chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site irritation
Clinical narrative: Patient noticed redness and irritation at injection site. Started on the next day after his vaccine was administered. Patient went to his doctor on 8/4/17 for treatment. MD diagnosis was (Cellulitis - allergy initial encounter).
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Contusion, Pain, Skin warm, Viral upper respiratory tract infection
Clinical narrative: Pt received PNEUMOVAX 23 vaccine on Tuesday (8/1/17) on right arm. Pt reports on 8/4/17 of "black and blue" bruise on right arm, that is warm and painful. Pt also reports cold s/sx.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction-no respiratory symptoms. Erythema and swelling at site measuring 4.5 cm in diameter with light ring erythema measuring 4.5 cm. No lymphadenopathy. No other weals. Tx'd with antihistamines.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: Seen in office by Dr. on 8-4-17 forearm due to persistent arm pain at site of vaccine x couple wks. Flu. Care. Vaccine distributer Merck contacted. Phone f/u with family compresses for contact.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Seen in office by Dr. on 8-4-17 forearm due to persistent arm pain at site of vaccine x couple wks. Flu. Care. Vaccine distributer Merck contacted. Phone f/u with family compresses for contact.
Age: 0.08
Sex: M
Vaccine: HIBV
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 4-week-old male patient who received HIBERIX (batch number 2S27K, expiry date 17th September 2017). On 9th March 2017, the patient received the 1st dose of HIBERIX .5 ml. On 9th March 2017, immediately after receiving HIBERIX, the patient experienced injection site hyperpigmentation. On an unknown date, the outcome of the injection site hyperpigmentation was unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were provided as follows: The patient had a black dot being left at the injection site of HIBERIX and had not faded by the date of the next dose. On 12th May 2017, the patient received 2nd dose of HIBERIX 0.5 ml (Batch number: 4294M, Expiry date 20th January 2018). On 13th July 2017, the patient received 3rd dose of HIBERIX 0.5ml (Batch number: 4B745, Expiry date: 23 February 2018). This was purely cosmetic and no additional adverse events were reported. This was one of the two cases reported by the same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: History taken from mom. Patient is a 4 y.o. O m.o female who presents in office today for evaluation of RT thigh swelling with onset mom noticed today but mom was not with pt yesterday. Pt has redness on right thigh at site of DTaP/IPV injection that was done in office this Wednesday. Raised and Warm to the touch of pain. No discharge. Appetite and activity levels are normal. Sleep is normal. No ill contact. No other contributing factors.
Age: 0.17
Sex: U
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 2-month-old patient who received HIBERIX (batch  number 4294M, expiry date 20th January 2018). On 4th April 2017, the patient received HIBERIX .5 ml. On 4th April 2017, immediately after receiving HIBERIX, the patient experienced injection site hyperpigmentation. On an unknown date, the outcome of the injection site hyperpigmentation was unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were provided as follows: The patient had a black dot being left at the injection site of HIBERIX and had not faded by the date of the next dose. On an unknown date, the patient received 2nd dose of HIBERIX 0.5ml (Batch number: 4B745, Expiry date: 23 February 2018). This was purely cosmetic and no additional adverse events were reported. This was one of the two cases reported by the same reporter.
