chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Pruritus, Rash, Vomiting
Clinical narrative: Coughing 10 min after admin. Vomiting 15-20 min after admin. Itching 30 min after. Rash 30 min after (widespread).
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: 6 mm x 5 mm hot to touch, hard tender skin and tender when touched.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Sore arm, redness at the injection site with pain. Flu-like symptoms. MD visit required which resulted in antibiotic prescribed.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Laboratory test, Pain in extremity
Clinical narrative: Sore arm, redness at the injection site with pain. Flu-like symptoms. MD visit required lab works done. Systemic in reaction diagnosed. Antibiotics required.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Immediately after giving vaccines, both thighs developed red area 4" by 3" to right thigh 3" by 3" to (L) thigh - both areas warm to touch. 12:50 PM - (L) thigh resolved. Called Mom 2 hrs. later, redness resolved.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cyanosis, Eczema, Hypokinesia, Irritability, Opisthotonus
Clinical narrative: 48 hrs after vaccination, patient had just finished breast feeding. Mother was burping him and he went still and turned blue. It lasted for approx. 1 min. Mother hit his back several times and he returned to himself. This occurred on a weekend. Mother did not call until 2 days later and he was seen then. Has had back arching fussiness since. Mother also insists eczema due to vaccines.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin burning sensation
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 55-year-old female patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. On 20th February 2018, 14 days after receiving SHINGRIX, the patient experienced shingles, rash and burning skin. The patient was treated with VALTREX and triamcinolone. On an unknown date, the outcome of the shingles, rash and burning skin were not recovered/not resolved. It was unknown if the reporter considered the shingles, rash and burning skin to be related to SHINGRIX. Additional details were provided as follows: The physician reported that after receiving a dose of SHINGRIX the patient developed an active shingles infection. The physician did not have the lot or expiry date for the SHINGRIX given, it was given at a pharmacy. The patient was treated with VALTREX 1 gm TID and triamcinolone cream.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Chills, Cold sweat, Disorientation, Dizziness, Feeling abnormal
Clinical narrative: Per phone note dated 02/28/18: cold sweats, feeling disoriented, having trouble lifting his arms due to very sore at injection sites. Started a few hours after vaccines were given. Still feeling off that morning. Headache, feels dehydrated but drinking water. Was dizzy, improved w/water intake. Cold sweats resolved. 02/28/2018 - Office visit. 29 year old Male comes in today c/o chills fever sweat after having the vaccines Flu vaccine Tdap and PNEUMOVAX yesterday he thinks he had reaction to the shots. L upper arm painful to raise beyond 90 degrees has not taken temp but has felt feverish, chilled, sweaty. Got Tdap R deltoid, Flu and pneumococcal V23 L deltoid.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: Per phone note dated 02/28/18: cold sweats, feeling disoriented, having trouble lifting his arms due to very sore at injection sites. Started a few hours after vaccines were given. Still feeling off that morning. Headache, feels dehydrated but drinking water. Was dizzy, improved w/water intake. Cold sweats resolved. 02/28/2018 - Office visit. 29 year old Male comes in today c/o chills fever sweat after having the vaccines Flu vaccine Tdap and PNEUMOVAX yesterday he thinks he had reaction to the shots. L upper arm painful to raise beyond 90 degrees has not taken temp but has felt feverish, chilled, sweaty. Got Tdap R deltoid, Flu and pneumococcal V23 L deltoid.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Breath holding, Eye movement disorder, Hypotonia, Inappropriate schedule of drug administration, Musculoskeletal stiffness
Clinical narrative: Patient given 6 month-old Immunization on a delayed scheduled. While being given the vaccinations, eyes rolled back, stiffened, held breath, went  limp-lasting a couple of minutes; after 20 minutes of observation was back to baseline. This was the first of two similar reactions. The other patient was a 2 month-old who had a similar reaction.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eye movement disorder, Hypotonia, Pallor
Clinical narrative: Patient given 2 month-old immunizations - while being given the vaccinations, eyes rolled back, went limp, pale - lasted a few minutes, by 20 minutes of observation was back to base line. This is our second similar episode - the first was in a 6 month old receiving PEDIARIX/HIB/PREVNAR.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection area on right thigh was red, swollen and hard. Instructed to apply ice pack. Called on 3/5/18 and the mother said the swelling went down. Just a small hard area Left, coloring looks like when a bruise starts to heal.
