chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash morbilliform, Selective eating disorder
Clinical narrative: 11/4/17 1:00 AM until ~11:00AM 11/5/17 Fever between 100.2-102.6. ~1:00PM on 11/5/17, measles like rash appeared and remained until 11/13/17. Rash covered head, neck torso, buttocks, all extremities, and dorsum surfaces of feet and hands. Tylenol was given on 11/4/17 at 12:00 PM, 5:00PM, and 8:00PM. Fever between 99.0-99.8 came and went from 12:00PM 11/5/17 until 9:00PM 11/6/17. Patient was examined by Dr. on 11/7/17 and as per Dr., patient had vesicles in his throat. As per Dr., patient's symptoms were possibly caused by a reaction to the MMR vaccine that patient received on 10/26/17. Pt refused to eat acidic foods such as oranges and tomatoes from 11/5/17 until 11/10/17. Patient also presented with symptoms of irritability, avoidance of firm foods (bread, meat, apples), and difficulty sleeping.
Age: 0.92
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Lymphadenopathy, Pain in extremity
Clinical narrative: 24 hours after shot, I had significant pain in left arm, some in right arm. Appeared to have swollen lymph glands in left arm. Low energy, then I developed joint pain throughout in the PM. Slept 4 hours during the day. I am a healthy older person with no history of reactions, and am an active member of a Fire Department. Symptoms have decreased significantly by 1900 tonight. No other symptoms.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Severe shoulder pain felt the day after receiving influenza vaccine and ongoing 4+ weeks later. I get the vaccine each year but this time it was given higher up my arm than previous years (near the shoulder).
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Head discomfort, Injection site pain, Insomnia, Tenderness, Wrong drug administered
Clinical narrative: Tender leg, inability to sleep, holding her head a lot, soreness at injection site, she was given the tDap instead of tdap.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site swelling, Local reaction
Clinical narrative: Injected FLUAD in Left Arm Deltoid, once injected patients arm swelled up at injection site (looked like a bruise). This took place in a matter of seconds. Patient stated she did have allergic reactions to a couple of antibiotics (penicillin and sulfa) and bovine. Patient waited for about 10-15 minutes before leaving pharmacy, she stated she was feeling fine and the injection caused a local reaction.
Sex: U
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a child patient who received FLULAVAL QUADRIVALENT (batch number Z39X5, expiry date unknown). In November 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. In November 2017, less than a week after receiving FLULAVAL QUADRIVALENT, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not reported to anyone previously. The age at vaccination was not reported. It was reported that, five school-age patients passed out following vaccination with FLULAVAL QIV at different sites, during the week of 6th to 10th November 2017. No further information was provided. This is 1 of 5 cases reported by the same reporter.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of difficulty breathing in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine and an unknown time after starting VENTOLIN HFA and ADVAIR, the patient experienced difficulty breathing. The patient was treated with VENTOLIN HFA and ADVAIR. On an unknown date, the outcome of the difficulty breathing was unknown. It was unknown if the reporter considered the difficulty breathing to be related to Influenza vaccine. Additional information provided as follows: The age at vaccination not reported. The patient experienced breathing problems 2 weeks ago from the date of reporting. The reporter stated that it could be related to the weather changing or a reaction to the flu shot received. The patient also stated that he was using VENTOLIN more for breathing recovery because of congestion or trouble breathing. The reporter has agreed to have GlaxoSmithKline's Safety team follow-up with them via postal mail. This case was not associated with product complaint.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of local reaction in a child male patient who received FLUARIX Quadrivalent (batch number TS5F3, expiry date 9th June 2017). On 18th October 2016, the patient received FLUARIX Quadrivalent .5 ml. On an unknown date, several days after receiving FLUARIX Quadrivalent, the patient experienced local reaction, injection site erythema, injection site swelling and injection site tenderness. The patient was treated with diphenhydramine, cephalexin and hydrocortisone. On an unknown date, the outcome of the local reaction was recovered/resolved and the outcome of the injection site erythema, injection site swelling and injection site tenderness were unknown. The reporter considered the local reaction, injection site erythema, injection site swelling and injection site tenderness to be possibly related to FLUARIX Quadrivalent. Additional details were reported as follows: No concomitant medications or vaccines were reported. The patient received FLUARIX QIV vaccine in the left deltoid. The patient was not seen in the office for the FLUARIX reaction. This was reported by the parent after the fact and the reaction was no longer visible. The patient was given Diphenhydramine, Cephalexin, and hydrocortisone ointment as treatment. This case was linked with cases and, reported by the same reporter. The reported batch number (TD5F3) of FLUARIX QIV did not exist and was updated to TS5F3, as per the sales database. This case is one of the 5 cases (US2017169224, US2017169193, US2017169230 and US2017169229) reported by