chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Pneumonia, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning three elderly patients (exact age and gender were not provided). There was no information about patients' concurrent conditions, medical history or concomitant medications. In October 2017, the patients were vaccinated with PNEUMOVAX 23 lot # N019348 with expiration date of 08-FEB-2019 or lot # N020501 with expiration date of 03-MAR-2019 (route of administration and anatomical location were not reported), for routine vaccination. It was not reported which patient received which vaccine. On unknown dates, the patients experienced injection site swelling, pneumonia like symptoms, and fever. The outcome of pneumonia and injection site swelling was reported as recovered on unknown date. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review the event pneumonia was considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N013886, expiry date: 09-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA002182: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with improperly stored M-M-R-II (lot # N010495, expiry date: 31-MAR-2019) reconstituted with improperly stored sterile diluent, lot # M014034, expiry date: 20-NOV-2018. The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case : 1802USA002182 US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA002182: US-009507513-1802USA004692.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with improperly stored M-M-R-II (lot # N010495, expiry date: 31-MAR-2019) reconstituted with improperly stored sterile diluent, lot # M014034, expiry date: 20-NOV-2018. The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA002182: US-009507513-1802USA004692.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with improperly stored M-M-R-II (lot # N010495, expiry date: 31-MAR-2019) reconstituted with improperly stored sterile diluent (lot # M014034, expiry date: 20-NOV-2018) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA002182: US-009507513-1802USA004686.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Myalgia, Pyrexia, Tremor, Vomiting
Clinical narrative: Mom reports that patient..."was up all night with a 103 degree fever, vomiting and terrible body tremors". Vomiting stopped, but continued with fever and some muscle aches in legs by 24 hours later. By 02/08/2018 at 9:00 am had a temperature spike in the night, but better this morning.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Feeling hot, Gait disturbance, Headache, Injection site pain
Clinical narrative: Patient complaining of very sensitive pain at site of injection. Also headache the night of injection. Following day experiencing severe muscle pain that made it difficult to walk. By Midday felt very nauseous and passed out for a few seconds . He came to and was then feeling very warm, Took temperature it was 99. Advised patient to take 2 TYLENOL and see how he felt. After a couple of hours his temperature had gone back to normal and had finally fallen asleep. Followed up Friday 2/9/18 left two messages but have not heard back. Also reported it to his primary care doctor.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Loss of consciousness, Myalgia, Nausea
Clinical narrative: Patient complaining of very sensitive pain at site of injection. Also headache the night of injection. Following day experiencing severe muscle pain that made it difficult to walk. By Midday felt very nauseous and passed out for a few seconds . He came to and was then feeling very warm, Took temperature it was 99. Advised patient to take 2 TYLENOL and see how he felt. After a couple of hours his temperature had gone back to normal and had finally fallen asleep. Followed up Friday 2/9/18 left two messages but have not heard back. Also reported it to his primary care doctor.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Several minutes after receiving the vaccine (between 10- 20 minutes), the child passed out standing up. She fell to the floor and convulsed for several seconds. She "came to" shortly thereafter and was fine.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pallor, Syncope
Clinical narrative: Pt came in to the pharmacy not feeling very well, looking pale and shivering. Pt wanted flu shot, despise the suggestion of waiting until feeling completely well to get the shot. Pt and her daughter insisted on getting the flu shot anyway. The flu shot was administered around 3 pm of the 26th.  About 10 minutes later, she was shivering more and turned more pale and finally fainted, faced down to the floor. We called 911, had pt lie still, faced up and legs up on the chair until the paramedic arrived. Pt was responsive the whole time of the incident.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Instant hives. Pt was given Diphenhydramine HCL 3.75 mg.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Patient reported to me on 2/9/18 that by the evening of 02/06/2018 she was experiencing aching, throbbing, tenderness in the right arm from shoulder to wrist. She took some generic Tylenol, 325mg, and reported that by the morning of 02/07/2018 the arm was only a little tender, with minor ache, and that this subsided by noon.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Instant hive reaction post vaccine administration. Pt given 4.5 ml oral diphenhydramine.
Age: 63.0
Sex: F
Vaccine: HEPA, TYP, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Developed Shingles rash on right upper back.  Itching, sharp intermittent pain, redness, sores.  Currently on 2/9/2018 Shingles are still present.  Diagnosis confirmed by family physician on 1/29/2018.