Age: 1.58
Sex: M
Vaccine: HEPA, IPV, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria 3-4 hours after vaccine (IPV, PREVNAR and Hep A) No respiratory prob - no vomiting; no pallor. BENADRYL oral give office ->outpatient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site discomfort and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site discomfort and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was contacted by the pharmacy technician on Friday 23rd February 2018 to know that a patient who was also a nurse had a written prescription for SHINGRIX and got it filled at the Pharmacy. The patient took the vaccine offsite to have a friend that was a nurse administer the vaccine to her. There was no information on how the patient stored the vaccine or how long after picking up the vaccine it was administered. On 23rd February 2018 the patient called the pharmacy back complaining that she was having a reaction consisting of a three inch red circle around the injection site with some pain or discomfort. She wanted to check and see if that was a normal reaction. The pharmacy also did ask her to follow up with her physician as well. Upon speaking with the pharmacist on Friday February 23rd he informed the GSK vaccine account manager that the patient had SHINGRIX administered in the gluteus. The vaccine account manager reviewed proper dosing and administration, storage and handling for SHINGRIX with the pharmacist and contacted a medical science liaison to follow up with the pharmacy.
Sex: M
Vaccine: FLUC4
Symptoms: Impaired work ability, Influenza, Vaccination failure
Clinical narrative: This spontaneous case, reported by physician and initially received on 22-Feb-2018, concerns a male patient of unspecified age. The patient's relevant medical history was not reported. On 19-Jan-2018, the patient was vaccinated with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018 (reported as Jun-2018), dose, route of administration and anatomical location: not reported) (considered as vaccination failure). On an unspecified date in Feb-2018, after vaccination, the patient experienced flu. Reportedly as per the 'MD note', the patient stated that 'he needs to be out of work due to the flu'. The outcome of the event was not reported.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Influenza like illness, Malaise, Sinus congestion, Vaccination complication
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of vaccination adverse reaction in a 65-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included FLOVENT 110 inhaler (batch number BG8J, expiry date December 2018) for asthma. The patient's past medical history included blood pressure. Concomitant products included Losartan and VENTOLIN HFA. In November 2017, the patient received Influenza vaccine Quadrivalent. In 2010, the patient started FLOVENT 110 (inhaled) 2 puff(s) twice daily (4 puff(s) daily). In November 2017, less than a month after receiving Influenza vaccine Quadrivalent and not applicable after starting FLOVENT 110, the patient experienced vaccination adverse reaction, influenza-like symptoms, sinus congestion, unwell and tiredness. FLOVENT 110 was continued with no change. In December 2017, the outcome of the vaccination adverse reaction, influenza-like symptoms, sinus congestion, unwell and tiredness were recovered/resolved. It was unknown if the reporter considered the vaccination adverse reaction, influenza-like symptoms, sinus congestion, unwell and tiredness to be related to Influenza vaccine Quadrivalent. It was unknown if the reporter considered the influenza-like symptoms, sinus congestion, unwell and tiredness to be related to FLOVENT 110. Additional details were provided as follows: The patient was transferred from the GlaxoSmithKline patient assistance program to report the above symptoms that the patient believes were caused by her flu shot that she received at her local pharmacy. She did not believe these symptoms were caused by FLOVENT received in 2010.
