chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Induration, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: Patient developed an allergic reaction following her Pneumovax on 7/20/2018. Pt indicated that her arm was swollen, hard & painful, her heart was racing and she had to use her inhaler.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin eruption in a 78-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ELIQUIS with an associated reaction of rash macular (discontinued medication) and XARELTO with an associated reaction of rash macular (discontinued medication). Concurrent medical conditions included penicillin allergy and chronic obstructive pulmonary disease. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 3 hrs after receiving SHINGRIX, the patient experienced skin eruption and erythromacular rash. On an unknown date, the patient experienced injection site pain. The patient was treated with CLARITIN. On an unknown date, the outcome of the skin eruption and erythromacular rash were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the skin eruption, erythromacular rash and injection site pain to be related to SHINGRIX. Additional details were provided as follows: At around 7 pm, the patient received SHINGRIX in the left deltoid. Three hours after receiving the SHINGRIX he started breaking out, had a reaction with little tiny red spots all over his body especially on his arms and chest. The patient was asked if they were itchy and he said he did not let it get that far because, he took a CLARITIN. The patient said he would not describe them as hives because they were not raised. CLARITIN stopped the redness and it was clearing up but then after 24 hours of taking the CLARITIN they started coming back so the patient took another CLARITIN on 1st August 2018 and another CLARITIN on the day of reporting. The reporter stated that, he had reported this adverse event to the Centers for Disease Control and Prevention (CDC) but not to his doctor of medicine (MD). Less than a week after receiving SHINGRIX, the patient had a little soreness in his arm (at the injection site) which had resolved. The patient was referred to his physician.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Rash, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin eruption in a 78-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ELIQUIS with an associated reaction of rash macular (discontinued medication) and XARELTO with an associated reaction of rash macular (discontinued medication). Concurrent medical conditions included penicillin allergy and chronic obstructive pulmonary disease. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 3 hrs after receiving SHINGRIX, the patient experienced skin eruption and erythromacular rash. On an unknown date, the patient experienced injection site pain. The patient was treated with CLARITIN. On an unknown date, the outcome of the skin eruption and erythromacular rash were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the skin eruption, erythromacular rash and injection site pain to be related to SHINGRIX. Additional details were provided as follows: At around 7 pm, the patient received SHINGRIX in the left deltoid. Three hours after receiving the SHINGRIX he started breaking out, had a reaction with little tiny red spots all over his body especially on his arms and chest. The patient was asked if they were itchy and he said he did not let it get that far because, he took a CLARITIN. The patient said he would not describe them as hives because they were not raised. CLARITIN stopped the redness and it was clearing up but then after 24 hours of taking the CLARITIN they started coming back so the patient took another CLARITIN on 1st August 2018 and another CLARITIN on the day of reporting. The reporter stated that, he had reported this adverse event to the Centers for Disease Control and Prevention (CDC) but not to his doctor of medicine (MD). Less than a week after receiving SHINGRIX, the patient had a little soreness in his arm (at the injection site) which had resolved. The patient was referred to his physician.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 67-year-old female patient who received SHINGRIX (batch number 75GJ5, expiry date 2nd February 2021) for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced a full body rash. No further details were provided.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Received the first SHINGRIX vaccination. During the night I had to go to the bathroom at least 8 times. May have slept only five hours. The next day I was very tired. On the third day I noticed redness covering most of my chest. Most of the redness was gone by the fourth day. On the sixth day I experienced some itching.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Nocturia, Pruritus
Clinical narrative: Received the first SHINGRIX vaccination. During the night I had to go to the bathroom at least 8 times. May have slept only five hours. The next day I was very tired. On the third day I noticed redness covering most of my chest. Most of the redness was gone by the fourth day. On the sixth day I experienced some itching.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Headache, chills, fever, muscle aches, arm soreness. Subsided 24 hours later.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swelling, soreness, itching at injection site.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Musculoskeletal discomfort