Age: 63.0
Sex: F
Vaccine: HEPA, TYP, VARZOS
Symptoms: Skin ulcer
Clinical narrative: Developed Shingles rash on right upper back.  Itching, sharp intermittent pain, redness, sores.  Currently on 2/9/2018 Shingles are still present.  Diagnosis confirmed by family physician on 1/29/2018.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased
Clinical narrative: Difficulty moving arm, no swelling - started soon after injection, improved after first day then worsened again. Went to urgent care, MD saw no swelling or fluid build up, prescribed ibuprofen - planned to follow up with PCP.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Feb. 5th at approx. 730pm started feeling ill with muscle aches, chills, rapid heart rate, dizziness and temp. of 100.1. By 9pm had body shaking, bad headache, nausea, rapid breathing and fever of 102.0 that escalated to 103.2 by 1145pm, at which time, mild edema around eyes noted. Tylenol 650mg was taken every 4-5 hours starting from about 830pm that evening. Temp. at 615am Feb 6th was 102.6, at which time, Ibuprofen 200mg and Diphenhydramine 25mg was taken. The remainder of that day and the following day headache, fatigue, mild dizziness and low grade temp. continued. By Feb.8th, symptom free and well. Rapid onset of symptoms, exacerbation of symptoms and high fever very concerning with this influenza vaccine.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Myalgia, Nausea, Periorbital oedema, Pyrexia
Clinical narrative: Feb. 5th at approx. 730pm started feeling ill with muscle aches, chills, rapid heart rate, dizziness and temp. of 100.1. By 9pm had body shaking, bad headache, nausea, rapid breathing and fever of 102.0 that escalated to 103.2 by 1145pm, at which time, mild edema around eyes noted. Tylenol 650mg was taken every 4-5 hours starting from about 830pm that evening. Temp. at 615am Feb 6th was 102.6, at which time, Ibuprofen 200mg and Diphenhydramine 25mg was taken. The remainder of that day and the following day headache, fatigue, mild dizziness and low grade temp. continued. By Feb.8th, symptom free and well. Rapid onset of symptoms, exacerbation of symptoms and high fever very concerning with this influenza vaccine.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory rate increased, Tremor
Clinical narrative: Feb. 5th at approx. 730pm started feeling ill with muscle aches, chills, rapid heart rate, dizziness and temp. of 100.1. By 9pm had body shaking, bad headache, nausea, rapid breathing and fever of 102.0 that escalated to 103.2 by 1145pm, at which time, mild edema around eyes noted. Tylenol 650mg was taken every 4-5 hours starting from about 830pm that evening. Temp. at 615am Feb 6th was 102.6, at which time, Ibuprofen 200mg and Diphenhydramine 25mg was taken. The remainder of that day and the following day headache, fatigue, mild dizziness and low grade temp. continued. By Feb.8th, symptom free and well. Rapid onset of symptoms, exacerbation of symptoms and high fever very concerning with this influenza vaccine.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Fibrous histiocytoma, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient complains of an itchy "bump" on his left shoulder which he feels developed 2-3 weeks after he received his seasonal influenza vaccine. He notes it has progressively grown in size. He denies adverse reactions to prior vaccines. He denies generalized cutaneous and systemic symptoms. He denies fever/chills.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: 7 CM REDNESS AND TENDERNESS, TX: BENADRYL AND TYLENOL WARMTH AND COLD COMPRESSES, F/U IN 1 WEEK IF NOT RESOLVED.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: Had injection site swelling 3 hours after injection. Patient called us 2 days later to report symptoms. Patient came into office to have doctor examine reaction. Doctor prescribed Benadryl and drew circle on area on redness area and informed her if the redness goes outside the circle to call us to receive antibiotics. Reports area warm to the touch with redness.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Localized red and itchy at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Pt was given the HPV9 vaccine and it was one day expired. Pt is fine and will be revaccinated 02/09/2018. Given 02/02/18. Expired 02/01/18.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling hot, Headache, Injection site pain
Clinical narrative: Soreness of upper left arm, chills, upset stomach, feeling hot all over but no fever, headache, muscle aches, malaise.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: Soreness of upper left arm, chills, upset stomach, feeling hot all over but no fever, headache, muscle aches, malaise.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Neuralgia, Pain
Clinical narrative: Patient reports pain with injection that progressed to extreme pain which limited range of motion as well as shooting /nerve type pain. Pain reported in injection site arm only.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Rash, Rash macular, Vaccination site swelling
Clinical narrative: Redness and swelling at both vaccine site started 2 days after vaccination. 9 days later started having vomiting, diarrhea, and macular rash on trunk.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Vomiting
Clinical narrative: Redness and swelling at both vaccine site started 2 days after vaccination. 9 days later started having vomiting, diarrhea, and macular rash on trunk.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Muscle spasms, Neck pain
Clinical narrative: Excruciating and sudden onset of pain and spasm and cramps in left shoulder shooting down arm and into elbow and upper neck area.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Screaming
Clinical narrative: Excruciating and sudden onset of pain and spasm and cramps in left shoulder shooting down arm and into elbow and upper neck area.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash erythematous
Clinical narrative: Experienced erythematous rash.
