chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: PATIENT DESCRIBED PAIN AND SWELLING A FEW HOURS AFTER ADMINISTRATION. THE AREA TURNED ITCHY AND WARM TO THE TOUCH. PER PATIENT, THE AREA WAS ALSO SWOLLEN AND HARD. THE FIRST NIGHT SHE WAS NOT ABLE TO MOVE HER ARM BUT ON 12/12/19 SHE WAS ABLE TO GET BETTER RANGE OF MOTION. NOTIFIED PATIENT TO TRY TAKING BENADRYL OR ZYRTEC TO DECREASE THE SYMPTOMS THE LOOK TO BE AN ALLERGIC REACTION AT SITE OF INJECTION. NOTIFIED HER TO SEEK MEDICAL ATTENTION AS SOON AS POSSIBLE IF SYMPTOMS DO NOT RESOLVE OR GET WORSE. WILL CALL PATIENT TO FOLLOW UP TODAY TO SEE HOW SHE IS DOING.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: 12 days later I developed hives on my back, left arm and neck and my right foot and shin. They lasted for 10 days.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Myalgia, Nasal congestion, Nausea
Clinical narrative: Note: You do not have "Shingrix" on your drop-down menu so I had to select "unknown vaccine."    I received my 2nd dose of the Shingrix vaccine yesterday, 12/11/2019.  I received my 1st dose of Shingrix approximately 2.5 months ago on 09/24/2019,   I the same symptoms described below but not as severe.    After my 2nd dose of Shingrix, I had some more severe  adverse outcome regarding aches and pains all over my body, and a fever of 100 degrees, cold shivers, slightly nauseated stomach, head ache, stuffy nose, and muscle pain in my injection arm.    These severe symptoms started approximately 3 hours after the vaccine and reach the peak of pain that evening, approximately 12 to 24 hours after injection.  I still have all of these symptoms today but am feeling slightly better.  Important note:  I had all of the symptoms when I received the first dose of Shingrix on 09/24/19 but they were not as severe.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Note: You do not have "Shingrix" on your drop-down menu so I had to select "unknown vaccine."    I received my 2nd dose of the Shingrix vaccine yesterday, 12/11/2019.  I received my 1st dose of Shingrix approximately 2.5 months ago on 09/24/2019,   I the same symptoms described below but not as severe.    After my 2nd dose of Shingrix, I had some more severe  adverse outcome regarding aches and pains all over my body, and a fever of 100 degrees, cold shivers, slightly nauseated stomach, head ache, stuffy nose, and muscle pain in my injection arm.    These severe symptoms started approximately 3 hours after the vaccine and reach the peak of pain that evening, approximately 12 to 24 hours after injection.  I still have all of these symptoms today but am feeling slightly better.  Important note:  I had all of the symptoms when I received the first dose of Shingrix on 09/24/19 but they were not as severe.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash erythematous, Rash macular, Skin discolouration
Clinical narrative: The patient developed a macular rash on the face predominating around the cranium. The rash onset was within one minute after administration. The rash was erythematous at onset, it turned purple in color with time, and it decreased in intensity prior to the patient being discharged. The patient did not show any signs of anaphylaxis. There was no difficulty breathing. The rash did not spread to any other body part. The patient did not develop lethargy. The patient mantained stable vital signs.
