chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 20-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot # N013277, expiration date: 28-APR-2019 (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA002990: US-009507513-1805USA003480: US-009507513-1805USA003482: US-009507513-1805USA003483: US-009507513-1805USA003484.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 06-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot # N013277, expiration date: 28-APR-2019 (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003481: US-009507513-1805USA002990: US-009507513-1805USA003480: US-009507513-1805USA003483: US-009507513-1805USA003484.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 09-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot # N013277, expiration date: 28-APR-2019 (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003480: US-009507513-1805USA003481: US-009507513-1805USA003482: US-009507513-1805USA003484: US-009507513-1805USA002990.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Uveitis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of uveitis in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included herpes zoster dermatitis (distant history of herpes zoster vaccine dermatitis on arm). Concurrent medical conditions included hypertension, cardiac arrhythmia, hypothyroidism and drug allergy (horse serum allergy). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced uveitis (serious criteria GSK medically significant). On an unknown date, the outcome of the uveitis was unknown. It was unknown if the reporter considered the uveitis to be related to SHINGRIX. This case was reported via Webform. The patient did not had any history of iritis or uveitis. The patient was not immunocompromised. The patient experienced unilateral uveitis, the day after SHINGRIX administration. The reporter enquired, whether the uveitis was secondary to immune reaction to Herpes zoster antigen, as he had one mild uveitis case in the past after ZOSTAVAX vaccination, but this reaction was severe compared to the ZOSTAVAX vaccination.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Uveitis, Visual impairment
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of uveitis in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included herpes zoster dermatitis (distant history of herpes zoster vaccine dermatitis on arm). Concurrent medical conditions included hypertension, cardiac arrhythmia, hypothyroidism and drug allergy (horse serum allergy). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced uveitis (serious criteria GSK medically significant). On an unknown date, the outcome of the uveitis was unknown. It was unknown if the reporter considered the uveitis to be related to SHINGRIX. This case was reported via Webform. The patient did not had any history of iritis or uveitis. The patient was not immunocompromised. The patient experienced unilateral uveitis, the day after SHINGRIX administration. The reporter enquired, whether the uveitis was secondary to immune reaction to Herpes zoster antigen, as he had one mild uveitis case in the past after ZOSTAVAX vaccination, but this reaction was severe compared to the ZOSTAVAX vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site urticaria
Clinical narrative: 24 hours after injections of PREVNAR 13 and PEDIVAX patient had hives on Right thigh near injection site.
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced erythema of extremities and swelling arm. The patient was treated with Antibiotics Therapy (Unknown). On an unknown date, the outcome of the erythema of extremities and swelling arm were not reported. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient received an unspecified influenza injection years before the reporting date. This case has been linked with case US2018077566, reported by same reporter for same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Severe diarrhea, vomiting, and dizziness.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Inflammation, Pyrexia, Rash
Clinical narrative: Fever. Rash and inflammation on entire torso, arms, forehead, partial legs. Inconsolable crying.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient Fainted after the vaccine was administered.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Rash, Vomiting
Clinical narrative: PT BEGAN TO EXPERIENCE CONSTANT VOMITING AND RASH AFTER ABOUT 30-45 MINUTES AFTER RECEIVING VACCINE.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 3 female patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot number N037533, expiration date: 17-MAY-2018 (exact dose, route of administration were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001644: US-009507513-1805USA001645: US-009507513-1805USA001646: US-009507513-1805USA001647: US-009507513-1805USA001642: US-009507513-1710USA011550.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patient were vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot number N037533, expiration date: 17-MAY-2018 (exact dose, route of administration were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001642: US-009507513-1805USA001643: US-009507513-1805USA001645: US-009507513-1805USA001646: US-009507513-1805USA001647: US-009507513-1710USA011550.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ orally, lot number M041184, expiration date: 31-MAY-2018 (dose and dose number were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested.; Sender's Comments: US-009507513-1805USA001642: US-009507513-1805USA001643: US-009507513-1805USA001644: US-009507513-1805USA001646: US-009507513-1805USA001647: US-009507513-1710USA011550:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 21 female patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot number N005274, expiration date: 03-APR-18, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001642: US-009507513-1805USA001643: US-009507513-1805USA001644: US-009507513-1805USA001645: US-009507513-1805USA001647: US-009507513-1710USA011550.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 29 male patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot number N005274, expiration date: 03-APR-2018 (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001642: US-009507513-1805USA001643: US-009507513-1805USA001644: US-009507513-1805USA001645: US-009507513-1805USA001646: US-009507513-1710USA011550.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Laboratory test, Seizure
