chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in July 2018). In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, 1 day after receiving SHINGRIX, the patient experienced fever, chills, fatigue and pain in arm. On an unknown date, the outcome of the fever, chills, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, chills, fatigue and pain in arm to be related to SHINGRIX. Additional details were reported as follows: Approximately 24 hours later receiving SHINGRIX, the patient experienced arm soreness, fever, chills, shivering and fatigue. The symptoms lasted for about 3 days and were resolved. The reporter did not consent to follow up. This case has been linked with case US2019019135, reported by the same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in July 2018). In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, 1 day after receiving SHINGRIX, the patient experienced fever, chills, fatigue and pain in arm. In January 2019, the outcome of the fever, chills, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, chills, fatigue and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. Approximately 24 hours later receiving SHINGRIX, the patient experienced arm soreness, fever, chills, shivering, and fatigue. The symptoms lasted for about 3 days and have resolved. The reporter did not consent to follow up. This case has been linked with case US2019019126, reported by the same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle cramp in a 69-year-old male patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 31st January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st January 2019, less than a day after receiving SHINGRIX, the patient experienced muscle cramp. On an unknown date, the outcome of the muscle cramp was not recovered/not resolved. It was unknown if the reporter considered the muscle cramp to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on an unknown arm.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient showed pharmacist a photograph of her rash that developed approximately a day or so after receiving SHINGRIX. The rash was described as being on the left arm about 1 inch from the injection site. The height of the rash was about 6 inches and the width was about 2 and a half inches below the injection site. The rash had resolved at time of report. The reporter consented to follow up.  No further details were known at time of report.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, chills, pain and influenza-like symptoms. On an unknown date, the outcome of the fever, chills, pain and influenza-like symptoms were recovered/resolved.  It was unknown if the reporter considered the fever, chills, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: On 19th September 2018, the patient developed fever, chills and achiness like the flu about 10 hours after getting SHINGRIX. The symptoms lasted about 36 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult female patient who received SHIGRIX 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 injection site pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported a patient developed an injection site reaction after the dose of SHINGRIX, including soreness, itching and a 2 inch reddened oval area. No vaccine information was available. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number CX5BG, expiry date 18th May 2021) for prophylaxis. On 30th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 31st January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration, injection site pain and injection site bruising. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site induration and injection site pain were not recovered/not resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site pain and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: On 31st January 2019, the patient noticed a red area at the injection site. She took Benedryl same day.  On 1st February 2019, she noticed the red area was 4 times bigger than yesterday. It was red, hard and sore like a bruise, but not hot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Influenza like illness, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On 27th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, pain, pain in arm, neck pain, sore back and influenza-like symptoms. The patient was treated with prednisone. On an unknown date, the outcome of the fatigue, pain and influenza-like symptoms were recovered/resolved and the outcome of the pain in arm, neck pain and sore back were not recovered/not resolved. It was unknown if the reporter considered the fatigue, pain, pain in arm, neck pain, sore back and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in right arm. The patient reported flu like symptoms described as achy and fatigue. The patient also reported that her arms were both sore, her neck was still sore, and it radiated to her back. The events of flu like symptoms resolved, but the soreness was still being experienced. The patient's doctor had placed on a medication, which was Prednisone 2.5 mg and she was not sure about how many to take but knew they were 2.5 mgs. On 17th November 2018, the patient received 2nd dose of SHINGRIX. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On 27th July 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, pain, pain in arm, neck pain, sore back and influenza-like symptoms. The patient was treated with prednisone. On an unknown date, the outcome of the fatigue, pain and influenza-like symptoms were recovered/resolved and the outcome of the pain in arm, neck pain and sore back were not recovered/not resolved. It was unknown if the reporter considered the fatigue, pain, pain in arm, neck pain, sore back and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in right arm. The patient reported flu like symptoms described as achy and fatigue. The patient also reported that her arms were both sore, her neck was still sore, and it radiated to her back. The events of flu like symptoms resolved, but the soreness was still being experienced. The patient's doctor had placed on a medication, which was Prednisone 2.5 mg and she was not sure about how many to take but knew they were 2.5 mgs. On 17th November 2018, the patient received 2nd dose of SHINGRIX. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Insomnia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sleeplessness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced sleeplessness, injection site rash, general body pain, injection site pain and injection site swelling. On an unknown date, the outcome of the sleeplessness, injection site rash, general body pain, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the sleeplessness, injection site rash, general body pain, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient after receiving the 1st dose of the SHINGRIX vaccine, she was unable to sleep, and she had body aches. She also described pain, swelling and a rash at the injection site. The reporter thought that the patient might still be experiencing the symptoms but could not confirm. Unable to obtain additional information from the reporter. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site deformation, Injection site discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 64-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 26th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site discomfort and injection site deformation. On an unknown date, the outcome of the injection site discomfort and injection site deformation were not recovered/not resolved. It was unknown if the reporter considered the injection site discomfort and injection site deformation to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT 2018-2019 season in the left arm. The patient experienced a dent forming in the upper part of her left arm starting about 2 weeks ago. The dent had gotten worse, such that her arm looked deformed, or like something was dislocated. On 28th January 2019, the patient  saw her chiropractor, who verified that it was not a problem with her bones and that she had all of her range of motion. She then went to a specialist who never saw anything like it. The specialists best guess was that it was a delayed reaction to the flu vaccine which she received in September 2018. There was a round circle in the middle of the dent that looked like it could have come from the vaccine injection. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Oligohydramnios, Preterm premature rupture of membranes
Clinical narrative: This is a serious observational study case initially received  on 30-Jan-2019, concerning a 28-year-old, adult female, pregnant, subject of body weight: 146.4 lbs, height: 65.5 inches and body mass index (BMI). The subject had no maternal or paternal history with major congenital malformations. The subject's obstetrical history included 2 previous pregnancy with 1 live birth and 1 spontaneous abortion. No birth defects were reported in previous pregnancies. The father did not receive any medications prior to conception. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medications included: prenatal vitamin for pregnancy. The subject's last menstrual period (LMP) date was 27-Aug-2018. On 05-Nov-2018, prenatal blood-work performed, and no major congenital malformation was noted. On 06-Nov-2018, at gestation age of 10 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (influenza vaccine, dose, batch number, route of administration, expiry date and anatomical location: not reported) (explicitly considered as vaccine exposure during pregnancy) for an unknown indication. On 18-Dec-2018, at gestation age of 16.1 weeks, the subject had spontaneous abortion. It was reported that for a foetal loss, factors that might have had an impact were previable rupture of membranes, anhydramnios and chorioamnionitis. The subject's estimated delivery date (EDD) was reported as 03-Jun-2019. Reporter's Comments: A 28-year-old pregnant subject experienced chorioamnionitis, anhydramnios, previable rupture of membranes and spontaneous abortion, 1 month 12 days after receipt of Flu vaccine egg split QIV (considered as vaccine exposure during pregnancy). Considering implausible temporal relationship and the infective origin of the event chorioamnionitis, the causal role of study vaccine is ruled out. Hence, the causality of the event assessed as not related. The event previable rupture of membrane can be explained by the underlying chorioamnionitis and the event anhydramnios and spontaneous abortion are the consequences of the underlying events. Hence, causality assessed as not related to these events. The decision to administer a vaccine during pregnancy is related to medical decision made by the mother and her physician and is not related to any property of the medication. Hence, the event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling that responded to BENADRYL and ice packs/compresses. Pain noted as well.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Like I typed before, I have fatigue, headache, shivers, upset stomach and fever.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Developed a fever over 104. Developed a severe headache.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Dizziness, Eye pain, Headache, Nausea, Palpitations
Clinical narrative: Sudden on set. Intense headache that lasted until midnight (6 hrs). Light sensitivity. Dizziness, Heart racing very nauseous. Eye pain. Shakiness. Those symptoms lasted 1.5 hours. Acetaminophen given. When she woke up in the morning o 2/7/19 - all symptoms were gone.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Photophobia, Tremor
Clinical narrative: Sudden on set. Intense headache that lasted until midnight (6 hrs). Light sensitivity. Dizziness, Heart racing very nauseous. Eye pain. Shakiness. Those symptoms lasted 1.5 hours. Acetaminophen given. When she woke up in the morning o 2/7/19 - all symptoms were gone.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). The patient suffered painful sensations of burning, tingling and sudden sharp localized pain. As a result of her symptoms, the patient presented to a medical provider and was ultimately diagnosed with internal shingles. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Internal shingles was considered disabling. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-FEB-2019 regarding a case in litigation from a lawyer concerning an approximately 62 year old female patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-FEB-2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. In 2010, 2017 and 2018, the patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: FLUC3, PNC13
Symptoms: Blood test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician. A male patient of an unspecified age received PREVNAR 13 and FLUCELVAX, both via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient reported a change in the biological markers for Vectra DA test, 4 weeks after receiving the vaccine on an unspecified date. The reporter wanted to know if both the vaccines can cause a change in biological markers that can affect the results of Vectra DA test. Outcome of the event was unknown. Information on batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Pain
Clinical narrative: This is a spontaneous report from a contactable healthcare professional reported that an 18-year-old patient of an unspecified gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for booster. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced body aches, chills, and headache. The patient mentioned that he took TYLENOL. Outcome of the events was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An adult patient of an unspecified gender received PREVNAR 13, (Lot number and expiration date were not reported), with route of administration unspecified, on 25Jan (year was not reported), at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had an injection site reaction; and rash, redness and bumps at the injection site. The outcome of the events, injection site reaction, and rash, redness and bumps at the injection site, was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 2 patients. This is the second of 2 reports. A patient of unspecified age and gender received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain on an unspecified date. The outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2019046468 same reporter/drug, similar event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, (lot number: X13882 and expiration: 01Sep2020), intramuscularly at the left deltoid, on an unspecified date at a single dose for immunization. Medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient had little red spots on her legs after receiving the vaccine. The patient described the reaction as being similar to the reaction she gets after having penicillin. The patient took BENADRYL and it went away, but returned on her face and eyes on an unspecified date. The doctor suggested she take diphenhydramine again. The patient recovered from the event at an unknown date.
Age: 8.0
Sex: M
Vaccine: FLU4, IPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling of the arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Facial pain, Immediate post-injection reaction, Inflammation, Influenza like illness
Clinical narrative: Immediately after receiving the vaccine, the patient reports she began to experience redness/swelling/soreness in her arm in which she received the vaccine (though at the time it was mild enough that she attributed it to typical side effects from any vaccine). Within 3 days, she had developed a large, angry red patch covering her entire shoulder area. There were also symptoms of fever and flu-like symptoms, she reports. She did not visit her doctor regarding the symptoms, but has a photo of the inflammation in her arm. Even now, there is some residual redness/tenderness. She also notes a new small red/painful patch on her face (cheek) that she reports is painful and feels "similar" to how her arm did following the shingles vaccine. I advised her to follow up with her doctor at this time regarding both her lingering symptoms and new/worsening symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Immediately after receiving the vaccine, the patient reports she began to experience redness/swelling/soreness in her arm in which she received the vaccine (though at the time it was mild enough that she attributed it to typical side effects from any vaccine). Within 3 days, she had developed a large, angry red patch covering her entire shoulder area. There were also symptoms of fever and flu-like symptoms, she reports. She did not visit her doctor regarding the symptoms, but has a photo of the inflammation in her arm. Even now, there is some residual redness/tenderness. She also notes a new small red/painful patch on her face (cheek) that she reports is painful and feels "similar" to how her arm did following the shingles vaccine. I advised her to follow up with her doctor at this time regarding both her lingering symptoms and new/worsening symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased activity, Fatigue, Headache, Injection site erythema
Clinical narrative: Swelling and redness around injection on left shoulder. Muscle pain left shoulder and neck. Headache, sore throat, shivering, nausea and ache all over. Tired and sluggish preventing regular activity.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: Swelling and redness around injection on left shoulder. Muscle pain left shoulder and neck. Headache, sore throat, shivering, nausea and ache all over. Tired and sluggish preventing regular activity.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sluggishness
Clinical narrative: Swelling and redness around injection on left shoulder. Muscle pain left shoulder and neck. Headache, sore throat, shivering, nausea and ache all over. Tired and sluggish preventing regular activity.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Dysphagia, Erythema, Heart rate decreased, Malaise, Pruritus
Clinical narrative: Client took one pill Feb 4, 2019 no reaction. Took second pill on Feb 6, 2019 in the evening. On Feb 7/2019 in the afternoon, she started to feel "unwell, itchy". By 2/7/2019 in the evening client reported she took a bath and noticed a rash 5 -10 hive like red spots. She was very itchy and took BENADRYL. At midnight she woke up having a difficult time to swallow and had a really low pulse she stated at bout 40. She took more BENADRYL and called to report the reaction in the morning 02/08/2019. Public health nurse called her doctor and asked she be seen. Client states she had a bad reaction to tetanus 10 years ago and went to the hospital for it.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Client took one pill Feb 4, 2019 no reaction. Took second pill on Feb 6, 2019 in the evening. On Feb 7/2019 in the afternoon, she started to feel "unwell, itchy". By 2/7/2019 in the evening client reported she took a bath and noticed a rash 5 -10 hive like red spots. She was very itchy and took BENADRYL. At midnight she woke up having a difficult time to swallow and had a really low pulse she stated at bout 40. She took more BENADRYL and called to report the reaction in the morning 02/08/2019. Public health nurse called her doctor and asked she be seen. Client states she had a bad reaction to tetanus 10 years ago and went to the hospital for it.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient is complaining swelling, redness and pain at/around injection site. The symptoms are finally getting better on 4th day after vaccine administration.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, VARCEL
Symptoms: Crying, Epistaxis, Fall, Syncope
Clinical narrative: Patient finished receiving vaccines by 1030. Pt. was agitated had to be restrained by parents in order to safely receive vaccinations. Once the patient was done receiving vaccinations they cheered up and appeared as if nothing had happened. The child was asked if they felt fine, and the child said they did feel fine. The child then went into an interview room to schedule a return appointment with a support staff member. After about 5 minutes, the support staff member called me in and said the patient had fainted briefly and fell into her chair. When I arrived in the room, the patient was crying, sitting on the fathers lap with a nose bleed. Immediately I got tissues and had the father pinch the patient's nose and instructed him not to blow it. During this time I performed a brief neurological assessment. I also assessed the child for s/s of an anaphylactic reaction. The child showed no signs and symptoms of neurologic abnormalities nor signs and symptoms of anaphylaxis. No abrasions or bruises were noted on the child. After 2 minutes of pinching the nose, the bleeding stopped completely. Vital signs were then taken. BP: 95/53; HR: 75; Respirations: 20. At this point I took the child on a brief walk down the hallway to assess his gait and it was completely steady. The child stayed for observation for about 30 more minutes. During this time he was playing with toys in our waiting room. The parents were educated that fainting is common after vaccination and other medical procedures that produce a sympathetic response. The parents were also instructed to bring the child to the emergency department immediately if any symptoms returned later in the day. The child left in good condition.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Approximately 16 hours after receiving the vaccination chills/shivering with a low-grade fever (100.0 F) started. Symptoms lasted approximately 12 hours. Mild pain with  some redness occurred at the injection site, starting about 24 hours after injection and lasting for approximately 48 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Pruritus generalised
Clinical narrative: Patient received vaccine on 2/8/19. She reports that on 2/9/19 in the afternoon, she noticed her hands were red and itchy. The itchiness then spread to arms and entire body. She took 2 OTC Benadryl and was directed by a physician friend to take another 1 Benadryl an hour later. The symptoms all resolved by three hours and patient reports no long lasting effects.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mild redness to right upper arm and pain in muscle. Pt wanted reported.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema
Clinical narrative: This spontaneous report as received from a 63 year old male patient, who was referring to himself. The patient was in good health and did not been bedridden with colds / flu in life in 30 year, immune system pretty good. He got flu vaccine 01-SEP-2017. No other information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 15-NOV-2017, the patient was vaccinated with ZOSTAVAX (dose, route of adminstration, indication, lot #, expiration date were not reported). In approximately November 2017, the patient experienced no side effects except the normal redness and burning sensation. The patient waited 2 and a half months after getting flu vaccine before the ZOSTAVAX and asked how long should he wait to get PREVNAR 13. The patient was advised to go back to his doctor because he/she knows best of his medical conditions and most appropriate to make the recommendation. The outcome of injection normal redness (mostly went away 24 hrs) and burning sensation (for a couple of week then went away) was reported as recovered/resolved. Causality relatedness was not reported.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant therapies were not reported. On 15-NOV-2018, the patient was vaccinated with a first dose of M-M-R II, subcutaneously (dose, lot# and expiry date were not reported) for vaccination against measles, mumps, and rubella. On an unknown date (reported as recently), the patient's serologic testing reported that the patient was immune to rubella and mumps (clarified as having high rubella and mumps titers), but not immune to measles. The patient sought medical attention at the pharmacy. The outcome of the event was unknown. The causality assessment was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from nurse referring to a 25-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-SEP-2018, the patient was vaccinated with her first dose of GARDASIL 9 intramuscularly (lot # N035032 and expiration date 24-SEP-2020) (dose and frequency not reported) for prophylaxis. On 02-OCT-2018, the patient received her second dose of GARDASIL 9 (lot # N035957 and expiration date 10-OCT-2020) (dose, frequency, route not reported). No adverse effect reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Leiomyoma, Prenatal screening test, Ultrasound antenatal screen abnormal
Clinical narrative: This is a serious observational study case initially received on 07-Nov-2018, concerning a 28-year-old, adult pregnant. The subject had 1 previous pregnancy in which she had a spontaneous abortion. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included history of depression and anxiety. The subject's last menstrual period date was 09-Sep-2018. The pregnancy status of the subject was collected, and no complication was noted. The subject's concomitant medications included ZOLOFT for depression and Prenatal vitamins for pregnancy. On 25-Oct-2018, the subject underwent ultrasound, and no major congenital malformation was noted. On 06-Nov-2018, the pregnant subject (gestation period: 8 weeks) was administered Flu Vaccine Egg Split QIV CSL (influenza vaccine, batch number: YF41708, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication (explicitly considered as vaccine exposure during pregnancy). On 30-Nov-2018, the subject underwent first trimester screening and no major congenital malformation was noted. On 10-Jan-2019, the subject underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and no major congenital malformation was noted. On an unspecified date after vaccination, the subject developed leiomyoma (reported as leiomyoma x 3) which was noted by the ultrasound scan on 25-Jan-2019. The subject's estimated delivery date (EDD) was reported as 10-Jun-2019. Non-significant amendment (07-Nov-2018): The subject's EDD was corrected from 31-May-2019 to 10-Jun-2019 in narrative. Follow up received from the investigator on 30-Jan-2019: The subject's prenatal tests (first trimester screening, maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and ultrasound scan) were added in the relevant tests of patient tab. Added two new events leiomyoma and ultrasound scan abnormal in the event tab and listedness was done accordingly. The narrative was amended accordingly. Reporter's Comments: A 28-year-old pregnant female, was diagnosed with leiomyoma more than 2 months after receipt of Flu Vaccine Egg Split QIV CSL. The event had multitude of causes ranging from genetic, familial, hormonal and environmental factors. Considering no known biological mechanism to explain the event following vaccination, the causality was assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy was assessed as not related to suspect vaccine, due to intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: Approx. 2 x 3 in erythematous/indurated wheal to (L) upper out arm. Mometasone applied in clinic 20/2 DEPOMEDROL/DECADRON IM, Hydroxyzine Rx.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Contusion, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: PATIENT HAD MULTIPLE BRUISES OVER HIS BODY-1CM AND BACK OF HEAD, CHEST AND MIDDLE OF FOREHEAD, LEFT EAR. WE SENT HIM TO THE EMERGENCY ROOM. HIS PLATELETS WERE LESS THAN 0.4K/cumm.  HE WAS ADMITTED FOR OVERNIGHT OBSERVATION WAS GIVEN IV IMUUNE GLOBLIN AND LABS REPEATED IN THE AM WERE  0. 7K/cumm. HE SAW HEMATOLOGY TODAY AND HE WAS UP TO  107K/cumm. HEMATOLOGY CLEARED HIM  TO RECEIVE ALL FUTURE VACCINATIONS.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Flank pain, Musculoskeletal pain, Pain in extremity, Productive cough
Clinical narrative: Client also reports a reaction she believes is from her flu shot given on 1-23-19. Client states approximately one week after injection, she devoloped pains in her left buttock, left flank, and left thigh. She reports a fever of 101, productive cough, and poor appetite for 3 days. Client states she did not present to a clinic. She is unsure if this is a reaction to the immunization or possible contact with someone with influenza prior to her body reaching full immunity to the flu. Client states she always has a minor local reaction of pain and soreness at the injection site. This time she had injection on left hip, which she thinks would explain the pains she had on her left side. Of note, documentation states the injection was received in right deltoid. Currently she feels fully recovered.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Client also reports a reaction she believes is from her flu shot given on 1-23-19. Client states approximately one week after injection, she devoloped pains in her left buttock, left flank, and left thigh. She reports a fever of 101, productive cough, and poor appetite for 3 days. Client states she did not present to a clinic. She is unsure if this is a reaction to the immunization or possible contact with someone with influenza prior to her body reaching full immunity to the flu. Client states she always has a minor local reaction of pain and soreness at the injection site. This time she had injection on left hip, which she thinks would explain the pains she had on her left side. Of note, documentation states the injection was received in right deltoid. Currently she feels fully recovered.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever and nausea.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site vesicles, Rash, Varicella post vaccine
Clinical narrative: Localized rash, blisters around injection site consistent with Chicken Pox.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pain, Urticaria
Clinical narrative: Short term irritation and soreness at the injection site. About 5 or 6 days after the injection, I developed severe hives on my head, neck and body on both left and right sides of my front and back.  I made an early morning visit to the clinic and received prescription for a regimen of steroid tablets.  The hives nearly cleared and the prescription was changed to Claritin and Pepcid in the morning and Benydril in the evening. The symptoms have become less severe. The prescription was then change to Cetrizine HCL tablets and Pepcid AC in the morning and Montelukast in the evenings. The symptoms remained the same. After a couple weeks I saw an allergist who prescribed Centrizine HCL and Pepic AC twice daily and Montelukast in the evening. Symptoms persist.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Pyrexia, Skin warm
Clinical narrative: Fever, red, warm, itchy arm- BENADRYL and hydrocortisone cream for tx.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Immediate post-injection reaction, Injection site erythema, Pharyngitis, Rash generalised
Clinical narrative: Redness at site of vaccine immediately, one week later developed pharyngitis, a cough, and a total body rash starting trunk and covering the whole body. Seen at an urgent care and advised it was a rash due to the vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Injection site erythema, Injection site nodule
Clinical narrative: Huge red swelling knot at injection site, feel like I have the flu .. headache muscle aches feel horrible.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Huge red swelling knot at injection site, feel like I have the flu .. headache muscle aches feel horrible.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Induration, Injection site erythema, Injection site swelling, Mass
Clinical narrative: Patient complained of a hard lump 2 weeks after the injection. I instructed her to try a heat pack over the weekend. She awoke Monday morning with redness and swelling to right upper arm. Seen and prescribed and antibiotic.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In December 2016, the patient was inoculated with ZOSTAVAX at a health center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 02-FEB-2010, the patient was inoculated with ZOSTAVAX by a physician at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated by a Dermatologist for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-DEC-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.