chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Swelling, Vaccination site bruising
Clinical narrative: Area around vaccination is bruised and red. Advised pt to take ibuprofen for pain and swelling.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonia, Immediate post-injection reaction, Pallor
Clinical narrative: This child had a hypotonic, pale reaction immediately after her PEDIARIX, PEDVAXHIB, PREVNAR 13 and ROTATEQ. She was admitted to the hospital.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt reported outbreak of shingles 3 weeks after receiving the ZOSTAVAX vaccine. Pt is associating her outbreak to the vaccine.
Age: 35.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Cognitive disorder, Headache, Lymphadenopathy, Neck pain, Pain
Clinical narrative: Client developed fever, body aches, headache and experienced enlargement of the lymph nodes several hours after receiving MMR, TWINRIX and Tdap. Continues with neck aches, vision problems and cognitive difficulties, vertigo.
Age: 35.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Pyrexia, Vertigo, Visual impairment
Clinical narrative: Client developed fever, body aches, headache and experienced enlargement of the lymph nodes several hours after receiving MMR, TWINRIX and Tdap. Continues with neck aches, vision problems and cognitive difficulties, vertigo.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot number and route were not reported), expiration date 22-AUG-2014. Co-suspect and concomitant therapies were not reported. The certified medical assistant reported expired PNEUMOVAX was inadvertently administered to a patient on 16-OCT-2014. No adverse effects reported. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction, Vaccination site reaction
Clinical narrative: Local reaction about 3-4 cm posterior to vaccination site.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of arm from shoulder to right above elbow, heated and very painful for approximately 4 days of right arm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain
Clinical narrative: My doctor advised that I should have a shingles shot. I am 70 years old and had the shingles in November of 1998. So I said ok and got the shot on October 8, 2014. About 2 hours later after just getting home, my midsection tightened up into camp like feelings and pangs of pain and this is the same area generally that I had the shingles in 1998. These new feelings lasted for about 3 days and went away. On Wednesday, October 29, again the cramps and pain pangs developed in the same area and have stayed intermittently for 4 days including this day that I am reporting this. I have not been sick to me stomach, my bowel normal. normal appetite..... just have the cramping and pains.....I am male with diabetes and sometimes high blood pressure. My blood glucose and blood pressure haven't changed during these episodes.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Blood immunoglobulin E, Immune system disorder, Neuralgia, Pain
Clinical narrative: Two weeks after receiving a ZOSTAVAX vaccine, I developed a painful rash with pain and itching. I am seeing a dermatologist who even took biopsys. It seems my immune system is now working in over drive and I itch constantly. We have tried LYRICA for nerve pain and numerous lotions and creams to no avail. I am now schedule for a XOLAIR injection to try and calm my immune system down. Some of the rash present as almost shingles for and certainly mimicked the pain I have been told about. PATIENT NOTE: I had never had chicken pox but my mother had them when she was carrying me and since I was never able to catch them, I assumed I had the virus in my system so took the shot.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: Two weeks after receiving a ZOSTAVAX vaccine, I developed a painful rash with pain and itching. I am seeing a dermatologist who even took biopsys. It seems my immune system is now working in over drive and I itch constantly. We have tried LYRICA for nerve pain and numerous lotions and creams to no avail. I am now schedule for a XOLAIR injection to try and calm my immune system down. Some of the rash present as almost shingles for and certainly mimicked the pain I have been told about. PATIENT NOTE: I had never had chicken pox but my mother had them when she was carrying me and since I was never able to catch them, I assumed I had the virus in my system so took the shot.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Feeling hot, Headache, Induration, Pain
Clinical narrative: Swelling, hot, hard, painful, headache, elevated blood pressure, onset 2:10 pm 11/6/14. ER visit. Ice and pain med 1 tab NORCO 5/325, methylprednisolone 125mg IM.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling, hot, hard, painful, headache, elevated blood pressure, onset 2:10 pm 11/6/14. ER visit. Ice and pain med 1 tab NORCO 5/325, methylprednisolone 125mg IM.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a 5 year old patient. Medical history and concurrent conditions were not reported. The healthcare worker reported that patient was vaccinated with the first dose on 15-JUN-2004 and the second dose on 27-JUN-2008, of M-M-R II (dose, dose number, lot number, expiration date and route were not reported). The patient has not reported or demonstrated any adverse effects. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccine underdose in a 56-year-old female patient who received ENGERIX B (batch number AHBVC199AA, expiry date 5th February 2015). On an unknown date, the patient received ENGERIX B .5 ml. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. It was unknown if the reporter considered the vaccine underdose to be related to ENGERIX B. Additional information received: Per HCP, MA at facility has been administering 0.5 ml dose of ENGERIX B to adult patient. One patient has been identified, HCP believes there are several other patients.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of expired PNEUMOVAX 23 (lot # J004058; exp date: October 2014)(dose, frequency were not reported). No adverse symptoms were reported. The physician stated that the PNEUMOVAX 23 did not have any previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-OCT-2014 the patient was inadvertently administered a expired dose of ZOSTAVAX lot # J002241, expiration date 21-MAY-2014, subcutaneous, single dose. Does was not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reportd by a pharmacist and described the occurrence of drug dose administration intreval too short in a 43-year-old male patient who received HAVRIX adult (batch number PC527, expiry date 8th June 2015). Concomitant products included HAVRIX (adult). On 29th September 2014, the patient received the 2nd dose of HAVRIX adult. On 29th September 2014, an unknowntime after receiving HAVRIX adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the drug dose administration interval too short to be related to HAVRIX adult. Additional information: On 29 September 2014, the patient received a 1st dose of HAVRIX. On 29 September 2014, a 2nd dose of HAVRIX was given by mistake which led to maladministration "drug dose administration interval too short". The local recommendation was 6 to 12 months between the 2 doses.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test abnormal, Pharyngitis streptococcal, Pyrexia
Clinical narrative: This spontaneous report as received from a 55 year old female consumer with Th1 immune deficiency syndrome refers to herself. On 28-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J005071, expiry date: 19-JAN-2015 (also reported as 19-FEB-2015), dose and anatomical location was unknown). The reporter stated that the physician suggested this vaccine because her "Sil-R" levels were low and to boost her levels the vaccine was given. No concomitant medications were reported. Approximately on 04-SEP-2014 (reported as 1 week after vaccination) the patient experienced strep throat and low grade fever. No treatment was given for the events. The patient spoke to physician and sought medical attention. The event did not cause hospitalization or prolongation of hospitalization. The outcome of the events was reported as recovered/resolved. The causality was unknown. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received PEDIARIX (batch number 372DT, expiry date July 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to PEDIARIX. Additional details information received: Inadvertent administration of PEDIARIX to an 18 months. INFANRIX was meant to be given.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 13-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX (0.65 ml, frequency: single dose) (batch and lot # not provided) subcutaneous. On 13-OCT-2014, the patient received a second dose of ZOSTAVAX, after patient had received ZOSTAVAX two years earlier. No adverse effects were reported. The reporter declined to provide any patient identifying information. The patient called in to report that she filled out paperwork to receive a flu shot (name/dosage/manufacturer unknown) and she was accidentally given ZOSTAVAX. The outcomes of the events were unknown. The relatedness between the events and suspect drug was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-NOV-2013, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. The second dose was administered on 09-AUG-2014 and the third dose on 23-OCT-2014. Lot number and expiration date were not reported. No adverse effects reported. Additional information is not expected. No allowed to contact physician.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old male patient who received HAVRIX (batch number 793JR, expiry date February 2016). Concomitant products included HAVRIX and ENGERIX B. On 25th June 2014, the patient received the 2nd dose of HAVRIX. On 25th June 2014, an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too long. (Dechallenge was unknown). Rechallenge with HAVRIX was unknown. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the drug dose administration interval too long to be related to HAVRIX. Additional information: Per HCP, client was inadvertently given 2nd dose of HAVRIX too soon which led to maladministration.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 year old female patient (currently 7 years old). Medical history and concurrent conditions were not reported. In 2010 the patient was vaccinated with M-M-R II. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. Medical assistant reported that the patient received a dose on Measles vaccine (unspecified) and Rubella vaccine (unspecified) at about 1 years old on an unspecified date (approximately in 2008). Patient was not administered a mumps vaccine at about 1 year of age. Patient was then administered M-M-R II on an unspecified date in 2010. Vaccines were administered on a schedule outside of the prescribing information. No adverse events were reported. Additional information has been requested.