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 12-year-old non-pregnant female patient, who was also the reporter's niece. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 28-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included ATIVAN and LAMICTAL. On 12-DEC-2017, the patient experienced her first seizure. Since that first seizure, the patient had consistent headaches as well had increased frequency and duration of seizures. The pharmacist stated that the patient received unspecified treatment for the events, sought medical attention and was hospitalized multiple times on unspecified dates. On unknown dates, the patient was performed "all kinds of test", however no result was provided. The administration of GARDASIL 9 was continued. The outcome of seizures and headache was reported as not recovered. The relatedness between the events and the suspect therapy was not reported. Upon internal review, the event of seizure was considered to be medically significant.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: I am a 63 year old very healthy male with a good immune system. I have had numerous vaccines over the course of my life to prevent various diseases including the earlier shingles vaccine. I have never had a reaction to any previous vaccine. After consultation with the pharmacist who gave the injection and reading about the potential side effects, I was prepared for some pain in my left arm, some swelling and some redness around the injection site. What I was not prepared for was the entire area of the deltoid part of my arm became red and swollen as well as some pain which was manageable. In addition, for 2 days I had a low grade fever and chills. This is highly irregular!  My wife, who is an R.N. has never seen a reaction like this to a vaccine. I would strongly suggest that no one should receive this vaccine and especially those with a compromised immune system.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: I am a 63 year old very healthy male with a good immune system. I have had numerous vaccines over the course of my life to prevent various diseases including the earlier shingles vaccine. I have never had a reaction to any previous vaccine. After consultation with the pharmacist who gave the injection and reading about the potential side effects, I was prepared for some pain in my left arm, some swelling and some redness around the injection site. What I was not prepared for was the entire area of the deltoid part of my arm became red and swollen as well as some pain which was manageable. In addition, for 2 days I had a low grade fever and chills. This is highly irregular!  My wife, who is an R.N. has never seen a reaction like this to a vaccine. I would strongly suggest that no one should receive this vaccine and especially those with a compromised immune system.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site hyperaesthesia
Clinical narrative: I am a 63 year old very healthy male with a good immune system. I have had numerous vaccines over the course of my life to prevent various diseases including the earlier shingles vaccine. I have never had a reaction to any previous vaccine. After consultation with the pharmacist who gave the injection and reading about the potential side effects, I was prepared for some pain in my left arm, some swelling and some redness around the injection site. What I was not prepared for was the entire area of the deltoid part of my arm became red and swollen as well as some pain which was manageable. In addition, for 2 days I had a low grade fever and chills. This is highly irregular!  My wife, who is an R.N. has never seen a reaction like this to a vaccine. I would strongly suggest that no one should receive this vaccine and especially those with a compromised immune system.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: I am a 63 year old very healthy male with a good immune system. I have had numerous vaccines over the course of my life to prevent various diseases including the earlier shingles vaccine. I have never had a reaction to any previous vaccine. After consultation with the pharmacist who gave the injection and reading about the potential side effects, I was prepared for some pain in my left arm, some swelling and some redness around the injection site. What I was not prepared for was the entire area of the deltoid part of my arm became red and swollen as well as some pain which was manageable. In addition, for 2 days I had a low grade fever and chills. This is highly irregular!  My wife, who is an R.N. has never seen a reaction like this to a vaccine. I would strongly suggest that no one should receive this vaccine and especially those with a compromised immune system.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose normal, Hyperhidrosis, Nausea, Neurological examination
Clinical narrative: Vaccine was administered to pt., and upon exiting the interior clinic door, pt. collapsed onto waiting room floor and hit head. Pt. was found responsive but diaphoretic, weak, pale and reporting feeling nauseated. Pt.'s vital signs initially were 90/55, 72, 96% on RA and glucose 83. Pt. was able to roll over and sit up and was escorted back to an examination room where she improved quickly, was able to sit up and was given a neurological examination by physician. Pt.'s B/P improved to 100/76. Pt. tolerated PO fluids, and left clinic with grandmother.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor
Clinical narrative: Vaccine was administered to pt., and upon exiting the interior clinic door, pt. collapsed onto waiting room floor and hit head. Pt. was found responsive but diaphoretic, weak, pale and reporting feeling nauseated. Pt.'s vital signs initially were 90/55, 72, 96% on RA and glucose 83. Pt. was able to roll over and sit up and was escorted back to an examination room where she improved quickly, was able to sit up and was given a neurological examination by physician. Pt.'s B/P improved to 100/76. Pt. tolerated PO fluids, and left clinic with grandmother.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Both vaccines were given simultaneously, patient fainted following administration of vaccines. She was unconscious for 15 seconds; she was lowered to the ground from chair. Reports she had only eaten "a little yogurt this morning". She was given juice, refused anything to eat. She remained with nursing staff for 1 hour then we taken to the school nurse.