Age: 0.17
Sex: U
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 2-month-old patient who received HIBERIX (batch  number 4294M, expiry date 20th January 2018). On 4th April 2017, the patient received HIBERIX .5 ml. On 4th April 2017, immediately after receiving HIBERIX, the patient experienced injection site hyperpigmentation. On an unknown date, the outcome of the injection site hyperpigmentation was unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were provided as follows: The patient had a black dot being left at the injection site of HIBERIX and had not faded by the date of the next dose. On an unknown date, the patient received 2nd dose of HIBERIX 0.5ml (Batch number: 4B745, Expiry date: 23 February 2018). This was purely cosmetic and no additional adverse events were reported. This was one of the two cases reported by the same reporter.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site swelling, Peripheral swelling, Urticaria
Clinical narrative: Swelling around site and down left arm. Eventual hives, swelling continued into the next day, eventually patient diagnosed w/cellulitis.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Fatigue, Nausea, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 11-year-old male patient who received BOOSTRIX (batch number 7Y29Z, expiry date 17th August 2019). On 31st July 2017, the patient received the 1st dose of BOOSTRIX .5 ml. On 31st July 2017, immediately after receiving BOOSTRIX, the patient experienced nausea, abdominal pain, tiredness and vomiting. On 31st July 2017, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the nausea was recovering/resolving and the outcome of the abdominal pain and tiredness were unchanged. The reporter considered the nausea, abdominal pain, tiredness and vomiting to be possibly related to BOOSTRIX. Additional details were provided as follows: The patient complained of nausea immediately following vaccination with BOOSTRIX. Within minutes, the patient vomited twice. One hour after vaccination, the patient experienced abdominal soreness and tiredness. The clinic had kept the patient for observation over the hour, and the patient reported no further vomiting, but continued abdominal soreness, mild nausea, and tiredness.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted several hours after administration.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red inflamed site of injection status post receipt of PREVNAR - 13 vaccine. Recommended hydrocortisone cream twice daily.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness to (L) arm.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Hyporeflexia, Respiratory viral panel
Clinical narrative: Self limited left foot numbness and markedly decreased deep tendon reflex on left Achilles.
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site induration in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint. On an unknown date, the outcome of the injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint were unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint to be related to BEXSERO. Additional details were provided as follows: At the time of the call, patient specifics and lot number were not available. The male patient had a baseball sized induration, erythema, myalgia, headache, felt faint, and the injection site was warm to the touch. GlaxoSmithKline representative was given info from the medical assistant, who would give a call early next week to provide specific information about patients and vaccine lot. She told the representative that she felt that the female and the male with the more mild adverse events aligned with what was in the patient information. This was one of 3 cases reported by same reporter.
Sex: M
Vaccine: MENB
Symptoms: Myalgia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site induration in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint. On an unknown date, the outcome of the injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint were unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint to be related to BEXSERO. Additional details were provided as follows: At the time of the call, patient specifics and lot number were not available. The male patient had a baseball sized induration, erythema, myalgia, headache, felt faint, and the injection site was warm to the touch. GlaxoSmithKline representative was given info from the medical assistant, who would give a call early next week to provide specific information about patients and vaccine lot. She told the representative that she felt that the female and the male with the more mild adverse events aligned with what was in the patient information. This was one of 3 cases reported by same reporter.
Sex: M
Vaccine: RAB
Symptoms: Antibody test negative, Therapeutic response decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received Rabies Vaccine. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Rabies Vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had lower antibodies titer of Rabies, but information on titer levels was not available, which led to decreased therapeutic response. The health care provider inquired if the patient can be given booster dose of RABAVERT due to the low titer. It was unknown which rabies vaccine series the patient received in the past. No further information provided.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain
Clinical narrative: Rt arm redness, pain (not at site of injection) but lower on arm and to the inside. RPh advised icing area and maybe BENADRYL, and anti-inflame (but patient cannot take due to other meds that he takes regularly).