Clinical narrative: Right arm discomfort at muscle / injection site within 12 hours. Within 18 hours joint discomfort throughout body. Discomfort level on scale of 3 out of 10 (10 being SEVERE). Discomfort disappeared within 36 -48 hours.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Nasal congestion, Nasopharyngitis
Clinical narrative: Developed mild chest pain about 9-days post receipt of primary SPV. While in route to facility, patient had chest pain and shortness of breath "on and off" on 25 July.  He also noted significant tenderness and some swelling in his left armpit, but denies fever, chills, fatigue or body aches.  He also denied palpitations, diaphoresis, N/V or radiation of pain. On a pain scale, his pain was never >2/10.  It did not get worse with deep breaths, but seemed to get worse when lying back and better when sitting or standing. He reports catching a mild cold from his wife around 24 Jul (nasal congestion, PND and mild sore throat).  No cough or earache or chest congestion. No rashes. On 25 Jul, patient sought evaluation at Urgent Care.  No labs were drawn and nothing was prescribed, but patient was told he could take Ibuprofen as needed.  Patient has not experienced chest pain and shortness of breath since evaluation. He did take Ibuprofen 400mg 3x/day for 24 hours.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Oropharyngeal pain, Swelling, Tenderness, Upper-airway cough syndrome
Clinical narrative: Developed mild chest pain about 9-days post receipt of primary SPV. While in route to facility, patient had chest pain and shortness of breath "on and off" on 25 July.  He also noted significant tenderness and some swelling in his left armpit, but denies fever, chills, fatigue or body aches.  He also denied palpitations, diaphoresis, N/V or radiation of pain. On a pain scale, his pain was never >2/10.  It did not get worse with deep breaths, but seemed to get worse when lying back and better when sitting or standing. He reports catching a mild cold from his wife around 24 Jul (nasal congestion, PND and mild sore throat).  No cough or earache or chest congestion. No rashes. On 25 Jul, patient sought evaluation at Urgent Care.  No labs were drawn and nothing was prescribed, but patient was told he could take Ibuprofen as needed.  Patient has not experienced chest pain and shortness of breath since evaluation. He did take Ibuprofen 400mg 3x/day for 24 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Hypersomnia, Incorrect route of drug administration
Clinical narrative: Redness in entire upper left arm around injection site. The day after the injection I experienced Shivering for 2 1/2 hours followed by temp of 101.6 and I slept the entire day. The second day after the injection I continued experiencing pain in my upper arm and redness and extreme tiredness. Again slept most of the day. The third day less pain in my upper arm but still tired most of the day. The 3rd day after the injection I continued experiencing pain in my upper arm and redness and extreme tiredness. Again slept most of the day. The third day less pain in my upper arm but still tired most of the day. I received my injection of the SHINGRIX vaccine subcutaneously instead of intramuscularly.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Redness in entire upper left arm around injection site. The day after the injection I experienced Shivering for 2 1/2 hours followed by temp of 101.6 and I slept the entire day. The second day after the injection I continued experiencing pain in my upper arm and redness and extreme tiredness. Again slept most of the day. The third day less pain in my upper arm but still tired most of the day. The 3rd day after the injection I continued experiencing pain in my upper arm and redness and extreme tiredness. Again slept most of the day. The third day less pain in my upper arm but still tired most of the day. I received my injection of the SHINGRIX vaccine subcutaneously instead of intramuscularly.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. On unspecified date, the patient was inadvertently administered improperly stored VARIVAX lot # R002054, expiration date 22-JAN-2020, N034559, expiration date 05-DEC-2019, N031938, expiration date 13-NOV-2019 (strength, dose, frequency and route were not provided). The excursion temperature was 6 to 14 degree Fahrenheit for 2 hours 10 minutes. There was no previously temperature excursion. The call was because of a data logger. Concomitant therapy included STERILE DILUENT. The STERILE DILUENT used to reconstitute the product was stored properly. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA002557.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Adverse event, Contraindication to vaccination
Clinical narrative: Information has been received from a physician assistant via a company representative referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On unknown date in 2018 (reported as a couple weeks ago), the patient was vaccine with ZOSTAVAX and PNEUMOVAX 23 (strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. Other suspect therapy was sterile diluent (strength, dose, frequency, route, lot #, expiration date and indication were not provided). The physician assistant reported that the patient received the ZOSTAVAX and PNEUMOVAX 23 on the same day. The patient was immuno-compromised at the time of receiving both vaccines and then developed "unspecified issues. The outcome of the event was reported as recovered. The reporter's causality assessment was not reported.