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of tingling in a adult female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown. It was unknown if the reporter considered the tingling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. This case described the first nurse's adverse event. A reporter told that 1, 2 or as many as 3, was not even sure, nurses who had the FLULAVAL QUADRIVALENT vaccine experienced side effects outside of clinical trials. On 23rd January 2018, the reporter spoke with nurses at a clinic and the reporter reported some nurses experiencing possible adverse reactions with FLULAVAL. The patient experienced tingling on one side of her face. The unrelated questions from the physician were sent, but that these events had not yet been reported to safety. This was 1 of 3 case, reported by same reporter.
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling bad in a female patient who received BEXSERO. Previously administered products included BEXSERO (received in December 2016). On 1st February 2018, the patient received BEXSERO. On 1st February 2018, less than a day after receiving BEXSERO, the patient experienced feeling bad and drug dose administered interval too long. On an unknown date, the outcome of the feeling bad and drug dose administration interval too long were unknown. It was unknown if the reporter considered the feeling bad to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient was the reporter's daughter. In February 2018, almost 2 years after 1st dose, the patient was inadvertently given a dose of BEXSERO, which led to lengthening of the vaccination schedule. Her college contacted her and told her she needed an additional dose that she received yesterday. The patient was feeling very poorly on the day of reporting. The reporter wanted to know if this was a concern.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a patient who received SHINGRIX. On 3rd February 2018, the patient received SHINGRIX. On 4th February 2018, 1 days after receiving SHINGRIX, the patient experienced erythema. In February 2018, the patient experienced pain, swelling and feeling of warmth. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the swelling, erythema and feeling of warmth were unknown. It was unknown if the reporter considered the pain, swelling, erythema and feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Less than a week after receiving SHINGRIX, the patient experienced some pain, swelling and warm.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Allergy test, Headache, Laboratory test, Nausea, Vision blurred
Clinical narrative: Headaches, nausea, vomiting, blurry vision. Given ibuprofen 600mg, Amoxil 500mg, ZOFRAN 4mg.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Headaches, nausea, vomiting, blurry vision. Given ibuprofen 600mg, Amoxil 500mg, ZOFRAN 4mg.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at site of KINRIX and MMR localized, no induration no cellulitis.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On 1st February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, fatigue and headache. In February 2018, the patient experienced myalgia. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, myalgia and fever were not recovered/not resolved and the outcome of the fatigue and headache were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, myalgia, fever, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Reporter was inquiring on behalf of his wife (patient). The patient received her first injection in a series of two for the SHINGRIX vaccine yesterday in her HCP's office. On 2nd February 2018, the patient woke up in the morning with complaints of pain, redness and swelling at the injection site, fatigue, headache and low grade fever. Less than a week after vaccination, the patient experienced myalgia. The reporter was inquiring whether she can take TYLENOL for her symptoms or if we recommend anything else. Informed the caller we could not provide medical advice and advised the caller to contact the doctor's office where the vaccine was administered.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On 1st February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, fatigue and headache. In February 2018, the patient experienced myalgia. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, myalgia and fever were not recovered/not resolved and the outcome of the fatigue and headache were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, myalgia, fever, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Reporter was inquiring on behalf of his wife (patient). The patient received her first injection in a series of two for the SHINGRIX vaccine yesterday in her HCP's office. On 2nd February 2018, the patient woke up in the morning with complaints of pain, redness and swelling at the injection site, fatigue, headache and low grade fever. Less than a week after vaccination, the patient experienced myalgia. The reporter was inquiring whether she can take TYLENOL for her symptoms or if we recommend anything else. Informed the caller we could not provide medical advice and advised the caller to contact the doctor's office where the vaccine was administered.