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Culture throat, Lymphadenopathy, Mononucleosis heterophile test negative, Myalgia, Oropharyngeal pain
Clinical narrative: Patient presented to clinic on 8/7/17 reporting she had be given the MMR vaccine on 7/27/17 and notes becoming febrile on 8/2/17 (tmax 103). She notes the fever continued with muscle pain to fluctuate over 5 days with onset of throat pain and swollen glands starting 8/6/17. Today, a rapid culture has been done and sent out; pending results. Patient instructed to increase fluids, rest, and use of ADVIL/TYLENOL as needed.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Patient presented to clinic on 8/7/17 reporting she had be given the MMR vaccine on 7/27/17 and notes becoming febrile on 8/2/17 (tmax 103). She notes the fever continued with muscle pain to fluctuate over 5 days with onset of throat pain and swollen glands starting 8/6/17. Today, a rapid culture has been done and sent out; pending results. Patient instructed to increase fluids, rest, and use of ADVIL/TYLENOL as needed.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Injection site scab, Laboratory test, Loss of personal independence in daily activities, Nervous system disorder
Clinical narrative: This spontaneous report was received from a 68 year old male patient, referring to himself. The patient did  not have pertinent medical history or drug reactions/allergies. The concomitant medication was not provided. On an unknown date in February in 2015, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, concentration, dose and frequency were unknown) subcutaneously for prophylaxis. Several days later, after receiving the shot in February 2015, the patient began experiencing redness, hives and excessive itching mainly on his arms. The patient also had pain at the injection site, which has not entirely subsided. The patient was prescribed an unspecified allergy medication by his dermatologist. No lab diagnostics was performed. There was no intervention to prevent serious criteria. However, the medication has not improved his condition; the outcome of events was reported as not recovered. The causality between events and ZOSTAVAX was not provided. No product quality complaint (PQC) was involved.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nodule, Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a 68 year old male patient, referring to himself. The patient did  not have pertinent medical history or drug reactions/allergies. The concomitant medication was not provided. On an unknown date in February in 2015, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, concentration, dose and frequency were unknown) subcutaneously for prophylaxis. Several days later, after receiving the shot in February 2015, the patient began experiencing redness, hives and excessive itching mainly on his arms. The patient also had pain at the injection site, which has not entirely subsided. The patient was prescribed an unspecified allergy medication by his dermatologist. No lab diagnostics was performed. There was no intervention to prevent serious criteria. However, the medication has not improved his condition; the outcome of events was reported as not recovered. The causality between events and ZOSTAVAX was not provided. No product quality complaint (PQC) was involved.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin erosion, Skin necrosis, Sleep disorder, Tenderness
Clinical narrative: This spontaneous report was received from a 68 year old male patient, referring to himself. The patient did  not have pertinent medical history or drug reactions/allergies. The concomitant medication was not provided. On an unknown date in February in 2015, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, concentration, dose and frequency were unknown) subcutaneously for prophylaxis. Several days later, after receiving the shot in February 2015, the patient began experiencing redness, hives and excessive itching mainly on his arms. The patient also had pain at the injection site, which has not entirely subsided. The patient was prescribed an unspecified allergy medication by his dermatologist. No lab diagnostics was performed. There was no intervention to prevent serious criteria. However, the medication has not improved his condition; the outcome of events was reported as not recovered. The causality between events and ZOSTAVAX was not provided. No product quality complaint (PQC) was involved.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a 68 year old male patient, referring to himself. The patient did  not have pertinent medical history or drug reactions/allergies. The concomitant medication was not provided. On an unknown date in February in 2015, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, concentration, dose and frequency were unknown) subcutaneously for prophylaxis. Several days later, after receiving the shot in February 2015, the patient began experiencing redness, hives and excessive itching mainly on his arms. The patient also had pain at the injection site, which has not entirely subsided. The patient was prescribed an unspecified allergy medication by his dermatologist. No lab diagnostics was performed. There was no intervention to prevent serious criteria. However, the medication has not improved his condition; the outcome of events was reported as not recovered. The causality between events and ZOSTAVAX was not provided. No product quality complaint (PQC) was involved.
Age: 68.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Erythema, Induration
Clinical narrative: 4 days after the administration from a couple of inches below the injection site to pass my elbow became swollen/painful and red. ALLEGRA and CEPHRA prescribed.