Age: 49.0
Sex: M
Vaccine: FLUR4, HEP
Symptoms: Dizziness, Immediate post-injection reaction, Injection site swelling
Clinical narrative: Flublok provided to patient in right arm first.  Engerix B given in the left arm (1st of 3 doses).  Immediately after injection, patient's left deltoid began swelling up to a golf-ball size at the injection site.  Patient also began to feel dizzy.  Pharm D brought ice to help reduce swelling after having patient lie down on the floor to help dizziness.  Patient's PCP was called to advise.  Per PCP (who spoke to pt directly while in presence of PharmD), continue icing and pt can still receive subsequent doses of vaccine.  After lying down for 10 minutes, pt began feeling better.  He was able to walk on his own and return to work same day.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Local reaction
Clinical narrative: Painful lump on top of shoulder above injection site. No treatment.A month later, no pain. Small lump remains. Was told by an orthopedic surgeon that it was the result of the shot.She called it a local soft tissue reaction.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Anal incontinence, Hypoaesthesia, Paraesthesia, Urinary incontinence
Clinical narrative: Tingling in foot and thigh shortly (a few days)  after and pt thought nothing of it.   Went to ER on 19th and was transferred to hospital where she was inpatient 21st to the 28th. She was numb from the waist down and lost control of bowels and bladder,  Right side was the worst.  She is now back home recovering follow up with primary gained us the knowledge on 12/9   I called patient today
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye inflammation, Eye swelling, Scab, Scratch, Skin haemorrhage
Clinical narrative: On approximately 12/11/19 patient developed "scratch marks" and bleeding, scab spots on one side of his face (cheek area) and the other side of face "cheek area" looked like finger scratches.  On 12/12/19 the patient's face looked swollen.  The left eye was swollen and inflammed, but not itchy or tearing and no discharge.  Patient said vision was not impaired.  Patient did not scratch his face.  Patient said face was not itchy. Patient at no time had a fever or shortness of breath.  No eye pain.  No other part of the patient's body was affected.   This description is per patient's wife after consulting with husband.  This was per a phone conversation.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: On approximately 12/11/19 patient developed "scratch marks" and bleeding, scab spots on one side of his face (cheek area) and the other side of face "cheek area" looked like finger scratches.  On 12/12/19 the patient's face looked swollen.  The left eye was swollen and inflammed, but not itchy or tearing and no discharge.  Patient said vision was not impaired.  Patient did not scratch his face.  Patient said face was not itchy. Patient at no time had a fever or shortness of breath.  No eye pain.  No other part of the patient's body was affected.   This description is per patient's wife after consulting with husband.  This was per a phone conversation.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient states she initially had pain when the pneumonia vaccine was administered, as the day/night went on the pain radiated down her arm to her hands. By the next day she could barely lift her arm.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: patient had extreme pain in his left arm only a few hours after the shot
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site bruise, Administration site rash, Injection site warmth
Clinical narrative: Patient's arm was bruised at the site of administration and a rash appeared under the site of the administration. Rash felt warm to the touch and seemed to have spread to the patient's elbow. Patient came in 2 days after vaccine administration and was told to watch for further spreading and be seen by doctor as soon as possible. Pt reportedly was going to PCP the next morning.
Age: 63.0
Sex: M
Vaccine: FLUC4, TDAP, VARZOS
Symptoms: Anxiety, Asthenia, Condition aggravated, Fatigue, Feeling cold
Clinical narrative: Patient stated he felt cold, then he comment that he felt tired. Patient received the vaccine at approximately 3:40-3:45p. He was shivering prior to the vaccine and I asked him what was wrong and he said he was just really cold. We waited about 15-20min after the vaccine and still was the same. He was cognitive and was talking to me. We offered him water and a mint candy, but didn't want it. We called his son to see if he could come pick him up because he didn't seem as if he could drive with how anxious and shivering he was. This was about 4:10-4:159 and his son arrived about 4:30p.  When his son and daughter arrived, about 5 minutes later, he got weak and had shallow breathing. He wasn't responding to us. We called the ER and they arrived within 10-15min.
