chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: PNC13
Symptoms: Antibody test negative, Hypersensitivity, Infection, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 9-year-old female patient received a dose of PREVNAR 13, (Batch/lot # W51762, exp date 30Jun2020) IM at 0.5 ml, single at deltoid right  on 01Oct2018 at 15:30 at 9 years and 10 months for immunisation, for low pneumococcal antibody titers, administered at Physician Office. She was recommended having an additional dose after receiving 5 previous doses of PCV7 since titers were still low. Medical history and concomitant medications were none. The patient previously received pneumococcal polysaccharide vaccine on 15Dec2010 (Lot: 1246Y, Expiry 21Jan2011) and 5 doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PCV7) intramuscular at 0.5 ml, single: 1st on 06Jan2009 at 1 month (58 days) (No lot/expiry), 2nd on 17Jul2009 at 8 months (Lot: D75884, Expiry: Feb2012), 3rd on 29Aug2009 at 9 months (Lot: D92436, Expiry: Apr2012), 4th on 02Nov2009 at 11 months (Lot: D67170, Expiry: Jan2012), 5th on 22Feb2010 at 15 months (Lot: E20366, Expiry: Oct2013) for pneumococcal infection, all IM for immunisation. Regarding PCV7 injections, the caller could not determine from the records if there was a lack of effect or another reason for receiving 5 doses of PCV7. No adverse event occurred following prior vaccinations. No prior vaccinations (Within 4 weeks). On 03Oct2018 the patient experienced fever, itchiness at injection site, with redness, and pain. The events required a visit to Physician Office. The events were considered serious as important medical events. The outcome of the event fever was recovered 0Oct2018, the other events were recovering. Course of events: After receiving the PREVNAR 13 on 01Oct2018 the patient developed a fever and local reaction of itchiness at injection site, with redness, and pain on 03Oct2018 and was seen back at the office that morning. The patient was prescribed Cephalexin on 03Oct2018 for a suspected allergy versus infection following the PREVNAR 13 administration. On 04Oct2018 the patient was seen again and was given a topical steroid and told to stop the Cephalexin, as the provider did not feel it was necessary. On 04Oct2018 the patient was afebrile and the painfulness of the injection site has improved but the redness has increased. States it was about 32 hours after injection that the reactions occurred. Relevant tests were none. A Product Complaint was filed. The reporter considered there was a reasonable possibility that all events were related to the vaccine. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported events
Age: 9.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Local reaction, Product complaint, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 9-year-old female patient received a dose of PREVNAR 13, (Batch/lot # W51762, exp date 30Jun2020) IM at 0.5 ml, single at deltoid right  on 01Oct2018 at 15:30 at 9 years and 10 months for immunisation, for low pneumococcal antibody titers, administered at Physician Office. She was recommended having an additional dose after receiving 5 previous doses of PCV7 since titers were still low. Medical history and concomitant medications were none. The patient previously received pneumococcal polysaccharide vaccine on 15Dec2010 (Lot: 1246Y, Expiry 21Jan2011) and 5 doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PCV7) intramuscular at 0.5 ml, single: 1st on 06Jan2009 at 1 month (58 days) (No lot/expiry), 2nd on 17Jul2009 at 8 months (Lot: D75884, Expiry: Feb2012), 3rd on 29Aug2009 at 9 months (Lot: D92436, Expiry: Apr2012), 4th on 02Nov2009 at 11 months (Lot: D67170, Expiry: Jan2012), 5th on 22Feb2010 at 15 months (Lot: E20366, Expiry: Oct2013) for pneumococcal infection, all IM for immunisation. Regarding PCV7 injections, the caller could not determine from the records if there was a lack of effect or another reason for receiving 5 doses of PCV7. No adverse event occurred following prior vaccinations. No prior vaccinations (Within 4 weeks). On 03Oct2018 the patient experienced fever, itchiness at injection site, with redness, and pain. The events required a visit to Physician Office. The events were considered serious as important medical events. The outcome of the event fever was recovered 0Oct2018, the other events were recovering. Course of events: After receiving the PREVNAR 13 on 01Oct2018 the patient developed a fever and local reaction of itchiness at injection site, with redness, and pain on 03Oct2018 and was seen back at the office that morning. The patient was prescribed Cephalexin on 03Oct2018 for a suspected allergy versus infection following the PREVNAR 13 administration. On 04Oct2018 the patient was seen again and was given a topical steroid and told to stop the Cephalexin, as the provider did not feel it was necessary. On 04Oct2018 the patient was afebrile and the painfulness of the injection site has improved but the redness has increased. States it was about 32 hours after injection that the reactions occurred. Relevant tests were none. A Product Complaint was filed. The reporter considered there was a reasonable possibility that all events were related to the vaccine. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported events
