chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Memory impairment, Nervousness, Palpitations
Clinical narrative: Withing 5 days had a severe episode of insomnia, which she had never experienced in her life. 10 later protruding neck glands, & very painful lymph nodes.  Trouble with simple tasks, could not recall basic piano notes/chords. 26 days later debilitating  insomnia returned and this time lasted nightly for almost 5 weeks. Sleeping very little and saying she "forgot" how to sleep. Didn't matter how tired she was, she would not fall asleep. She was baffled and could not figure out what/why this was happening. She refused to take naps for fear of being even more awake at night.  Sleeping finally improved after much research and giving her anti inflammatories such as Turmeric. However, she continues to have a "racing heart" beat, excessive worry, nervousness which she never had before.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt is under the age of one and was given Kinrix. No signs or symptoms of any reaction. Provider notified and mother.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 10/14/2019 Grandmother noticed redness, swelling, and warmth to touch at injection site around 10:00 PM.  Grandmother applied ice pack to injection site and surrounding swollen area.  Grandmother and patient arrived in clinic again 8/16/19 to have arm observed.   On 8/16/19 at 10:27 AM, I observed upper left arm was swollen about 10 inch diameter area, redness, pain, and warm to touch at the site.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Chills
Clinical narrative: chills for 3 hrs until i took Ibuprophin
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site warmth, Pain, Pyrexia, Swelling
Clinical narrative: Aches, fever, fatigue lasting two days. Swelling and pain, excessive heat at injection site lasting ten days. Fatigue still present today.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: the evening of shingrix shot patient had flu-like symptoms, fever & chills that lasted 24 hours.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chills, Contusion, Dizziness, Erythema
Clinical narrative: Severe brusing (still healing over 2 weeks later), red arm below the bruise, arm pain for days, severe flu like symptoms: body aches, chills, dizziness, anxiety lasting 2-3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: Severe brusing (still healing over 2 weeks later), red arm below the bruise, arm pain for days, severe flu like symptoms: body aches, chills, dizziness, anxiety lasting 2-3 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received PPSV23 vaccination on 08/14/19.  Since then, he has had painful, expanding area of erythema on the left upper arm.  No fevers.  No nausea, no vomiting.  He otherwise feels well.  The arm is sore to touch.  He has not taken any medication for it. Assessment/Plan:  Diagnoses and all orders for this visit:  Postimmunization reaction, initial encounter  Left upper arm pain  Patient has an exaggerated, but likely normal reaction to the pneumococcal vaccine.  Doubt cellulitis.  Recommended cool compresses to the arm and over-the-counter acetaminophen as needed for pain.  Return precautions were discussed.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Patient explained that he had chills, muscle pain, and soreness throughout the left side of his body.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Tremor
Clinical narrative: Vaccine was administered on Saturday 8/3/19; patient states about 36 hours following vaccine, patient began shaking severely. Went to ER, shaking subsided within about 5 hours. Was kept for observance for 2 days at hospital, Patient reports all tests came back normal.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncopal reaction related to the HPV vaccine.  Recovered well with fluids and food.  Remain in the clinic for about 30 minutes and was able to leave in good standing with his father.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: It was red and swollen. The Dr. prescribed cefdinir capsule 300 mg.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness
Clinical narrative: passed out / checked by DR /  closed monitored / offered fluids / went home with a friend in stable condition.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administered every five years for 65 plus year olds; No adverse effect reported; Information has been received from a nurse via a company representative, referring to an unknown number of 65 plus years old patients(gender unknown). The patients' pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.      On unknown dates, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (once every 5 years; dose, route, batch/lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). The reported called to get the price of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and stated it was very expensive especially since it was administered every five years for 65 plus year olds. No adverse effect was reported.