Age: 1.75
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 21 month old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 31-JUL-2018, the patient was vaccinated with an expired dose of RECOMBIVAX HB (dose, route of administration and anatomical location were not reported) lot # J006511 and expiration date: 28-JAN-2016, indicated for prophylaxis. Additionally, the medical assistant was unable to confirm if the vaccine had temperature excursions prior to be administered. No adverse effects reported.
Age: 5.0
Sex: F
Vaccine: MMRV, MMR, MMRV, VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5-year-old female patient. Patient's medical history, current conditions and concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with expired PROQUAD (therapy type: rHA), lot # N001488, expiration date: 12-JUL-2018, (strength and dose were unknown) (route: injection) for Immunisation. As of 01-AUG-2018, it was unknown if the patient would continue PROQUAD.
Age: 5.0
Sex: F
Vaccine: MMRV, MMR, MMRV, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5-year-old female patient. Patient's medical history, current conditions and concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with expired PROQUAD (therapy type: rHA), lot # N001488, expiration date: 12-JUL-2018, (strength and dose were unknown) (route: injection) for Immunisation. As of 01-AUG-2018, it was unknown if the patient would continue PROQUAD.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, and drug reactions/allergies were not provided. On unspecified date, the patient was inadvertently administered improperly stored Oka/Merck VARIVAX lot # R002054, expiration date 22-JAN-2020, N034559, expiration date 05-DEC-2019, N031938, expiration date 13-NOV-2019 (strength, dose, frequency and route were not provided). The excursion temperature was 6 to 14 degree Fahrenheit for 2 hours 10 minutes. There was no previously temperature excursion. The call was because of a data logger. Concomitant therapy included sterile diluent. The sterile diluent used to reconstitute the product was stored properly. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA010208.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to two patients who are over 65 year old. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date in 2018 (reported as within the past 6 months), the patients were vaccinated with PNEUMOVAX23 (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date in 2018, the patient experienced serious (severe) injection site reactions after receiving PNEUMOVAX23, including swelling, redness, pain, tenderness, and rash. No prescription drug treatment was given for the event. The outcome of the events was reported as recovered on an unknown date in 2018. Causality assessment was not provided.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 17 year old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 05-MAY-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # N020353, expiry date: 28-APR-2020) (anatomical location, route of administration, dose and frequency were not reported) for prophylaxis. No product quality complaint was involved. The GARDASIL 9 was exposed to a temperature below 0 degree Celsius (°C) (-2.10°C) for 20 minutes. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects have been reported to date. The patients' guardians were notified that the patient needed to be re-vaccinated. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA004276.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash papular, Skin warm
Clinical narrative: Patient received Prevnar 13 vaccine on 7/31/18 in Left Deltoid.  Unknown specific date when patient's symptoms started, however, patient stated erythema, warmth, and itching of left upper arm worsened over the weekend, and became stable on 8/6/18.  Patient presented to PCP office on 8/6 with above complaints.  MD noted "17 by 12 cm in diameter left upper arm erythematous, mildly warm and raised.  No other apparent skin lesions".  Patient did not use antihistamines or topicals.  MD recommended cetirizine 5mg daily, hydrocortisone 1% topical, and ice packs.  On 8/7, patient presented to PCP again with worsening symptoms.  MD prescribed cephalexin 500mg BID and prednisone 20mg daily x 4 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: After the first dose, I had pain at the injection site and then experienced headache, nausea and fatigue beginning an hour after the injection and lasting two days. I told the nurse that before the second injection. She consulted with the doctor who advised me to take Tylenol before experiencing any side effects.  I did that.  At the time of the second injection, I experienced significant burning at the injection site.  About two hours later, a headache started and I also became agitated and fatigued. That lasted at least 12 hours and I wasn't able to sleep until about 3 a.m.  When I woke, I noticed that I had itching on my shoulder and saw that it was a red rash, which was also painful when touched.  I get eczema from time to time but this didn't look like that.  The injection site was red and swollen and I couldn't sleep on that side when I went to bed. Today is the third day since I got the injection and I'm back to work, feeling mostly recovered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Nausea, Rash, Rash erythematous
