chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Computerised tomogram normal, Confusional state, Decreased appetite, Dysstasia, Electrocardiogram normal
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Electroencephalogram normal, Encephalitis viral, Erythema, Fatigue, Generalised tonic-clonic seizure
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Hyperaesthesia, Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Injection site warmth, Loss of consciousness, Mental status changes, Nuclear magnetic resonance imaging brain normal, Pain in extremity
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Scan with contrast normal, Seizure, Skin warm, Somnolence, Tremor
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Weight decreased, White blood cell count increased
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a consumer refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 30-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On 31-AUG-2017, the patient received the second dose of GARDASIL 9 (strength, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that the unspecified patient was late for her third dose of GARDASIL 9 (approximately on an unspecified date in January 2018). No adverse events were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 31-MAY-2018, the patient was vaccinated with VARIVAX (dose, anatomical location, lot# and expiration date were not reported) and M-M-R II (dose, lot#, expiration date and anatomical location were not reported) via intramuscular route for prophylaxis. No adverse effects were reported.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Injection site pruritus, Injection site warmth, Local reaction, Rash
Clinical narrative: Patient was given yellow fever vaccine on 6/4/18. Pt states that site of injection started to feel hot and itchy and rash on face on 6/5/18. Patient started taking CLARITIN and BENADRYL. Patient came in clinic on 6/7/18 to have site looked at. Local reaction looked within normal limits but rash on face was not. Referred to nurse and provider for further evaluation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: I was given the first of two SHINGRIX vaccines on Sunday, May 6th. On Wednesday, May 15 I felt what I thought was a bug bite. On Thursday, May 16th a red semi-circle spot appeared on my neck. Two days later another smaller spot appeared on my neck. I thought it was a bug bite but it did not itch. I had some discomfort turning my head and some radiating pain but it was mild. The following Tuesday, May 23rd I went to an urgent care facility where I was diagnosed with Shingles.  I was given Valaciclovir HCL 1 gram which I took three times a day for seven days. The mild radiating shooting pain subsided by weeks end. Shooting pain subsided.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Feeling hot, Heart rate increased, Swelling
Clinical narrative: Swelling redness chills and burn up alternate and increase ht rate for several weeks.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Electrocardiogram normal, Erythema, Feeling abnormal, Heart rate increased
Clinical narrative: Swelling redness chills and burn up alternate and increase ht rate for several weeks.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hot flush, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Swelling redness chills and burn up alternate and increase ht rate for several weeks.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: She received the vaccine Tuesday morning 6/5. She notes pain in the injection area starting Tuesday evening and a rash and minor swelling around the injection site starting Late Tuesday into Wednesday. I examined the area Thursday (6/7), the injection area is red with some swelling and feels warm to the touch, it appears to me to be an injection site reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse event to report. The SHINGRIX was reconstituted with the wrong diluent. It was reconstituted with 0.7ml of Sterile Water from Merck Sharp and Dohme that is used for ZOSTAVAX. Exp Nov 28.2019 lot NO21894.
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized redness, swelling, and pain.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Food allergy, Hyperhidrosis, Insomnia
Clinical narrative: Swelling. Rash from the shoulder to the elbow, fever, sweats, joint pain, fatigue, nashis, unable to sleep, exhausted, irritable.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Irritability, Pyrexia, Rash, Swelling
Clinical narrative: Swelling. Rash from the shoulder to the elbow, fever, sweats, joint pain, fatigue, nashis, unable to sleep, exhausted, irritable.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Nausea, Pyrexia, Rash
Clinical narrative: Swelling. Rash from the shoulder to the elbow, fever, sweats, joint pain, fatigue, nashis, unable to sleep, exhausted, irritable.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Feeding disorder, Feeling cold, Hunger, Impaired work ability
Clinical narrative: AE-  Whole body aches, shivers, chilly, couldn't go to work, hungry but can't eat. Treatment - TYLENOL for aches and pain, working up to light meal of crackers, resting as much as possible. Outcome - at the moment patient believes it's just about peaked and will not need a doctors visit.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain
Clinical narrative: AE-  Whole body aches, shivers, chilly, couldn't go to work, hungry but can't eat. Treatment - TYLENOL for aches and pain, working up to light meal of crackers, resting as much as possible. Outcome - at the moment patient believes it's just about peaked and will not need a doctors visit.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain, Back pain, Vomiting
Clinical narrative: Back pain, belly pain, vomiting once within 15min of vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Product storage error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a unk patient who received SHINGRIX (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and incorrect storage of drug. On an unknown date, the outcome of the injection site pain and incorrect storage of drug were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The reporter was patient's son calling to ask about information in regards to SHINGRIX vaccine that was stored in the freezer by the pharmacy and was administered to the patient, which led to incorrect storage of vaccine. He reported that his father had been experiencing pain at the injection site reaction for about a week by the time of reporting. The patient received a call from his pharmacy that SHINGRIX that was administered to him was stored in the freezer and he needed to go back in to get a new dose. The patient had denied permission to contact their physician. The reporter had very limited information, and wanted to hold on to providing information for the adverse event report. The reporter was referred to have their health care provider or pharmacist call GlaxoSmithKline medication information department for further data.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Gait disturbance, Hemihypertrophy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within (4) hours mom noted that he had pain, resistance to walking and swelling of his right thigh. No fever. Later that evening thigh had become red and felt warm to the touch. He was evaluated in the ER on 06/05/2018,diagnosed with cellulitis and given one dose of KEFLEX. He was walking well. No fever. He was seen here in clinic on 06/06/2018 for a follow up. Dr. determined the quickness of development and resolution was not consistent with cellulitis, it is more likely a large local reaction to a vaccine known as hemihypetrophy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Local reaction, Pain
Clinical narrative: Within (4) hours mom noted that he had pain, resistance to walking and swelling of his right thigh. No fever. Later that evening thigh had become red and felt warm to the touch. He was evaluated in the ER on 06/05/2018,diagnosed with cellulitis and given one dose of KEFLEX. He was walking well. No fever. He was seen here in clinic on 06/06/2018 for a follow up. Dr. determined the quickness of development and resolution was not consistent with cellulitis, it is more likely a large local reaction to a vaccine known as hemihypetrophy.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: RUE deltoid w/edema and mild TTP.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Chills, Headache, Pain, Pyrexia
Clinical narrative: Significant body aches, fever, chills, headache, elevated blood glucose.
Age: 10.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient left deltoid red and hot. Lines drawn around the area and parent informed to contact the clinic if the red area grows outside the drawn lines and/or if the area becomes hotter to the touch.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a company representative referring to two patient of unknown age and gender. The patient's historical and concurrent conditions were not reported. There were no concomitant medications reported. On an unspecified date, the patients were vaccinated once with improperly stored doses of M-M-R II albumin status: recombinant human albumin (rHA) (dose, anatomical location and frequency were not reported) lot # N011005 and expiration date: 05-APR-2019, indicated for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 11 degrees centigrades for 30 minutes recording by a data logger on unspecified dates. There were no previous excursions reported. No adverse effects reported.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MEN, MMR
Symptoms: Abdominal discomfort, Back pain, Blood test, Eye swelling, Fatigue