Sex: U
Vaccine: MMR
Symptoms: Antibody test positive, Extra dose administered
Clinical narrative: No adverse effects; the patient received a dose ofMMR II on 10/08/2002/the patient received another dose of MMR II on 07/18/2019; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. Concomitant therapy included sterile diluent.  On 08-OCT-2002, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, injection site, route of administration, albumin status, lot # and expiration date were not provided) for prophylaxis. On 24-AUG-2015, the patient had positive titers. On 18-JUL-2019, the patient was vaccinated with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(rHA) lot # S006647 (lot number was assessed as valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)), expiration date: 05-MAR-2021 (exact dose, injection site and route of administration were not provided) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: The patient received unspecified dose of vaccine and experienced anaphylaxis; This spontaneous report was received from a nurse and referring to a female patient of unknown age. The information about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history were unknown by the reporter.  On an unknown date (reported as when the patient was a child), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection as measles, mumps rubella prevention (strength, and dosage schedule were not reported, route, lot number and expiration date were unknown by the reporter). The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with Merck sterile diluent (dosage schedule, route, lot number and expiration date were not reported).  Later, the patient experienced anaphylaxis (anaphylactic reaction). The nurse stated that she had very few details of this event as it was on patient's youth. It was reported that the patient sought unspecified medical attention and received an unspecified treatment for the event. On an unknown date, the patient was recovered from anaphylactic reaction.  Furthermore, it was unknown by the reported if any laboratory diagnostic or studies were performed.   The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and anaphylactic reaction was considered as related; and between the sterile diluent and anaphylactic reaction was not provided.  The event anaphylactic reaction was considered to be life threatening by the investigator and upon internal review was considered to be medically significant.   This is one of two cases received from the same reporter
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; the patient received her first dose of Gardasi 3 years ago; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose for prophylaxis (route of administration, injection site, lot # and expiration date were not reported). On 09-AUG-2019, the patient visited the office to receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, 1 dose for prophylaxis, lot# N017832, expiration date: 16-NOV-2016 (route of administration and injection site were not reported). No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: One unspecified patient recieved one dose of GARDASIL 9 and fainted after receiving the injection; This spontaneous report was received from a physician via company representative regarding a 12 year- old male patient. The patient's concurrent conditions, drug reactions, allergies, and concomitant therapies were unknown by the reporter.   On 09-AUG-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, one dose, for routine vaccination (prophylaxis) (dose, frequency, route of administration, lot number and expiration date were unknown by the reporter). Therefore, on the same date, the patient fainted (syncope) after receiving the injection It was unspecified which dose in the series the patient received. Also, it was unknown by the reporter if treatment was given for the event, and if  laboratory diagnostics and studies were performed.  On the same date, the patient recovered from the syncope event.  The causal relationship between the event syncope and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event syncope was considered to be medical significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; The patient received the first dose of GARDASIL 9 on an unspecified date in February 2018 and the second dose on 13-AUG-2019; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date in February 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N022584, expiration date: 15-JUN-2020; and on 13-AUG-2019, with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  lot # R009615, expiration date: 07-DEC-2020 (route of administration and anatomical location were not provided for any dose) as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects reported; an unspecified 19 year old patient was inadvertently administered a pediatric dose, 0.5 ml, of VAQTA; This spontaneous report was received from a nurse practicioner referring to a 19 year old patient of unknown gender.  The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 07-AUG-2019, the patient was vaccinated with a pediatric dose (0.5 ml) of hepatitis a vaccine, inactivated(VAQTA) lot # S007769 and expiration date 24-JUL-2020 (frequency and route were not provided) for prophylaxis (incorrect dose administered). No adverse events were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: injection site reaction 8 hours after vaccine was administered; rash; pain; This spontaneous report was received from a pharmacist refers to a 77 year old female patient. Concomitant therapies included verapamil, azathioprine, aspirin, fluticasone propionate(FLOVENT), atorvastatin, hydroxychloroquine sulfate, sertraline hydrochloride 100 mg, albuterol sulfate(VENTOLIN) and insulin glargine (BASAGLAR). Information on pertinent medical history and drug reactions or allergies were reported as none. On 22-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S002582, expiry date: 10-AUG-2020, route, dose and anatomical location was not reported) for prophylaxis (reported as vaccine). On 22-JUL-2019, 8 hrs after vaccination, the patient had injection site reaction. The patient used warm compresses until the rash and pain went away (injection site reaction, injection site pain and injection site rash).The reporter had requested for lot check (Reporter concern). On 25-JUL-2019 (reported as 3 days after the vaccine was administered), patient was recovered from the events injection site reaction, injection site pain and injection site rash. Causality assessment was not reported.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Local reaction, Peripheral swelling