the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Injury associated with device, Needle issue, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of needle injury in a neonate patient who received ENGERIX B PEDIATRIC (batch number P7EE2, expiry date 9th March 2019). On 27th October 2017, the patient received ENGERIX B PEDIATRIC (intramuscular) .5 ml. On 27th October 2017, immediately after receiving ENGERIX B PEDIATRIC, the patient experienced needle injury and needle issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the needle injury, needle issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the needle injury to be related to ENERGERIX B PEDIATRIC. Additional details were reported as follows: The age at vaccination was not reported. The nurse administered dose intramuscularly to newborn baby, after removal of syringe, found needle had separated from prefilled syringe halfway in infant's injection site. Needle removed with no harm to patient. At the time of reporting, reporter had the defective product.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site scab
Clinical narrative: A week after injection, patient had red spot appear in the area and complained of pain in the muscle up to joint. Patient came to pharmacy today to report and states now pain is only where spot is. Has been present for 3 weeks. Referred to doctor. Patient also states it had scabbed over and had been scratching it.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Injection site pain/painful to touch beginning a few hours after injection. Took ALEVE for pain without relief. No swelling/redness/oozing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Patients mother states at 3 pm she noticed patients lip begin to swell and his left eye. Doctor ordered BENADRYL and Prednisone in office. Patient is being sent to ER for further assessment.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in (L) arm (entire arm) (same as injection arm) no redness, warmth. Paresthesia in hand lasting several days.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Possible cellulitis treated with a course of antibiotics return instructions given.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Discomfort, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left deltoid area- no issues until day after vaccine. - Woke up with discomfort - went back to bed. Woke this morning with swollen red left arm. 33 cm of erythema, swelling, increased warmth, tender to palpation. BP: 12/78. Pulse: 102. Resp: 18. Temp: 99.3 degrees F (37.4 degrees C). TempSrc: Temporal. Weight: 64.1 kg (141 lb 5 oz). No ice or MOTRIN or BENADRYL given. Currently on Amoxicillin for sinusitis. Treatment-Can take 600 mg of MOTRIN as needed every 6 hours for pain and swelling. Can do BENADRYL-50 mg - no more than twice a day. Try cool compresses.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Left deltoid area- no issues until day after vaccine. - Woke up with discomfort - went back to bed. Woke this morning with swollen red left arm. 33 cm of erythema, swelling, increased warmth, tender to palpation. BP: 12/78. Pulse: 102. Resp: 18. Temp: 99.3 degrees F (37.4 degrees C). TempSrc: Temporal. Weight: 64.1 kg (141 lb 5 oz). No ice or MOTRIN or BENADRYL given. Currently on Amoxicillin for sinusitis. Treatment-Can take 600 mg of MOTRIN as needed every 6 hours for pain and swelling. Can do BENADRYL-50 mg - no more than twice a day. Try cool compresses.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear discomfort
Clinical narrative: Information has been received from a pharmacist referring to a 76 years old female patient. The patient had no drug reaction or allergies, medical conditions. There was no illness at time of vaccination. On 24-OCT-2017, the patient was vaccinated with the first dose of ZOSTAVAX (dose unknown; lot# N025387, expiration date 12-DEC-2018) subcutaneously in left arm to prevent shingles. Later that same day (reported as "a few hours after administration of vaccine"), the patient developed a pressure and popping in the ears. While pressure was annoying, it was not life threatening. The patient was instructed if it become worse to go to the emergency room. On 25-OCT-2017 (reported as "the next day"), the pharmacy called the patient and the symptom had resolved on its own. No further action was taken, other than calling to verify if any symptom had ever been reported in the past. It was confirmed that no similar symptom of pressure had been reported previously and informed to the patient. The causality between the event and ZOSTAVAX was unknown.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, IPV, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 12- year-old male patient who received BOOSTRIX (batch number 22X79, expiry date 14th December 2019). Co-suspect products included ENGERIX B ADULT (batch number 53P39, expiry date 12th February 2020). Concomitant products included IPOL. On 14th November 2017, the patient received BOOSTRIX and the 1st dose of ENGERIX B ADULT 1 ml. On 14th November 2017, not applicable after receiving BOOSTRIX and unknown after receiving ENGERIX B ADULT, the patient experienced overdose and adult product administered to child. In November 2017, the patient experienced pain in arm. On 16th November 2017, the patient experienced headache. In November 2017, the outcome of the pain in arm and headache were recovered/resolved. On an unknown date, the outcome of the overdose and adult product administered to child were unknown. It was unknown if the reporter considered the pain in arm and headache to be related to BOOSTRIX. It was unknown if the reporter considered the headache to be related to ENGERIX B ADULT. Additional information was reported as follows: This case was reported by pharmacy intern. The patient received BOOSTRIX in right arm and ENGERIX B in left arm. The 12 year old patient received an adult dose of ENGERIX-B which led to overdose and adult product administered to child. In November 2017, 2 days after vaccination, the patient developed a headache that lasted several hours. In November 2017, less than week, after receiving BOOSTRIX, the patient developed arm soreness in right arm. Both adverse events have resolved. The reporter did not collect IPOL lot or expiration.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, IPV, TDAP