Age: 63.0
Sex: M
Vaccine: FLUC4, TDAP, VARZOS
Symptoms: Hypopnoea, Impaired driving ability, Unresponsive to stimuli
Clinical narrative: Patient stated he felt cold, then he comment that he felt tired. Patient received the vaccine at approximately 3:40-3:45p. He was shivering prior to the vaccine and I asked him what was wrong and he said he was just really cold. We waited about 15-20min after the vaccine and still was the same. He was cognitive and was talking to me. We offered him water and a mint candy, but didn't want it. We called his son to see if he could come pick him up because he didn't seem as if he could drive with how anxious and shivering he was. This was about 4:10-4:159 and his son arrived about 4:30p.  When his son and daughter arrived, about 5 minutes later, he got weak and had shallow breathing. He wasn't responding to us. We called the ER and they arrived within 10-15min.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Oropharyngeal pain, Tremor
Clinical narrative: Patient reported to RPh on 12/11/19 that 2nd dose of Shingrix given on 12/06/19 gave patient severe shivering and shaking, sore throat, and headache. RPh counseled patient that these are listed as possible side effects.  However patient felt they were adverse effects because it lasted 4 days (12/6-12/10) and was severe. Patient had to rest at home. Patient almost went to the ER but did not. Patient resolved with home OTC medication. Patient did not reach out to MD to consult. Patient requested this to be reported as an adverse event  Patient only had soreness at injection site after the 1st dose in 8/8/2019
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Oropharyngeal pain, Tremor
Clinical narrative: Patient received 2nd Shingrix dose on 12/06/19. Patient reported severe shivering, shaking, sore throat, and headache. Patient's wife also received same vaccine on 12/6 and both experienced same symptoms, although wife's were more severe to the point that patient almost took her to the ER but did not. He did not report the symptoms to his MD, nor to pharmacy until he was shopping at pharmacy on 12/11/19 and reported to RPh when he saw RPh. He stated it lasted from 12/6-12/10 and better on 12/11 with just injection site soreness. They took care of symptoms at home with OTC medications. RPh explained that these symptoms were listed in possible side effects.However patient wanted this to be reported as adverse effect because he felt it was severe. Both patient and wife had 1st dose on 8/8/19 and only had soreness at injection site. Lot#5552S, Expiration date 02/26/2022
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Haematoma, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness, pain, and swelling the size of a baseball at the injection site.  She went to the ER due to continued symptoms 2 days after the injection.  The clinician who treated her at the ER observed that the injection had been in the subcutaneous tissue rather than the muscle, causing a hematoma, per the patient's report to the pharmacy.  The doctor prescribed acetaminophen, ice, and cephalexin as treatment.  The patient reports she did not take the cephalexin because her symptoms were improving  before she could fill the prescription the next day.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient's husband called me to report the patient was experiencing redness swelling and itching at the injection site. They stated they did not have this reaction with the first vaccination. They were encouraged to put a cold compress on the site and continue to monitor. They were instructed to seek medical attention if the swelling continued to spread and become severe.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Erythema, Fatigue, Injection site discomfort, Injection site erythema
Clinical narrative: On the morning of December 7, 2019, Patient noticed pain & swelling of her Right upper arm where she received the vaccine. Her arm was red near the injection site and redness started to move over the next 24 hours. Pt felt fatigued & burning in arm. The area of discomfort and redness in upper arm seems to have stopped expanding, but is not yet resolving. She denies any pruritus in that area or anywhere else in the body. No swelling or itching of her throat. She was breathing comfortably in the office. No history of past reactions to vaccine. Has received flu vaccine in the past without incident. This was her first pneumococcal vaccine.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: On the morning of December 7, 2019, Patient noticed pain & swelling of her Right upper arm where she received the vaccine. Her arm was red near the injection site and redness started to move over the next 24 hours. Pt felt fatigued & burning in arm. The area of discomfort and redness in upper arm seems to have stopped expanding, but is not yet resolving. She denies any pruritus in that area or anywhere else in the body. No swelling or itching of her throat. She was breathing comfortably in the office. No history of past reactions to vaccine. Has received flu vaccine in the past without incident. This was her first pneumococcal vaccine.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Depressed level of consciousness, Immediate post-injection reaction, Injection site pain
Clinical narrative: reports immediate pain @ injection site which caused her to almost pass out, says did not happen w/ prev vaccines including prev HPV vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Rash