Clinical narrative: arm got terrible swollen; This case was reported by a consumer and described the occurrence of swelling arm in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in 2013).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm. The patient was treated with prednisone. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received a dose of Shingrix about 8 months ago before reporting date and had severe reaction of arm got terribly swollen. The physician put the patient on short dose of prednisone. The patient was afraid to get or not to get the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient informed the pharmacist who had given the vaccine, about the event but he did not get any answer about why the he got such localized reaction in the arm.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: tiredness; low grade fever; body aches; This case was reported by a consumer and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced tiredness, low grade fever and general body pain. On an unknown date, the outcome of the tiredness, low grade fever and general body pain were unknown.   It was unknown if the reporter considered the tiredness, low grade fever and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received a dose of Shingrix last night of reporting date and was experiencing low grade fever, body aches and tiredness. The reporter inquired if those events caused by the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Myalgia, Pyrexia
Clinical narrative: tiredness; low grade fever; body aches; This case was reported by a consumer and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced tiredness, low grade fever and general body pain. On an unknown date, the outcome of the tiredness, low grade fever and general body pain were unknown.   It was unknown if the reporter considered the tiredness, low grade fever and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received a dose of Shingrix last night of reporting date and was experiencing low grade fever, body aches and tiredness. The reporter inquired if those events caused by the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: low grade fever; muscle soreness; shivering/cold; feeling cold; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced low grade fever, muscle soreness, shivers and feeling cold. On 6th August 2019, the outcome of the low grade fever, muscle soreness and shivers were not recovered/not resolved. On an unknown date, the outcome of the feeling cold was unknown.   The reporter considered the low grade fever and muscle soreness to be related to Shingrix. It was unknown if the reporter considered the shivers and feeling cold to be related to Shingrix.  Additional information received were as follows: The patient stated that she received her 2nd dose of Shingrix on left deltoid, the day before the reporting date. The patient reported that on the reporting date, she started to experience muscle soreness, low-grade fever, shivering and being cold. The advised symptoms may last 2-3 days but if they persist or become bothersome to please follow up with her physician. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Myalgia, Pyrexia
Clinical narrative: low grade fever; muscle soreness; shivering/cold; feeling cold; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced low grade fever, muscle soreness, shivers and feeling cold. On 6th August 2019, the outcome of the low grade fever, muscle soreness and shivers were not recovered/not resolved. On an unknown date, the outcome of the feeling cold was unknown.   The reporter considered the low grade fever and muscle soreness to be related to Shingrix. It was unknown if the reporter considered the shivers and feeling cold to be related to Shingrix.  Additional information received were as follows: The patient stated that she received her 2nd dose of Shingrix on left deltoid, the day before the reporting date. The patient reported that on the reporting date, she started to experience muscle soreness, low-grade fever, shivering and being cold. The advised symptoms may last 2-3 days but if they persist or become bothersome to please follow up with her physician. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Localized rashes at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) for prophylaxis.   On 2nd August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional information received were as follows: The patient experienced localized rashes at injection site and when she reported it was 4 by 4 inches.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Myalgia, Pain in extremity
Clinical narrative: arm really hurts; muscles really hurts; little upset tummy; tired; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, muscle pain, upset stomach and tiredness. On an unknown date, the outcome of the pain in arm, muscle pain, upset stomach and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain, upset stomach and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient reported pain in arm and muscle really hurts and a little upset tummy and tired.
Sex: U
Vaccine: DTP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swollen arm; Arm bright red; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine at an unknown dose and Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine and Shingles vaccine, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to DTP vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received DTP boosters and the shingles vaccine a couple of years ago and patient arm was so swollen and bright red.  Get your pneumonia vaccine and tetanus also.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: red rash; This case was reported by a pharmacist via sales rep and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. In August 2019, less than 6 months after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by field reporter. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient got a red rash from Shingrix in the last 2 days. The reporter did not consent to follow-up. This case had been linked to the case US2019143171, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Disability, Somnolence, Vaccine positive rechallenge