Clinical narrative: This spontaneous report has been received from the 17 years old female patient's father. The patient had no relevant medical history, drug reactions/allergies or concomitant medications. The reporter mentioned that the patient also received on 22-MAY-2018 (reported as 2 days prior) a "non-merck" hepatitis A virus vaccine (unspecified) (dose, strength, frequency, lot #, expiration date, indication and route of administration were not reported) and a meningococcal vaccine (unspecified) (dose, strength, frequency, lot#, expiration date, indication and route of administration were not reported). On 24-MAY-2018, the patient was vaccinated with M-M-R II lot# N025895 and 19-SEP-2019 expiration date for routine vaccinations (dose, strength, frequency and route of administration were not reported). Also the patient on the same date was vaccinated with GARDASIL 9 lot#/batch reported as N028092 and 28-MAY-2020 expiration date for prophylaxis (dose, strength, frequency and route of administration were not reported) and a poliovirus vaccine inactivated (unspecified) (dose, strength, frequency, lot #, expiration date, indication and route of administration were not reported). The reporter stated that on 27-MAY-2018 (reported as 3 or 4 days after receiving M-M-R II and GARDASIL 9, the patient experienced swelling in her lymph nodes, puffy eyes, abdominal discomfort, back pain, difficulty with normal movement and a slight fever of 100°F. Additionally on an unknown date in 2018, the patient was seen by the physician and thought it could be mononucleosis. The reporter stated that his daughter had improved but was still feeling very fatigued. An unspecified blood work on an unspecified date was made with an unknown result. The causal relationship between the events and M-M-R II and GARDASIL 9 was not reported. No Product Quality Complaint was present.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MEN, MMR
Symptoms: Lymphadenopathy, Movement disorder, Pyrexia
Clinical narrative: This spontaneous report has been received from the 17 years old female patient's father. The patient had no relevant medical history, drug reactions/allergies or concomitant medications. The reporter mentioned that the patient also received on 22-MAY-2018 (reported as 2 days prior) a "non-merck" hepatitis A virus vaccine (unspecified) (dose, strength, frequency, lot #, expiration date, indication and route of administration were not reported) and a meningococcal vaccine (unspecified) (dose, strength, frequency, lot#, expiration date, indication and route of administration were not reported). On 24-MAY-2018, the patient was vaccinated with M-M-R II lot# N025895 and 19-SEP-2019 expiration date for routine vaccinations (dose, strength, frequency and route of administration were not reported). Also the patient on the same date was vaccinated with GARDASIL 9 lot#/batch reported as N028092 and 28-MAY-2020 expiration date for prophylaxis (dose, strength, frequency and route of administration were not reported) and a poliovirus vaccine inactivated (unspecified) (dose, strength, frequency, lot #, expiration date, indication and route of administration were not reported). The reporter stated that on 27-MAY-2018 (reported as 3 or 4 days after receiving M-M-R II and GARDASIL 9, the patient experienced swelling in her lymph nodes, puffy eyes, abdominal discomfort, back pain, difficulty with normal movement and a slight fever of 100°F. Additionally on an unknown date in 2018, the patient was seen by the physician and thought it could be mononucleosis. The reporter stated that his daughter had improved but was still feeling very fatigued. An unspecified blood work on an unspecified date was made with an unknown result. The causal relationship between the events and M-M-R II and GARDASIL 9 was not reported. No Product Quality Complaint was present.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 31 year old patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD subcutaneously, lot # M044720 and expiration date: 07-MAY-2018 (dose and frequency were not reported). No adverse event was reported. The outcome of events was unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt experienced all of the expected symptoms for 36 hrs after injection including fatigue, low grade fever and arm soreness. No redness at injection site. 5/31/18 PM area around injection site was red, hot and swollen. Rx'd with Clindamycin 300mg TID x 7d.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt experienced all of the expected symptoms for 36 hrs after injection including fatigue, low grade fever and arm soreness. No redness at injection site. 5/31/18 PM area around injection site was red, hot and swollen. Rx'd with Clindamycin 300mg TID x 7d.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event. Patient was supposed to get tdap and I gave Hep B.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Red inflammation, heat, and pain at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Musculoskeletal pain, Myalgia, Nausea, Pain in extremity
Clinical narrative: Fever, pain in arm and shudder, red, hot rash down arm and and across chest, nausea, fatigue and muscle aces!
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: Fever, pain in arm and shudder, red, hot rash down arm and and across chest, nausea, fatigue and muscle aces!
Age: 55.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Hypersomnia, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 55 YO patient came in for follow-up Hep A #2. Previous Hep A dose without reaction. Received Hep A #2 and SHINGRIX #1 on 5/31/18. Stated went home and laid down to sleep at 11 AM and didn't wake for 24 hours. She stated fever on/off during that time. Her arm is red, swollen, bruised, at site of injection for 3 days and was "hot to touch". She was taking acyclovir 400 mg daily. She is wondering if a 2nd dose of SHINGRIX is still recommended based on side effects after SHINGRIX. Please make recommendation.