Age: 90.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Pt. noticed pain in arm quickly after receiving immunization. Stated pain got worse and she became dizzy through the night until 5 AM the next morning. Eventually felt back to normal 24-28 hours after time of immunization.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 5 inches x 5 inches erythema, warmth, firmness left deltoid MCV, Tdap.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: About 24 hours after vaccine she experienced fever, neck pain, arm pain, and extreme fatigue. She experienced these adverse effects for 48 hours after the vaccine.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site rash
Clinical narrative: After injection done, pt experienced a nod at the injection site. A large circle around the injection site. A redness area turned into a rash with little dots all over it around the injection site after a week. Pt came in on Saturday, May 13 and RPh recommended her BENADRYL cream plus  BENADRYL capsules. Pt applied cream not taking the capsules. Now, it starts spreading around and going down to the elbow area.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Erythema, Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: 102.6 fever for 6 hrs, took acetaminophen after calling NP at 6pm, resolved by 8 pm (to 99). Swelling, redness, pain of entire arm 3in (7.5 cm) BELOW injection site, resolved after 3 days (no pain or swelling at injection site). Shoulder stiffness, resolved after 3 days. Fatigue, loss of appetite, queasy stomach, resolved after 3 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: 102.6 fever for 6 hrs, took acetaminophen after calling NP at 6pm, resolved by 8 pm (to 99). Swelling, redness, pain of entire arm 3in (7.5 cm) BELOW injection site, resolved after 3 days (no pain or swelling at injection site). Shoulder stiffness, resolved after 3 days. Fatigue, loss of appetite, queasy stomach, resolved after 3 days.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Neck pain, Pain, Pain in extremity
Clinical narrative: 24 hours after vaccine: fever, neck pain, arm pain, body aches, chills, exhaustion- felt this way for 48 hours.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 24 hours after vaccine: fever, neck pain, arm pain, body aches, chills, exhaustion- felt this way for 48 hours.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Microscopy, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Extensive severe rash with blisters to the bilateral upper extremities, chest, back, and face.  Rash erupted approximately 9 hours after vaccine administered. Worsened over the course of two days to have blisters. Denies burning of rash, is pruritic.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: The day after receiving the SHINGRIX vaccine, I woke up with a severe headache, muscle ache, and chills. These symptoms lasted about six hours and then rapidly disappeared.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase normal, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: 5 DAYS AFTER RECEIVING VACCINE PATIENT COMPLAINING OF MUSCLE PAIN IN BOTH THIGHS, ONGOING FOR 1 MONTH NOW.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: Approximately 36 hours after receiving the dose the patient started experiencing nausea that got quite severe at one point. She never vomited. She also developed a fever and the injection site was warm to touch, fever never got above 100 degrees F. The injection site was NOT red or swollen. She also developed body aches and fatigue. Symptoms lasted about 3 days. She used ibuprofen for fever and body aches. Symptoms have resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Very sore, red, and swollen injection site approximately 3" by 4"; Sore, achy body joints; Temperature the first 12 hrs after injection 101.8 degrees F.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Immediately following vaccination on 13 Apr 2018 at 2:30pm my arm swole up in hives and fever. A 3: diameter welt formed around the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown dates, the patients were vaccinated with multiple improperly stored doses of ZOSTAVAX (strength, dose, frequency and administration route were not reported) lot number M038351, expiration date 06-DEC-2017, for prophylaxis. Concomitant therapies included a properly stored sterile diluent (unknown lot number and expiration date) used for reconstitution. On an unspecified date, the vaccines were exposure to a temperature excursion; the data logger registered a temperature range between 15°Fahrenheit (F) and 46°F during a time frame of 27 hours. There was a previous temperature excursion. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because of patient identifiers. Follow-up information has been received from a pharmacist on 11-MAY-2018. On 05-OCT-2017, two patients were vaccinated with ZOSTAVAX (dose, units, frequency, route not reported), lot # M03851, expiration date: 06-DEC-2017, with temperature excursion.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 7-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 03-MAY-2018, the patient was vaccinated with a dose of M-M-R II injection, lot # M045400 with expiration date on 14-NOV-2018 (dose and route of administration were not reported) and, on the same day, with a dose of VARIVAX injection, lot # reported as N008826 with expiration date on 16-MAR-2019 (dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a physician via Center regarding a baby unknown age and gender. The patient's relevant medical and drug histories and concomitant medications were unknown. On an unknown date, the office staff inadvertently administered an expired M-M-R II to the patient (indication, strength, dose, frequency, route, lot number and expiry date were unknown) (expired product administered). The physician reported that the baby was okay. Relevant lab data was unknown. As of 04-MAY-2018, it was unknown if the patient will be revaccinated with M-M-R II. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1805USA002977; US-009507513-1805USA002757.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown dates, the patients were vaccinated with multiple improperly stored doses of ZOSTAVAX (strength, dose, frequency and administration route were not reported) lot number M038351, expiration date 06-DEC-2017, for prophylaxis. Concomitant therapies included a properly stored sterile diluent (unknown lot number and expiration date) used for reconstitution. On an unspecified date, the vaccines were exposure to a temperature excursion; the data logger registered a temperature range between 15°Fahrenheit (F) and 46°F during a time frame of 27 hours. There was a previous temperature excursion. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because of patient identifiers. Follow-up information has been received from a pharmacist on 11-MAY-2018. On 20-OCT-2017, two patients were vaccinated with ZOSTAVAX (dose, units, frequency, route not reported), lot # M03851, expiration date: 06-DEC-2017, with temperature excursion (product storage error).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Rt deltoid w/redness and warmth to the area.
Age: 4.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Confusional state, Delirium, Lethargy, Pruritus
Clinical narrative: Fever (101.5), chills/shaking, confusion/delirium, lethargy, complaint that "my yawns are making my body itch"; most symptoms subsided by morning.
Age: 4.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia, Tremor, Yawning
Clinical narrative: Fever (101.5), chills/shaking, confusion/delirium, lethargy, complaint that "my yawns are making my body itch"; most symptoms subsided by morning.
Age: 29.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: I mistakenly mixed the MenA lyophilized conjugate with sterile diluent instead of MenCYW liquid conjugate component. Today when another employee counted the vaccines and found the vial of MenCYW, she realized my mistake. I called the patient to let him know my mistake. He came in and reported no symptoms/reactions. We revaccinated him with the full vaccine today.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: Patient states she had bad flu like symptoms after the vaccine and on Saturday 5/12 her arm was swollen and red. It so bad she came into the pharmacy and showed us her arm, we instructed her to go to the doctor. She went to the urgent care and was told her had cellulitis. She has to be on Cephalexin for 7 days.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Aphasia, Crying, Gait inability, Inability to crawl, Infantile back arching
Clinical narrative: One hour following vaccination: Child was unresponsive; slept for longer than 6 hours. Awoke with a fever of 103.0 F and high pitched scream with back arching. Inconsolable crying throughout the night. This pattern continued to repeat itself, every night for 5 nights straight. The following day- the child could no longer crawl, talk or walk. All language was lost and child only reacted with a high pitched squeal. Previous language included 10-20 words, child crawled independently by 6 months and was walking mostly independently at the time of the vaccination. Child was vaccinated on a delayed vaccination schedule due to previous illness requiring hospitalization and time constraints.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Screaming, Unresponsive to stimuli