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Asthenia, Constipation, Defaecation urgency, Dizziness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 19-year-old female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received in December 2016) and BEXSERO (2nd dose received in February 2017). Concomitant products included biotin, vitamin d and Probiotic. On 31st January 2018, the patient received BEXSERO. On 31st January 2018, unknown after receiving BEXSERO, the patient experienced extra dose administered. On 1st February 2018, the patient experienced nausea, general body pain, feeling unwell, light headedness, feelings of weakness, gagging, stomach discomfort, defecation urgency and absent bowel movement. On an unknown date, the outcome of the nausea, general body pain, feeling unwell, gagging and stomach discomfort were not recovered/not resolved and the outcome of the light headedness, feelings of weakness, defecation urgency, absent bowel movement and extra dose administered were unknown. It was unknown if the reporter considered the nausea, general body pain, feeling unwell, light headedness, feelings of weakness, gagging, stomach discomfort, defecation urgency and absent bowel movement to be related to BEXSERO. Additional details were provided as follows: This case was reported by the registered nurse who is the mother of the patient. The age at vaccination was not reported. The patient received the BEXSERO vaccine at her college health clinic after receiving an email from the school about mandatory vaccinations before being admitted into classes. The patient received BEXSERO even though she had already previously received her first dose of BEXSERO in December 2016 and then the second dose in the BEXSERO series in February 2017, which led to extra to extra dose administered. On 1st February 2018, 1 day after BEXSERO, the patient experienced nausea, extreme body aches, feeling unwell, light headedness, gagging, feelings of weakness, stomach feels like it is in knots with the feeling of needing to have a bowel movement but being unable to have a bowel movement. The reporter thinks her daughter's stomach may be cramping based on her described symptoms. The patient keeps gagging but had not been able to vomit. The patient currently feels really weak and lightheaded. The reporter gave permission to be contacted by agency.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, Malaise, Nausea, Pain, Retching
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 19-year-old female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received in December 2016) and BEXSERO (2nd dose received in February 2017). Concomitant products included biotin, vitamin d and Probiotic. On 31st January 2018, the patient received BEXSERO. On 31st January 2018, unknown after receiving BEXSERO, the patient experienced extra dose administered. On 1st February 2018, the patient experienced nausea, general body pain, feeling unwell, light headedness, feelings of weakness, gagging, stomach discomfort, defecation urgency and absent bowel movement. On an unknown date, the outcome of the nausea, general body pain, feeling unwell, gagging and stomach discomfort were not recovered/not resolved and the outcome of the light headedness, feelings of weakness, defecation urgency, absent bowel movement and extra dose administered were unknown. It was unknown if the reporter considered the nausea, general body pain, feeling unwell, light headedness, feelings of weakness, gagging, stomach discomfort, defecation urgency and absent bowel movement to be related to BEXSERO. Additional details were provided as follows: This case was reported by the registered nurse who is the mother of the patient. The age at vaccination was not reported. The patient received the BEXSERO vaccine at her college health clinic after receiving an email from the school about mandatory vaccinations before being admitted into classes. The patient received BEXSERO even though she had already previously received her first dose of BEXSERO in December 2016 and then the second dose in the BEXSERO series in February 2017, which led to extra to extra dose administered. On 1st February 2018, 1 day after BEXSERO, the patient experienced nausea, extreme body aches, feeling unwell, light headedness, gagging, feelings of weakness, stomach feels like it is in knots with the feeling of needing to have a bowel movement but being unable to have a bowel movement. The reporter thinks her daughter's stomach may be cramping based on her described symptoms. The patient keeps gagging but had not been able to vomit. The patient currently feels really weak and lightheaded. The reporter gave permission to be contacted by agency.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema
Clinical narrative: (L) arm slight redness.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old male patient who received SHINGRIX. On 30th January 2018, the patient received SHINGRIX. On 31st January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On 5th February 2018, the patient experienced neuralgia and localized feeling of warmth. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the neuralgia and localized feeling of warmth were not recovered/not resolved. The reporter considered the injection site erythema and neuralgia to be possibly related to SHINGRIX. It was unknown if the reporter considered the localized feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to any one. The patient vaccinated with SHINGRIX in the left arm by staff pharmacist. In the next morning, the patient had redness at the injection site. On 5th January 2018, 6 days after receiving SHINGRIX, the patient awoke with some back nerve-like pain, described as a warm sensation on his back. At the time of reporting, the patient noted that the nerve pain in the back only occurs at night.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old male patient who received SHINGRIX. On 4th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site rash and erythromacular rash. On an unknown date, the outcome of the injection site swelling, injection site rash and erythromacular rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site rash and erythromacular rash to be related to SHINGRIX. Additional details were reported as follows: The patient had little raised red spots around the injection site. The reporter reported that it was not itchy. The pharmacist refused to go through the adverse events.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 71-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 4th February 2018, the patient received SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was not recovered/not resolved. The reporter considered the injection site warmth to be probably related to SHINGRIX. Additional details were provided as follows: The case was reported by a Registered pharmacist. The patient received SHINGRIX in left deltoid. The reporter saw patient today (at the time of reporting) and the patient reported having warmth in the arm where she received the injection. The reporter referred her to urgent care but the patient said she was just going to call her physician. She did not have access to urgent care.
Age: 97.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 97-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included carvedilol, Alendronate, Furosemide, Levothyroxine and ELIQUIS. On 31st January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st January 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, neck pain and headache. On an unknown date, the outcome of the general body pain, neck pain and headache were not recovered/not resolved. The reporter considered the general body pain, neck pain and headache to be probably related to SHINGRIX. Additional information was reported as follows: The pharmacist reported that the patient planned to continue follow-up with his physician on an unknown date.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Rash with redness and swelling.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: PATIENT STATED THAT SHE WENT TO ER AND WAS INFORMED THAT SHE HAS GUILLAIN-BARRE SYNDROME, GBS.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Hypersensitivity
Clinical narrative: PATIENT STATED THAT SHE WENT TO ER AND WAS INFORMED THAT SHE HAS GUILLAIN-BARRE SYNDROME, GBS.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient came in to get a history of her flu shot and informed us that she had an allergic reaction, Guillain-Barre Syndrome (GBS). She went to the ER and was informed about GBS. The ER doctor mentioned to her that it was probably the flu shot and she needs to follow up with PCP. She got the flu shot, FLUARIX QUAD, on 1/11/18. I told her that I will update her profile to being allergic to flu vaccines.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Hypersensitivity
Clinical narrative: Patient came in to get a history of her flu shot and informed us that she had an allergic reaction, Guillain-Barre Syndrome (GBS). She went to the ER and was informed about GBS. The ER doctor mentioned to her that it was probably the flu shot and she needs to follow up with PCP. She got the flu shot, FLUARIX QUAD, on 1/11/18. I told her that I will update her profile to being allergic to flu vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Echocardiogram normal, Electrocardiogram normal, Pallor, Respiratory arrest
Clinical narrative: Baby had a series of inconsolable screaming while crying that started after the injection was given. Two days after the injection, he was found with a pale grey complexion, unresponsive & not breathing. He was found quickly enough that we were able to bring him to and then brought him to the ER to be monitored. The more I research about vaccines, the more sickened I become by them. Giving a newborn any amount of formaldehyde, mercury, aluminum, and aborted fetus cells is both disturbing and unethical.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming, Unresponsive to stimuli
Clinical narrative: Baby had a series of inconsolable screaming while crying that started after the injection was given. Two days after the injection, he was found with a pale grey complexion, unresponsive & not breathing. He was found quickly enough that we were able to bring him to and then brought him to the ER to be monitored. The more I research about vaccines, the more sickened I become by them. Giving a newborn any amount of formaldehyde, mercury, aluminum, and aborted fetus cells is both disturbing and unethical.
Age: 14.0
Sex: F
Vaccine: FLUC4, MMR
Symptoms: Syncope
Clinical narrative: PPATIENT FAINTED 15 MINUTES AFTER SHOT  GIVEN.