Age: 55.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Pyrexia
Clinical narrative: 55 YO patient came in for follow-up Hep A #2. Previous Hep A dose without reaction. Received Hep A #2 and SHINGRIX #1 on 5/31/18. Stated went home and laid down to sleep at 11 AM and didn't wake for 24 hours. She stated fever on/off during that time. Her arm is red, swollen, bruised, at site of injection for 3 days and was "hot to touch". She was taking acyclovir 400 mg daily. She is wondering if a 2nd dose of SHINGRIX is still recommended based on side effects after SHINGRIX. Please make recommendation.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injected limb mobility decreased, Pain in extremity, Rash
Clinical narrative: Evening after administration of PPSV23 the patient stated she had pain, bruising, and a rash all over her left arm. She stated she could not move her arm until the following day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Pain, Productive cough
Clinical narrative: Severe pain from my buttocks down to my toes; body aches and pains particularly in the knees; cough with yellow phlegm; severe diarrhea; tiredness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Sputum discoloured
Clinical narrative: Severe pain from my buttocks down to my toes; body aches and pains particularly in the knees; cough with yellow phlegm; severe diarrhea; tiredness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Nodule, Skin warm, Swelling
Clinical narrative: Patient reported abnormal burning while getting injection, she said about an inch below injection site, she had swelling and her arm was red, also reported having bad red and hot knot and these symptoms lasted about 1 week.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient reported an itchy, warm, nagging sensation in her upper left arm three days after the injection. It continued to itch and grow and become raised like hives. The area of the injection grew red and spread on the upper arm. It spread toward the patient's elbow. She saw NP who documented the area and diagnosed it as a histamine reaction. She prescribed cephalexin 500mg for the patient to use in case the area of redness spread after the patient uses Benadryl and ice for 24 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: The patient reported an itchy, warm, nagging sensation in her upper left arm three days after the injection. It continued to itch and grow and become raised like hives. The area of the injection grew red and spread on the upper arm. It spread toward the patient's elbow. She saw NP who documented the area and diagnosed it as a histamine reaction. She prescribed cephalexin 500mg for the patient to use in case the area of redness spread after the patient uses Benadryl and ice for 24 hours.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Fatigue, Flushing, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient developed a rash after the first dose of HPV (10/6/2016) on body and injection site was red and swollen. At this visit, shortly after receiving the flu and HPV vaccine, his face was flushed and he felt 'tired". Patient was given benadryl and fluid. He was observed for 20 minutes and felt better.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient had a large red swollen area on her arm - more than normal or expected. It was hot and itchy and spread over a day.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Irritability, Skin reaction, Vaccination site nodule, Vaccination site pain
Clinical narrative: A few days after immunization, mom noticed a small red bump and some swelling at the vaccine site on her left thigh. This has become larger, more "knot" like, and continued to have redness. She seems irritable and does not like anyone to touch it. Noted 2-3 cm of erythema and swelling of the left thigh that has continued to worsen since vaccines (including MMR and varicella) one week and a half ago. Presentation consistent w/ delayed local reaction to vaccines, likely due to MMR and/or varicella vaccines given time frame of delayed reaction within two weeks. No respiratory symptoms and today afebrile. Advised cold compressed and tylenol/ibuprofen as needed for pain control.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: A few days after immunization, mom noticed a small red bump and some swelling at the vaccine site on her left thigh. This has become larger, more "knot" like, and continued to have redness. She seems irritable and does not like anyone to touch it. Noted 2-3 cm of erythema and swelling of the left thigh that has continued to worsen since vaccines (including MMR and varicella) one week and a half ago. Presentation consistent w/ delayed local reaction to vaccines, likely due to MMR and/or varicella vaccines given time frame of delayed reaction within two weeks. No respiratory symptoms and today afebrile. Advised cold compressed and tylenol/ibuprofen as needed for pain control.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: 3 hours after vaccine passed out after getting out of hot tub and taking a hot shower.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The injection site swelled significantly over several days. It was very hot to the touch and it hurt. The whole upper arm swelled.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Vaccination complication
Clinical narrative: 15 YO had adverse reaction to HPV. Patient fainted immediately after given the shot. Inhaled ammonia and returned to consciousness. Vitals checked BP 97/67 RR 18 temp 97.6 no complaints of pain. Pulse 68. Patient was observed by the nurse for 15 minutes and discharged. VIS given to the family.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Patient had redness and swelling in the site of the injection, she aslo had rigors, chills and myalgia.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a 27 year old male patient (currently 28 year old), referring to himself. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The patient informed that on an unspecified date, approximately in November 2017 (reported as "six months ago"), the patient was vaccinated with the first dose of GARDASIL 9 Injection, in the deltoid region of his arm (did not specify which one) for prophylaxis (strength, dose, route, lot # and expiration date were not reported). He was subsequently vaccinated with the second dose of GARDASIL 9 approximately in January 2018 (also reported as "two months after"), in the deltoid region of his arm (did not specify which one) for prophylaxis (strength, dose, route, lot # and expiration date were not reported). No adverse reaction was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant, and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ Oral liquid, orally, lot # N034401, expiration date 09-MAY-2019, for prophylaxis (strength and dose were not reported). The reporter stated that this dose was stored at 47.3 F during 30 minutes, without a previous temperature excursion. No adverse symptoms reported. This call was made because of a data logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patients received unspecified number of doses of ROTATEQ lot # N026686, oral for prophylaxis following a temperature excursion (product storage error). The vaccines were exposed to a temperature of 1.4 Celsius degrees for 28 hours without previous temperature excursion. There was a call because of a data logger. No adverse events were reported.