Clinical narrative: Complete lack of energy; slept for 24 hrs almost straight; incapacitated; This case was reported by a consumer via interactive digital media and described the occurrence of disability in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of disability (for tolerance of 1st dose, refer case US2019AMR142110).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), feeling of total lack of energy and sleepiness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the disability and sleepiness were recovered/resolved and the outcome of the feeling of total lack of energy was unknown.   It was unknown if the reporter considered the disability, feeling of total lack of energy and sleepiness to be related to Shingrix.  Additional details were received as follows: The patient's age at vaccination was not reported. Previously, the patient had received vaccine but was not effective as Shingrix.  The patient was incapacitated for 3 days, had complete lack of energy and was slept for 24 hours almost straight. The patient had prescription of Shingrix but vaccine was received late because patient's physician warned that Shingrix could cause flu like symptoms for 4 days. The patient considered that, Shingles was way worse than a mild case of flu and received vaccines. The patient complained to GlaxoSmithKline that they were misleading the patient's as the side effects listed were massive and debilitating. It is one of two cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: pain; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported through online chat that the patient experienced pain and swelling after 1st dose of Shingrix. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Musculoskeletal pain, Pain
Clinical narrative: shingles; blisters/painful blisters; painful; burning sensation; soreness in the right shoulder; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date unknown) for prophylaxis.   The patient's past medical history included chickenpox (at age 7 or 8 yrs old). Previously administered products included Zostavax (received 5  to 6 year ago).   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, 1 days after receiving Shingrix, the patient experienced shoulder soreness. On 2nd August 2019, the patient experienced shingles, blister, pain and burning sensation. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the shingles, blister, pain and burning sensation were not recovered/not resolved and the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shingles, blister, pain, burning sensation and shoulder soreness to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and developed soreness in the right shoulder that lasted for approximately 2 to 3 days.  On 2nd August 2019, 17 days days after vaccination, the patient experienced shingles, blister, pain and burning sensation. The patient stated that he noticed blisters forming on his right hip and stated that it was painful and experienced a burning sensation.  The patient stated that the area on his hip that was affected was approximately 3 or 4 square inches and there were a few lesions.  The patient stated that he went to his dermatologist and was diagnosed with Shingles.  The physician prescribed Valacyclovir and a steroid. The reporter consented to follow up. Emergency room visit required. The caller did not provide any additional information and did not have additional contact information for the health care professional at the time of the call.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: red rash; This case was reported by a pharmacist via sales rep and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. In August 2019, less than 6 months after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by field reporter. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient got a red rash from Shingrix in the last 2 days. The reporter did not consent to follow-up. This case had been linked to the case US2019AMR148399, reported by the same reporter.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site rash, Rash
Clinical narrative: Rash; This case was reported by a other health professional via call center representative and described the occurrence of widespread rash in a 5-year-old male patient who received HAV (Havrix) (batch number PA99T, expiry date 7th June 2021) for prophylaxis.   On 6th August 2019, the patient received Havrix. On 6th August 2019, immediately after receiving Havrix, the patient experienced widespread rash. The patient was treated with prednisone and ibuprofen (Motrin). On 6th August 2019, the outcome of the widespread rash was recovered/resolved.   It was unknown if the reporter considered the widespread rash to be related to Havrix.  Additional information received were as follows: The office administrator reported that the patient experienced a rash immediately following a dose of Havrix. The rash was described as spreading from left shoulder across the entire chest.  The healthcare professional noted that the patient was immediately treated with Prednisone and Motrin.   The rash completely resolved within approximately ten minutes. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: general malaise; soreness in injection arm; This case was reported by a consumer via call center representative and described the occurrence of general malaise in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced general malaise and pain in arm. On an unknown date, the outcome of the general malaise and pain in arm were recovered/resolved.   It was unknown if the reporter considered the general malaise and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on unknown arm. Caller is the patient's husband. The patient developed soreness in the injection arm and general malaise following the vaccine. The reporter gave consent to follow up.  The reporter did not provide any additional details.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Mass, Pain in extremity
Clinical narrative: lump; redness; pain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number Y2D94, expiry date 21st September 2021) for prophylaxis.   On 2nd August 2019, the patient received Shingrix (intramuscular) .5 ml. On 3rd August 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, fatigue and erythema of extremities. On 5th August 2019, the patient experienced mass. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovering/resolving and the outcome of the fatigue was recovered/resolved and the outcome of the mass was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue and erythema of extremities to be related to Shingrix. The reporter considered the mass to be probably related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The next day of vaccination the patients arm was red and painful, but nothing terrible and she felt very fatigued for 2 days. The fatigue had resolved and her arm was less painful and only a little red. The day before reporting she noticed a lump under her clavicle. She happened to be at her dermatologist's office, so she had her dermatologist look. Her dermatologist said the lump was probably due to Shingrix and to wait a month and see what happens. The reporter gave consent to follow up. Emergency room visit required.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: LPN gave the DTAP/POLIO dose of the PENTACEL combination. No HIB was injected. Patient tolerated injection well with no physical adverse reactions. Plan to vaccinate patient with HIB vaccine and then return to the PENTACEL schedule.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Joint effusion, Ultrasound scan