Age: 14.0
Sex: F
Vaccine: FLUC4, MMR
Symptoms: Cellulitis, Rash, Vaccination complication
Clinical narrative: PPATIENT FAINTED 15 MINUTES AFTER SHOT  GIVEN.
Age: 34.0
Sex: M
Vaccine: FLUC4, MMR
Symptoms: Syncope
Clinical narrative: Pt. developed a rash from vaccine. Pt. was admitted to hopsital ward for cellulitis but rash was determined to be adverse reaction to MMR vaccine by provider.
Age: 34.0
Sex: M
Vaccine: FLUC4, MMR
Symptoms: Cellulitis, Rash, Vaccination complication
Clinical narrative: Pt. developed a rash from vaccine. Pt. was admitted to hopsital ward for cellulitis but rash was determined to be adverse reaction to MMR vaccine by provider.
Age: 0.25
Sex: M
Vaccine: DTAP, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Irritable, fever.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cerebral haemorrhage, Computerised tomogram abnormal, Epstein-Barr virus infection, Fatigue, Feeling cold
Clinical narrative: Severe muscle pains and aches, severe headache, fatigue, hot and cold sensations, by 11/09 severe ringing in the ears, and untimately a triggering of the Epstein-Barr virus. I am still suffering from this three months later. I continue to have fatigue and ringing in my ears.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Headache, Migraine, Myalgia, Tinnitus
Clinical narrative: Severe muscle pains and aches, severe headache, fatigue, hot and cold sensations, by 11/09 severe ringing in the ears, and untimately a triggering of the Epstein-Barr virus. I am still suffering from this three months later. I continue to have fatigue and ringing in my ears.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Severe muscle pains and aches, severe headache, fatigue, hot and cold sensations, by 11/09 severe ringing in the ears, and untimately a triggering of the Epstein-Barr virus. I am still suffering from this three months later. I continue to have fatigue and ringing in my ears.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Immediate post-injection reaction, Musculoskeletal disorder
Clinical narrative: Patient experienced burning sensation immediately and has progressively lost up to 80% of function/strength in right arm over 5 months.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Peripheral coldness
Clinical narrative: After getting the shot he stood on the side of counter waiting for his parents to finish getting their shot.  After couple minutes he looked pale and said he's dizzy & lightheaded.  Laid him on the floor and lifted legs unto a chair.  He also said he felt nauseated, hands cold and sweaty.  After laying on the floor the dizziness and lightheadedness subsided, returned after standing for a few minutes.  Had him stay in the pharmacy for over half an hour monitored for further syncope episode subsided.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: The shot site didn't hurt at first but each day after the injection my left shoulder started hurting more and more. My osteopath was out of town so I decided I would try to go get a therapeutic massage. I had to ask the masseuse to stop because I could not bear the pain. I cannot raise my arm over my head or move my arm behind my back. I have better range of motion moving forward. The pain often radiates down my arm to my hand without doing anything and I cannot sleep on my left side at all. I am a caregiver for my 88 yr old father (and a recording artist by trade) I don't do anything strenuous...I haven't even been to the gym in months. It took speaking with a loved one on the phone that is married to physician that it might have been from my flu shot. I immediately called the pharmacy once I made the full connection. I wanted to initiate this complaint in case your agency can advise what tests/treatments can be done. I have an appointment with my osteopath.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea
Clinical narrative: Sudden, extreme dizziness. It lasted from 6:30 pm through early morning hours, the next day. Minimal nausea.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Severe pain and decreased mobility in arm where vaccine was administered.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient called a few days after his vaccine to report 2 stripes on his forearm, not in injection site. The stripe was 1/4 inch wide, bright red and itched intermittently BENADRYL and cortisone helped the symptoms. He stated the only new drug he had was the vaccine.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: Patient called a few days after his vaccine to report 2 stripes on his forearm, not in injection site. The stripe was 1/4 inch wide, bright red and itched intermittently BENADRYL and cortisone helped the symptoms. He stated the only new drug he had was the vaccine.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia, Feeling hot
Clinical narrative: 5 minutes post injection patient  got very dizzy and couldn't stand. Her dad propped her up until I got a chair for her. She sat for 15 minutes and her dad applied a cool compress to her forehead, as she was hot. I gave her cups of water and her dad got her a nutrition bar which she ate.  She hadn't had lunch yet according to her dad. She felt better after 15 minutes and then walked with her dad to the front of the store. I called her at 4:50PM today and she is fine now.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin warm
