chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urticaria
Clinical narrative: Patient received 3 vaccines around 1045AM. I returned to the exam room about 4 minutes later with a copy of vaccine record - patient was dressed and had his winter coat on - no issues noted. Around 11AM - patient and mother are at registration area - checking out - patient is crying, and scratching his body - clerk called triage nurse. Patient was given BENADRYL. Face swollen and body red, hot with hives EPIPEN Jr. administered approximately 1110 AM. Ambulance called to Health Center. Patient and mother transported to ECU.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Mobility decreased, Pain in extremity
Clinical narrative: The patient stated that she experienced severe discomfort and pain and had trouble utilizing her arm. She decided to consult with her physician. The doctor concluded there was nothing that could be done, it's possible the shot was given too high, but there was no conclusion other than just giving it time to heal.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre (Documented and Treated) (Has had Flu vaccine for past 5-10 years with no previous problems).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Limb mass, Pain, Swelling
Clinical narrative: Patient came to clinic on 11/14/18, she reports the afternoon after receiving the PNEUMOVAX vaccine she reportedly had a lump on her inside of her left forearm she reports it was swollen, red and painful and there was a red streak down her arm below this lump. She showed RN on 11/14/18 this area, the area still had swelling about 1/2 cm high and 3 cm by 3 cm area, it was not red or painful. The RN received a call on 11/27/18 reporting that she now having pain in the same arm this time on the back of her arm from the elbow to the shoulder, there was no swelling or red area. Her physician was contacted.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Musculoskeletal pain
Clinical narrative: Pain started after shot. No redness/inflammation. Initial bruise for a few days but pain still persists. Described as more shoulder pain especially w/heavy lifting.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Red and swollen left arm - hot to touch - very painful - about 6-7". MD treating with Prednisone.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Hypoaesthesia, Lip swelling, Pain in extremity, Pyrexia
Clinical narrative: Fever 101.0 on 11/10/18 in the office per mom, pt c/o HA, sore arm after injection swollen lips and both arms numbness.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Rash
Clinical narrative: Rash same day vaccine was administered, and affected area got bigger by t he end of the day. Patient went to ER and was diagnosed with cellulitis. ER prescribers did not confirm its vaccine related.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received approximately 10 years ago before the date of reporting). On 1st August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, pain burning and vesicular rash. The patient was treated with Steroids. On an unknown date, the outcome of the headache was unknown and the outcome of the pain burning and vesicular rash were not recovered/not resolved. It was unknown if the reporter considered the headache, pain burning and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced headache and also experienced burning rash in center of back, along hip and up to breast and also along hairline on the scalp. The patient described rash as pimple like and looks like chicken pox. The patient reported rash has been treated with steroids so far but has not resolved. The reporter did not consent to follow-up. The patient declined follow up with physician and declined to provide demographics. The patient stated that, the physician did report this to the Centers for Disease Control and Prevention (CDC) already.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received approximately 10 years ago before the date of reporting). On 1st August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, pain burning and vesicular rash. The patient was treated with Steroids. On an unknown date, the outcome of the headache was unknown and the outcome of the pain burning and vesicular rash were not recovered/not resolved. It was unknown if the reporter considered the headache, pain burning and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced headache and also experienced burning rash in center of back, along hip and up to breast and also along hairline on the scalp. The patient described rash as pimple like and looks like chicken pox. The patient reported rash has been treated with steroids so far but has not resolved. The reporter did not consent to follow-up. The patient declined follow up with physician and declined to provide demographics. The patient stated that, the physician did report this to the Centers for Disease Control and Prevention (CDC) already.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Redness, large wheal 11.5x7.5cm, warm to touch and painful to left deltoid.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient reported on 11/28/2018 to have redness in the arm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Bone pain, Dyspnoea, Headache, Musculoskeletal pain