Age: 68.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4 days after the administration from a couple of inches below the injection site to pass my elbow became swollen/painful and red. ALLEGRA and CEPHRA prescribed.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, UNK, HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: MA administered PROQUAD rather than MMR.  Telephone F/U conducted over 10 days with no fever or seizures. did have a little lump at injection site with 2 little vesicles which improved.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, UNK, HEPA, MMRV, VARCEL
Symptoms: Injection site mass, Injection site vesicles
Clinical narrative: MA administered PROQUAD rather than MMR.  Telephone F/U conducted over 10 days with no fever or seizures. did have a little lump at injection site with 2 little vesicles which improved.
Age: 23.0
Sex: M
Vaccine: PNC13, RAB, YF, RAB
Symptoms: Anxiety, Dizziness, Nausea, Pain, Palpitations
Clinical narrative: EE to Health Center at 15:50 c/o nausea, lightheadedness, heart racing, BP 132/70, HR 64, Temp 98.3, Pain 0. EE stating "It could be anxiety" EE denies bkfst. Did eat lunch. Very warm day.
Age: 23.0
Sex: M
Vaccine: PNC13, RAB, YF, RAB
Symptoms: Dizziness, Nausea, Palpitations
Clinical narrative: EE to Health Center at 15:50 c/o nausea, lightheadedness, heart racing, BP 132/70, HR 64, Temp 98.3, Pain 0. EE stating "It could be anxiety" EE denies bkfst. Did eat lunch. Very warm day.
Age: 17.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Blood glucose decreased, Fall, Loss of consciousness, Syncope
Clinical narrative: PATIENT FAINTED AFTER 4 MINUTES AFTER VACCINE WAS ADMINISTERED, HE WAS TALKING AND SUDDENLY FELL DOWN, HE REGAINED CONSCIOUSNESS WITHIN FEW SECONDS. PARAMEDICS CAME IN AND FOUND OUT THAT HIS GLUCOSE LEVEL WAS LOW. THEY GAVE HIM LIQUID GLUCOSE AND HE BECAME ALRIGHT.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to three unspecified patients (ages and gender unknown). The patients' medical histories, concurrent conditions and concomitant medications were not provided. On 17-JUL-2017 three patients were administered M-M-R II (route, lot# and expiration date unknown) that were improperly stored and underwent a temperature excursion.  The vaccines were reconstituted with sterile diluent (STERILE DILUENT) (route, lot# and expiration date unknown) that was properly stored. No adverse events were reported. A data logger was involved.  Temperature excursion: 47 degrees F to 77 degrees F. Time frame: 4 hours 32 minutes. There were no previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant concerned a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 17-JUL-2017 the patient was inadvertently administered an expired dose of VARIVAX, (lot # L019127, expiration date 27-MAY-2017), (route unknown) for prophylaxis. This was the patient's first dose. The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (Reported Lot# L024102, expiration date 31-MAR-2018). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a nurse prescriber via a field representative concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date were not reported ) subcutaneously for prevention of shingles. On an unknown date, the patient developed shingles. It was not known by the primary reporter if treatment was provided. At the time of the report, the outcome of the event was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report has been received from a physician referring to a currently 79 year old female patient. There were no pertinent medical history or drug reactions/allergies. Concomitant therapies included CELEBREX and EVISTA. On an unspecified date, the patient was vaccinated with first dose in vaccination series of GARDASIL (intramuscular, dose, lot # and expiration date not reported) for prevention of skin cancer (product use in unapproved indication). On an unknown date, the patient developed lymphadenopathy within an unspecified time frame after receiving first dose in vaccination series. The patient sought medical attention via physician visit. No treatment was given for the event. No lab diagnostics were performed. The patient received second dose in vaccination series of GARDASIL (intramuscular, dose, lot # and expiration date not reported) for prevention of skin cancer on an unspecified date. At the time of the report, the outcome of the event was reported as not recovered. The causality between lymphadenopathy and GARDASIL was not reported.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 77 year old female patient. The concurrent condition, medical history and concomitant therapy were not reported. On 16-JUL-2017, the patient was vaccinated with single dose of PNEUMOVAX 23 (lot # N005096 and the expiration date of 22-OCT-2018) intramuscularly for prophylaxis which was recommended by physician. On 17-JUL-2017, the patient experienced pain, tenderness, redness and swelling in her arm at injection site. No lab diagnostics or studies were performed. The patient did not seek medical attention. The patient had received unspecified treatment and was recovering from the events at the reporting time. Action taken with the vaccine was not applicable. The causality between the events and therapy was not reported.