Symptoms: Drug administered to patient of inappropriate age, Headache, Overdose, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 12- year-old male patient who received BOOSTRIX (batch number 22X79, expiry date 14th December 2019). Co-suspect products included ENGERIX B ADULT (batch number 53P39, expiry date 12th February 2020). Concomitant products included IPOL. On 14th November 2017, the patient received BOOSTRIX and the 1st dose of ENGERIX B ADULT 1 ml. On 14th November 2017, not applicable after receiving BOOSTRIX and unknown after receiving ENGERIX B ADULT, the patient experienced overdose and adult product administered to child. In November 2017, the patient experienced pain in arm. On 16th November 2017, the patient experienced headache. In November 2017, the outcome of the pain in arm and headache were recovered/resolved. On an unknown date, the outcome of the overdose and adult product administered to child were unknown. It was unknown if the reporter considered the pain in arm and headache to be related to BOOSTRIX. It was unknown if the reporter considered the headache to be related to ENGERIX B ADULT. Additional information was reported as follows: This case was reported by pharmacy intern. The patient received BOOSTRIX in right arm and ENGERIX B in left arm. The 12 year old patient received an adult dose of ENGERIX-B which led to overdose and adult product administered to child. In November 2017, 2 days after vaccination, the patient developed a headache that lasted several hours. In November 2017, less than week, after receiving BOOSTRIX, the patient developed arm soreness in right arm. Both adverse events have resolved. The reporter did not collect IPOL lot or expiration.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Exostosis, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: 8 days after injection, developed severe pain in right shoulder both at rest and with movement. Severe reduction in range of motion. Unable to sleep at night. No relief from acetaminophen 500mg and 200mg ibuprofen every 6 hours. Unable to perform daily household work due to pain.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain, X-ray limb abnormal
Clinical narrative: 8 days after injection, developed severe pain in right shoulder both at rest and with movement. Severe reduction in range of motion. Unable to sleep at night. No relief from acetaminophen 500mg and 200mg ibuprofen every 6 hours. Unable to perform daily household work due to pain.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Limb mass, Pain in extremity
Clinical narrative: I was 5 weeks pregnant when I received this vaccine. I noticed a painful lump in my left inner thigh two days later. I miscarried at 7 weeks pregnant on 10/20/17.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 48-year-old patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. The reporter stated that on 23-OCT-2017, the patient received a pediatric dose of RECOMBIVAX HB 2.5/0.5 (units not provided), injection (lot #, expiration date, route of administration were not reported) for prophylaxis. No adverse effects were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, who referred to a 60-year-old female patient. The patient did not have any allergies, birth defects, relevant medical history and illnesses at time of vaccination. On 14-JUN-2017, the patient was vaccinated with ZOSTAVAX 1 dose, subcutaneously in the left arm (lot# M041510 and expiration date: 27-JUL-2017) for prevention of Herpes Zoster. The patient's concomitant medications included lansoprazole and estradiol (YUVAFEM). On 14-JUN-2017, within 12 hours from the vaccination, the patient experienced a large, itchy, bothersome rash around the injection site. It was reported that the rash started out small and grew to 3 inches in diameter. The rash was slightly raised and itched. The patient did not seek for medical attention but she used hydrocortisone to relieve the itching, which lessened the itch, but it did not go away. It was also reported that the experience did not require drug treatment prescription. The rash lasted approximately 7 days - resolved on approximately 21-JUN-2017. At the time of the report the patient did not recover from the itching. The relatedness between the events and the suspect therapy was not reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 04-AUG-2017, the patient was vaccinated with an expired dose of PROQUAD rHA lot number M004891 and expiration date of 25-JUL-2017 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, referring to a 2 year old female patient. The patient's medical history and concurrent conditions were not reported.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) Lot number N013284 with expiration date on 10-OCT-2019. On 30-OCT-2017 at a private doctor's office/hospital, the patient was vaccinated with and improperly stored second dose of VARIVAX lot # N020015 with expiration date on 17-JUL-2019 in the left arm (administration route was not reported) for prophylaxis. It was reported that the vaccine was purchased with private funds. No adverse effects were reported. The reporting medical assistant stated that "per Merck vaccine's were still in a safe temperature" (unspecified temperature). The vaccine had a temperature excursion of -11.5 Celsius (C) during a time frame of 1 hour with 40 minutes and it was confirmed that no previous temperature excursions occurred.