Clinical narrative: Patient had Shingrix vaccine, first dose 9/11/2019, second dose 11/12/2019. 3 weeks later she noted onset of rash which was later diagnosed as eczematous dermatitis. She does not have a history of eczema.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain of skin, Skin induration
Clinical narrative: That evening patient experienced reddness, soreness and a hardening of the skin. Mother reported giving Ibuprofen. Patient did report to mother that his arm "hurt". Patient came in Wednesday The 4th to have arm looked at. Nurse was unavailable and secretary told mother to have MD look at it or come back on later date. Patient and mother came on Friday the 6th and Nurse measured site on Left deltoid. It was 4 1/2 inches by 3 1/4 inches, reddness noted and warm to touch. Told Mother to given Ibuprofen or Tylenol and place cold packs to site for a few minutes throughout the day. Nurse also outlined area with a marker to show if reddness was increasing or decreasing. I called Mother on 12/9/19 to follow up and she said the reddness was "gone" and her son was fine and playing.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Patient had a very sore arm for 2 or 3 days after injection. It is now three months later and patient still has a sore arm. Has trouble sleeping on that side. Hurts when he sneezes. Hurts to push himself out of bed with that arm. Has tried Heat and cold therapy and has taken ibuprofen for 5-6 days, with little relief.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rash, Skin lesion, Urticaria
Clinical narrative: Round RASH Started on Right Cheek on 12/6/19. Started with Raised lesions on legs and buttock. Given Prelone & Benadryl. Hives should go away in a few days. Moisturize skin frequently. Will obtain Food Allergy Panel @ 1 yr WCC.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Wrong drug administered; This report was identified from a line listing obtained on request by the Company from the FDA (agency # 746590) under the Freedom of Information Act on 20-SEP-2018.   This spontaneous report refers to a 12 years old female patient. The patient's medical history included lymphadenopathy. The patient didn't have current illness or other medications.   On 06-SEP-2017, 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 # M032650, expiration date auto-generated as 31-MAR-2019, intramuscular in the right arm, strength and dose detail were unknown) for prophylaxis. Then, on the same day, she received the first dose of meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) (lot # R24748, intramuscular in the left arm, strength and dose detail were unknown). It was reported that meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) was given as an alternative to meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) or meningococcal ACYW conj vaccine (CRM197) (MENVEO) (wrong drug administered).  No adverse reactions were reported to this facility. Information about prescriptions, over-the-counter medications, dietary supplements or herbal remedies being taken at the time of vaccination was reported as none. There was no medical test and lab results related the events.    Follow-up information has been received from a registered nurse via FDA (agency # 746590) on 30-OCT-2019. This patient was not pregnant. The patient was allergic to sulfacetamide sodium.  Follow-up information has been received from a health care professional on 09-DEC-2019.  The healthcare worker wished to clarify that no adverse events had occurred with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given to the patient on the same day as meningococcal b rfhbp vaccine (e. coli) (TRUMENBA). It was reported meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) was given to the patient as alternative to meningococcal ACYW conj vaccine (CRM197) (MENVEO). The reporter stated that multiple unspecified college age patients received meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) as alternative to meningococcal ACYW conj vaccine (CRM197) (MENVEO). She stated that had been reported previously. No adverse events had taken place.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Allergy: Pneumococcal Vaccines; Information has been received on 21-NOV-2019, from medical records of a case in litigation (# 1806USA003312), concerning a currently 83-year-old male patient with medical history of chicken pox diagnosed in 1947 (at approx. 11 years of age), shingles and melanoma (treated with surgery) in 1986.   On 22-OCT-1993, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) injection (dose, route of vaccination, vaccination site, lot # and expiry were not specified) at a County Health Department for prophylaxis. Concomitant therapies included influenza virus vaccine (unspecified).   On an unknown date, the pt experienced allergy to pneumococcal vaccines. The outcome of the event was unknown. The event was considered to be related to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  All available medical records will be provided upon request.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1806USA003312:
Age: 25.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Pyrexia
Clinical narrative: Malaise, feverish, chest tightness, SOB.  Sent to ED for treatment.
Age: 25.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram, Malaise
Clinical narrative: Malaise, feverish, chest tightness, SOB.  Sent to ED for treatment.