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Diarrhoea, Headache, Pain in extremity, Vomiting
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX. Co-suspect products included Pneumococcal vaccine. On 31st January 2018, the patient received SHINGRIX. On an unknown date, the patient received Pneumococcal at an unknown dose. On 1st February 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm and headache. In February 2018, the patient experienced vomiting, diarrhea and bedridden. On an unknown date, the outcome of the pain in arm, headache, vomiting, diarrhea and bedridden were unknown. It was unknown if the reporter considered the pain in arm, headache, vomiting, diarrhea and bedridden to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient received Pneumococcal vaccine at different site on body. In 2018, less than a week after vaccination, the patient experienced vomiting, diarrhea and was ended up being bedridden. The patient was fine at the time of reporting, but was concerned whether to received the 2nd dose. All the events were lasted for about 5 days. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Influenza like illness, Rash, Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 83-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma and RA. Concomitant products included CRESTOR, Folate, MgO, Vitamin C, vitamin d, valsartan, Omega-3, RESTASIS, ORENCIA, AZOPT, latanoprost, MINIVELLE, SYNTHROID, trazodone, Coq10 and selegiline. On 23rd January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced erythema, influenza like illness, dry skin, skin irritation and rash. On an unknown date, the outcome of the erythema, dry skin, skin irritation and rash were not recovered/not resolved and the outcome of the influenza like illness was recovered/resolved. The reporter considered the erythema, influenza like illness, dry skin, skin irritation and rash to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Less than a month after receiving vaccination, the patient had some mild flu-like symptoms initially, but they resolved after a few days. Several weeks later the patient noticed red streaks on her face going down in two lines from her nostrils towards her mouth and extending out towards her cheeks. At first the patient thought her skin was dry and irritated, but it had not improved in the past 3 to 4 weeks that she had been experiencing this. The patient described it as rash, but it was not raised or bumpy, and does not itch or peel. It was just like a bad sunburn, but it does not hurt. She thought it was spreading in area, going more toward nostrils and her cheeks, but had not changed in color.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia
Clinical narrative: Within 2 weeks of 3rd dose of HPV vaccine patient has experienced insomnia.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Angiotensin converting enzyme, Antibody test negative, Asthenia, Balance disorder, CSF test normal
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Cerebral venous thrombosis, Cervical radiculopathy, Coagulation test, Computerised tomogram head abnormal, Confusional state
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Culture negative, Diplopia, Disturbance in attention, Haematology test normal, Headache
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Injection site pain, Loss of personal independence in daily activities, Lumbar puncture, Mental status changes, Musculoskeletal stiffness
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Nausea, Noninfective encephalitis, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Polymerase chain reaction, Scan with contrast, Serology negative, Speech disorder, Subdural effusion
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: VIth nerve paralysis, Venogram, Vomiting
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Allergy to vaccine, Asthenia, Cerebral venous thrombosis, Confusional state, Headache
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Nausea, Paralysis, VIth nerve paralysis, Vomiting
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Unevaluable event
Clinical narrative: After a routine administration of influenza vaccine on 12/7/2017, patient called to report extreme headache, nausea, and vomiting. Patient presented to the Emergency Department on 12/25/2017 with severe headache, weakness, confusion, and nerve palsy. Patient was transferred to a larger medical facility and was found to have cerebral vein thrombosis with complications. Patient was hospitalized for a week and faces long recovery.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 26th February 2018, the patient received SHINGRIX (subcutaneous) .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site discomfort and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site discomfort were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema, injection site warmth and injection site discomfort to be possibly related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a doctor. The nurse at facility stated that the patient experienced the events with latency of less than a week after vaccination and returned on the reporting date with large red area, discomfort and hot to touch. She stated that the area was on the lower right deltoid and posterior. She noted it appeared the vaccination was given possibly subcutaneously based on the injection site and the location of the events, although documented as intramuscular in the right deltoid. Thus, it led to potential inadvertent administration of intramuscular formulation by other route. An emergency visit was required. This nurse's call was transferred to Medical Information System (MIS).
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 26th February 2018, the patient received SHINGRIX (subcutaneous) .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site discomfort and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site discomfort were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema, injection site warmth and injection site discomfort to be possibly related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a doctor. The nurse at facility stated that the patient experienced the events with latency of less than a week after vaccination and returned on the reporting date with large red area, discomfort and hot to touch. She stated that the area was on the lower right deltoid and posterior. She noted it appeared the vaccination was given possibly subcutaneously based on the injection site and the location of the events, although documented as intramuscular in the right deltoid. Thus, it led to potential inadvertent administration of intramuscular formulation by other route. An emergency visit was required. This nurse's call was transferred to Medical Information System (MIS).