Sex: U
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bruise on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization; and FLUZONE and SHINGRIX, both via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red spot about the size of a hand at the injection site on an unknown date. It was reported that 2 injections in same site (unspecified which drug). The outcome of the event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Haemolytic uraemic syndrome, Pneumococcal infection
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is the 1st of 4 reports. A patient of unspecified age and gender received PREVNAR 13, 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 experienced pneumococcal infection and hemolytic uremic syndrome on an unspecified date with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine towards the occurrence of pneumococcal infection in this patient cannot be completely excluded. Hemolytic uremic syndrome might represent the complication resulting from  pneumococcal infection. 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. Linked Report(s): US-PFIZER INC-2018410910 Same reporter/drug/event, different patient; US-PFIZER INC-2018410911 Same reporter/drug/event, different patient; US-PFIZER INC-2018410912 Same reporter/drug/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Bronchiolitis, Bronchoscopy normal, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer, who reported for herself, via Pfizer-sponsored program Patient Testimonial Recruitment. A female patient of an unspecified age received PREVNAR 13 on an unknown date in 2016 at single dose for immunisation. Patient reported she had pneumonia on and off since 2006. She went for 12 days of tests and was diagnosed with bronchiolitis and being treated, but she would still get pneumonia off and on. She had lingering wheezing and coughing and had a bronchioscope in Jul(year unspecified). Pathology showed no unusual infections. In Jul(year unspecified) she went to Urgent Care because she was having trouble breathing. By midnight she couldn't breathe and was stuck in hospital for 10 days with pneumonia. She was encouraged to follow-up with her doctor. They tried inhalers which never worked. She used the inhaler that was prescribed and got an appointment with a pulmonologist. She had a chest x-ray on an unknown date which showed she still had pneumonia. "The doctor said she really had a lung infection, but he was coding it as pneumonia for insurance purposes". In 2016, she got the pneumococcal 13-val conj vac (dipht crm197 protein) shot and she continued to get pneumonia. Final outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Lung infection, Pneumonia, Wheezing
Clinical narrative: This is a spontaneous report from a contactable consumer, who reported for herself, via Pfizer-sponsored program Patient Testimonial Recruitment. A female patient of an unspecified age received PREVNAR 13 on an unknown date in 2016 at single dose for immunisation. Patient reported she had pneumonia on and off since 2006. She went for 12 days of tests and was diagnosed with bronchiolitis and being treated, but she would still get pneumonia off and on. She had lingering wheezing and coughing and had a bronchioscope in Jul(year unspecified). Pathology showed no unusual infections. In Jul(year unspecified) she went to Urgent Care because she was having trouble breathing. By midnight she couldn't breathe and was stuck in hospital for 10 days with pneumonia. She was encouraged to follow-up with her doctor. They tried inhalers which never worked. She used the inhaler that was prescribed and got an appointment with a pulmonologist. She had a chest x-ray on an unknown date which showed she still had pneumonia. "The doctor said she really had a lung infection, but he was coding it as pneumonia for insurance purposes". In 2016, she got the pneumococcal 13-val conj vac (dipht crm197 protein) shot and she continued to get pneumonia. Final outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: MENB