Age: 25.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Pyrexia
Clinical narrative: Malaise, feverish, chest tightness, SOB.  Sent to ED for treatment.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: tenderness at injection site; nausea; headache; rashrash covering her entire upper arm where she got the injection; chills; fever; nerve painnerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder where she received the vaccine; Pain on left side/pain awful; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date with no side effects).   On 15th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site tenderness, nausea, headache, rash, chills and fever. On 20th November 2019, the patient experienced nerve pain and pain localized. In November 2019, the outcome of the injection site tenderness, nausea, headache, rash, chills and fever were recovered/resolved. On an unknown date, the outcome of the nerve pain and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, nausea, headache, rash, chills, fever, nerve pain and pain localized to be related to Shingrix.  Additional details were provided as follows: On 18th November 2019, the patients most of these side effects were gone by Monday  On the same date, the patient had acupuncture. On 29th November 2019, Wednesday, suddenly she started experiencing an awful pain. The patient said that it was not muscular pain, it was nerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder. This pain was located on her left side of the body where she received the vaccine.   The patient had massage therapy every 3 days and that's how they tracked down the nerve pain. She was pain free for two weeks but the pain is back again.  The pain was not as severe but it is a constant pain that she can't get distracted from. The reporter did not consent to follow-up. The outcome of injection site tenderness, nausea, headache, rash, chills and fever were reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site reaction, Nausea
Clinical narrative: tenderness at injection site; nausea; headache; rashrash covering her entire upper arm where she got the injection; chills; fever; nerve painnerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder where she received the vaccine; Pain on left side/pain awful; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date with no side effects).   On 15th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site tenderness, nausea, headache, rash, chills and fever. On 20th November 2019, the patient experienced nerve pain and pain localized. In November 2019, the outcome of the injection site tenderness, nausea, headache, rash, chills and fever were recovered/resolved. On an unknown date, the outcome of the nerve pain and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, nausea, headache, rash, chills, fever, nerve pain and pain localized to be related to Shingrix.  Additional details were provided as follows: On 18th November 2019, the patients most of these side effects were gone by Monday  On the same date, the patient had acupuncture. On 29th November 2019, Wednesday, suddenly she started experiencing an awful pain. The patient said that it was not muscular pain, it was nerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder. This pain was located on her left side of the body where she received the vaccine.   The patient had massage therapy every 3 days and that's how they tracked down the nerve pain. She was pain free for two weeks but the pain is back again.  The pain was not as severe but it is a constant pain that she can't get distracted from. The reporter did not consent to follow-up. The outcome of injection site tenderness, nausea, headache, rash, chills and fever were reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Neuralgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: tenderness at injection site; nausea; headache; rashrash covering her entire upper arm where she got the injection; chills; fever; nerve painnerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder where she received the vaccine; Pain on left side/pain awful; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date with no side effects).   On 15th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site tenderness, nausea, headache, rash, chills and fever. On 20th November 2019, the patient experienced nerve pain and pain localized. In November 2019, the outcome of the injection site tenderness, nausea, headache, rash, chills and fever were recovered/resolved. On an unknown date, the outcome of the nerve pain and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, nausea, headache, rash, chills, fever, nerve pain and pain localized to be related to Shingrix.  Additional details were provided as follows: On 18th November 2019, the patients most of these side effects were gone by Monday  On the same date, the patient had acupuncture. On 29th November 2019, Wednesday, suddenly she started experiencing an awful pain. The patient said that it was not muscular pain, it was nerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder. This pain was located on her left side of the body where she received the vaccine.   The patient had massage therapy every 3 days and that's how they tracked down the nerve pain. She was pain free for two weeks but the pain is back again.  The pain was not as severe but it is a constant pain that she can't get distracted from. The reporter did not consent to follow-up. The outcome of injection site tenderness, nausea, headache, rash, chills and fever were reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: tenderness at injection site; nausea; headache; rashrash covering her entire upper arm where she got the injection; chills; fever; nerve painnerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder where she received the vaccine; Pain on left side/pain awful; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date with no side effects).   On 15th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site tenderness, nausea, headache, rash, chills and fever. On 20th November 2019, the patient experienced nerve pain and pain localized. In November 2019, the outcome of the injection site tenderness, nausea, headache, rash, chills and fever were recovered/resolved. On an unknown date, the outcome of the nerve pain and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, nausea, headache, rash, chills, fever, nerve pain and pain localized to be related to Shingrix.  Additional details were provided as follows: On 18th November 2019, the patients most of these side effects were gone by Monday  On the same date, the patient had acupuncture. On 29th November 2019, Wednesday, suddenly she started experiencing an awful pain. The patient said that it was not muscular pain, it was nerve pain radiating from where the shingle shot was given down the arm, up the arm into the shoulder , into the neck, and down to her shoulder. This pain was located on her left side of the body where she received the vaccine.   The patient had massage therapy every 3 days and that's how they tracked down the nerve pain. She was pain free for two weeks but the pain is back again.  The pain was not as severe but it is a constant pain that she can't get distracted from. The reporter did not consent to follow-up. The outcome of injection site tenderness, nausea, headache, rash, chills and fever were reported as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site pain, Injection site rash
Clinical narrative: Vaccine Administered at Inappropriate Site; Tender rash; tenderness; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   On 30th November 2019, the patient received Shingrix (subcutaneous). In November 2019, less than a week after receiving Shingrix, the patient experienced rash, tenderness and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash, tenderness and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the rash and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix via subcutaneously on the left arm, which led to intramuscular formulation administered by other route The patient then developed a tender rash near the left arm injection site. The reporter Consented to follow up.