Clinical narrative: Hip effusion
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Acute kidney injury, Blood urine present, Condition aggravated, Eczema, Gait disturbance
Clinical narrative: FIRST SIGN PEEING BLOOD AFTER VACCINE  ACUTE KIDNYE FAILURE DIAGNOSED WITH IGA AND CHRONIC EXZEMA SO BAD COULD BARELY WALK
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: IgA nephropathy
Clinical narrative: FIRST SIGN PEEING BLOOD AFTER VACCINE  ACUTE KIDNYE FAILURE DIAGNOSED WITH IGA AND CHRONIC EXZEMA SO BAD COULD BARELY WALK
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash
Clinical narrative: Grandfather called clinic on 8/16 with a report of granddaughter having a "rash" and redness to left leg and chest.  Description was "redness that started around neck and faded away at chest." Denied having individual lesions, nothing on head.  Did not come into clinic for staff to observe.  Staff encouraged grandfather to take granddaughter to Health Center for evaluation if rash worsened or if he had other concerns. He stated his wife was immunocompromised but didn't know why.  Reported hx of anaphylaxis reactions to soda ash.  Grandfather stated he would seek care if rash worsened.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Angioedema
Clinical narrative: angioedema/anaphylaxis
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Vitreous floaters
Clinical narrative: Shingles vaccine. Floaters in left eye and eye pain in eyeball. Going to specialist today
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: Rash to left thigh where injection site is at. No induration and no fever. Pt did no have any other symptoms. Advise to apply ice to site and give Benadryl every 6 hrs and Motrin every 6-8 hrs for two days
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Induration, Lip exfoliation, Nausea
Clinical narrative: Her arm swelled and was red and hard at 2 days post administration. SHe went back to the pharmacy and they told her this was a typical reaction and use ice and Benadryl if needed.  she then went on to get, chills, body aches, swollen arm, nausea and the skin on her lips peeled off.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: Her arm swelled and was red and hard at 2 days post administration. SHe went back to the pharmacy and they told her this was a typical reaction and use ice and Benadryl if needed.  she then went on to get, chills, body aches, swollen arm, nausea and the skin on her lips peeled off.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient stated that within 24-48 hours she had some swelling to her right cheek as well as upper right lip. Patient stated that this lasted for 2 days and denied any pain or itching.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: pain, swollen, rash and redness at injection site
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Dyspnoea, Fatigue
Clinical narrative: Symptoms started at 6 am the morning after vaccination. Back, hip, and knee pain with increasing fatigue. As the morning progressed her skin started to hurt and spiked a fever with chills. She left work early due to the increasing severity of symptoms. At around 5 pm on the night after the vaccine, she was nauseous and the pain became severe enough she was having trouble drawing in a deep breath. She developed a sore throat and severe chills shortly after and she went to bed. In the middle of the night she woke up in a sweat like her fever had broken. On 08/16/2019 she felt better with mild soreness in her back and her skin, a slight headache, and a few hot flashes but no chills. The first injection was given on 06/05/2019 with only muscle soreness at the injection site for two to three days. The second dose was given on 08/14/2019 just past the two month mark.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hot flush, Impaired work ability, Injection site pain, Middle insomnia
Clinical narrative: Symptoms started at 6 am the morning after vaccination. Back, hip, and knee pain with increasing fatigue. As the morning progressed her skin started to hurt and spiked a fever with chills. She left work early due to the increasing severity of symptoms. At around 5 pm on the night after the vaccine, she was nauseous and the pain became severe enough she was having trouble drawing in a deep breath. She developed a sore throat and severe chills shortly after and she went to bed. In the middle of the night she woke up in a sweat like her fever had broken. On 08/16/2019 she felt better with mild soreness in her back and her skin, a slight headache, and a few hot flashes but no chills. The first injection was given on 06/05/2019 with only muscle soreness at the injection site for two to three days. The second dose was given on 08/14/2019 just past the two month mark.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Night sweats, Oropharyngeal pain, Pain of skin, Pyrexia
Clinical narrative: Symptoms started at 6 am the morning after vaccination. Back, hip, and knee pain with increasing fatigue. As the morning progressed her skin started to hurt and spiked a fever with chills. She left work early due to the increasing severity of symptoms. At around 5 pm on the night after the vaccine, she was nauseous and the pain became severe enough she was having trouble drawing in a deep breath. She developed a sore throat and severe chills shortly after and she went to bed. In the middle of the night she woke up in a sweat like her fever had broken. On 08/16/2019 she felt better with mild soreness in her back and her skin, a slight headache, and a few hot flashes but no chills. The first injection was given on 06/05/2019 with only muscle soreness at the injection site for two to three days. The second dose was given on 08/14/2019 just past the two month mark.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Flushing, Swelling face
Clinical narrative: Patient given Menveo #2 vaccine at approximately 9:50 a.m., remained in clinic with provider, APNP until approximately 10:15 a.m. for remainder of visit,  with no adverse reactions to vaccine. Patient left clinic with parent and returned at 11:30 a.m. with Grandmother reporting facial puffiness and flushing starting at approximately 11:00 a.m.  Patient vitals normal, provider evaluated patient for throat or mouth swelling, injection site, any other sign of allergic reaction,  with no complaints.  Provider conferred with ER and with pediatric department and was advised to send patient to ER for evaluation.  Pt was taken to ER by Grandmother.