Age: 0.43
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of possible overdose in a 5-month-old male patient who received KINRIX (batch number 54L2R, expiry date 23rd September 2016). On 17th October 2014 13:00, the patient received KINRIX (injection) .5 ml. On an unknown date, an unknown time after receiving KINRIX, the patient experienced possible overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the possible overdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the possible overdose, inappropriate age at vaccine administration and wrong vaccine administered to be related to KINRIX. Additional information received: No adverse reactions were reported at time of report.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site discomfort
Clinical narrative: This spontaneous report was received from a pharmacist who is a 50 year (reported as currently in 50's) old female patient regarding herself. Patient's concurrent conditions included drug reactions/allergies to streptomycin. The patient's medical history included removal of lung lobe on an unspecified date when she was 22 years old due to pneumonic plaque. The pharmacist became indicated to receive PNEUMOVAX 23 as a result of her past medical history. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route unspecified). Concomitant medications were not reported. The pharmacist stated that she had received 3 doses of PNEUMOVAX 23 prior to her 65 birthday. The pharmacist stated that after her last dose of PNEUMOVAX 23 on an unspecified date in 2004 she had suffered from more joint pain than usual after receiving a dose of PNEUMOVAX 23. She stated that whenever she had received a PNEUMOVAX 23 vaccine in the past on unspecified dates there was always discomfort at the injection site and she would feel tired after receiving the PNEUMOVAX 23. The patient sought medical attention. No treatment was given for the events. The outcome of the events was reported as recovered/resolved on an unknown date. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received TWINRIX (adult) (batch number MF3X3, expiry date July 2014). On an unknown date, the patient received TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to TWINRIX adult. Additional information: The pharmacist administered an expired dose of TWINRIX which led to maladministration.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dry mouth, Feeling hot, Visual impairment
Clinical narrative: I felt dizzy, hot, dry cotton mouth. I saw little stars but then it got better.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient reports severe arm swelling to elbow. Pt said been taking oral BENADRYL. Advised to seek medical advice.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Muscle swelling, Peripheral swelling, Urticaria
Clinical narrative: Hives several hours after vaccine, arm and muscle swelling, took BENADRYL oral and cream, better now 11/7/14.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Diet refusal, Full blood count, Irritability, Pyrexia
Clinical narrative: Developed fever 3-4  hours after shots. Has persisted x 3 days. Had rash on torso, back, face, extremities (no hives). Has been very fussy and crying, but non-toxic. Doesn't want to nurse well.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Developed fever 3-4  hours after shots. Has persisted x 3 days. Had rash on torso, back, face, extremities (no hives). Has been very fussy and crying, but non-toxic. Doesn't want to nurse well.