Clinical narrative: After the first dose, I had pain at the injection site and then experienced headache, nausea and fatigue beginning an hour after the injection and lasting two days. I told the nurse that before the second injection. She consulted with the doctor who advised me to take Tylenol before experiencing any side effects.  I did that.  At the time of the second injection, I experienced significant burning at the injection site.  About two hours later, a headache started and I also became agitated and fatigued. That lasted at least 12 hours and I wasn't able to sleep until about 3 a.m.  When I woke, I noticed that I had itching on my shoulder and saw that it was a red rash, which was also painful when touched.  I get eczema from time to time but this didn't look like that.  The injection site was red and swollen and I couldn't sleep on that side when I went to bed. Today is the third day since I got the injection and I'm back to work, feeling mostly recovered.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient called and stated she had started to have a fever after her 2nd SHINGRIX shot. This had occurred w/1st shot also. Had taken 2 doses of ibuprofen 200 mg during day but fever still 100 degrees plus. Took OTC TYLENOL but fever still increased to 104.3 degrees - PCP then advised her to go to ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Chest X-ray, Diarrhoea, Pyrexia, Seizure
Clinical narrative: Child started with fever night of July 31st, continued with fever and diarrhea through August 1st. August 1st at 10:22 PM, child experienced a seizure.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Disorientation, Dizziness, Dysgeusia, Ear discomfort
Clinical narrative: Swelling/soreness at injection site, increased ringing in ears, ringing in head, dizziness, vertigo, waves of nerve sensation through head at intervals, nausea, fatigue, disorientation, headache, ear pain, plugged ears, metal mouth, loss of appetite.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Swelling/soreness at injection site, increased ringing in ears, ringing in head, dizziness, vertigo, waves of nerve sensation through head at intervals, nausea, fatigue, disorientation, headache, ear pain, plugged ears, metal mouth, loss of appetite.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Sensory disturbance, Tinnitus, Vertigo
Clinical narrative: Swelling/soreness at injection site, increased ringing in ears, ringing in head, dizziness, vertigo, waves of nerve sensation through head at intervals, nausea, fatigue, disorientation, headache, ear pain, plugged ears, metal mouth, loss of appetite.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: She has redness and swelling from injection site in deltoid and down to elbow. She has been icing the shoulder and noticed some improvement. She reports the reaction occurred about 3-4 hours after injection and progressed to elbow, noticed the next morning upon awakening.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Mild fever, injection site is hard, swollen, red, inflamed, itches, burns, sore, difficulty walking.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Mild fever, injection site is hard, swollen, red, inflamed, itches, burns, sore, difficulty walking.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle pain, fever, tiredness, headache, nausea.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Sex: F
Vaccine: HPV9
Symptoms: Infertility female
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a female patients of unknown age. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patients was vaccinated with GARDASIL 9 for prophylaxis (dose, frequency, route of administration, lot #, expiration date were not reported). On an unknown date, the patients experienced infertility (infertility female). The outcome of the event was unknown. The reporter considered infertility female to be related to GARDASIL 9.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Muscular weakness, Paraesthesia
Clinical narrative: This spontaneous report was received from registered nurse and refers to an approximately 23 year old female patient. The patient did not have pertinent medical history, concomitant medication, drug reactions or allergies. On 31-JUL-2018, the patient was vaccinated with her first dose of GARDASIL 9 in her right deltoid, for routine vaccination (strength, dose, route, frequency, lot/batch # and expiration date were not reported). She reported that same evening, she complained of "tingling like pins and needles" in her right arm which spread through her entire body and has come and gone since. She also reported feeling fatigued and muscle weakness, on an unknown date in 2018. The patient did not need intervention to prevent serious criteria, did not performed lab diagnostics, did not present significant disability or incapacity and did not need hospitalization. The outcome of paraesthesia, fatigue and muscular weakness was reported as "ongoing". The causality assessment between paraesthesia, fatigue and muscular weakness with GARDASIL 9 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX lot # N031002, expiration date 03-NOV-2019, subcutaneously for prophylaxis. Concomitant therapy included sterile diluent which was used to reconstitute Oka/Merck VARIVAX and was properly stored. The doses of Oka/Merck VARIVAX experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-2.7 degrees Celsius) for 3 hours 45 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger. No adverse effects were reported. This is one of two reports received form the same reporter. Sender's Comments: US-009507513-1808USA004034.