Sex: F
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; a female patient received improperly stored M-M-R II; This spontaneous report was received from a medical assistant referring to an 18 month old female patient. The patient's pertinent medical history, concurrent condition and drug reactions/allergies were not provided.     On 04-NOV-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, route and strength were not provided; lot# R031680, expiration date 01-NOV-2020, therapy type rHA) for prophylaxis (incorrect product storage). The sterile diluent was properly stored. The temperature excursions included -58 fahrenheit degree and 46 fahrenheit degree (19.13 fahrenheit degree) for 1.5 hours. Temperature previously excursions included above 47 fahrenheit degree (54.93 fahrenheit degree) for 15 minutes, -58 fahrenheit degree and 46 fahrenheit degree for 12 hours and 15 minutes. There was a data logger involved. No additional adverse effect was reported.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: The patient came into the pharmacy 10 days after the injection to let us know she had experienced an adverse event from her shot on 12-2-19. She said she woke up the next day and her arm was swollen, red, and hot. Her skin was blotchy with a rash and she had a small bruise but it was not at the exact spot of the injection site. She told me she called her doctor to discuss it because she thought she was just having an adverse reaction to the shot. She said she only had the flu immunization once before and it was last year with the mist. She also had two children immunized the same day and they did not have any problems at all.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Tendonitis, Vaccination complication
Clinical narrative: THE DAY AFTER HER VACCINATION, HER ARM WAS SORE AND WEAK. HER ARM HAS CONTINUED  TO EXPERIENCE THIS PAIN FOR THE PAST 2 MONTHS. HER DR INFORMED HER THAT SHE HAD TENDONITIS AS A RESULT OF THE VACCINATION.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Erythema, Peripheral swelling
Clinical narrative: patient got pneumovax and fluzone high dose on 12/10/2019 and came by the pharmacy on 12/12/2019 to complain from redness and swelling in her injected arm and was advised to give her epinephrine and call 911 for her but she refused and saw her doctor later on 12/12/2019 who prescribed her prednisone and some cough medications
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: severe pain at the injection site; This spontaneous report was received from a nurse referring to 4 patients of unknown age and gender. There was no information about the patients' concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On an unknown dates, some of the patients received a first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot# S027047, expiration date was 20-MAY-2021), and some of the patients received 2 other unspecified lot numbers pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, dose, frequency and route were not reported)for prophylaxis.   On an unknown date (reported as a few hours after vaccination), the patients experienced severe pain in their entire arm. They sought medical attention and called to the clinic. The outcome of the event was reported as recovered (reported as the pain resolved after a week or so). The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  This is a non-valid case due to lack of patient identifier.  Follow up information has been received from a medical assistant via company representative on 11-DEC-2019 refers to an elderly patient. No product quality complaint (PQC) was involved with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1912USA006268: US-009507513-1912USA006286:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; a patient was administered VARIVAX by the intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 15-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not reported; lot # R017637, expiration date 20-JUL-2020) by the intramuscular route (incorrect route of product administration) for prophylaxis.  No adverse symptoms were reported.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: No additional adverse effects reported; both of which were over the age of 12, were administered one dose of PROQUAD each; both of which were over the age of 12, were administered one dose of PROQUAD each; This spontaneous report has been received from a nurse, referring to a 14 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.   On an unknown date in October 2019 (reported as last month), the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age and product use issue). No additional adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA008989:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; A pharmacist states that a patient received HA VRJX (unknown lot and expiration date) on 10/11/2019 and received VAQTA (lot S012250 expiration 07/06/2020) on 11/18/2019.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, concurrent condition and drug reactions/allergies were not provided.  On 11-OCT-2019, the patient received hepatitis A virus vaccine inactivated (HAVRIX).    On 18-NOV-2019 the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot# S012250, expiration date reported as 06-JUL-2020, but internal generated as 07-JUL-2020; dose, strength and route were not provided) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 16-DEC-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long term-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, on an unknown date, the pt experienced shingles and was treated at a local health system. As a direct and proximate result of use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain, medical care and treatment. Also, had significant medical and related expenses including but not limited to medical losses, and costs included care for hospitalization, physician care, monitoring treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages. At the reporting time, the pt was not recovered from shingles and it was considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye injury, Herpes zoster, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: eye and vision damage; vision damage; scarring; shingles outbreaks/numbness in her left leg/Pain and tingling sensations in her skin,; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On 11-SEP-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         At the beginning of January 2018, the pt experienced many shingles outbreaks causing to the pt tremendous pain, scarring (scar) and also eye (eye injury) and vision damage (visual impairment). These injuries were caused by zoster vaccine live (ZOSTAVAX). Then, the pt continued having reoccurring shingles outbreaks including extreme pain and numbness in her left leg which all resulted in medical treatment. Pain and tingling sensations in her skin were permanent and continued until reporting time. As a direct and proximate result, the pt's symptoms had resulted in physical limitations not present previously. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work. Also, as a result, the pt sustained severe and disfiguring personal injuries. Additionally, as a tragic consequence, pt suffered serious, progressive and incurable injuries, as well as significant conscious pain, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages.  At the reporting time, the pt was not recovered from the adverse experiences. The events were considered to be disabling.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Paraesthesia, Scar, Visual impairment
Clinical narrative: eye and vision damage; vision damage; scarring; shingles outbreaks/numbness in her left leg/Pain and tingling sensations in her skin,; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On 11-SEP-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         At the beginning of January 2018, the pt experienced many shingles outbreaks causing to the pt tremendous pain, scarring (scar) and also eye (eye injury) and vision damage (visual impairment). These injuries were caused by zoster vaccine live (ZOSTAVAX). Then, the pt continued having reoccurring shingles outbreaks including extreme pain and numbness in her left leg which all resulted in medical treatment. Pain and tingling sensations in her skin were permanent and continued until reporting time. As a direct and proximate result, the pt's symptoms had resulted in physical limitations not present previously. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work. Also, as a result, the pt sustained severe and disfiguring personal injuries. Additionally, as a tragic consequence, pt suffered serious, progressive and incurable injuries, as well as significant conscious pain, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages.  At the reporting time, the pt was not recovered from the adverse experiences. The events were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not provided.    In 2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for (lot #, dose, and frequency were not provided).         On an unknown date, subsequently to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare professional at local healthcare for shingles (herpes zoster). It was reported that as a direct and proximate result of  use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On or about 20-NOV-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (lot #, dose, and frequency were not provided) for the long-term prevention of shingles and/or zoster-related conditions.        On an unknown date, subsequently to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated at clinic for shingles (herpes zoster). It was reported that as a direct and proximate result of  use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.      The reporter considered herpes zoster to be related to the vaccination with Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Eye injury, Optic ischaemic neuropathy, Optic nerve injury
Clinical narrative: ischemic optic neuropathy; severe optic nerve damage; Information has been received from a lawyer concerning male patient of unknown age.    The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On 01-DEC-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for prevention of shingles (lot #, dose, and frequency were not provided).  After receiving vaccine, the patient suffered debilitating injuries including vision loss and eye injuries. Shortly thereafter,  07-JUN-2018, the patient was diagnosed with ischemic optic neuropathy and severe optic nerve damage.  In addition, it was reported that the symptoms had resulted in physical injuries and limitations not present prior to using zoster vaccine live (ZOSTAVAX). Also, the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  Upon internal review, Optic ischaemic neuropathy and Optic nerve injury were considered to be an important medical event, and the events were considered to be disabling.  The reporter considered that these injuries were caused by zoster vaccine live (ZOSTAVAX).