Age: 1.01
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 23.0
Sex: M
Vaccine: JEV1
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient developed a headache on 10/22/14. On 10/29/14 he called to say that the headache got progressively worse, it was now severe, his neck was stiff and sore. When I returned the call, he was at an E.D. On 10/30/14 he reported feeling better.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients. On an unknown date the patients was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). On unspecified dates, that were exposed to temperatures outside the proper storage range. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients. On an unknown date the patients was vaccinated with VARIVAX (Merck) (strength, dose, frequency, route, lot # and indication were not provided). On unspecified dates, that were exposed to temperatures outside the proper storage range. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL, 0.5 ml, intramuscularly (dose number and lot# not reported). No adverse events were reported. The outcome of event was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 16 year old male patient. On 09-MAY-2014 the patient was vaccinated with GARDASIL dose 1, 05.5 milliliters, intramuscularly. On 01-JUL-2014, the patient received the second dose of and the third dose on 15-JUL-2014. The patient experienced no adverse effect. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had none of drug reactions/allergies. On 03-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # K006439, exp.date: 05-AUG-2015, 0.65 ml, subcutaneously (dose number not reported). On 04-NOV-2014, the patient experienced a red lump, with minor pain, approximately 3.5 inches in diameter at the injection site, after receiving ZOSTAVAX. Pharmacist also reported that patient experienced muscle soreness, in both shoulders. The patient sought medical attention and was seen by pharmacist. No treatment was given for events. The outcome of event "a red lump, with minor pain, approximately 3.5 inches in diameter at the injection site" was unknown. The outcome of event "muscle soreness, in both shoulders" was reported as recovered/resolved on 05-NOV-2014. The causality was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. A patient received her first dose of GARDASIL (strength, dose, frequency, route, lot # and indication were not provided) on 26-SEP-2009, and she received her second dose of GARDASIL (strength, dose, frequency, route, lot # and indication were not provided) on 05-DEC-2009. The patient was in Doctor's office on 29-OCT-2014, and she would be receive her third dose of GARDASIL (strength, dose, frequency, route, lot # and indication were not provided) on 29-OCT-2014. No adverse experience had been reported or demonstrated by the patient. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 year old patient. On 31-OCT-2014 the patient was vaccinated a dose of PROQUAD (Merck) (lot # unknown) 0.5 ml, intramuscular and VARIVAX (Merck) (lot # unknown) 0.5 ml, intramuscular. No adverse events were reported. It was unknown if the patient had sought medical attention. Action taken was not provided. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender not reported). Nurse reported that an unspecified patient was inadvertently administered PNEUMOVAX 23 (lot#, dose and route unknown) and PREVENAR 13 on the same unspecified date. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, lot number and indication not provided). On an unknown date, the patient experienced inflammation and a rash around the injection site after receiving the PNEUMOVAX 23 vaccine. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient, without drug reaction or allergies and no pertinent medical history or current conditions reported. On 15-OCT-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, lot # K008881, expiration date 20-SEP-2015, subcutaneous in the right arm (deltoid). Concomitant therapy was not reported. On 17-OCT-2014, the patient who received the ZOSTAVAX experienced redness, swelling and heat at her injection site. The patient was unaware that she had any injection site reaction, but someone else noticed some redness on her arm. The patient told the pharmacist that the person asked her about the redness on her arm, and then she felt the injection site and noticed that it was swollen and warm. The patient did not sought any medical attention for the injection-site symptoms, so the seriousness criteria questions were not asked. No treatment was given for the adverse events. Varicella Zoster Virus Identification Program (VZVIP) offered to the pharmacist because the patient received ZOSTAVAX "two days ago," thought the patient was not exhibiting a rash. VZVIP packet was accepted by the pharmacist, and VZVIP packet would be faxed to the pharmacist. The outcome of a patient who received ZOSTAVAX experienced redness, swelling and heat at her injection site was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Rash generalised
Clinical narrative: Patient got shingles (rashes) on body 3 days after receiving vaccination. She is currently being treated with Acyclovir 800mg and PERCOCET 5/325.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Mass, Pruritus, Skin warm
Clinical narrative: Swollen, red circle that is itchy and warm to the touch. When touched it is soft like edema and is hooved up like a lump. Started 1 day after vaccination, pt. taking BENADRYL which helps-pt. said she is getting better.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blood pressure fluctuation, Blood test, Contraindication to vaccination, Culture