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 9 month old female patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot# N014945, expiration date 31-AUG-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 20-month-old male patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot# N014945, expiration date 31-AUG-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist via poison and drug center refers to a 63 year old female patient. The patient's medical history includes being fairly healthy. The patient's concomitant medication include "not a large drug profile". On 09-NOV-2017, the patient was vaccinated with expired ZOSTAVAX (strength, dose and frequency were not reported) lot # M032141 with expiry date 02-OCT-2017 for vaccine against herpes zoster. The outcome of expired product administered was unknown.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via poison and drug center refers to a 63 year old female patient. The patient's medical history includes being fairly healthy. The patient's concomitant medication include "not a large drug profile". On 09-NOV-2017, the patient was vaccinated with expired ZOSTAVAX (strength, dose and frequency were not reported) lot # M032141 with expiry date 02-OCT-2017 for vaccine against herpes zoster. The outcome of expired product administered was unknown.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Colitis ulcerative, Condition aggravated, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a nurse prescriber, and refers to a currently 43 year old female patient. No information was provided regarding the patient's concurrent conditions or concomitant medications; however, her medical history included ulcerative colitis. The patient had no drug reactions or allergies reported. On an unknown date,when the patient was young, she was vaccinated with M-M-R II for prevention of measles, mumps, and rubella (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced colitis ulcerative. The patient had been treated with HUMIRA. On a separate unspecified date, the same patient had measles, mumps, and rubella titers drawn and had low titers (rubella antibody negative) (antibody levels not provided). On 13-NOV-2017, the patient then received 1 dose of M-M-R II for prevention of measles, mumps, and rubella (route of administration, lot number and expiration date were not provided). At the reporting time, the patient had not recovered from colitis ulcerative and rubella antibody negative was unknown. Causality assessment between the events and M-M-R II was not provided. Upon internal review, the event of ulcerative colitis was considered to be medically significant.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a 75-year-old female patient with no medical history, concomitant medications, drug reactions nor allergies. On 13-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection, lot # N019983 with expiration date on 03-MAR-2019 (dose and route of administration were not reported). On 14-NOV-2017, the patient presented at the physician's office complaining of swollen, tender and sore arm. The patient also could not lift her arm at all. The physician recommended to treat the events with BENADRYL and ice as needed. The patient did not recover from the events at the time of the report. The relatedness between the events and PNEUMOVAX23 was not reported. The reporter considered the inability to lift the arm to be a significant disability/incapacity, as the patient had been written of the work for the week due to that event.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-JAN-2011, the patient was inoculated at a medical plaza with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-FEB-2014, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed acyclovir, prednisone, and gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 20-NOV-2017 from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 21-DEC-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed Acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 20-NOV-2017 from a lawyer and a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 25-MAR-2015, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-FEB-2016, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 20-NOV-2017 from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 19-FEB-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-OCT-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test abnormal, Cough, Electrocardiogram, Heart rate increased, Influenza like illness
Clinical narrative: I received the flu shot while at the doctor's office. Since and ongoing, I am experiencing flu like symptoms mimicking pneumonia. I am cold (all the time), coughing with phlegm expectorating, am in pain and am suffering malaise.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise, Nasopharyngitis, Pain in extremity, Productive cough
Clinical narrative: I received the flu shot while at the doctor's office. Since and ongoing, I am experiencing flu like symptoms mimicking pneumonia. I am cold (all the time), coughing with phlegm expectorating, am in pain and am suffering malaise.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Pain, Vomiting