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Previously administered products included SHINGRIX (1st dose received on an unknown date, without any adverse event). On 26th February 2018, the patient received the 2nd dose of SHINGRIX. On 26th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling and injection site pain to be related to SHINGRIX. Additional information was received as follows: On 28th February 2018, the patient returned to the pharmacy and reported that the pain was getting increasingly worsened and not improving. The patient did not require any hospitalization, medical intervention and visit to the physician. The batch number reported for SHINGRIX (324KL), did not exist and was updated to 3Z4KL, as per Sales database.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Previously administered products included SHINGRIX (1st dose received on an unknown date, without any adverse event). On 26th February 2018, the patient received the 2nd dose of SHINGRIX. On 26th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling and injection site pain to be related to SHINGRIX. Additional information was received as follows: On 28th February 2018, the patient returned to the pharmacy and reported that the pain was getting increasingly worsened and not improving. The patient did not require any hospitalization, medical intervention and visit to the physician. The batch number reported for SHINGRIX (324KL), did not exist and was updated to 3Z4KL, as per Sales database.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Injection site urticaria, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Sweats and headache and had about a dozen red nickel size spots that do not itch. Whole arm sore. Spots developed into a welt treated with BENADRYL, TYLENOL, oral fluids.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tremor
Clinical narrative: Sweats and headache and had about a dozen red nickel size spots that do not itch. Whole arm sore. Spots developed into a welt treated with BENADRYL, TYLENOL, oral fluids.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Rash erythematous, Urticaria
Clinical narrative: Sweats and headache and had about a dozen red nickel size spots that do not itch. Whole arm sore. Spots developed into a welt treated with BENADRYL, TYLENOL, oral fluids.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: I was given the PNEUMOVAX vaccine at the Health Care Facility and developed cellulitis due to improper sterility of the facility. It is suspected the nurse either did not clean the injection site properly or the facility has deficiencies in cleanliness or the injection itself was somehow compromised.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Bacterial test positive, Cellulitis, Inadequate aseptic technique in use of product
Clinical narrative: I was given the PNEUMOVAX vaccine at the Health Care Facility and developed cellulitis due to improper sterility of the facility. It is suspected the nurse either did not clean the injection site properly or the facility has deficiencies in cleanliness or the injection itself was somehow compromised.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, fatigue.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Anaemia, Blood count abnormal, Full blood count abnormal, Systemic lupus erythematosus
Clinical narrative: Abnormal blood counts, CBC, anemia followed by diagnosis of Lupus SLE. Several months after receiving HP4 #3 dose my daughter developed abnormal blood counts and anemia which later led to a diagnosis of Lupus SLE.
Age: 1.0
Sex: F
Vaccine: FLUX, MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Fever. Measles-like rash.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse and refers to an unspecified amount of unspecified patients of an unknown age and gender. Patients medical history, concurrent conditions and concomitant therapies were not reported. From 21-OCT-2017 to 30-NOV-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N013863, expiration date 31-OCT-2018 and VARIVAX lot # N010107, expiration date 18-MAR-2019, for prophylaxis (doses, routes, routes of administration and anatomical locations were not reported for any vaccine). The administered dose of the vaccines experienced a temperature excursion 6 to 14 degrees Fahrenheit for 2 hours, as recorded by a data logger. The sterile diluent was stored properly. No adverse effects were reported. Albumin status for PROQUAD lot number N013863 is rHA. Follow-up information was received on 02-MAR-2018. An inbound call was received from the registered nurse who informed that there was a temperature excursion for the past 30 minutes. No further information was available. Sender's Comments: US-009507513-1712USA001796.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as a nurse) referring to an unspecified number of patients of unknown age and gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patients involved were not reported. The medical assistant reported that on unspecified date, the patients were vaccinated with improperly stored doses of PROQUAD (rHa) lot # N019827 (expiration date: 09-JAN-2019) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. Temperature and time frame: 15 F to 46 F (15.5F) for 24 hours. Previous temperature excursion: 6 F to 14 F (7.1F) for 54 minutes. No adverse events were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from the reporter referring to a currently 1 year old female patient on 20-FEB-2018. On 25-JAN-2018 (previously reported as an unknown date), the patient was vaccinated with PROQUAD (rHa) (lot # N019827, expiration date of 09-JAN-2019, strength, dose and frequency were not reported) intramuscularly for prophylaxis. The other suspect therapies included PENTACEL (lot# C5296AB, expiration date, strength, dose and frequency were not reported) (previous vaccinated doses was one) and pneumococcal 13v conj vaccine (CRM197) (lot# S43262, expiration date, strength, dose and frequency were not reported) (previous vaccinated doses was three) both intramuscularly for prophylaxis.