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to a 5.5 months old patient of unknown gender. The  patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date the patient was vaccinated with a dose of ROTATEQ at 5.5 months old (dose, strength, frequency, lot # unknown, oral for prophylaxis), and then another dose of the vaccine at 6.5 months old (inappropriate age at vaccine administration). No known adverse effects were reported. No lab diagnostics or studies were performed.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 17 year old patient. On 01-AUG-2017 the patient was vaccinated with PROQUAD for prophylaxis. Other suspect therapies included VARIVAX. On 01-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to PROQUAD and VARIVAX.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company employee refers to a patient of unknown age. The physician reported multiple unspecified patients received one or two doses of GARDASIL per recommended dosing interval and finished the 3 dose series, with receiving one or two doses of GARDASIL 9 to equal a total of 3 doses of the HVP vaccine with recommended dosing interval, which was outside of the prescribing information. No adverse effects were reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: Information has been received from a 69 year old female patient referring to herself. The patient was allergic to preservatives. There was no medical history or concomitant medication. On 16-JUL-2017, the patient was vaccinated with ZOSTAVAX (dose, lot# and expiration date unknown) subcutaneously for prophylaxis. On 19-JUL-2017 (also reported as 72 hours later), the patient broke out with a "very bad rash on her hands, feet and in her mouth". The patient thought ZOSTAVAX might contain preservatives, which she was allergic to and that was the reason for getting the rash. The patient had to go to the emergency room where she was treated with prednisone (a week's supply) and other unspecified medications. The patient was met at the emergency room by her physician, an allergist, who confirmed that the patient did not have shingles. No lab diagnostics/studies were performed. The outcome of the events was reported as recovering. Upon internal review, the event of rash and treated with prednisone was determined to be medically significant.
Sex: U
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 04-AUG-2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # N000237, intramuscular in the left arm for prophylaxis. On 04-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old child of unknown gender. Medical history, current conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with PROQUAD (lot # M006103, expiry date 01-AUG-2017) as prophylaxis. No adverse effect was reported. No temperature excursion reported. No product quality complaint. The outcome of expired product administered and no adverse event was unknown.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20 year old female patient. There was no pertinent medical history or drug reactions/allergies. On 02-AUG-2017 the patient was vaccinated with an improperly stored (7 Fahrenheit for 60 hours) dose of VARIVAX (lot # M036292, expiration date 18-AUG-2017, subcutaneous) for prophylaxis. On 03-AUG-2017, the patient experienced redness and swelling at the injection site and was seen in the office on 04-AUG-2017. No treatment was provided to the patient. No lab diagnostics or studies were performed. Outcome of the events was reported as recovering. There was no temperature excursion previously. It was called because of a data logger.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (doses, route of administration, anatomical location, lot# and expiration date were not provided) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). Administered doses of vaccine underwent a temperature excursion between 9 degrees Celsius to 25 degrees Celsius for 48 hours. The digital data logger was not involved. No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Acne, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Small pimple like bump formed around the injection site. Then it became itchy and red from the injection site down about inch down my left bicep area. As of today 8 Aug 2017 not itching the bump as went down to just a small bump than before. Arm is still red as previously described. In regards to Item#20 on this form has patient recovered from the adverse event? The answer is yes and no.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Dermatitis acneiform, Eye swelling, Eyelid rash, Pain in extremity, Rash
Clinical narrative: Patient describes receiving vaccines during the day and by the evening, had broken out in a dry,  raised, red rash on her forehead that seemed to her like "acne." A similar rash developed on her eyelids and jaw. She also described arm soreness, which has improved as of the patient interview. Patient denies fever and denies rash on other parts of her body. As of today, she also describes swelling under her eyes and persistent rash. Patient has taken "TYLENOL" for discomfort associated with vaccines. Denies use of any new facial products.