Clinical narrative: Next day pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: Cellulitis with fever and chill. Patient went to Dr. the next day & was placed on amoxicillin 500mg 1 bid and ibuprofen 800 1 tid.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient presented to the emergency room due to rash. It started 10 minutes after getting flu shot. Has no history of prior allergy to influenza vaccine. Rash started on neck and face and spread after that. She had no throat closing, wheezing or SOB. Treated with IV SOLUMEDROL (125mg) and Famotidine 10 mg. Symptoms resolved, patient discharged and returned to work.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema
Clinical narrative: The right arm was red from the shoulder to the elbow.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt had soreness of injection site which has persisted x 2.5 months and pain is now extending up to her shoulder.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Discomfort, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Chronic achy pain, sometimes local, sometimes from top shoulder to elbow; sharp pain when moving certain ways; difficult to get comfortable in bed; dressing is sometimes problematic.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Started having itching within a few hours after vaccine administration that progressed to hives and difficulty breathing within 16-24 hours. Treated with EPIPEN and diphenhydramine at that time with a 10 day course of steroids. She states she has received the flu vaccine in previous years with no difficulty.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Myalgia
Clinical narrative: Muscle pain from shoulder to elbow, weakness.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Long lasting arm pain. back of arm above elbow.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX 23 in office and approximately 4hrs later had significant pain with chills overnight. Patient presented to urgent care and endorsed right arm swelling and pain, as well as fatigue. Patient took ibuprofen with some relief. MD instructed patient to use ibuprofen for pain, cetirizine for itching, ice packs, and elevate arm when resting. Patient followed up with PCP on 11/21 with decreased redness noted although right arm was still tender. Patient prescribed prednisone 20mg tablets take 2 tablets PO daily x 3 days.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Patient received PNEUMOVAX 23 in office and approximately 4hrs later had significant pain with chills overnight. Patient presented to urgent care and endorsed right arm swelling and pain, as well as fatigue. Patient took ibuprofen with some relief. MD instructed patient to use ibuprofen for pain, cetirizine for itching, ice packs, and elevate arm when resting. Patient followed up with PCP on 11/21 with decreased redness noted although right arm was still tender. Patient prescribed prednisone 20mg tablets take 2 tablets PO daily x 3 days.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Lacrimation increased, Peripheral swelling, Rash
Clinical narrative: Patient received PNEUMOVAX 23 vaccine in LD and influenza high dose vaccine in RD on 11/13.  On 11/15, patient called office stating "left arm swollen and warm to touch". Patient returned to office complaining of swollen arm, watery eyes, and rash.  Denied SOB, itching, chest pain, abdominal pain, vomiting, or wheezing. Patient stated reaction started on evening of 11/13. Patient noted to have mild redness of proximal left UE, around biceps area. Moderate swelling of upper arm to elbow, no evidence of cellulitis". Patient prescribed cetirizine and diphenhydramine.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Patient received PNEUMOVAX 23 vaccine in LD and influenza high dose vaccine in RD on 11/13.  On 11/15, patient called office stating "left arm swollen and warm to touch". Patient returned to office complaining of swollen arm, watery eyes, and rash.  Denied SOB, itching, chest pain, abdominal pain, vomiting, or wheezing. Patient stated reaction started on evening of 11/13. Patient noted to have mild redness of proximal left UE, around biceps area. Moderate swelling of upper arm to elbow, no evidence of cellulitis". Patient prescribed cetirizine and diphenhydramine.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Abdominal pain, Dizziness, Immediate post-injection reaction, Nausea, Pyrexia
Clinical narrative: Lightheaded immediately after receiving vaccine. Reports next 3 days: nausea, low grade fever, sharp abdominal pain if eating. States he took tylenol and omeprazole. Was not effective.
Age: 11.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Disorientation, Dizziness, Hyperhidrosis, Peripheral coldness, Syncope
Clinical narrative: Patient felt dizzy and fainted after her 3rd vaccine (varicella). Palms were sweaty, skin was cool. HR 60, BP 70/palp, SpO2 96%. Patient was responsive to voice commands within 30 seconds of fainting but was still disoriented. She was given some sips of water and moved to a supine position. BP was then 108/60, HR 60. Within 5 minutes her BP had returned to 120/70, HR 80, SpO2 98%. Patient rested and was closely monitored for another half hour, during which time she spoke to her father and her grandmother was at her side. Her father stated that she had been extremely anxious about getting the vaccine the night before and had not slept well. She has the same fear of needles that her father has, although this was not expressed prior to the injections. Sent home with her grandmother with instructions to speak with her primary care about the incident.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Asthenia, Myalgia, Pain in extremity
Clinical narrative: Patient complains of arm pain...mostly at night. This has not resolved itself. She also complained of muscle and joint pain and loss of strength and energy for 3 and 1/2 weeks after the vaccination. That has resolved itself, but the arm pain has not.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Weakness, fever, runny nose, cough lasted a week.
Age: 80.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3, TDAP
Symptoms: Asthenia, Chills, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: Weakness, fever, malaise, chills (1st week post vaccination). Still experiencing pain in legs, weakness in all limbs 3 weeks post-vaccination.
Age: 80.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3, TDAP
Symptoms: Pyrexia
Clinical narrative: Weakness, fever, malaise, chills (1st week post vaccination). Still experiencing pain in legs, weakness in all limbs 3 weeks post-vaccination.
Age: 80.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3, TDAP
Symptoms: Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Weakness, fever, malaise, chills (1st week post vaccination). Still experiencing pain in legs, weakness in all limbs 3 weeks post-vaccination.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: 4 x 5 cm welt on thigh, no pruritus, warm to touch, swelling and redness increased per parent from 11/10 to 11/11/2017. Advised Mom to give ZYRTEC 10 mg BID for next few days, also BENADRYL PRN until follow up.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Emp. received Varicella vaccine and state had local reaction of redness, raised and itchy. Reports it 11-20-17 at 12:45 and there is no redness, swelling there of at upper arm.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX lot # N020854 with expiration date on 31-JUL-2018 (strength, dose and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown), used to reconstitute the suspect vaccine. No adverse effect was reported. Reporter stated that the vaccines were stored between -14 Celsius degrees to -10 Celsius degrees for 30 hours 1 minute. On an unknown date, the vaccine underwent previous temperature excursion from -14 Celsius degrees to 10 Celsius degrees for 24 hours, -14 Celsius degrees to -10 Celsius degrees for 9 hours 25 minutes, -14 Celsius degrees to -10 Celsius degrees for 9 hours 29 minutes. The digital data logger was not involved. No product quality complaint was reported.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a 25-year-old female patient, who referred to herself. The patient's concurrent conditions included anxiety and depression. The patient was allergic to amoxicillin (+) clavulanate potassium (AUGMENTIN), sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA) and latex. On unknown dates in 2006, the patient received three doses of GARDASIL intramuscularly (lot# and expiration dates were not reported) as prevention of human papilloma virus (HPV). Concomitant medications included citalopram. On an unknown date in 2015, reported as approximately two years ago, the patient was diagnosed with an unspecified type of HPV. It was also reported, that on an unknown date, the patient had an abnormal pap smear. No treatment was provided for the events. The patient sought medical attention by contacting her physician. At the time of the report the patient did not recover from the reported events. No product quality complaint was involved. The relatedness between the events and the suspect therapy was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Decreased immune responsiveness, Herpes zoster, Herpes zoster oticus, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 13-JUN-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-APR-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and Ramsay Hunt Syndrome, a neurological disorder caused secondary to zoster infections. The patient also reported hearing loss and nonpulsatile tinnitus since being vaccinated with ZOSTAVAX (exact onset dates unknown). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, Ramsay Hunt Syndrome and hearing loss were determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 13-JUN-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-APR-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and Ramsay Hunt Syndrome, a neurological disorder caused secondary to zoster infections. The patient also reported hearing loss and nonpulsatile tinnitus since being vaccinated with ZOSTAVAX (exact onset dates unknown). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, Ramsay Hunt Syndrome and hearing loss were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 20-NOV-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 15-DEC-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-NOV-2015, the patient was treated by a physician at a hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles accompanied by post-herpetic neuralgia, a chronic condition of nerve damage and pain. The patient has been prescribed gabapentin, hydrocodone-acetaminophen, acetaminophen, hydrocodone bitartrate (NORCO), and lidocaine for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Malaise, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified manufacturer), via an unspecified route of administration on an unspecified date at single dose for pneumonia immunisation. The patient medical history and concomitant medications were not reported. Patient got pneumonia shot and 2 days later was very sick. It was turned out to be pneumonia and patient took 3 months to get over it. No follow-up attempts are possible. No further information is expected. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Burning sensation, Fatigue, Influenza like illness, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity started to receive 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 reporter stated that the paperwork from the pharmacy listed her dose of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) as 1mL (for clarification). On 28Sep2017, the patient experienced joint/hip pain, muscle pain, fatigue, flu-like symptoms, burning in legs and she was starting to get a sinus infection. Outcome of the event of burning in legs was recovered on an unspecified date in 2017, while outcome of the other events was unknown.