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age (reported as 17, unit unknown) and gender received TRUMENBA, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had an allergic reaction (could not breathe) on an unspecified date. The outcome of the events was unknown. The reporter would like to know what component in vaccine adjuvant was used that they needed to be aware of and to avoid in future. The information on the batch/lot number and expiration date has been requested.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Vomit/extreme chills and headache for 24 hours muscle ache and joints almost like a sever Flu.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomit/extreme chills and headache for 24 hours muscle ache and joints almost like a sever Flu.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: When administering the vaccine, I push the vaccine syringe into the pt's left deltoid muscle. When I pushed the plunger, the vaccine squirted out on either side. I called the drug manufacture (SP) and reported what happened. They recommended per the CDC guidelines that if anything less than what is in the barrel of the vaccine is administered to redo the vaccine. The drug manufacturer said that there will not be an overdose if another vaccine is administered. I called the pt and told her what the manufacturer said to do. She was concerned about getting another vaccine but I reassured her that the CDC and the drug manufacturer recommended another vaccine and there will not be an overdose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Nausea, Pain, Pyrexia
Clinical narrative: 2 hours later chills, fever, weakness, nausea, great body aches in all joints lasting for 2 days. My reaction to flu vaccines and shingles vaccines is so severe that it makes me think twice about having them. I am glad that I am now protected against shingles but I will probably not have the flu shot anymore. I know you eliminated thiomersal from the medium but I wonder if it is another component in the delivery medium. I can eat eggs, so it is not that.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Urticaria. 10/08/18 Patient presents with rash, child presented to the office for a flu shot. Received left arm standard flu vaccine. Within a couple minutes her left dorsal hand showed acute urticaria. No other symptoms. Patient accompanied by mother.
Age: 67.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Constipation, Diarrhoea
Clinical narrative: 24-36 hrs after shot stomach distress, gas, bloating, cramps, diarrhea, constipation. Went to dr. Pain in stomach continued to get worse and lasted until Monday 9/24/18.
Age: 67.0
Sex: M
Vaccine: HEPAB
Symptoms: Flatulence, Muscle spasms
Clinical narrative: 24-36 hrs after shot stomach distress, gas, bloating, cramps, diarrhea, constipation. Went to dr. Pain in stomach continued to get worse and lasted until Monday 9/24/18.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Presyncope, Vertigo
Clinical narrative: Pt stated about an hour-hour and a half the room began to spin. Pt was sitting in a car at the time. States she felt like was going to pass out. The feeling eventually went away. Pt called following day to inform us of occurrence. Stated that next day she was feeling well with no complaints but thought we should know about her near-syncopal episode. Patient was advised to follow up with her PCP to ensure there isn't any other health condition and to ensure pt's health and safety. RN.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 15th July 2018, refer case US2018GSK183755). On 3rd October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 3rd October 2018, 6 hrs after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced nausea, muscle soreness and headache. On an unknown date, the outcome of the nausea, muscle soreness and headache were not recovered/not resolved. It was unknown if the reporter considered the nausea, muscle soreness and headache to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details reported as follows: About 6 hours after vaccination, the patient experienced headache, sore muscles and a little bit of nausea. The patient felt worse after the 2nd dose as compared to 1st dose.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back disorder, Fatigue, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back disorder (back issues). Concomitant products included SHINGRIX. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th July 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. In July 2018, the patient experienced fatigue, pain in hip, shoulder pain and back disorder. On an unknown date, the patient experienced muscle pain and white blood cell count increased. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fatigue, muscle pain, pain in hip, shoulder pain and back disorder were not recovered/not resolved and the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the pain in arm, fatigue, muscle pain, pain in hip, shoulder pain, back disorder and white blood cell count increased to be related to SHINGRIX.  