Sex: U
Vaccine: MNQ
Symptoms: Cough
Clinical narrative: This case was reported in a literature article and described the occurrence of cough in a child subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a month after receiving Meningococcal ACWY-CRM vaccine, the subject developed cough. Serious criteria included other: serious per author. The outcome of cough was unknown. It was unknown if the investigator considered the cough to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of cough in a child aged between 2 and 10 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the retrospective observational cohort study that summarized the occurrence of 26 pre-specified events of interest (EOI)  and serious medically attended events (SMAEs) occurring up to 1 year after vaccination with MenACWY-CRM in children aged 2 through 10 years (inclusive-i.e., did not reach their 11th birthday) in routine clinical care. The study was conducted as part of a postmarketing commitment required by the regulatory authority at three medical centers within a particular healthcare system. In this study, most of the children had not received any prior MCV4 vaccinations. The patient was enrolled at  healthcare  system  for 6 or more months prior to the first dose of MenACWY-CRM in order to have 6 or more months of observation time to identify preexisting diagnoses. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 September 2014, the patient received MENVEO (administration site and route unspecified; dosages unknown; batch number not provided). (It was reported, in January 2011, MENVEO, (GSK) was approved by the Food and Drug Administration for children aged 2-10 years in this  country). [In this study, most children had not received another dose of MCV4 during their observation period (out of 327, 318 received 1 dose and 9 received 2 doses). The majority of children (n=236) received their index vaccination between 7 and 10 years of age]. The age of vaccination was not provided. On an unspecified date, within 30 days of vaccination, the patient was diagnosed with cough. (In this study, cough was considered as an SMAE). This case has been considered serious per author "SMAE". Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of cough and MENVEO. The authors concluded, "Data from this descriptive study do not suggest safety concerns associated with MenACWY-CRM vaccination when used as part of routine clinical care of children aged 2 through 10. However, the generalizability of the study results to the high risk child population with complement component deficiencies or functional or anatomic asplenia is more limited due to the small sample size of children with these medical conditions in our population". This is 1 of the 5 valid cases reported in the same literature article.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Headaches, dizziness, shortness of breath, foggy mind, weight loss, withing six months vomiting every day around 4 am for few months, weight loss continued, severe thirst, brittle nails and some would crack in the middle and fall out completely, hair loss was noticed which continued to fall out in patches throughout the following 3 years. Hair loss throughout the body: arms and legs and recently in the last 3 months pubic hair is falling off in patches as it started on the head.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Onychoclasis, Thirst, Vomiting, Weight decreased
Clinical narrative: Headaches, dizziness, shortness of breath, foggy mind, weight loss, withing six months vomiting every day around 4 am for few months, weight loss continued, severe thirst, brittle nails and some would crack in the middle and fall out completely, hair loss was noticed which continued to fall out in patches throughout the following 3 years. Hair loss throughout the body: arms and legs and recently in the last 3 months pubic hair is falling off in patches as it started on the head.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history included gastrooesophageal reflux disease. On 24-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M042849, expiration date 18-JAN-2018, one dose, subcutaneously for prophylaxis. Other suspect therapies included sterile diluent (lot# L025375 and expiration date 14-MAR-2018). On an unknown date in July 2017, the patient experienced injection site induration, nausea, headache, malaise, injection site erythema and injection site pain. The outcome of injection site induration, nausea, headache, malaise, injection site erythema and injection site pain was not recovered. The relatedness between the events and suspect therapies was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history included gastrooesophageal reflux disease. On 24-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M042849, expiration date 18-JAN-2018, one