Sex: F
Vaccine: MMR
Symptoms: Blood HIV RNA below assay limit, CD4 lymphocytes decreased, HIV infection, Measles antibody negative, Mumps antibody test negative
Clinical narrative: HIV infection; Still's Disease; titers for Measles Mumps and Rubella came back negative; titers for Measles Mumps and Rubella came back negative; titers for Measles Mumps and Rubella came back negative; This spontaneous report as received from a pharmacist refers to a 56-year-old female patient. The patient's concomitant therapies were not reported. She did not have any drug reactions or allergies.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (also reported as or MMR, it was unknown which vaccine the patient might have received) (lot number, expiration date, dose and frequency were not reported), administered subcutaneously to prevent Measles Mumps and Rubella.  On an unspecified date, the patient was diagnosed with Human immunodeficiency virus (HIV) (condition also reported as pertinent medical history). It was unknown if she received treatment for HIV. On an unspecified date, the patient was diagnosed with Still's Disease (condition also reported as pertinent medical history), as a treatment she received etanercept (ENBREL). On 22-MAR-2019, the patient's CD4 was 502 and 26% and her HIV load was not detectable. On 08-MAY-2019, the patient's titers for Measles, Mumps and Rubella came back negative. She saw an infectious disease physician. At the reporting time, outcome of all events was not reported.  Causality between the events and the suspect therapy was not reported.   Upon internal review, the events of HIV infection and Still's disease were considered to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative, Still's disease
Clinical narrative: HIV infection; Still's Disease; titers for Measles Mumps and Rubella came back negative; titers for Measles Mumps and Rubella came back negative; titers for Measles Mumps and Rubella came back negative; This spontaneous report as received from a pharmacist refers to a 56-year-old female patient. The patient's concomitant therapies were not reported. She did not have any drug reactions or allergies.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (also reported as or MMR, it was unknown which vaccine the patient might have received) (lot number, expiration date, dose and frequency were not reported), administered subcutaneously to prevent Measles Mumps and Rubella.  On an unspecified date, the patient was diagnosed with Human immunodeficiency virus (HIV) (condition also reported as pertinent medical history). It was unknown if she received treatment for HIV. On an unspecified date, the patient was diagnosed with Still's Disease (condition also reported as pertinent medical history), as a treatment she received etanercept (ENBREL). On 22-MAR-2019, the patient's CD4 was 502 and 26% and her HIV load was not detectable. On 08-MAY-2019, the patient's titers for Measles, Mumps and Rubella came back negative. She saw an infectious disease physician. At the reporting time, outcome of all events was not reported.  Causality between the events and the suspect therapy was not reported.   Upon internal review, the events of HIV infection and Still's disease were considered to be medically significant.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was vaccinated with improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a 3 unspecified patients of unknown age and gender. The patients' medical history, concomitant medications, drug reactions or allergies were not reported.  On 07-AUG-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # R031626, expiration date: 01-NOV-2020 (strength, route of administration and anatomical location were not provided) for prophylaxis. Temperature excursion was 11. Fahrenheit (F) during a time frame of 1 hour and 36 minutes which was recorded by a data logger. No previous temperature excursions were involved. No adverse effects were reported.   Follow up information was received form the nurse concerning a 3 years old female patient on 15-AUG-2019.   Patient demographics were updated.   On 07-AUG-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, lot number R031626, expiration date: 01-NOV-2020 in the right arm (strength was not provided) for prophylaxis.   The reporter stated that three doses of varicella virus vaccine live (oka/merck)(VARIVAX) were accidentally administered before realized the digital data logger noted an out of range temperature. Upon realized the out of range temperature measures were taken to address it staff was educated on excursion process and ways to prevent this from happening in the future.  This is one of three cases received by the same reporter.; Sender's Comments:  US-009507513-1908USA006567: US-009507513-1908USA006568: