous temperature excursion was 47.6°F for 5 minutes. There was a data logger involved. No adverse effects reported. This is one of several cases from the same source. Sender's Comments: US-009507513-1710USA010654: US-009507513-1710USA010655: US-009507513-1710USA010656: US-009507513-1710USA010312.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist, who is also the patient's mother, referring to her daughter, a child female patient of unknown age. No information was provided regarding the patient's medical drug and allergy history, concurrent conditions or concomitant therapies. On unknown dates, the patient was vaccinated with PNEUMOVAX 23 and with PREVNAR 13 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis; every 2 years; at age 2 years, 4 years, and 6 years, for both vaccines. The reporter stated that the patient had received 3 doses of both vaccines so far. The patient, had had "no antibodies to pneumococcal disease" since an unspecified age (it was unable to clarify whether this issue had been present since birth), which was detected by a bloodwork on an unknown date. As a result, the patient had been vaccinated using the schedule mentioned above. Then, the patient had an additional bloodwork on an unknown date, which showed that he still had not developed "antibodies to pneumococcal disease". It was unknown how many doses were administered when the bloodwork was drawn and how many times the bloodwork had been done since initiation of vaccination. The outcome of the patient for no antibodies to pneumococcal disease was unknown and the causality assessment between PNEUMOVAX 23 and the event was unknown. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1710USA001713.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: There was no adverse event the patient was given a high dose influenza vaccine instead of a regular influenza vaccine.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Swelling
Clinical narrative: Patient complained of excessive swelling and arm pain.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Back pain, Chest pain, Dizziness, Emotional distress
Clinical narrative: Flu shot given at 11:35. 5 minutes later another provider observed the participant complaining of nausea and dizziness. Progressed to chest pain and back pain. They were tearful. The Lead provider was notified. The participant was observed in general distress. Red, raised rash was developing. 911 called. 0.5mg Epi given. BP 116/80. Continued to monitor participant. Breathing was still labored. After Epi was given, the participant was still anxious but in a reduced state of stress. The rash was spreading to upper body and arms. EMS arrives. Employee was questioning giving another Epi but EMS had taken over situation. Participant was transfered to hospital. Flu clinic was shut down.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Rash erythematous, Stress, Tearfulness
Clinical narrative: Flu shot given at 11:35. 5 minutes later another provider observed the participant complaining of nausea and dizziness. Progressed to chest pain and back pain. They were tearful. The Lead provider was notified. The participant was observed in general distress. Red, raised rash was developing. 911 called. 0.5mg Epi given. BP 116/80. Continued to monitor participant. Breathing was still labored. After Epi was given, the participant was still anxious but in a reduced state of stress. The rash was spreading to upper body and arms. EMS arrives. Employee was questioning giving another Epi but EMS had taken over situation. Participant was transfered to hospital. Flu clinic was shut down.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction patient was given a high dose influenza vaccine and should of received a regular influenza vaccine.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: There was not a adverse event patient was given a high dose Influenza vaccine and should of received a regular Influenza vaccine.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Per Dad: Patient started breaking out in a rash on Monday 10/16/2017 pm all over her body. He states he cannot think of anything that is different other than the flu vaccine. Dad denies change in patient's diet, laundry detergent, environmental exposure. Patient had received the Flu Vaccine 10/16/2017 am @ School Based Flu Clinic. Dad states on Saturday 10/21/2017 patient started itching. They took her to her pediatrician: for eval and to Dermatology Clinic. Dad states patient is taking Steroids, Benadryl and now Claritin. Dad states the rash is still there, but seems to be getting a little better with the meds.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event happened the patient was given a high dose influenza vaccine instead of a regular influenza vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Oropharyngeal pain, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Experienced moderate limb pain in upper arm approximately 2-3 hours  s/p injection. Then developed itchy red rash over trunk, arms, legs and neck. Also developed headache and sore throat. Limb pain dissipated overnight but rash and headache worsened and persisted over next 2 days. Received Medrol dosage (4 mg methylprednisone) by private physician for rash. (rash was flat but blotchy - not edematous). Visited private physician on October 23, 2017 at 1:30 p.m. MD recommended to continue Medrol Dospak. Today (October 24, 2017) rash subsided with minor itching. Headache is gone.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Experienced moderate limb pain in upper arm approximately 2-3 hours  s/p injection. Then developed itchy red rash over trunk, arms, legs and neck. Also developed headache and sore throat. Limb pain dissipated overnight but rash and headache worsened and persisted over next 2 days. Received Medrol dosage (4 mg methylprednisone) by private physician for rash. (rash was flat but blotchy - not edematous). Visited private physician on October 23, 2017 at 1:30 p.m. MD recommended to continue Medrol Dospak. Today (October 24, 2017) rash subsided with minor itching. Headache is gone.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Borrelia test negative, Cough, Fatigue, Laboratory test normal
Clinical narrative: 5 days after getting shot, daughter started displaying intense fatigue, joint pain, sore throat, cough and a rash on her neck. 3 weeks later symptoms remain. Extensive testing done, as well as Lymes. All is normal.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Rash
Clinical narrative: 5 days after getting shot, daughter started displaying intense fatigue, joint pain, sore throat, cough and a rash on her neck. 3 weeks later symptoms remain. Extensive testing done, as well as Lymes. All is normal.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm same day and couldn't raise arm, Dr suggested going to ER and did and was given ibuprofen and is doing better.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient requested that the shot be administered in her gluteus maximus. She returned 1 week later complaining the injection site was red and hot to the touch. She said no fever was present. I asked her to get it checked out by a physician. She later told me that it was cellulitis.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: My right upper shoulder started to be in pain, then moved down shoulder area to upper arm. Took ALEVE, did ice and hot packs.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Erythema, Rash, Rash generalised
Clinical narrative: Development of generalized diffuse rash to abdomen on 10/24/17. Small well delineated bumps without generalized erythema. Rash (diffuse) to R AC/forearm starting 10/24 AM, however that may be associated with small area of poison sumac on R forearm with erythema/blistering starting 10/22/17 PM.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: PATIENT'S ARM BECAME VERY SWOLLEN, PAINFUL, ITCHY, AND RED ABOUT 4-6 HOURS AFTER DOSE WAS GIVEN. SWELLING GOT WORSE OVERNIGHT.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Tooth fracture, Tooth injury
Clinical narrative: Client came into the chorus room to receive flu vaccine. He walked back into the classroom and sat down, it was reported by another student that he had passed out. It was also reported that he hit and chipped his tooth. Not sure if he feel out of the chair and hit his tooth on the desk, did not witness the event nor did the teacher. The school nurse reported they called the parent and parent was coming to pick up child. She also reported that he had seen cardiologist in the past year for passing out, this was not known prior to vaccination.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Crying, Diarrhoea, Pyrexia
Clinical narrative: Fever to 102; high pitched cry; diarrheal stools.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Paraesthesia, Peripheral swelling
Clinical narrative: Patient received flu shot. Prior to vaccination Nurse asked if patient had any problems in past with flu shots or if she was allergic to eggs she said no. 5 minutes after giving flu shot patient complained of arm feeling funny and tingling noted. When I assessed patient her right arm it was extremely swollen. She denied any shortness of breath. I immediately placed an icepack on it and it still appeared to be extremely swollen , at 12:36pm 50mg of Diphenhydramine IM(lot#026327 expires 02/2018 was given directly into Right deltoid(location of flu shot). Patient was monitored by Nurse until 1:10pm. Swelling had decreased and patient denied any shortness of breath or any other symptoms. Patient was told to let her doctor know what had happened and to not have another flu vaccine again without having her doctor/allergist evaluate her and that she would have to have it done through her doctor if they feel she is safe to have it.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms
Clinical narrative: Severe muscle spasms in feet, calves, and thighs starting last night and continuing today.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives within 30 min of vaccination at site of injection and on wrist.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count normal, Loss of personal independence in daily activities, Metabolic function test normal, Musculoskeletal pain, Pain in extremity
Clinical narrative: Right shoulder and upper arm pain began after vaccine administration. The pain worsened affecting activities of daily living and disrupting sleep.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate normal, Sleep disorder, X-ray limb normal
Clinical narrative: Right shoulder and upper arm pain began after vaccine administration. The pain worsened affecting activities of daily living and disrupting sleep.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old, female patient. The patient's medical history was not reported. On 02-AUG-2017 at 8:45 AM, the ROTATEQ vaccine was subjected to incorrect storage. On 03-AUG-2017, the patient was vaccinated with incorrectly stored ROTATEQ (Strength, dose, frequency, anatomical location and expiration date were not reported) orally for prophylaxis. Co-suspect therapies included PENTACEL and PREVNAR. There were no concomitant therapies reported. There were no adverse symptoms or reactions noted. Sender's Comments: US-009507513-1708USA001493.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: Severe vertigo onset 12 hours following injection. Nausea and mild headache. Symptoms disappeared gradually over  18 hour period.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Pain to left upper arm with stiffness. Difficulty raising arm above shoulder.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysgeusia
Clinical narrative: 5 minutes after receiving the vaccine, patient reported a metallic taste in her mouth that lasted for 20 minutes. She also described feeling lightheaded for a few minutes.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: My daughter received the vaccine at about 11am on 10-21-15. By 4:30pm that same day, she spiked a fever of 101.9. She had a fever for about 24 hours. She had no other symptoms than a fever. We had to give her 2 extra strength TYLENOL to contain the fever. With 2 extra strength TYLENOL in her, the fever remained at a 101.7, it barely went down, for hours. We continued to give her TYLENOL every 4-6 hours to try to reduce the fever and the chills and headache she experienced.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: I'm not sure the exact influenza she was given. The day after her shot, she broke out in hives. I took her back to Dr. to ask if it's the shot. He said no and gave her a steroid drink to get rid of the hives with instruction to give her ZYRTEC and BENADRYL as needed. I noticed that if I skip a dose, the hives come back. I took her to Dr. again the following week. He did the scrape test and said she was getting better enough though now it's all over her body vs before where it was only on her limbs. He said to wait it out and continue to give her medicines. Last week, I took her to an allergist. He said she has Dermographic Urticaria and gave her a prescription medicine to get rid of it. I gave her that at night and ZYRTEC in the morning. She went for 3 days without hives. So I thought the medicine works. Yesterday morning I forgot to give her the ZYRTEC but gave her the prescription medicine at night. She broke out in hives. It's been almost 3 full weeks but the hives don't seem to ease up. I need to know who I can take my child to see regarding this problem or what medicine that will help get rid of her hives. We don't have pets nor have I exposed her to anything new. The flu shot was the only new thing in her life. Please help!!
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Small lump on right thigh. Painful at touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Chills, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt. experienced rash around injection sites. Itchiness, burning, and area felt warm. Mother states pt. was fussy and complaining of chills the night after the vaccines but no fever. Medical Staff Advised Mother to give pt. BENADRYL. Mother of child states child is doing better. Is still using BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Irritability
Clinical narrative: Pt. experienced rash around injection sites. Itchiness, burning, and area felt warm. Mother states pt. was fussy and complaining of chills the night after the vaccines but no fever. Medical Staff Advised Mother to give pt. BENADRYL. Mother of child states child is doing better. Is still using BENADRYL.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient showed up at the pharmacy on 10/23/17. He stated that his right arm was sore and he could barely lift it up sometimes and asked if that could have been from the flu shot. I told patient I was going to check with his PCP and get back with him. I spoke with (nurse) at the dr's office. She suggested he probably should be seen to make sure all is ok. I contacted patient and informed him of what the Dr's office said. Subsequently, he was seen by PCP on 10/23/17 and was prescribed MEDROL DOSE PACK. When patient came to pick up his Rx he stated that: his Dr gave him a steroid shot and Dr suggested possible brusitis & Dr was not sure if the cause was the flu shot or something else. I told patient I would follow up with him to check how he was doing.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Capillary nail refill test abnormal, Conjunctival hyperaemia, Cyanosis, Eyelid oedema, Injection site erythema
Clinical narrative: Redness, warmth, edema of bilateral lower extremities with acrocyanosis and delayed capillary refill.  Few small hives on upper extremities, red/puffy eyes and injected left conjunctiva.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site oedema, Injection site warmth, Ocular hyperaemia, Urticaria
Clinical narrative: Redness, warmth, edema of bilateral lower extremities with acrocyanosis and delayed capillary refill.  Few small hives on upper extremities, red/puffy eyes and injected left conjunctiva.