Rerun: Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced soreness in her left arm that lasted for approximately 1 week. Two weeks after she received the 2nd dose of SHINGRIX, the patient started experiencing fatigue, muscle aches, and joint pain. She stated that most of the joint pain was in her left hip, right shoulder and both knees. The patient underwent physical therapy for the pain and that had not helped. The patient stated that it hurts the most when she moved from sitting position to standing position and sometimes when rolling over in bed. The patient had a history of back issues, however, she had not had any problems with her back recently until after receiving the 2nd dose of SHINGRIX. The patient stated that approximately 2 weeks after receiving the 2nd dose of SHINGRIX, she could hear every vertebrae in her spine move and crack whenever she moved. A few weeks after receiving the 2nd dose of SHINGRIX, the patient had some blood work done and the results showed an increase in her white blood cell count. The patient had denied permission to contact their physician. For tolerance after 1st dose of SHINGRIX, refer US2018GSK186424.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back disorder (back issues). Concomitant products included SHINGRIX. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th July 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. In July 2018, the patient experienced fatigue, pain in hip, shoulder pain and back disorder. On an unknown date, the patient experienced muscle pain and white blood cell count increased. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fatigue, muscle pain, pain in hip, shoulder pain and back disorder were not recovered/not resolved and the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the pain in arm, fatigue, muscle pain, pain in hip, shoulder pain, back disorder and white blood cell count increased to be related to SHINGRIX.  Rerun: Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced soreness in her left arm that lasted for approximately 1 week. Two weeks after she received the 2nd dose of SHINGRIX, the patient started experiencing fatigue, muscle aches, and joint pain. She stated that most of the joint pain was in her left hip, right shoulder and both knees. The patient underwent physical therapy for the pain and that had not helped. The patient stated that it hurts the most when she moved from sitting position to standing position and sometimes when rolling over in bed. The patient had a history of back issues, however, she had not had any problems with her back recently until after receiving the 2nd dose of SHINGRIX. The patient stated that approximately 2 weeks after receiving the 2nd dose of SHINGRIX, she could hear every vertebrae in her spine move and crack whenever she moved. A few weeks after receiving the 2nd dose of SHINGRIX, the patient had some blood work done and the results showed an increase in her white blood cell count. The patient had denied permission to contact their physician. For tolerance after 1st dose of SHINGRIX, refer US2018GSK186424.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Vertigo
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache and vertigo. On an unknown date, the outcome of the headache and vertigo were not recovered/not resolved. It was unknown if the reporter considered the headache and vertigo to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced headache, experienced in front and back of the head, after vaccination with SHINGRIX. The pharmacy technician was reluctant to give out specific information about patient without their permission.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, weakness and nausea. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness and nausea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be 50 or 51 years. Field representative was informed by back office manager that a medical assistant at the practice experienced side effects from her 2nd dose of SHINGRIX that she did not had with the 1st dose and the events lasted about 4 days. Specifics date of vaccination and the onset of events were not known at the time of this report. Medical Assistant was also the patient she would receive follow up at the office if required. The field representative was educated about 24 hour reporting time frame.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 15th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, sickness and fever. On 15th July 2018, the outcome of the injection site pain, sickness and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, sickness and fever to be related to SHINGRIX. Additional details reported as follows: After vaccination, the patient experienced pain at the injection site that lasted for weeks and a slight bit of fever that day that went away fairly quickly. For tolerance after 2nd dose, refer case US2018180180.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Myalgia
Clinical narrative: Myalgia, Sore Throat, Fatigue.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Myalgia, Sore Throat, Fatigue.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Pruritus
Clinical narrative: Severe itching and burning. Redness noted around injection site. Onset actually not known. Treated with hydrocortisone cream and ALLEGRA (antihistamine).
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: The vaccine was prepared incorrectly. The adjuvant suspension component was mixed with sterile diluent which is not part of this vaccine instead of being mixed with its own supplied Lyophilized gE antigen component. No symptoms or treatments. Will need to re-vaccinate patient.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abdominal pain upper, Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: 5 pm on same date of shot, I was aches all over my body, I had chills, then sweats. My stomach hurt, I hade a headache and could not sleep. The next day was more of the same with throwing up add to it. I slept most of the day feeling  really bad. Called DR. told me to take Tylenol and ibuprofen. It didn't help much. I still couldn't eat anything, except for a few pieces of cereal. Saturday I started to feel better and toot some Ensure. It wasn't until Monday when I could do small things around the house and eat a little at a time. I am still very weak.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hyperhidrosis, Insomnia, Pain, Vomiting
Clinical narrative: 5 pm on same date of shot, I was aches all over my body, I had chills, then sweats. My stomach hurt, I hade a headache and could not sleep. The next day was more of the same with throwing up add to it. I slept most of the day feeling  really bad. Called DR. told me to take Tylenol and ibuprofen. It didn't help much. I still couldn't eat anything, except for a few pieces of cereal. Saturday I started to feel better and toot some Ensure. It wasn't until Monday when I could do small things around the house and eat a little at a time. I am still very weak.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Patient complained about itching in cheek area was still talking but started to complain about tingly tongue.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site urticaria
Clinical narrative: Evening after the vaccination, Patient experienced redness, soreness, and inflammation radiating from the injection site downward to the elbow. Morning after the vaccination patient experienced a hive at the injection site. Soreness continued until Friday following the vaccination (approx. 4 days).
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pallor, Pruritus, Rash, Rash papular
Clinical narrative: Rash. Fine papular rash locally covering approx. 8 x 6 cm. The area is itchy and sore. The area is warm to touch. No redness. Papules are pale. TMTC. Symptoms x 4 days. Treated with ZYRTEC 10 mg and Hydrocortisone 2.5% cream one application with instruction to use Hydrocortisone 1% twice daily as needed and ZYRTEC daily as needed. Return to clinic if not improving.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Rash. Fine papular rash locally covering approx. 8 x 6 cm. The area is itchy and sore. The area is warm to touch. No redness. Papules are pale. TMTC. Symptoms x 4 days. Treated with ZYRTEC 10 mg and Hydrocortisone 2.5% cream one application with instruction to use Hydrocortisone 1% twice daily as needed and ZYRTEC daily as needed. Return to clinic if not improving.
Age: 4.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Cyanosis central, Depressed level of consciousness
Clinical narrative: Called to pt room approx 3 min after administration of flu vaccine. Pt was on table with dad at bedside asking for help and being held in a seated position by him. Centrally cyanotic with decreased LOC and eyes open. Breathing spontaneously. Taken from dad, laid flat and no resistance or crying when removed from dad. EPI PEN JR administered in less than 1 min for presumed anaphylaxis NRB oxygen mask applied at high flow and bag inflated. One minute after admin resulted in centrally pink and fighting mask and asking for dad. EMS arrived in 2-3 min at which time we had him seated in dad's lap for comfort, spont non labored RR, pulse Ox 100% on NRB and HR 133. Unable to get BP during this time due to need for Tx inst.
Age: 4.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Called to pt room approx 3 min after administration of flu vaccine. Pt was on table with dad at bedside asking for help and being held in a seated position by him. Centrally cyanotic with decreased LOC and eyes open. Breathing spontaneously. Taken from dad, laid flat and no resistance or crying when removed from dad. EPI PEN JR administered in less than 1 min for presumed anaphylaxis NRB oxygen mask applied at high flow and bag inflated. One minute after admin resulted in centrally pink and fighting mask and asking for dad. EMS arrived in 2-3 min at which time we had him seated in dad's lap for comfort, spont non labored RR, pulse Ox 100% on NRB and HR 133. Unable to get BP during this time due to need for Tx inst.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypoaesthesia, Pyrexia
Clinical narrative: The day after the vaccines were administrated, 10/10/2018, she had fever and dizziness and bilateral lower extremity numbness where the patient states she could barely walk. She went to the emergency room and was admitted for a few hours for observation and was discharged same day. Patient is doing well today all symptoms resolved. Plan of care to hold second dose of HPV and order allergy testing for yeast.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: By the end of the day, I had a large red, itchy, hot, welt at the injection site, about 3 inches in diameter. The following day I developed a fever, which, at its height was 100.3 degrees F taken orally. The fever lasted about 24 hours. Additionally, I had headaches similar to those of a sinus infection. For 8 days, the headaches continued AND the welt grew larger, eventually flattening, but encircling my arm completely, before dissipating 10 days later. The area is still itchy however.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: By the end of the day, I had a large red, itchy, hot, welt at the injection site, about 3 inches in diameter. The following day I developed a fever, which, at its height was 100.3 degrees F taken orally. The fever lasted about 24 hours. Additionally, I had headaches similar to those of a sinus infection. For 8 days, the headaches continued AND the welt grew larger, eventually flattening, but encircling my arm completely, before dissipating 10 days later. The area is still itchy however.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Very sore arm by the evening of the vaccination. Next day had redness, swelling, pain distal to injection sites, but pt. states was closest to the flu shot. (Flu shot given anteriorly, PPSV posteriorly approx. 1 inch apart in the largest part of deltoid). States at its worst, the pain was 6-7 on scale of 0-10 with 10 most severe. At 74 hours (today at 12 noon, she rates pain at 1-2). Photographs of the affected limb taken at office today. Very red and still warm. Pt took acetaminophen for pain and used cool compresses. Pt was encouraged to call allergist, and advised I could mail photos if allergist wanted them.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Patient experienced fever/chills, migraine headache, fatigue, decreased appetite, and swelling in right side neck lymph nodes. No reaction at injection site. These symptoms lasted 2-3 days and then went away, pt still feels a little fatigue. she stated she felt like she had the flu. Patient did not seek medical attention.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pyrexia
Clinical narrative: Patient experienced fever/chills, migraine headache, fatigue, decreased appetite, and swelling in right side neck lymph nodes. No reaction at injection site. These symptoms lasted 2-3 days and then went away, pt still feels a little fatigue. she stated she felt like she had the flu. Patient did not seek medical attention.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: Swelling started about the 3rd day after vaccination. The swelling spread down the upper arm to the elbow. It was warm, raised, itchy and sore.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Feeling hot, Flushing, Nausea, Pain in extremity, Rash macular
Clinical narrative: Shortly after vaccination, while waiting here the required 15 min, patient developed symmetric blotchy flushing of chest and upper arms, and upper back, and face. Redness spared her bathing suit lines interestingly, and flushed on sun-exposed areas of chest only. She C/O being hot. She denied itching. Temp normal. Pulse OX 100% and remained so with continuous monitoring. HR 90-92. Lungs CTA. Heart with RRR. OP normal except the previously known tonsillolith. Exam repeated several times over the next hour and remained the same except for a gradual resolution of the flushing. Pt never developed cough, or shortness of breath. She had brief nausea, which resolved. No emesis. We gave 25 mg oral BENADRYL immediately - around 12:05 PM. Pt was observed in office for 30 min or so without resolution. Pt C/O legs hurting. Once pt stated her throat felt funny, then said it did not. After D/W MOC, I called for EMS transport to hospital for further monitoring and EKG. By the arrival of EMS 15 min later, patient was feeling better and flushing was resolving. EMS evaluated her, vitals were normal, and determined pt did not need EMS transport and that pt stable and could go to ER by car, or even go home for observation. Mom reports that patient had a lemonade and donut prior to vaccines, but had not had lunch. We monitored pt another 30 min and she remained stable, with resolution of Sx. Tolerated a POPSICLE and several glasses of water. O2 sats remained 100%. By 1 PM pt had remained stable at her baseline. Denied Sx. Flushing resolved. BP 110/70, HR 90, O2 sat 100%. Lungs CTA and heart with RRR. Pulse strong. Family elected to go home rather that the ER.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Throat irritation
Clinical narrative: Shortly after vaccination, while waiting here the required 15 min, patient developed symmetric blotchy flushing of chest and upper arms, and upper back, and face. Redness spared her bathing suit lines interestingly, and flushed on sun-exposed areas of chest only. She C/O being hot. She denied itching. Temp normal. Pulse OX 100% and remained so with continuous monitoring. HR 90-92. Lungs CTA. Heart with RRR. OP normal except the previously known tonsillolith. Exam repeated several times over the next hour and remained the same except for a gradual resolution of the flushing. Pt never developed cough, or shortness of breath. She had brief nausea, which resolved. No emesis. We gave 25 mg oral BENADRYL immediately - around 12:05 PM. Pt was observed in office for 30 min or so without resolution. Pt C/O legs hurting. Once pt stated her throat felt funny, then said it did not. After D/W MOC, I called for EMS transport to hospital for further monitoring and EKG. By the arrival of EMS 15 min later, patient was feeling better and flushing was resolving. EMS evaluated her, vitals were normal, and determined pt did not need EMS transport and that pt stable and could go to ER by car, or even go home for observation. Mom reports that patient had a lemonade and donut prior to vaccines, but had not had lunch. We monitored pt another 30 min and she remained stable, with resolution of Sx. Tolerated a POPSICLE and several glasses of water. O2 sats remained 100%. By 1 PM pt had remained stable at her baseline. Denied Sx. Flushing resolved. BP 110/70, HR 90, O2 sat 100%. Lungs CTA and heart with RRR. Pulse strong. Family elected to go home rather that the ER.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Extreme right arm pain first day home from the hospital after birth of my daughter. It lasted 2 days. Currently, I cannot fully extend my right arm the way that I used to, or compared to my left. No pain, but reduced mobility which makes it difficult to do some things.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Injection site inflammation, Injection site warmth, Musculoskeletal pain, Pain
Clinical narrative: Woke the next morning, on 9/28  with severe shoulder/arm pain. The pain is sharp, aches, burns, tingles and sometimes causes a tingling/numbing sensation from shoulder to fingertips. It's now been 17 days of constant pain. Went to my physician on 10/4/18 and 10/11/18. Currently have an MRI scheduled for 10/17/18 to determine the cause/source of pain.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Woke the next morning, on 9/28  with severe shoulder/arm pain. The pain is sharp, aches, burns, tingles and sometimes causes a tingling/numbing sensation from shoulder to fingertips. It's now been 17 days of constant pain. Went to my physician on 10/4/18 and 10/11/18. Currently have an MRI scheduled for 10/17/18 to determine the cause/source of pain.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Joint range of motion decreased, Pain
Clinical narrative: Woke the next morning, on 9/28  with severe shoulder/arm pain. The pain is sharp, aches, burns, tingles and sometimes causes a tingling/numbing sensation from shoulder to fingertips. It's now been 17 days of constant pain. Went to my physician on 10/4/18 and 10/11/18. Currently have an MRI scheduled for 10/17/18 to determine the cause/source of pain.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Petechiae, Stomatitis
Clinical narrative: Multiple black sores in mouth of various sizes, and Petechiae (lower extremities).
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling hot, Malaise, Pallor
Clinical narrative: Patient received flu shot, got up from the chair and was talking to her siblings while Mom got her shot, followed by Dad. As Dad was about to get up, Mom who was behind the flu shot screen called for help saying patient wasn't feeling well. Dad and I got out from behind the screen and patient was laid on the floor (feeling over heated / light headed, and pale) as Pharmacy Staff called 911. Her jacket was removed while she was tended to. No breathing difficulties.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Large red lump that is warm to touch.
Age: 23.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Hypotension
Clinical narrative: Patient almost immediately had a short seizure then was sweating, rapid heart rate, dizzy - EMT's were called and arrived within minutes - patient had low blood pressure and tingling/numbness in hands. Patient was seated and conscious at all times except during seizure which lasted about 15 seconds.