Clinical narrative: One hour following vaccination: Child was unresponsive; slept for longer than 6 hours. Awoke with a fever of 103.0 F and high pitched scream with back arching. Inconsolable crying throughout the night. This pattern continued to repeat itself, every night for 5 nights straight. The following day- the child could no longer crawl, talk or walk. All language was lost and child only reacted with a high pitched squeal. Previous language included 10-20 words, child crawled independently by 6 months and was walking mostly independently at the time of the vaccination. Child was vaccinated on a delayed vaccination schedule due to previous illness requiring hospitalization and time constraints.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blood test, Cardiac disorder, Cerebrovascular accident, Computerised tomogram
Clinical narrative: Diarrhea, nausea, dehydration, loss of weight, weakness, loss of appetite. On May 31, 2017, my husband went to the hospital for his annual checkup. At that time his primary care doctor commented that he was in very good shape for an 83 year old man. Then he gave him a pneumonia shot, PREVNAR 13. He said that it might make him a little sick but that would go away. Within a day or so he began feeling bad, threw up every thing he ate, got severe diarrhea and got very weak. Started getting dehydrated, and lost weight. We took him to the doctor again and he ran tests. The doctor was very surprised at how he looked. Even commented that he looked awful. Sent him home with some medication. But within a few days we took him back to the Emergency Room. They sent him home with medication. A few days later we took him to the emergency room again. And then to an other Emergency room. Still no results. Back to the hospital, and they were required to admit him They ran many tests. CT scan, MRI. Then one night he developed a heart problem (he never had any heart issues up till then). They moved him to another hospital. Cardiac ward. They did more tests and found that he had 2 massive strokes. He died on July 15, 2017. Up until the time he got that PREVNAR 13 shot he was a very healthy man. At 83 years old he could outwork a man 40 years old. He never had any heart issues. The most health problem he had was a prostate problem. Which he was being treated for. None of the doctors could find a reason for him being so sick. It all started with the shot that he was given on May 31. I would like some answers. What killed him? Was it the shot?
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Death, Decreased appetite, Dehydration, Diarrhoea, Feeling abnormal
Clinical narrative: Diarrhea, nausea, dehydration, loss of weight, weakness, loss of appetite. On May 31, 2017, my husband went to the hospital for his annual checkup. At that time his primary care doctor commented that he was in very good shape for an 83 year old man. Then he gave him a pneumonia shot, PREVNAR 13. He said that it might make him a little sick but that would go away. Within a day or so he began feeling bad, threw up every thing he ate, got severe diarrhea and got very weak. Started getting dehydrated, and lost weight. We took him to the doctor again and he ran tests. The doctor was very surprised at how he looked. Even commented that he looked awful. Sent him home with some medication. But within a few days we took him back to the Emergency Room. They sent him home with medication. A few days later we took him to the emergency room again. And then to an other Emergency room. Still no results. Back to the hospital, and they were required to admit him They ran many tests. CT scan, MRI. Then one night he developed a heart problem (he never had any heart issues up till then). They moved him to another hospital. Cardiac ward. They did more tests and found that he had 2 massive strokes. He died on July 15, 2017. Up until the time he got that PREVNAR 13 shot he was a very healthy man. At 83 years old he could outwork a man 40 years old. He never had any heart issues. The most health problem he had was a prostate problem. Which he was being treated for. None of the doctors could find a reason for him being so sick. It all started with the shot that he was given on May 31. I would like some answers. What killed him? Was it the shot?
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Nuclear magnetic resonance imaging, Vomiting, Weight decreased
Clinical narrative: Diarrhea, nausea, dehydration, loss of weight, weakness, loss of appetite. On May 31, 2017, my husband went to the hospital for his annual checkup. At that time his primary care doctor commented that he was in very good shape for an 83 year old man. Then he gave him a pneumonia shot, PREVNAR 13. He said that it might make him a little sick but that would go away. Within a day or so he began feeling bad, threw up every thing he ate, got severe diarrhea and got very weak. Started getting dehydrated, and lost weight. We took him to the doctor again and he ran tests. The doctor was very surprised at how he looked. Even commented that he looked awful. Sent him home with some medication. But within a few days we took him back to the Emergency Room. They sent him home with medication. A few days later we took him to the emergency room again. And then to an other Emergency room. Still no results. Back to the hospital, and they were required to admit him They ran many tests. CT scan, MRI. Then one night he developed a heart problem (he never had any heart issues up till then). They moved him to another hospital. Cardiac ward. They did more tests and found that he had 2 massive strokes. He died on July 15, 2017. Up until the time he got that PREVNAR 13 shot he was a very healthy man. At 83 years old he could outwork a man 40 years old. He never had any heart issues. The most health problem he had was a prostate problem. Which he was being treated for. None of the doctors could find a reason for him being so sick. It all started with the shot that he was given on May 31. I would like some answers. What killed him? Was it the shot?
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Got the vaccine on 10/12 and then on 10/14 my shoulder was red, itch, pain and swelling part of my arm. Went to ER at hospital. After couple lab test they told me I have reaction to the vaccine, which they call "cellulitis". They admit me to the hospital with pain medication and antibiotic. Stay at hospital for couple day (2 days). Go back to my medical doctor because still painful and red, the doctor told me that is reaction to the pneumonia shot, so give a time. Well in about a week or two I feel like it I lost mobility on my right arm more and more, so I went to see my medical doctor. She told me again to give a time (11-15-2017). On January 5 2018 I visit my medical doctor and I saw Dr. and she told me that I have adhesive capsulitis and she send the order to see a rehabilitation Dr. (frozen shoulder). I start the rehab 3x weekly. But still pain, and not gain much mobility. On January 25 I went to see my Dr. and he order a MRI on my right shoulder. I went to health system. The report was rotator cuff tear and they send me to rehab 3x weekly. But still pain and not improve to moving so they do the operation on my R shoulder in March and now I'm still do the rehab. Hope to back my normal life and move my shoulder, my arm to touch the sky. By the way in December 2017 I went to visit my family. While I was there on 12/18/17 I have another episode of cellulitis infection. Went to doctor and he prescribe 5 injection of penicillin (one x day).
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Injection site swelling, Laboratory test, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Got the vaccine on 10/12 and then on 10/14 my shoulder was red, itch, pain and swelling part of my arm. Went to ER at hospital. After couple lab test they told me I have reaction to the vaccine, which they call "cellulitis". They admit me to the hospital with pain medication and antibiotic. Stay at hospital for couple day (2 days). Go back to my medical doctor because still painful and red, the doctor told me that is reaction to the pneumonia shot, so give a time. Well in about a week or two I feel like it I lost mobility on my right arm more and more, so I went to see my medical doctor. She told me again to give a time (11-15-2017). On January 5 2018 I visit my medical doctor and I saw Dr. and she told me that I have adhesive capsulitis and she send the order to see a rehabilitation Dr. (frozen shoulder). I start the rehab 3x weekly. But still pain, and not gain much mobility. On January 25 I went to see my Dr. and he order a MRI on my right shoulder. I went to health system. The report was rotator cuff tear and they send me to rehab 3x weekly. But still pain and not improve to moving so they do the operation on my R shoulder in March and now I'm still do the rehab. Hope to back my normal life and move my shoulder, my arm to touch the sky. By the way in December 2017 I went to visit my family. While I was there on 12/18/17 I have another episode of cellulitis infection. Went to doctor and he prescribe 5 injection of penicillin (one x day).
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rotator cuff syndrome, Shoulder operation, Vaccination complication
Clinical narrative: Got the vaccine on 10/12 and then on 10/14 my shoulder was red, itch, pain and swelling part of my arm. Went to ER at hospital. After couple lab test they told me I have reaction to the vaccine, which they call "cellulitis". They admit me to the hospital with pain medication and antibiotic. Stay at hospital for couple day (2 days). Go back to my medical doctor because still painful and red, the doctor told me that is reaction to the pneumonia shot, so give a time. Well in about a week or two I feel like it I lost mobility on my right arm more and more, so I went to see my medical doctor. She told me again to give a time (11-15-2017). On January 5 2018 I visit my medical doctor and I saw Dr. and she told me that I have adhesive capsulitis and she send the order to see a rehabilitation Dr. (frozen shoulder). I start the rehab 3x weekly. But still pain, and not gain much mobility. On January 25 I went to see my Dr. and he order a MRI on my right shoulder. I went to health system. The report was rotator cuff tear and they send me to rehab 3x weekly. But still pain and not improve to moving so they do the operation on my R shoulder in March and now I'm still do the rehab. Hope to back my normal life and move my shoulder, my arm to touch the sky. By the way in December 2017 I went to visit my family. While I was there on 12/18/17 I have another episode of cellulitis infection. Went to doctor and he prescribe 5 injection of penicillin (one x day).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure abnormal, Feeling abnormal, Heart rate abnormal, Peripheral swelling, Rash
Clinical narrative: In opposite arm (not the injection site) she awoke on the second day after immunization with hives, rash and swelling of entire right arm, into her neck and on one side of her face. She went to urgent care quickly where she received a steroid injection. She was given a Rx for oral steroids, but has not taken them as the injection has affected her blood pressure and heart rate, and has made her "feel funny" so she is scared to take the oral medication. The rash is currently resolved, but now she is worried about her reaction to the treatment.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: In opposite arm (not the injection site) she awoke on the second day after immunization with hives, rash and swelling of entire right arm, into her neck and on one side of her face. She went to urgent care quickly where she received a steroid injection. She was given a Rx for oral steroids, but has not taken them as the injection has affected her blood pressure and heart rate, and has made her "feel funny" so she is scared to take the oral medication. The rash is currently resolved, but now she is worried about her reaction to the treatment.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Erythema, Heart rate increased
Clinical narrative: PT states Saturday morning she started feeling lethargic, weak, she had nightmares, high pulse rate, chills and diarrhea. Pt states she spent two days in bed because she couldn't function. She also states she had muscle pain in opposite shoulder as well as the arm the vaccine was given along with redness and swelling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Loss of personal independence in daily activities, Myalgia, Nightmare, Pain in extremity
Clinical narrative: PT states Saturday morning she started feeling lethargic, weak, she had nightmares, high pulse rate, chills and diarrhea. Pt states she spent two days in bed because she couldn't function. She also states she had muscle pain in opposite shoulder as well as the arm the vaccine was given along with redness and swelling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: PT states Saturday morning she started feeling lethargic, weak, she had nightmares, high pulse rate, chills and diarrhea. Pt states she spent two days in bed because she couldn't function. She also states she had muscle pain in opposite shoulder as well as the arm the vaccine was given along with redness and swelling.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Arm swelling, redness, and pain, lasting 3 weeks so far.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Pt reported severe pain, swelling, and itching within 2 hours of injection time. Pain continued to increase as well as redness around injection site. Pt then began experiencing widespread hives starting on 5/11/18 and was seen at the Emergency Department that evening.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Headache, Injection site erythema
Clinical narrative: 5/2: Around noon became weak, feverish, muscle aches, headache, chilled, despite fever unable to get warm, nauseous. Left arm very sore. This condition persisted the next day with arm becoming red and swollen at injection site. By 5/4 symptoms began to improve, but arm was too sore to move much. By 5/5 began to feel better, after 2 1/2 days of bed rest. 5//7: Around 3 pm the symptoms returned suddenly -- weak, fever, chills, nausea, head ache, though arm was no longer sore. Returned to bed until symptoms began to improve in the evening of 5/9.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 5/2: Around noon became weak, feverish, muscle aches, headache, chilled, despite fever unable to get warm, nauseous. Left arm very sore. This condition persisted the next day with arm becoming red and swollen at injection site. By 5/4 symptoms began to improve, but arm was too sore to move much. By 5/5 began to feel better, after 2 1/2 days of bed rest. 5//7: Around 3 pm the symptoms returned suddenly -- weak, fever, chills, nausea, head ache, though arm was no longer sore. Returned to bed until symptoms began to improve in the evening of 5/9.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Rash
Clinical narrative: Developed a rash across chest 4 d after injection. Also had myalgias and arthralgias which can be expected.
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, fever (99.9), fatigue, joint pain, headache.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling - redness hot to the touch left deltoid.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Rash developed a few days after vaccinations. Looks like diffusely - spread red bumps with itching. Treat supportively with calamine lotion and BENADRYL PRN, itching.