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient's mother). A female patient of unspecified age received the 3rd dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took 2 doses of TRUMENBA for immunisation. The patient passed out about 6 months before report, after the third dose of TRUMENBA, with outcome of unknown. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Age: 30.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Incomplete course of vaccination, Pruritus generalised, Urticaria
Clinical narrative: CLIENT STATES THAT SHE AWOKE THE DAY AFTER IMMUNIZATIONS WITH SEVERE ITCHING ALL OVER BODY & THEN NOTICED THAT SHE WAS "COVERED FROM HEAD TO TOE WITH HIVES". SHE STATES THAT THE ITCHING and HIVES LASTED ABOUT TWO DAYS and THAT SHE REQUIRED REPEAT DOSES OF BENADRYL TO HELP WITH SYMPTOMS. SHE DENIES ANY WHEEZING OR TROUBLE BREATHING, FEVER, OR OTHER SYMPTOMS/REACTIONS. SHE DID NOT SEEK MEDICAL TREATMENT OR ADVICE.  SHE STATES THAT SHE WILL NOT BE COMPLETING THE SERIES.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, Fever of 100.6 lasting about 10 hrs.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient stated that around 1:30pm she felt shoulder pain up and down her arm. She iced the shoulder. By 3pm she was unable to move her arm, and went to see her doctor. MD gave her a prescription for NORCO 5/325, and a sling for the arm. She was also instructed to not receive the second shot.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No actual adverse event transpired. Third dose of vaccine was given less than 6 months after first dose. This was discovered 12 months later on a routine followup of patients records. CDC advised that another third dose be administered to assure adequate immunity. Patient contacted and will come in to repeat third dose of the ENGERIX-B.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: After vaccination was administered, patient developed a rash and swelling at and around the injection site. Patient came to the pharmacy 48 hours after administration and had a large area around the deltoid muscle that was red, swollen, irritated and hot to touch.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Noticed rash on feet yesterday. Rash on arms and legs after shower this morning. Patient to treat symptoms with Claritin. Will monitor for worsening symptoms then to f/u with MD.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Loss of personal independence in daily activities, Syncope, Vomiting
Clinical narrative: INJECTION GIVEN, PATIENT WAITED -- GOT UP FELT FAINT AND FAINTED WHEN WE GOT BACK TO THE TABLE -- MOM THEN CALLED ABOUT 2 HRS LATER AND STATED THAT SHE HAD VOMITED, AND HAD A BAD HEADACHE -- WAS ASLEEP AND WHEN SHE WOKE UP, STILL HAD A HEADACHE, BUT WASN'T VOMITING. NEXT DAY WAS FINE, BUT STAYED HOME FROM SCHOOL.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab
Clinical narrative: Rash developed approx 24 hours after vaccine - started on both upper arms and flanks, by next day spread to forearms, chest, stomach and thighs. Today is 9 days post vaccine and the rash is still lightly present on arms chest and thighs... small scabs and slightly itchy.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Epistaxis, Eye movement disorder, Face and mouth X-ray abnormal
Clinical narrative: The DTap and the Meningococcal was given in the left arm then the HPV was given immediately in the right arm. My daughter was on the exam table and the height was high enough there is a step stool to get on and get off the table for all patients. The nurse placed a band-aide onto the right arm after the HPV, said she was good to go. My daughter went to stand up onto the step stool and immediately eyes rolled to the back and she fainted continuing to fall face first onto the tile, the distance was approximately 2-3 feet. There was a loud cracking noise and slap from her landing face first, blood was coming out from both of her nostrils and mouth. I immediately grabbed papertowels by the sink and cleaned my daughter up. The nurse went to get the doctor. We were informed to go to the emergency room where the Xrays indicated a fracture in her nose and chip in her chin. Everything happened immediately after one another. She complained of dizziness, shortness of breath, headache, tooth ache and stuffy nose.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Face injury, Facial bones fracture, Fall, Headache, Immediate post-injection reaction
Clinical narrative: The DTap and the Meningococcal was given in the left arm then the HPV was given immediately in the right arm. My daughter was on the exam table and the height was high enough there is a step stool to get on and get off the table for all patients. The nurse placed a band-aide onto the right arm after the HPV, said she was good to go. My daughter went to stand up onto the step stool and immediately eyes rolled to the back and she fainted continuing to fall face first onto the tile, the distance was approximately 2-3 feet. There was a loud cracking noise and slap from her landing face first, blood was coming out from both of her nostrils and mouth. I immediately grabbed papertowels by the sink and cleaned my daughter up. The nurse went to get the doctor. We were informed to go to the emergency room where the Xrays indicated a fracture in her nose and chip in her chin. Everything happened immediately after one another. She complained of dizziness, shortness of breath, headache, tooth ache and stuffy nose.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Jaw fracture, Mouth haemorrhage, Nasal congestion, Syncope, Toothache
Clinical narrative: The DTap and the Meningococcal was given in the left arm then the HPV was given immediately in the right arm. My daughter was on the exam table and the height was high enough there is a step stool to get on and get off the table for all patients. The nurse placed a band-aide onto the right arm after the HPV, said she was good to go. My daughter went to stand up onto the step stool and immediately eyes rolled to the back and she fainted continuing to fall face first onto the tile, the distance was approximately 2-3 feet. There was a loud cracking noise and slap from her landing face first, blood was coming out from both of her nostrils and mouth. I immediately grabbed papertowels by the sink and cleaned my daughter up. The nurse went to get the doctor. We were informed to go to the emergency room where the Xrays indicated a fracture in her nose and chip in her chin. Everything happened immediately after one another. She complained of dizziness, shortness of breath, headache, tooth ache and stuffy nose.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports the immunization site is red, swollen, hot. Patient could not move arm until today. She took 2 ibuprofen tablets and today she is able to move it. She says this usually happens with most immunizations. She reports no difficulty breathing or chest pain.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myositis
Clinical narrative: Red, inflamed bicep x 1 day in duration.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Feeling abnormal, Influenza like illness
Clinical narrative: Patient started shivering very badly around 7:00 PM 6/6/18, then decided to check her temperature. Her temp was 102F. She felt like she had flu-like symptoms, with achiness in her bones, and literally all over her body. She took 800 mg Ibuprofen and rechecked her temp around 8:00 PM and it was still 102F. The Ibuprofen did not help her at all. She felt bad all night and continued Ibuprofen when appropriate. The fever finally went down this morning 6/7/18, but was at 99.7F. As of this afternoon around 3:15 PM, she was starting to feel better, but still had some aches in her hips and legs. I called her around 6:00 PM and she was feeling better.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient started shivering very badly around 7:00 PM 6/6/18, then decided to check her temperature. Her temp was 102F. She felt like she had flu-like symptoms, with achiness in her bones, and literally all over her body. She took 800 mg Ibuprofen and rechecked her temp around 8:00 PM and it was still 102F. The Ibuprofen did not help her at all. She felt bad all night and continued Ibuprofen when appropriate. The fever finally went down this morning 6/7/18, but was at 99.7F. As of this afternoon around 3:15 PM, she was starting to feel better, but still had some aches in her hips and legs. I called her around 6:00 PM and she was feeling better.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Injection site erythema, Injection site warmth
Clinical narrative: Due to prior reaction (itchiness, rash) to another formulation of Hep B vaccine, client went to HCP after HEPLISAV was given and took a medication (unknown) to try to prevent reaction. Client stated that at 11:00 am on 6/6/18 (25h after vaccine admin), she started experiencing flushing, hotness, sweatiness, itchiness, and mild airway constriction. Antihistamines decreased these symptoms and she has only been experiencing a "needles and pins" feeling (through 6/7/18 - ongoing). Injection site remains warm and red (about a 40mm circle) today (53 hours after vaccine admin). Client will visit HCP today for exam and recommendations, as our Health Clinic cannot provide this intervention.