dose, subcutaneously for prophylaxis. Other suspect therapies included sterile diluent (lot# L025375 and expiration date 14-MAR-2018). On an unknown date in July 2017, the patient experienced injection site induration, nausea, headache, malaise, injection site erythema and injection site pain. The outcome of injection site induration, nausea, headache, malaise, injection site erythema and injection site pain was not recovered. The relatedness between the events and suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ lot # M041184, expiration date 31-MAY-2018, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint(PQC) involved. This is one of the two reports received from same reporter.; Sender's Comments:  US-009507513-1708USA003308:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated received a dose of RECOMBIVAX HB (dose, route, lot# and expiration date unknown) as an initial dose, and then a second dose seven months later for prophylaxis, which was not in accordance with the prescribing information. No adverse effects were reported in the patient. No other information was available. There was no Product Quality Complaint (PQC) involved.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Axillary pain, Injection site nodule, Muscular weakness
Clinical narrative: Pain in armpit for one day, weakness in the whole arm for one day, nodule in muscle where shot administered.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea
Clinical narrative: Nausea and headache reported after receiving shot.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, Vaccination error
Clinical narrative: Vaccine error, they gave patient a 3rd dose of Hep A, when it was on her chart and not needed. I am not sure of the Hep A type that was given.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 3 days after the vaccine I developed hives on the back of my neck, scalp and face. I began taking Benadryl and the symptoms were relieved after 3 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site warmth
Clinical narrative: REDNESS, IRRITATION, HEAT, AND ITCHINESS AT SITE OF INJECTION. LASTED FOR 4 DAYS.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Patient admitted for fever s/p vaccine injection. Monitored. No respiratory distress rashes or morbid events.
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Asthenia, Blood test normal, CSF test normal, Computerised tomogram head, Enterovirus test positive
Clinical narrative: Fever, weakness, altered mental state. CT head ? increased intracranial pressure. Admission, IV antibiotics. (+) for enterovirus on NP. CSF and blood encephalitis panels neg. Fully recovered.
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Human rhinovirus test positive, Mental disorder, Pyrexia
Clinical narrative: Fever, weakness, altered mental state. CT head ? increased intracranial pressure. Admission, IV antibiotics. (+) for enterovirus on NP. CSF and blood encephalitis panels neg. Fully recovered.
Age: 0.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong patient received medication
Clinical narrative: Sibling in office getting MMR and Varicella Vaccines. These vaccines were inadvertently given to patient at 1 month of age.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Note for KINRIX regarding dose #: DTaP #5, IPV #4. Approximately 10 minutes after vaccination, parent reported rash and provider noted an approximate 1 cm raised erythematous area, with ~ 3 mm erythema around this. Area is to the right of KINRIX vaccine site, and above the VARIVAX vaccine site on L. lateral upper arm. NO: dyspnea, swelling of face, tongue or wheezing, dizziness, weakness. Cool cloth was applied and parent was advised to apply cool compress x 1-2 weeks, to monitor closely and call on call or go to ED if any other symptoms. Parent called the following day (8/3/17), reported that child has another lump on arm, stated that arm was red and swollen. Mom had tried ice and TYLENOL. Parent advised to schedule appointment if symptoms worsened, offered appointment next day but parent declined. Parent brought child to ED 8/3/17 and left upper arm was noted to be warm, erythematous and painful, "rash present". Diagnosed as cellulitis and prescription for BACTRIM was given. 8/8/17 follow-up call made and parent reports that patient is doing fine now.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Limb mass, Peripheral swelling