Sex: U
Vaccine: HEP, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number and expiration date unknown), RECOMBIVAX HB (lot number and expiration date unknown) and M-M-R II (lot number and expiration date unknown) for prophylaxis. Nurse also reports it is not certain if the sterile diluent (lot number & expiration date unknown) used to reconstitute M-M-R II underwent a temperature excursion. Temperature and time frame was unknown by reporter. There was no previous temperature excursion involved. No adverse effects reported in any patients. No further information provided. The call was because of a data logger. Follow up information has been received from the Registered Nurse on 19-FEB-2018 regarding the case mentioned above. The reporter called back and mentioned that the M-M-R II that was administered had been maintained in recommended temperature, and had not experienced a temperature excursion. Therefore, the vaccines that underwent a temperature excursion were GARDASIL 9 and RECOMBIVAX HB. The temperature excursion and time frame for both vaccines was between 32F to 35F for a cumulative time of 111 hours.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse refers to a 21 year old non-female patient. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as "no". On 19-JAN-2018, the patient was vaccinated with 3rd dose of GARDASIL 9 (dose, unit and frequency not reported) (expiration date: 28-APR-2018 and lot number: M019923) intramuscularly in the left deltoid for the prevention of human papilloma virus. On 26-JAN-2018 (1 week later), patient was seen at the office because she developed a 2 cm lump that is painful to the touch at the injection site. Nurse reports that during that office visit the Physician determined that the lump was an injection site reaction, no induration, no erythema and no rash present. It was reported that no lab tests or studies were performed. The patient was treated for the events. Nurse reports that patient was treated with ice, heat and Ibuprofen (manufacturer unknown) without relief. Patient continues to follow-up with Physician for further unspecified treatment. The outcome of the events was reported as not recovered/not resolved.  Causality of the events was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 4-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 29-OCT-2014, at the age of 1 year, the patient was vaccinated with a dose of M-M-R II. On 29-JAN-2015, the patient received a dose of VARIVAX. On 18-OCT-2017 and 15-FEB-2018, the patient was vaccinated with doses of PROQUAD. Doses, lot numbers and expiration dates were not reported for any of the vaccines. No adverse symptoms were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. Information on pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced swelling, soreness and erythema at the injection after receiving PNEUMOVAX 23. The outcome of injection site swelling, injection site erythema and injection site pain were unknown. Causality assessment between the events and the PNEUMOVAX 23 was not reported. Product quality complaint not involved.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This Spontaneous report was received from a supervisor referring to a male patient of unknown age with medical history of non-Hodgkin's lymphoma, chemotherapy. Also, the patient's concurrent conditions included immune system disorder (reported as immune-compromised). There was no information about the patient's concomitant therapies. On 19-FEB-2018, the patient was vaccinated with ZOSTAVAX, injection, 1 dose in the left arm for prophylaxis, lot# N020939 with expiration date of 26-OCT-2018; (strength, frequency, and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). The patient reported that after he went home and read the package insert he realized that he was given ZOSTAVAX instead of SHlNGRIX. Also the patient stated that he was concerned because 10 years ago he had received chemotherapy to treat non-Hodgkin's lymphoma and his treating doctor told him not to get ZOSTAVAX. The patient signed the consent form for the ZOSTAVAX, but he assumed consent was for SHINGRIX. At the reporting time, the patient had not reported any side effects.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 57-year-old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with PROQUAD (albumin status was not provided) lot # N019251 with an expiration date 20-DEC-2018, subcutaneously for prophylaxis (anatomical location was not reported). Concomitant therapies included sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, third dose, lot # N004815 with expiration date on 07-OCT-2018. The vaccine underwent a temperature excursion of 51.8 degrees Fahrenheit for 55 minutes. Digital Data Logger was used in the recording of the excursion. No previous temperature excursions were reported. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 22-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU vial, lot # M041669; expiry date 09-JAN-2018, subcutaneously. No information regarding sterile diluent (STERILE DILUENT) was provided. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT) No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX)(lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fall, Intensive care, Loss of consciousness, Lung infection, Malaise