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a 63 year old male patient. Pertinent medical history and drug reactions/allergies were unspecified. On 18-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date unspecified) one shot (route: injection). Concomitant medication was unspecified. On 19-OCT-2014, patient woke up with rash/blisters. On 20-OCT-2014, the patient was admitted to a hospital for 5 days (location unknown). On 25-OCT-2014, when patient was discharged, the diagnosis was cellulitis (hospitalization and disability). Patient was treated with unspecified pain medicine and sought medical attention. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Dizziness, Drug administered at inappropriate site, Haemorrhage, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a 63 year old male patient. Pertinent medical history and drug reactions/allergies were unspecified. On 18-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date unspecified) one shot (route: injection). Concomitant medication was unspecified. On 19-OCT-2014, patient woke up with rash/blisters. On 20-OCT-2014, the patient was admitted to a hospital for 5 days (location unknown). On 25-OCT-2014, when patient was discharged, the diagnosis was cellulitis (hospitalization and disability). Patient was treated with unspecified pain medicine and sought medical attention. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Rash pustular, Skin exfoliation, Swelling
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a 63 year old male patient. Pertinent medical history and drug reactions/allergies were unspecified. On 18-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date unspecified) one shot (route: injection). Concomitant medication was unspecified. On 19-OCT-2014, patient woke up with rash/blisters. On 20-OCT-2014, the patient was admitted to a hospital for 5 days (location unknown). On 25-OCT-2014, when patient was discharged, the diagnosis was cellulitis (hospitalization and disability). Patient was treated with unspecified pain medicine and sought medical attention. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wound
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a 63 year old male patient. Pertinent medical history and drug reactions/allergies were unspecified. On 18-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date unspecified) one shot (route: injection). Concomitant medication was unspecified. On 19-OCT-2014, patient woke up with rash/blisters. On 20-OCT-2014, the patient was admitted to a hospital for 5 days (location unknown). On 25-OCT-2014, when patient was discharged, the diagnosis was cellulitis (hospitalization and disability). Patient was treated with unspecified pain medicine and sought medical attention. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Cellulitis, Rash
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a 63 year old male patient. Pertinent medical history and drug reactions/allergies were unspecified. On 18-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date unspecified) one shot (route: injection). Concomitant medication was unspecified. On 19-OCT-2014, patient woke up with rash/blisters. On 20-OCT-2014, the patient was admitted to a hospital for 5 days (location unknown). On 25-OCT-2014, when patient was discharged, the diagnosis was cellulitis (hospitalization and disability). Patient was treated with unspecified pain medicine and sought medical attention. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a 63 year old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. On 28-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, one single shot, lot # K009199, subcutaneously (dose number, site of injection, expiration date unknown). On 30-OCT-2014, the patient experienced a red marked area about 3 inches wide with a slight blister at the injection site. The outcome of the adverse events was reported as not recovered/not resolved. Relatedness between vaccination with ZOSTAVAX and the adverse events was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a 63 year old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. On 28-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX, one single shot, lot # K009199, subcutaneously (dose number, site of injection, expiration date unknown). On 30-OCT-2014, the patient experienced a red marked area about 3 inches wide with a slight blister at the injection site. The outcome of the adverse events was reported as not recovered/not resolved. Relatedness between vaccination with ZOSTAVAX and the adverse events was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Emotional distress, Feeling hot, Insomnia, Pyrexia, Urticaria
Clinical narrative: Started getting hives then on 11/6/2017 hot a 102.5 fever. 11/7/2017 became hard to console and would not sleep, stayed up all night.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: I do know that it was about a month ago and that my symptoms began that night. There was nothing unusual about the actual shot. If course it hurt but no worse than any other. There was no muscle tenderness or knot at the injection site. That night in bed, the pain in my joint woke me out of my sleep. I could not move my arm or lie on it. The next morning I could not extend my arm past my bday more than 3-4 inches without experiencing excruciating pain. I took ibuprofen and later could move my arm more but not much without pain. Touching my shoulder and even pushing on it does not hurt but it is like engaging the joint is where the pain comes from. A month later it is somewhat better but still there. I can't wait for a morning when I wake up and can move my arm without this pain! I am otherwise healthy and active person and it is very frustrating to all of a sudden feel so feable and elderly because I took a shot basically forced on my by my job.
Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Burning sensation, Erythema, Rash, Skin warm, Swelling
Clinical narrative: Rash, burning, spot about 2 inches by 2 inches red raised hot to touch.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Swelling, Tenderness, Urticaria
Clinical narrative: Swelling, tenderness, welts, pain at injection site and 15 cm surrounding area.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Intussusception, hospitalized til 7/3/14, air enema to treat.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Pain at injection site with itching, redness and mild inflammation in a 15 cm area. Treated with warm packs to site and injection Depomedrol 40 mg IM times one.