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019, subcutaneously for prophylaxis. Concomitant therapy included sterile diluent which was used to reconstitute VARIVAX and was properly stored. The doses of VARIVAX experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-2.7 degrees Celsius) for 3 hours 45 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger. No adverse effects were reported. This is one of two reports received form the same reporter. Sender's Comments: US-009507513-1808USA003893.
Age: 23.0
Sex: F
Vaccine: HPVX, MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 23-year-old female patient received the first dose of TRUMENBA, via an unspecified route of administration, in the arm, on an unspecified date at 0.5 ml, single dose for immunization. The patient's medical history was not reported was not reported. Concomitant vaccine included HPV vaccine in the same arm and may have received other vaccines (unspecified) as well in the opposite arm. The patient experienced burning and pain at the injection site on an unspecified date. The outcome of the event was unknown. Information on batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 20-year-old female patient received TRUMENBA (0.5 ml), via an unspecified route of administration on an unspecified date at 0.5 ml, single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's arm began to swell several hours after receiving the vaccine. Eighteen hours later, it resulted in a golf ball size swelling surrounded by redness around the injection site area. The swelling lasted for three days. She also experienced headache, tiredness, soreness and pain on an unspecified date. Outcome of the event 'Vaccination site swelling' was recovered on an unspecified date; outcome of the other events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 20-year-old female patient received TRUMENBA (0.5 ml), via an unspecified route of administration on an unspecified date at 0.5 ml, single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's arm began to swell several hours after receiving the vaccine. Eighteen hours later, it resulted in a golf ball size swelling surrounded by redness around the injection site area. The swelling lasted for three days. She also experienced headache, tiredness, soreness and pain on an unspecified date. Outcome of the event 'Vaccination site swelling' was recovered on an unspecified date; outcome of the other events was unknown. Information on the batch number has been requested.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 12-year-old female patient received the first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, headache and severe arm soreness for 3 days on an unspecified date. The outcome of all the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Injection site nodule
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer-sales representative. A patient of unspecified age and gender received pneumococcal PREVNAR 13, via an unspecified route of administration on an unspecified date, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced knot developed around the injection site on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPVX, MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 18-year-old female patient received the first dose of TRUMENBA, via an unspecified route of administration in an arm, on an unspecified date, at 0.5 ml, single for immunization. The patient's medical history was not reported. Concomitant medication included HPV vaccine at the same arm at the visit. The patient experienced burning and pain at the injection site on an unspecified date. The outcome of the event was unknown. Information on batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red rash around injection site, itchy, painful, warm to the touch.  Patient to contact primary care provider.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: Stomach ache, lightheaded, sweaty, unable to focus, chills.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Facial paralysis
Clinical narrative: Right eye drooping and right hand joint pain developed @ 2-3 days after receiving Tdap vaccination.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Patient called on 7/24/2018. She reported that she had pain and swelling on her left arm, at the site of a SHINGRIX vaccine that was administered on 7/16/18. She went to the ER on her own accord. She said she was diagnosed with cellulitis and prescribed CEFTIN.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Site became reddened and hot to touch, swollen, and hard knot where shot was given.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever of 100.5, fatigue, body aches.
Age: 42.0
Sex: M
Vaccine: HEP, HPV4
Symptoms: Arthralgia, Asthenia, Drug administered to patient of inappropriate age, Fatigue, Gait disturbance
Clinical narrative: Short-term: general weakness and debilitating fatigue, joint pain, even difficulty walking. Long-term: debilitating fatigue - 6 years later after going on an organic vegan diet, my energy levels have returned to about 80% of pre-vaccination levels.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Paraesthesia
Clinical narrative: About 5 hours after the injection I started feeling tired and achy (around 6 PM). I went to bed early because I wasn't feeling any better. In the middle of the night I was achy had a slight fever and my skin felt prickly. I also had a headache. I took some ibuprofen. I got up at 5 AM to go to work and still had the same symptoms but my temperature was done to 99.9 degrees. I took more ibuprofen. I only worked 2.5 hours and had to leave work early. I went straight to bed at 9:15 AM. I woke up at noon and ate lunch, took another ibuprofen and went back to sleep. I woke up at 3:30 PM and only had a residual headache. The next day, 8/2/2018 I felt fine, just a sore arm. I was able to go to work.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: About 5 hours after the injection I started feeling tired and achy (around 6 PM). I went to bed early because I wasn't feeling any better. In the middle of the night I was achy had a slight fever and my skin felt prickly. I also had a headache. I took some ibuprofen. I got up at 5 AM to go to work and still had the same symptoms but my temperature was done to 99.9 degrees. I took more ibuprofen. I only worked 2.5 hours and had to leave work early. I went straight to bed at 9:15 AM. I woke up at noon and ate lunch, took another ibuprofen and went back to sleep. I woke up at 3:30 PM and only had a residual headache. The next day, 8/2/2018 I felt fine, just a sore arm. I was able to go to work.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Insomnia, Pain
Clinical narrative: Patient describes that the vaccination make her "doozy" and achy and sleeping problem on the site of injection. Also, a large red spot on the deltoid area where the injection is place.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Decreased appetite, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Injection in left shoulder, extremely painful, got worse as time went on, arm became very swollen from shoulder to elbow, hot to the touch. I started to feel very sick, weak, all joints were very painful all over my body. I got worse at night from 9:00pm on through the night I felt that I could hardly move in the bed. It took a long time and great pain to slide off bed and make it to toilet and back. I arm could hardly move. I could not sleep. By 5:00am I made myself get up with great effort and slowly got to kitchen for water. I went back to bed and stayed til mid morning and got up again....got to kitchen (extremely small apt, not far from bed to kitchen). Got water and made myself get part of banana. Stayed in bed til night at which time I started to get strength in my legs.  Had to put arm in sling that I had because I could not lift my are from pain. Got better at night but was very weak and arm was still very painful and swollen and flesh felt "lumpy". Getting better and eating light food.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Peripheral swelling, Skin warm
Clinical narrative: Injection in left shoulder, extremely painful, got worse as time went on, arm became very swollen from shoulder to elbow, hot to the touch. I started to feel very sick, weak, all joints were very painful all over my body. I got worse at night from 9:00pm on through the night I felt that I could hardly move in the bed. It took a long time and great pain to slide off bed and make it to toilet and back. I arm could hardly move. I could not sleep. By 5:00am I made myself get up with great effort and slowly got to kitchen for water. I went back to bed and stayed til mid morning and got up again....got to kitchen (extremely small apt, not far from bed to kitchen). Got water and made myself get part of banana. Stayed in bed til night at which time I started to get strength in my legs.  Had to put arm in sling that I had because I could not lift my are from pain. Got better at night but was very weak and arm was still very painful and swollen and flesh felt "lumpy". Getting better and eating light food.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt. received Tdap and MENACTRA and was fine. Given HPV shortly after pt. yawned and said she felt dizzy. Color became pale. Pt. diaphoretic. Cool cloth to back. Pt. did start steps with legs then moved to exam table to lay down. Legs elevated. Offer water. Talking the whole time. Pulse is steady and strong. Pt. observed for 20 min. Changed position to sitting for a few minutes then to standing without complications. Declined lightheadedness lips are pink. No longer diaphoretic. Pt. released with grandmother.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Flushing
Clinical narrative: Dyspnea accompanied by flushing onset 1 minute after administration of vaccine. Lasted 2-3 minutes and resolved without treatment.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Bone pain, Chills, Full blood count normal, Nausea
Clinical narrative: Chills, fever of 102, nausea. Bones and teeth aching. Had to go back to the doctor to get medicine to relieve fever. Pain and chills, sore neck and arm for 3 weeks. August 3, 2018 still in pain.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia, Toothache
Clinical narrative: Chills, fever of 102, nausea. Bones and teeth aching. Had to go back to the doctor to get medicine to relieve fever. Pain and chills, sore neck and arm for 3 weeks. August 3, 2018 still in pain.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cafe au lait spots, Injection site rash, Irritability, Pyrexia, Rash papular
Clinical narrative: Rash (raised, red dots) on leg at injection site and low grade fever, fussy for a few days, mom has now noticed a café au lait spot that she hadn't noticed before.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: On the evening of 8/8/18, child developed fever up to 102.5.  Mom began alternating Tylenol and Motrin, this morning temp is 101.5.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: The second dose of Hep A was given too early (one month after dose #1, instead of 6 months after dose #1).   RN explained the error, and that the dose given on 8/8/18 will not be counted, and that she should get another dose of Hep A 6 months from now on or after February 8th, 2019.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: I had fever of 102 to 103 for 5 days. Relieved by ADVIL. Then temperatures of 101. Weakness. Total body ache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Patient went to the ER on 08/4/18 and parent stated that patient developed a temp of 104 the day of her vaccines (08/02/18) and she had pain and redness around the injection site on her right thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother presented to health department the day after immunizations and patient's right upper arm had  a localized reaction consisting of redness, warmth, and patient reported "it hurts a little".  Mother reports the redness started last night but the swelling has gotten worse.  She states she will take patient to the doctor if no improvement by this afternoon.
Age: 49.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: The dose of Pneumovax expired on 8/4/18 and was administered on 8/8/18.