Age: 23.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Paraesthesia, Seizure
Clinical narrative: Patient almost immediately had a short seizure then was sweating, rapid heart rate, dizzy - EMT's were called and arrived within minutes - patient had low blood pressure and tingling/numbness in hands. Patient was seated and conscious at all times except during seizure which lasted about 15 seconds.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Chills, Painful respiration, Pyrexia
Clinical narrative: Said she had fever, chills, chest hurt with deep breaths.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Dizziness, Dysgeusia, Erythema, Malaise
Clinical narrative: I GAVE THE PNEUMOVAX FIRST AND THE FLUZONE HD SECOND. AFTER THE FLUZONE HD WAS GIVEN THE PATIENT HAD A RED FACE AND NECK AND FELT DIZZY. SHE COMPLAINED OF A FUNNY TASTE IN HER MOUTH AND FELT A LITTLE "SICK". AFTER 3 MINUTES THE REDNESS WENT AWAY COMPLETELY AND THE PATIENT COMPLAINED THAT HER LOWER BACK HURT AND FELT WALKING WOULD BE DIFFICULT. THE PATIENT THEN STOOD UP AND COULD WALK JUST FINE. HER BLOOD PRESSURE WAS NORMAL AND SHE WAITED 15 MORE MINUTES BEFORE LEAVING. THE PATIENT SAID ON HER WAY TO THE CAR WITH HER HUSBAND SHE FELT A LITTLE DIZZY BUT AFTER EATING LUNCH SHE FELT JUST FINE. I CALLED HER PRIMARY CARE PHYSICIAN AND MADE HIM AWARE. I FOLLOWED UP WITH THE PATIENT 4 HOURS LATER AND SHE STATED SHE WAS FEELING FINE.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient says that she has had a sore shoulder for approximately 2 weeks so far since she received the vaccine. She says that she did not look while getting the vaccine, but that compared to other vaccines, it felt that it may have been given too high up. She said the pain has been constant (has not gone away and come back). The patient called 10/14/2018 and the pharmacist working at the time said she told her to take over-the-counter anti-inflammatory drugs and try to massage the area. Patient has not yet seen a doctor or other healthcare professional about this at the time of report.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Leukocytosis, Pain, Pyrexia, Spinal pain
Clinical narrative: Pt called the pharmacy complaining of high fever, pain that radiated to the spine, headache, etc on 10.14.18 and was referred to the emergency room. The emergency room admitted her to the hospital for leukocytosis of unknown origin, possibly related to the vaccination.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Dehydration, Muscle spasms, Muscle spasticity, Muscular weakness
Clinical narrative: Extreme weakness in lower limbs especially, leg cramping and spasticity, concern of Guillan-Barre Syndrome, dehydration all within a few hours of the vaccination.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling below injection site. This area was also warm to touch.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient has had pain at injection site and shoulder arthritis since his shot (2 months ago). He states that he can't lift his arm past his shoulder. Patient has not talked to a physician about the problem. I advised him to see his primary care doctor.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash
Clinical narrative: Rash around injection site, tiredness.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient came to the pharmacy on Monday 10/15/18 at 9:30 AM. Both arms were red and warm where she received her Flu and PREVNAR injections. Both injection sites were too low on the arms and not in the Deltoid muscle area. I informed patient that both injections were given too low and suggest she see her doctor.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure like phenomena
Clinical narrative: Patient had seizure like synptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pyrexia, Rash, Rash vesicular
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 22nd September 2018, the patient received the 1st dose of SHINGRIX. On 4th October 2018, 12 days after receiving SHINGRIX, the patient experienced injection site rash, rash herpetiform, fever, pain and rash. On an unknown date, the outcome of the injection site rash, rash herpetiform, fever, pain and rash were unknown. It was unknown if the reporter considered the injection site rash, rash herpetiform, fever, pain and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 74 or 75 years. After receiving SHINGRIX, the patient experienced rash at the injection site (similar to zoster rash), fever, pain and rash in the palmar side of his hands. The initials of the patient was unknown. The nurse agreed to be contacted for follow up.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 65 year old female patient. There was no information about the patient's concurrent conditions or concomitant therapies. The patient was vaccinated with PREVNAR 13 in July 2018. The patient had allergy to iodine, AUGUMENTIN, BETADINE, BIAXIN, KEFLEX, vancomycin and latex. On 04-OCT-2018 (reported as today), the patient was administered with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) with only 3 months separation from the injection of PREVNAR 13. On 04-OCT-2018, reported as after the vaccine injection, the patient developed redness and was swollen at the injection site. No adverse effects were reported. The patient was seen by the physician and received treatment for the events. No lab diagnostic studies were performed. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.