Age: 0.65
Sex: M
Vaccine: DTAP
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Entire shoulder very painful; cannot apply ice. Limited movement.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Feeling abnormal, Hot flush
Clinical narrative: Hot flashes redness fuzzy feeling dizziness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Oropharyngeal pain, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Throat became very sore & swollen, hard to swallow. Extreme aches, fever. This lasted about 8 or 9 hours. I did not call 911 or seek treatment, but slept fitfully due to throat swelling. Thought I should report the throat swelling, as it isn't among the most common reactions. I've never had a reaction to a flu shot before.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Reports fever 101.5. Left upper arm with mild swelling, mild erythema.  No drainage from injection site. Tender to palpation.  No ecchymosis or streaking noted. Diagnosed cellulitis left upper arm. Treatment includes course of abx, Keflex 500mg 1 tid x10days and Tylenol Extra Strength 500mg 1 tid prn.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: Left eye twitching and occasionally left cheek and above lip. Has occurred past three years after flu shot. Usually last about 1 month.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Infection, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Received the flu vac on 11/5/2014 around 11 am. Complained of pain throughout the day and by 8 pm had a dime sized red mark at the site. On 11/06/2014 patient had a quarter sized bright red circle around her vaccination site at 8am It was painful and warm to the touch. It grew in size throughout the day but not substantially. On the morning of 11/07/2014 the bright red area was the size of a softball with a quarter sized circle that was brownish inside of it. There was a deep red line all the way around the big circle, still painful and warm to the touch. Patient was taken to the pediatrician who diagnosed her with cellulitis from the vaccination, she was put on antibiotic. She is still infected and the antibiotics are not finished. Dr follow up is required to make sure the infected area doesn't get a pus-filled pocket.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Asthenia, Central nervous system inflammation, Cytomegalovirus test negative, Enterovirus test negative, Epstein-Barr virus test negative
Clinical narrative: Child woke up unable to bare weight on her lower extremities which later progressed to upper body weakness with a diagnosis of transverse myelitis.  Residual paralysis remains present two months later.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes simplex serology negative, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal, Paralysis, Weight bearing difficulty
Clinical narrative: Child woke up unable to bare weight on her lower extremities which later progressed to upper body weakness with a diagnosis of transverse myelitis.  Residual paralysis remains present two months later.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: Pt developed rash at site of injection, complained of itching.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Computerised tomogram, Cough
Clinical narrative: Coughing for 16 days no coughing at night but would cough non uncontrollably all day till exhaustion falling asleep at night. No medication relieved cough at all. Breathing treatments no effective. After 4 MD visits went to naturalist was given essential oils that stopped cough within the hour.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Pain in extremity, Productive cough
Clinical narrative: Patient stated that 2-3 hours after vaccine was administered he developed swelling around the eyes, a productive cough and a lot of pain in the arm the vaccine was administered.  He said symptoms lasted for 2-3 hours from the time that the symptoms started.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: THE INJECTION SITE WAS RED, SWOLLEN, AND LUMPY. PATIENT FELT MODERATE PAIN WHEN TOUCHED IT.
Age: 43.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP, YF
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Reports severe bilat upper arm pain w/ limitation on ADLs and ROM;  some relief w/ application of heat; pain initially 8/10; now reports chronic pain ~ 3/10;  patient did not contact the office about this problem - learned of issue when she returned for follow up care on 11/8/2014.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Body temperature increased, Chills, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Patient felt runny nose and sore throat coming on. By 3:30pm, patient was vomiting, had chills, 101 degree temperature, achy arms and hurt everywhere.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Patient felt runny nose and sore throat coming on. By 3:30pm, patient was vomiting, had chills, 101 degree temperature, achy arms and hurt everywhere.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Neuralgia, Pain, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Fever lasting 5-6 days; body aches; red, bumpy rash; nerve pain in arm beginning 1 week after vaccine and lasting to present.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Reaction at injection site: patient experienced redness, warm to touch, itching, and pain, and a hard knot. Headache. No treatment reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Reaction at injection site: patient experienced redness, warm to touch, itching, and pain, and a hard knot. Headache. No treatment reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Patient called to say she went to emergency room because of severe pain in arm. Says DX may be tendonitis. Will be seeing other doctors.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Skin irritation, Urticaria
Clinical narrative: Itchy hives and rash to both underarms, sides of torso. Spreading to belly and arms. I took 25 mg Benadryl and it helped. Then, 10 hours later, I was itchy again and noticed hives on the lower part of my torso, spreading on my legs. I took 25 mg Benadryl but it did not help, so I took another 50 mg after about 90 mins. Still stayed itchy and irritated, I took Zyrtec 10 mg. Next morning no hives, but a lingering rash. I have never had hives before in my life prior to this. I am a nurse and received the flu shot at work (mandatory for my job).