Age: 49.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The dose of Pneumovax expired on 8/4/18 and was administered on 8/8/18.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Headache, Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: The next day the arm was numb. Following has been a leg numb for past 3 months. Headaches. Tingling in arms and legs. Shooting pain in limbs. Problems with vision. She had MRI. Echo test, a lot of blood work, many trips to ER.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Paraesthesia, Ultrasound scan, Visual impairment
Clinical narrative: The next day the arm was numb. Following has been a leg numb for past 3 months. Headaches. Tingling in arms and legs. Shooting pain in limbs. Problems with vision. She had MRI. Echo test, a lot of blood work, many trips to ER.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: PATIENT WAS ADMINISTERED SHOT ACCORDING TO PROTOCOL AND HUSBAND CONFIRMS HE SAW ME SWIPE WITH AN ALCOHOL SWAB BEFORE ADMINSTRATION. SHOT WAS ADMINISTERED ON 8/6/18. HE CAME IN FOR AN ANTIBIOTIC ON 8/9/18 AND SAID THEY BELIEVE THAT SHE DEVELOPED CELLULITIS BECAUSE OF THE SHOT. IT STARTED TO TURN RED UNDER THE DELTOID AND THE REDNESS TRAVELED TOWARD THE INNER ASPECT OF THE ELBOW.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Headache, Hypoaesthesia, Myalgia, Nausea
Clinical narrative: Today is Wednesday, on Monday at 1600 pt received TRUMENBA to the left deltoid. Around 1800 Left arm started to get sore and numb. Then by 2300 had body aches and then by 6 am. Had nausea, vomiting and diarrhea that lasted a few hours. Her body then began to hurt more--describes widespread muscle aches. No rashes. She tried to go to work but had to go home. She did report a fever of 102.6 last night. This morning she had a headache to the frontal part of her head and her eyes. No mention of photophobia.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Today is Wednesday, on Monday at 1600 pt received TRUMENBA to the left deltoid. Around 1800 Left arm started to get sore and numb. Then by 2300 had body aches and then by 6 am. Had nausea, vomiting and diarrhea that lasted a few hours. Her body then began to hurt more--describes widespread muscle aches. No rashes. She tried to go to work but had to go home. She did report a fever of 102.6 last night. This morning she had a headache to the frontal part of her head and her eyes. No mention of photophobia.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site cellulitis, Myalgia, Pyrexia
Clinical narrative: Cellulitis at injection site; fever; joint and muscle aches.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac monitoring, Palpitations
Clinical narrative: Patient reported to physician with heart palpitations. Was hooked to a heart monitor to check rhythms and for any sign of a cardiac event. Started on magnesium and symptoms resolved. Vaccine was the only new thing in her regimen (no new meds, disease states, etc.).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient described the actual injection of the vaccine as painful, and pain at the injection site has continued since vaccination. Two days after vaccination (8/7/18) patient developed redness around the injection site, which was still present at time of reporting. Two days after that (8/9/18), patient developed severe itching around injection site which has not resolved as of time of reporting.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Injury associated with device, Scratch, Underdose
Clinical narrative: RN started to inject MMR vaccine into patient's left thigh, IM, and patient kicked, dislodging needle. Not all of the vaccine was administered, and needle scratched skin of left thigh with a pin sized scratch during dislodgement. Guardian was informed that dose needed to be repeated because not all of vaccine was administered, either repeated today or in 1 month. Guardian chose to have dose repeated in 1 month and an appointment was made.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: Patient complains of a painful and burning rash on her upper, center back. The rash is comprised of six small, round, red bumps. Her skin appears irritated around the bumps. Patient reports pain from touch and clothing at the site of rash. Patient denies pruritis. Her primary care physician's office was closed for the day when she presented to the pharmacy. We were able to get ahold of Dr. on his personal number. He prescribed Valacyclovir 1g 3 times per day for 7 days. She is to be examined at his office tomorrow (8/10/18). I also recommended, and she purchased, OTC Lidocaine 4% cream. Patient reports that she has been immunized with ZOSTAVAX in the past, but I do not have the date recorded at the pharmacy. She told me that she was planning to babysit her four-month-old grandchild this week, and I advised against it.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Dizziness, Fall, Gait disturbance, Herpes zoster
Clinical narrative: Patient complains of a painful and burning rash on her upper, center back. The rash is comprised of six small, round, red bumps. Her skin appears irritated around the bumps. Patient reports pain from touch and clothing at the site of rash. Patient denies pruritis. Her primary care physician's office was closed for the day when she presented to the pharmacy. We were able to get ahold of Dr. on his personal number. He prescribed Valacyclovir 1g 3 times per day for 7 days. She is to be examined at his office tomorrow (8/10/18). I also recommended, and she purchased, OTC Lidocaine 4% cream. Patient reports that she has been immunized with ZOSTAVAX in the past, but I do not have the date recorded at the pharmacy. She told me that she was planning to babysit her four-month-old grandchild this week, and I advised against it.