Clinical narrative: This spontaneous report was received from a 59 year old female patient, who was reporting on herself. The patient's concurrent condition included gastroparesis, type 1 diabetes and allergies to tetracyclines. On an unknown date in December 2017 (reported as "about two months ago"), the patient was vaccinated with PNEUMOVAX 23 and unspecified influenza virus vaccine (dose, route of administration, lot # and expiry date date were not reported for both). The patient's concomitant medications included unspecified medications. On an unknown date in 2018 (reported as 3 weeks later), the patient became sick with a lung infection and pneumonia. On an unknown date, she was admitted to the emergency room at hospital and was treated by physicians. On an unknown date in 2018, in hospital a X-Ray was performed (result was not provided). The patient was released from the hospital after 3 to 4 days of care and given prescription for unspecified antibiotics. On an unknown date in February 2018 (reported as "seven hours after she was released from that hospital), the patient stopped breathing, fell unconscious and was admitted to another hospital. The patient was resuscitated, tubed, experienced two blood clots (unspecified), and was treated for lung infection and pneumonia. The patient said she was in the intensive care unit for two weeks and was released on 19-FEB-2018. At the time of the report, the patient was in in-patient hospital where she was still receiving treatment. The patient said that she was improving and breathing on her own with oxygen but she was still very sick. The causality assessment was not provided. Upon internal review, the events of lung infection, stopped breathing, fell unconscious and thrombosis were considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pneumonia, Respiratory arrest, Resuscitation, Thrombosis, X-ray
Clinical narrative: This spontaneous report was received from a 59 year old female patient, who was reporting on herself. The patient's concurrent condition included gastroparesis, type 1 diabetes and allergies to tetracyclines. On an unknown date in December 2017 (reported as "about two months ago"), the patient was vaccinated with PNEUMOVAX 23 and unspecified influenza virus vaccine (dose, route of administration, lot # and expiry date date were not reported for both). The patient's concomitant medications included unspecified medications. On an unknown date in 2018 (reported as 3 weeks later), the patient became sick with a lung infection and pneumonia. On an unknown date, she was admitted to the emergency room at hospital and was treated by physicians. On an unknown date in 2018, in hospital a X-Ray was performed (result was not provided). The patient was released from the hospital after 3 to 4 days of care and given prescription for unspecified antibiotics. On an unknown date in February 2018 (reported as "seven hours after she was released from that hospital), the patient stopped breathing, fell unconscious and was admitted to another hospital. The patient was resuscitated, tubed, experienced two blood clots (unspecified), and was treated for lung infection and pneumonia. The patient said she was in the intensive care unit for two weeks and was released on 19-FEB-2018. At the time of the report, the patient was in in-patient hospital where she was still receiving treatment. The patient said that she was improving and breathing on her own with oxygen but she was still very sick. The causality assessment was not provided. Upon internal review, the events of lung infection, stopped breathing, fell unconscious and thrombosis were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 8 year old child patient. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On 23-FEB-2018, the patient was inadvertently vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), (dose, frequency, lot number and expiry date not reported) instead of Oka/Merck VARIVAX (wrong drug administered), subcutaneously for prophylaxis. No adverse effects were reported in the patient. No further information was provided. A product quality complaint was not present.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a female nurse of unknown age via company representative regarding herself (the nurse). The patient's concurrent condition, medical history, past drug, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with 3 dose series of RECOMBIVAX HB (route and dose unknown) (expiration date and lot number not specified) as prophylaxis. It was not specified if it was RECOMBIVAX HB vaccine. On an unknown date, after the patient received 3 dose series, titers were not showing that she converted (hepatitis B surface antibody negative). The patient had the 3-dose series again and still did not show that she registered on titer check. The patient sought medical attention with a doctor visit. The patient received unspecified treatment for the event and there was no intervention to prevent serious criteria. The patient did not have significant disability or incapacity and hospitalization and event was not life threatening. The outcome of the event hepatitis B surface antibody negative was reported as recovered/resolved on an unknown date. The reporter did not assess the causality of the event with suspect therapy. Product quality complaint was not involved.
Sex: M
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 14 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. On 26-FEB-2018, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, intramuscularly, for Human Papillomavirus (HPV) prevention (strength, lot # and expiration date were not reported). On that same date, while patient was waiting post vaccination, he fainted, having a syncopal episode, two times. The physician stated one of the times patient fell, he was out of a chair, but there was no sign of any injury. The physician also stated that patient did not need treatment and stayed in the doctor's office under observation for one hour. No any laboratory study was performed. At the reporting time, the patient was recovered from the syncope and the fall. The causality assessment between the events and vaccination with GARDASIL 9 was not provided.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter of unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was potentially vaccinated with Oka/Merck VARIVAX subcutaneously (dose, lot number and expiration date were not reported) for prophylaxis, when she was suppose to receive the Oka-Merck PROQUAD vaccination (wrong drug administered). No adverse effects reported.