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Difficulty breathing, wheezing.  Albuterol nebulizer 3 times over the course of next 12 hours.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Significant local reaction, swelling, erythema, warmth, and inability to move R arm. Vaccine was given in the R deltoid.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Unusual pain in arm immediately upon vaccine administration; arm pain continued to gradually worsen each day; pt reporting can hardly use arm 11/8/2014.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein, Chills, Headache, Liver function test, Muscle spasms
Clinical narrative: Muscle aches, severe cramping, headache, fever of 103.0*F without relief with Tylenol, chills, nausea.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches, severe cramping, headache, fever of 103.0*F without relief with Tylenol, chills, nausea.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Severe local reaction including swelling, heat under skin and soreness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Extreme redness, large area, hard, hot, itchy, pins and needles feeling on site. Still have a distinct mark.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Extreme redness, large area, hard, hot, itchy, pins and needles feeling on site. Still have a distinct mark.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Alopecia, Asthenia, Blood test, Cough, Dysphonia
Clinical narrative: Sore Throat, Headaches, Fever, Fatigue, Aches, Coughing, Hoarseness, Itching, Weakness and Hair Loss.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: Sore Throat, Headaches, Fever, Fatigue, Aches, Coughing, Hoarseness, Itching, Weakness and Hair Loss.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia, X-ray
Clinical narrative: Sore Throat, Headaches, Fever, Fatigue, Aches, Coughing, Hoarseness, Itching, Weakness and Hair Loss.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pronounced swelling, redness, heat and hardness at the site of the injection.
Age: 5.0
Sex: F
Vaccine: FLUN4, TYP
Symptoms: Arthralgia, Blood creatinine normal, Blood test normal, Gait disturbance, Pain
Clinical narrative: Pink-red spots on legs and buttocks, painful to touch but not itchy.  Some pain while walking.  Went to ER - suspect Henoch-Schonlein Purpura (HSP).  Next day, (11/08/2014) spots looked better (had turned purple color) and in the PM, new sudden pain in ankles and feet that made walking painful, along with new pink-red spots on feet.  Gave ibuprofen.  Seemed to get better over a couple of hours.  Still keeping an eye on her.  Of note - she had a cough during the week before the spots, and continues to have cough on occasion.  Otherwise healthy (no fever, eating fine, active, urination and bowel movements ok).
Age: 5.0
Sex: F
Vaccine: FLUN4, TYP
Symptoms: Pain in extremity, Platelet count normal, Rash erythematous
Clinical narrative: Pink-red spots on legs and buttocks, painful to touch but not itchy.  Some pain while walking.  Went to ER - suspect Henoch-Schonlein Purpura (HSP).  Next day, (11/08/2014) spots looked better (had turned purple color) and in the PM, new sudden pain in ankles and feet that made walking painful, along with new pink-red spots on feet.  Gave ibuprofen.  Seemed to get better over a couple of hours.  Still keeping an eye on her.  Of note - she had a cough during the week before the spots, and continues to have cough on occasion.  Otherwise healthy (no fever, eating fine, active, urination and bowel movements ok).
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient states arm was extremely sore and hurt to move with radiating pain to shoulder and back. Patient still experiencing pain about 20 days after the vaccine. Patient states she was going to urgent care to be checked out.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states arm was extremely sore after receiving vaccine about 10-13 days before it was feeling better. Pt. states arm felt numb and was difficult to move and perform activities.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Insomnia, Pyrexia, Retching
Clinical narrative: Dry heaving. Decreased appetite. Insomnia. Fever (99.6 degrees). Pt. is increasing fluids as tolerated.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: The day after the injection, pt's arm turned black and blue from shoulder to elbow. Cold compress. Pt refused to see Dr. Condition resolved on its own.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: About 2 to 2 1/2 hrs after injection, pt got hives on waist and about 3 hrs after, hives were also all over chest.