Clinical narrative: Felt like I couldn't get enough air in my left lung. Left arm above my elbow, shoulder blade, shoulder and joints in the area were very sore and ached. Fairly severe headache. It took about 4 hours for 1,000 mg Ibuprofen to make my headache go away, although the pain in my shoulder and collar bone area still hurt upon movement. I didn't feel in danger, except on my own I monitored my ing breathing for awhile.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Felt like I couldn't get enough air in my left lung. Left arm above my elbow, shoulder blade, shoulder and joints in the area were very sore and ached. Fairly severe headache. It took about 4 hours for 1,000 mg Ibuprofen to make my headache go away, although the pain in my shoulder and collar bone area still hurt upon movement. I didn't feel in danger, except on my own I monitored my ing breathing for awhile.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia, Speech disorder
Clinical narrative: 3 year old who presented to hospital with the inability to ambulate, speech disturbances and fever.  Workup underway with MRI and LP. Results pending. Symptoms began morning after receiving Influenza vaccine.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: The injection was very painful, it felt like it was too high on my left arm and hit something. Shortly after the injection, I was having aching, then I was unable to fully use my arm even to take my scrubs off. I have pain when I move my arm lifting small items, closing the car door, shampooing my hair. Difficult to have a good night sleep and get out of bed, as my left arm continues to give me pain. Pain continues everyday and it has been over 1 month since receiving the shot.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Product administered at inappropriate site, X-ray normal
Clinical narrative: The injection was very painful, it felt like it was too high on my left arm and hit something. Shortly after the injection, I was having aching, then I was unable to fully use my arm even to take my scrubs off. I have pain when I move my arm lifting small items, closing the car door, shampooing my hair. Difficult to have a good night sleep and get out of bed, as my left arm continues to give me pain. Pain continues everyday and it has been over 1 month since receiving the shot.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: This spontaneous report was received from the pharmacist and refers to a 56 year old male patient. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 31-OCT-2018, the reporter stated that when he was attempting to vaccine the patient with PNEUMOVAX 23 lot # R018735, expiration date: 06-APR-2020 (dose was not reported) for prophylaxis, the "finger flange" on the syringe broke (it was clean break and no cracks noted to the syringe). The pharmacist removed the broken syringe and vaccinated successfully the patient with a new PNEUMOVAX 23, (dose, indication, route of administration, lot # and expiration date were not reported) for prophylaxis. It was also reported that the product would not be collected by the reporter, as it was hazardous and he did touch the patient. The outcome of the syringe broke was reported as recovered/resolved. Relatedness between the breakage of syringe and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an office manager in charge of vaccine storage referring to a child (reported as vaccine for children (VFC)) of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 25-OCT-2018, the patient was vaccinated with improperly stored GARDASIL 9 (lot # 1586749 and expiration date 31-FEB-2021; route, strength, dose and frequency were not reported) for prophylaxis after the second temperature excursion which occurred on 24-OCT-2018. No patients received the improperly stored GARDASIL 9 between the first excursion and the second one. No adverse effects were reported. The vaccine was exposed to temperature below 32 Fahrenheit (-13.46 Fahrenheit) for 16 minutes. The previous excursion was 47 Fahrenheit to 77 Fahrenheit (47.6 Fahrenheit) for 15 hours. The call was because of a data logger.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the patient's wife, referring to her husband, a 79 years old patient of unknown gender with congestive heart failure. Information about medical history and concomitant therapy was unknown. On 11-DEC-2014, the patient was vaccinated with PNEUMOVAX 23 (1 injection (1 dosage form), route reported as injection; strength, frequency, lot# and expiration date were unknown) for prophylaxis (Product use in unapproved population). On 26-OCT-2017, the patient was vaccinated with PREVNAR 13 for prophylaxis.
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. On an unspecified date in October 2018, the patient received first dose of PREVNAR 13 (manufacturer unknown) (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. On 16-NOV-2018, the patient mistakenly received second dose of PREVNAR 13 (manufacturer unknown) (lot # W11305, expiry date: 30-APR-2020; strength, dose, frequency and route were not reported) instead of PNEUMOVAX 23, intramuscularly for prophylaxis, due to an order entry error. No adverse effects were reported. No product quality complaint involved.