Clinical narrative: Note for KINRIX regarding dose #: DTaP #5, IPV #4. Approximately 10 minutes after vaccination, parent reported rash and provider noted an approximate 1 cm raised erythematous area, with ~ 3 mm erythema around this. Area is to the right of KINRIX vaccine site, and above the VARIVAX vaccine site on L. lateral upper arm. NO: dyspnea, swelling of face, tongue or wheezing, dizziness, weakness. Cool cloth was applied and parent was advised to apply cool compress x 1-2 weeks, to monitor closely and call on call or go to ED if any other symptoms. Parent called the following day (8/3/17), reported that child has another lump on arm, stated that arm was red and swollen. Mom had tried ice and TYLENOL. Parent advised to schedule appointment if symptoms worsened, offered appointment next day but parent declined. Parent brought child to ED 8/3/17 and left upper arm was noted to be warm, erythematous and painful, "rash present". Diagnosed as cellulitis and prescription for BACTRIM was given. 8/8/17 follow-up call made and parent reports that patient is doing fine now.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV
Symptoms: Dyskinesia, Eye movement disorder, Neurological examination, Pericardial rub, Posture abnormal
Clinical narrative: At 1618 the RN adminiters three of the four vaccines to the patient whom is sitting on the exam table. As the RN reaches to retrieve the varicella syringe (1619) the patient starts to lean back, the RN's hand is on the patients thigh, thus far the patient has tolerated the procedure well and smiling. The RN notes that the patient continues to slump down and her eyes begin to roll. THe RN quickly guides the patient's head down to the exam table as she begins to sieze. The RN keeps the patient safe on the table as the parents finally notice something is wrong. The RN calls out the room for an additional RN. Once the two RNs communicate the additional RN brings in the emergency kit and has the front desk personnel activate 911 (1622). The additional gets help from the medical director to assess the patient(1623). The doctor is doing a neurological exam and the additional nurse calls the language line (1623) to assist the doctor. This RN is consoling the patuient as she answers questions related to orientation. This RN begins to take postictal vital on the pt, pulse 49bpm, temp 98.1 (pt was unable to close her mouth completely), BP 116/70 (1625). The EMS arrives (1630), one Spanish speaking, and begins to recieve a report from this RN. The EMS begin to lissten to heart tones on the patient and stated that her hears a rub. The EMS and family decide to take the patient to clinic (1631). A copy of the child's shot record was given to the EMS and parents. The mother informs everyone, after being questioned by the doctor, that she was told the cause of the previous two seizures were due to premature birth and delayed brain development. THe past two seziures happend as the patient was standing and she collapsed onto the floor and they weren't vaccine related.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV
Symptoms: Seizure, Syncope
Clinical narrative: At 1618 the RN adminiters three of the four vaccines to the patient whom is sitting on the exam table. As the RN reaches to retrieve the varicella syringe (1619) the patient starts to lean back, the RN's hand is on the patients thigh, thus far the patient has tolerated the procedure well and smiling. The RN notes that the patient continues to slump down and her eyes begin to roll. THe RN quickly guides the patient's head down to the exam table as she begins to sieze. The RN keeps the patient safe on the table as the parents finally notice something is wrong. The RN calls out the room for an additional RN. Once the two RNs communicate the additional RN brings in the emergency kit and has the front desk personnel activate 911 (1622). The additional gets help from the medical director to assess the patient(1623). The doctor is doing a neurological exam and the additional nurse calls the language line (1623) to assist the doctor. This RN is consoling the patuient as she answers questions related to orientation. This RN begins to take postictal vital on the pt, pulse 49bpm, temp 98.1 (pt was unable to close her mouth completely), BP 116/70 (1625). The EMS arrives (1630), one Spanish speaking, and begins to recieve a report from this RN. The EMS begin to lissten to heart tones on the patient and stated that her hears a rub. The EMS and family decide to take the patient to clinic (1631). A copy of the child's shot record was given to the EMS and parents. The mother informs everyone, after being questioned by the doctor, that she was told the cause of the previous two seizures were due to premature birth and delayed brain development. THe past two seziures happend as the patient was standing and she collapsed onto the floor and they weren't vaccine related.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Insomnia, Pain, Pain in extremity, Tenderness, Urticaria
Clinical narrative: Since injection has had pain in right arm from neck to wrist. Can move arm but very painful. Any pressure on arm is also painful. Can't sleep d/t pain. Also having hives. Giving BENADRYL, TYLENOL, ibuprofen.