Clinical narrative: No other vaccines on this date. Pt has a 5x5 red, warm (not raised) arm in the deltoid area. She noticed this after she got home from work on 2/9/18.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Asthenia, Back pain, Blood test, Decreased appetite, Eyelid function disorder
Clinical narrative: Started with tingling in fingers and toes, then achy legs, aching back, aching jaw, trouble keeping left eye open, light sensitivity, vomiting, staggered walking, falling down, extreme fatigue, weakness, loss of appetite, loss of personality.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Fall, Fatigue, Gait disturbance, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Started with tingling in fingers and toes, then achy legs, aching back, aching jaw, trouble keeping left eye open, light sensitivity, vomiting, staggered walking, falling down, extreme fatigue, weakness, loss of appetite, loss of personality.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Pain in jaw, Paraesthesia, Personality change, Photophobia, Urine analysis
Clinical narrative: Started with tingling in fingers and toes, then achy legs, aching back, aching jaw, trouble keeping left eye open, light sensitivity, vomiting, staggered walking, falling down, extreme fatigue, weakness, loss of appetite, loss of personality.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Vomiting
Clinical narrative: Started with tingling in fingers and toes, then achy legs, aching back, aching jaw, trouble keeping left eye open, light sensitivity, vomiting, staggered walking, falling down, extreme fatigue, weakness, loss of appetite, loss of personality.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Lymphadenopathy, Skin reaction
Clinical narrative: Redness, sore, and pain at the inject site and spread to under arm. No fever, but increased tiredness.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Marked, local swelling and pain around injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Roughly 24 hours after the shot (not sure which shot) 4 year old has a swollen left arm. Arm is warm to touch, red and hard.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in arm, elbow and wrist continuing for approximately 4 months, still ongoing.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Ear swelling, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: He said his upper arm was swollen and hurting. It was swollen all the way up to his ear. Doctor advise him to take BENADRYL. (It started swelling on the 8th).
Age: 5.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Condition aggravated, Deafness, Facial paralysis, Immune system disorder, Joint stiffness
Clinical narrative: 100% deaf - left side facial palsy- scarring to skull bones- immune disease- temporary joint stiffness.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Scar
Clinical narrative: 100% deaf - left side facial palsy- scarring to skull bones- immune disease- temporary joint stiffness.
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Musculoskeletal pain, Nausea, Neck pain, Pyrexia
Clinical narrative: Nausea, low grade fever, severe shoulder pain up into my lower part of my neck, right sided chest pain.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Cough, Erythema, Headache, Skin warm, Swelling
Clinical narrative: Symptoms included: redness, swollen, and hot to touch above and below vaccination site, headache, coughing, and minimal wheezing. BENADRYL was given upon coughing and wheezing which subsided symptoms. The coughing and wheezing occurred on 12/5/17. The redness, swollen, and hot arm symptoms have occurred almost evert time Anthrax has been administered. This was the first time I have had issues with the feeling that my throat was closing.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Throat tightness, Wheezing
Clinical narrative: Symptoms included: redness, swollen, and hot to touch above and below vaccination site, headache, coughing, and minimal wheezing. BENADRYL was given upon coughing and wheezing which subsided symptoms. The coughing and wheezing occurred on 12/5/17. The redness, swollen, and hot arm symptoms have occurred almost evert time Anthrax has been administered. This was the first time I have had issues with the feeling that my throat was closing.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Anal incontinence, Asthenia, Balance disorder, Feeling abnormal, General symptom
Clinical narrative: Approximately 9 hours after vaccination, mild to moderate generalized symptom of not feeling well for 1/2 hour followed by sudden and rapid onset of perfuse sweating, feeling weak and off balance, and generalized symptom of feeling very poor. Husband and 6 friends were present and said that my facial color quickly disappeared. I felt nauseous and was helped to the bathroom as I felt too weak to walk and I vomited the dinner I had just eaten. At the same time I lost temporary control of my bladder and anal sphincter. I went home and immediately went to bed. I did not have any other episodes of vomiting or diarrhea. I felt weak in the morning but felt back to almost normal (90%) after breakfast and hot tea. I had normal bowel movements the next day and urine was clear.