Age: 34.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 34 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided. On an unspecified date in November 2016 (reported as "2 years ago"), the patient was vaccinated with a dose of GARDASIL 9) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Laboratory test normal
Clinical narrative: This spontaneous report was received from a physician via a field employee refers to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, units, frequency, lot # and expiration date unknown) for prevention HPV. On an unknown date the patient experienced severe fatigue. On an unknown date the patient was tested for everything and all results came back negative. The outcome of fatigue was unknown. The causality of the event fatigue was not reported. No PQC (product quality complaint) was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 19-OCT-2016 the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2012, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In or about 2015, the patient was treated by a physician at an office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 27-NOV-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # R007991, expiration date on 18-OCT-2019, orally, for prophylaxis (strength, dose and anatomical location were not reported). The vaccine was improperly stored at a temperature between 32°F to 35°F during a time frame of 30 minutes and between 47°F to 77°F for 30 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012116: US-009507513-1811USA012115.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 27-NOV-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # R007991, expiration date on 18-OCT-2019, orally, for prophylaxis (strength, dose and anatomical location were not reported). The vaccine was improperly stored at a temperature between 32°F to 35°F during a time frame of 30 minutes and between 47°F to 77°F for 30 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012111: US-009507513-1811USA012116.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 27-NOV-2018, the patient was vaccinated with an improperly stored dose of VAQTA lot # R013859, expiration date on 14-JUN-2019, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). The vaccine was improperly stored at a temperature between 32°F to 35°F during a time frame of 30 minutes and between 47°F to 77°F for 30 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012115: US-009507513-1811USA012111.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: Client come to health unit requesting a flu vaccine. Flu vaccine sheet reviewed with client for contraindications and clue vaccine was administered at 1400. Client stayed for 10 mins of observation in front lobby of health clinic. At 1409, RN went to check on client and client reported 5/10 sharp pain above left eye and that eye "felt sluggish." Client also reported SOB. Client was escorted to bed room and VS taken at 1410 BP 114/79 HR- 64 PO2- 99% on RA RR-21 and T-97.4 degrees F. Client then reported 4/10 chest tightness/pressure just below the top of the sternum. 1411 6L of O2 face mask was administered to client. 1412 cap refill and heart sounds assessed and lung clear. 1415 VS BP 106/71 HR- 62 PO2 99% on 6L O2 face mask RR-21 and A&O x4. Client continued to complain of SOB, chest pain and headache. 1418 EMS was initiated. 1423 VS BP 129/74 PO2 99% on 6L O2 face mask RR-20 HR-65. 1428 EMS arrived, report given and care transferred. EMS took client out for additional testing at 1437 and reported EKG clean. Client refused EMS transfer and RTW at 1455.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Vertigo
Clinical narrative: Sudden, severe vertigo.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Flushing, Rash erythematous
Clinical narrative: The patient developed a flat, erythematous, confluent rash on the chest and upper back about 5 minutes after the vaccine was given. She appeared flushed. She did not have any hives, shortness of breath, dysphagia, itching of her lips, trouble swallowing or wheezing. She was given 50 mg of BENADRYL and monitored for 35 minutes afterwards. The redness and rash improved. She did not develop any other symptoms. She was advised to take another dose of BENADRYL in 4 hours. She is to go to the ER if she develops any further hives, SOB, wheezing, trouble swallowing. Her mother drove her home.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Patient described a rash/hives appearing below the injection site about 30 minutes afterwards. Patient stated it resolved the next day.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site oedema, Injection site pruritus, Injection site reaction, Rash papular
Clinical narrative: She developed little red bumps at the injection site immediately after her vaccine. She was seen on 11/29/18 because the erythema became larger, (12x12 cm) with edema and mildly pruritic. She had a local reaction last year as well and went to Urgent care and received Prednisolone. Dr. consulted with a local allergist, who recommended giving Prednisolone 2 mg/kg the day of vaccination prior to the vaccine and the day after to avoid reactions.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccine positive rechallenge
Clinical narrative: She developed little red bumps at the injection site immediately after her vaccine. She was seen on 11/29/18 because the erythema became larger, (12x12 cm) with edema and mildly pruritic. She had a local reaction last year as well and went to Urgent care and received Prednisolone. Dr. consulted with a local allergist, who recommended giving Prednisolone 2 mg/kg the day of vaccination prior to the vaccine and the day after to avoid reactions.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 101.4, chills, body aches.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient noticed numbness/weakness in both arms/hands and legs/feet and finally resolved after 1.5 months.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Fainted after the shot, did not fall or hit on fall. Given some drink and got recovered after 10-15 minutes.
Age: 10.0
Sex: U
Vaccine: FLU4, HPV9
Symptoms: Fall, Loss of consciousness
Clinical narrative: Passed out, fall on her head, have to bring physician to check for concussion. Evaluated for and other signs and symptoms for seizure. Observed in the room for 10-20 minutes, finally recovered given lot of fluid.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant referring to a currently 23 year old female patient. The patient's concomitant medication included Vitamin D3. The patient had penicillin allergy and SULFA allergy. The patient had no medical history. On 23-FEB-2018, the patient received the first dose of GARDASIL 9 (intramuscular; strength, lot# and expiration date were not reported) for prophylaxis. On 14-MAY-2018, the patient received the second dose of GARDASIL 9 (intramuscular; strength, lot# and expiration date were not reported) for prophylaxis. On 28-SEP-2018, the patient received the third dose of GARDASIL 9 (intramuscularly in left deltoid, lot# R002345, expiration date was 16-NOV-2020; strength was not reported) for prophylaxis. On an unknown date in 2018, the patient experienced pain at the injection site. On an unknown date in 2018, the patient developed a "bump or cyst" at the injection site. A physician saw the patient on 26-OCT-2018. On the same day, the patient reported she was feeling better and the bump was smaller but she continued with discomfort at the injection site when she slept on her left arm. On the same day, the physician reported there was a 1.5 cm cyst at the injection site and there was no real tenderness with pressure at the injection site. The physician prescribed an unspecified dose of ibuprofen and told the patient to massage the cyst. The physician was unsure if this was a cyst or reaction from the immunization. No lab test was performed. The patient had a follow up appointment on 09-NOV-2018. The outcome of the events was reported as recovering. The causality between the events and GARDASIL 9 was not reported.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Exposure during pregnancy, Headache, Nausea
Clinical narrative: This spontaneous prospective pregnancy report was received from a 31-year-old female patient who was reporting on herself. The patient pertinent medical history included asthma and unspecified heart problems. The patient had allergy to latex and experienced drug reaction to DEMEROL. The patient was vaccinated with GARDASIL when she was at age 17, 18 and 19 (captured in MARRS # 1811USA012530). The patient was taking unspecified prenatal medication. At the time of the report the patient was 29 weeks and 5 days pregnant. The patient became pregnant with estimated last menstrual period (LMP) of 08-APR-2018 (calculated based on subtracting 29 weeks and 5 days of gestation age from the date of the report) end estimated delivery date of 13-JAN-2019. The pregnancy outcome was pending and fetal outcome was unknown. On 02-NOV-2018, the patient was supposed to receive diphtheria toxoid, pertussis acellular vaccine (manufacturer unknown) to protect the baby from whooping cough but instead she was vaccinated with GARDASIL 9 (lot number, expiration date, dose and strength were not provided) by shot in the left arm. After receiving GARDASIL 9, she started to experience nausea, weakness (unspecified) and headache. The patient reported that the office stated the GARDASIL 9 was in the diphtheria toxoid, pertussis acellular vaccine box (manufacturer unknown). At the time of the report, the outcome of the events was reported as not recovered. The reported did not provided causality assessment between the events and suspected therapies. This is one of the two reports from the same reporter who is also the patient. Sender's Comments: US-009507513-1811USA012530.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via field representative referring to an 1 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date (at the age of 1 year), the patient was vaccinated with VARIVAX (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. The physician informed that on 16-NOV-2018, the patient came into the office for something unrelated (unspecified). The patient mentioned that she had a rash on her right thigh and had been there since receiving the shot with varicella VARIVAX at the age of one year. The patient had not been to the doctor or emergency room and had not received treatment for the adverse event. The event was not life-threatening. The outcome of rash was unknown. Causality assessment was not provided. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: PPV
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. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 19-NOV-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012550 and expiration date: 25-JAN-2020 (dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported. The administered dose of vaccine was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (20.3 Celsius) for 22 hours. Digital data logger was involved. There were no previous excursions reported. Sender's Comments: US-009507513-1811USA012584: US-009507513-1811USA012585: US-009507513-1811USA012586.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 20-NOV-2016, the patient's healthcare provider at a health care facility administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 15-DEC-2016, the patient was treated by a physician at the same facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 27-NOV-2018 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-SEP-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-NOV-2016, the patient was treated by a healthcare provider at a health clinic for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2014, a physician at an office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In or about 2014, the patient was treated by the same physician. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a 31-year-old female patient who was reporting on herself. The patient pertinent medical history included asthma and unspecified hear problems. The patient had a drug reaction to DEMEROL and allergy to latex. No information regarding the patient's concomitant medication was provided. On unknown date in 2004, 2005 and 2006 (reported also as when she was the age of 17 years old, 18 years old, and 19 years old), the patient was vaccinated with doses of GARDASIL (lot number, expiration date, route of administration and dose were not provided). No adverse effects were reported. The outcome of inappropriate schedule of product administration and no adverse event is unknown. This is one of the two reports from the same reporter who is also the patient. Sender's Comments: US-009507513-1811USA001939.
Sex: U
Vaccine: PPV
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. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 19-NOV-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012550 and expiration date: 25-JAN-2020 (dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported. The administered dose of vaccine was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (20.3 Celsius) for 22 hours. Digital data logger was involved. There were no previous excursions reported. Sender's Comments: US-009507513-1811USA009749: US-009507513-1811USA012585: US-009507513-1811USA012586.
Sex: U
Vaccine: PPV
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. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 19-NOV-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012550 and expiration date: 25-JAN-2020 (dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported. The administered dose of vaccine was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (20.3 Celsius) for 22 hours. Digital data logger was involved. There were no previous excursions reported. Sender's Comments: US-009507513-1811USA009749: US-009507513-1811USA012584: US-009507513-1811USA012586.
Sex: U
Vaccine: PPV
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. There was no information about the patient's medical history, concurrent conditions, and concomitant medications provided. On 20-NOV-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012550 and expiration date: 25-JAN-2020 (dose, site and route of administration were not reported) for prophylaxis. No adverse effects were reported. The administered dose of vaccine was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (20.3 Celsius) for 22 hours. Digital data logger was involved. There were no previous excursions reported. Sender's Comments: US-009507513-1811USA009749: US-009507513-1811USA012584: US-009507513-1811USA012585.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself, a 65-year-old female patient who received PREVNAR 13, (lot number and expiration date unknown) at the left arm, via an unspecified route of administration on 06Nov2018 at 11:00 at a single dose for immunisation. The patient stated that she got it because about 2 years ago, she got the PNEUMOVAX for immunization. Medical history included diabetes mellitus (reported as diabetic) from 2017 and ongoing, irritable bowel syndrome, acupuncture, and histamine reaction. The patient was told that she was diabetic and she wanted it to be less than 7 as it was way up before that. She took supplements to manage her glucose. The patient stated that in her records, it was documented that she has irritable bowel syndrome. She states that she has thrown up since and has gut pain. The patient got acupuncture below the curve of her left arm for irritable bowel syndrome and that one vein bubbled up 3/4 of inch. The patient stated that she was told that she had a histamine reaction, and she was bruised up from the reaction until 2 days ago. Concomitant medication included ANTRONEX tablet ongoing since Oct2018; the patient's nutritionist told her that whenever she got cold symptoms/sneezing or coughing to take this. The patient also took other unspecified whole food supplements and vitamins. On 06Nov2018, the patient got panic attacks at the site of a needle and she experienced sweats and chills. The patient stated that she was fatigued on an unspecified date in 2018 after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was administered and that she slept for the whole day. She had another appointment that she was supposed to go to that day and did not attend it. The patient stated that on 07Nov2018, she was disoriented and had pain in her left shoulder. On 07Nov2018, she stated that all over her shoulder was a big red rash that lasted for 10 days, and she had nausea. She states that on 12Nov2018, she was throwing up and had diarrhea. The patient tried to resolve the disorientation when she went to her last appointment on 19No2018. She stated that the left shoulder pain resulted in red rash. They did not give her an antihistamine or anything for it. The patient had doctor's appointment for acupuncture and she mentioned the adverse events but she stated that they were not listening. The patient had constipation on an unspecified date. The patient underwent lab tests and procedures on 06Nov2018 which included HgBa1c: 7.8, Liver panel: Normal, Chem 7: Normal, Iron: abnormal low, Vitamin D: 17.9, abnormal. She stated that the doctor told her that she needs a daily iron supplement. She states that the doctor told her that her vitamin D range is supposed to be 30-100. Pain in left shoulder recovered on an unspecified date. Outcome of big red rash, panic attacks and chills was recovering; while outcome of sweats, nausea, vomiting, diarrhea and constipation was not recovered. The outcome of the other events was unknown. Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Irritability, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 67-year-old female patient received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on 15Jun2018 at a single dose for immunisation. Medical history included heart racing. Concomitant medication included TENORMIN (50 mg tablet) for heart racing. On 15Jun2018, the patient experienced extreme nausea, weakness, terrible irritability and chills. The patient just didn't feel good and it just made her lay down for about three days. No treatment was received for the events. The outcome of the events was recovered on 17Jun2018. Information on the lot/batch number has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Local swelling and redness as well as tenderness near the injection site. Treatment with ice and CLARITIN. Started treatment today. Will follow up with patient on Monday.
Age: 53.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Off label use
Clinical narrative: Patient is a 53 year old male who was given this vaccine off licence (label). He didn't have any adverse reaction to the vaccine.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red traveled across chest and to left side up face and into hairline. Red areas not raised, no SOB. BENADRYL 25mg P.O. administered 9:03, red areas calmed slightly pt observed for 2 hours reddness and swelling w pain at site remained x3 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER AND CHILLS.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Generalized Itchy Rash x 1 month.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER AND CHILLS.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: The night of 6/18/18, the patient experienced fever, malaise and chills that required him to lie down. The vaccine was administered in the afternoon.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to touch.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Widespread bumpy rash across entire chest, lasting 2 weeks.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever, malaise and chills started about 12 hours post vaccine administration. They did not interfere with patient's activities.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: On 11/27/2018 patient woke up and felt a little under the weather. This is fairly common for SHINGRIX. On 11/28 when she woke up though she noticed redness on her arm and later in the day she noticed a red streak going a little ways down her arm. On 11/29 she came into the pharmacy and showed her arm to the pharmacist and the pharmacist recommended that she see her doctor. She saw her doctor on 11/30 and said that her arm is not infected and that she will be fine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 03-AUG-2011, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 11-AUG-2013, the patient was treated by a physician at an internal medicine office for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema
Clinical narrative: REDNESS ON SITE OF INJECTION/CHILLS.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Erythema, Induration, Mass, Pain
Clinical narrative: Left arm with hard lump 50 x 50 mm, 30 x 30 mm bruised area in center, with 60 x 25 mm area of redness, warm to touch, painful.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Skin warm
Clinical narrative: Left arm with hard lump 50 x 50 mm, 30 x 30 mm bruised area in center, with 60 x 25 mm area of redness, warm to touch, painful.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Within 3 hours, felt extreme pain in both arms just resting, especially the shingles, moving arms was very painful. About 4 1/2 hours after I was shivering, chills and aches in my entire body, could not stop shaking and twitching. Massive headache. Entire night was awake, every hour taking temperature, was 100.3-100.5 till 9 am. then went down to 99. (My body temp is usually low, 97.) Aches and chills eventually calmed down, headache still awful, went back to bed by 10:30 a.m. slept till 3:30 pm. Spent the rest of the evening exhausted. Now on day two I'm still having a low temp fever of 99, but body aches, chills, headache etc gone. Able to get back to my work although feeling weak and a bit foggy.