chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1 (route, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient was administered the first dose of GARDASIL 9 and then experienced a swollen arm that spread down her arm. The outcome of the patient's arm swelling that spread down her arm was unknown. Causality assessment was not reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient in her late 60s or early 70s.The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date in 2016, (reported as sometime in the past year), the patient was vaccinated with ZOSTAVAX (dose, lot number and expiration date were not provided) subcutaneously for prevention of shingles. On an unknown date, the patient experienced a mild outbreak of shingles after receiving the ZOSTAVAX. The patient sought medical attention for her mild outbreak of shingles by visiting her primary doctor but it was unknown if the patient had received any treatment. It was reported that the patient was "doing fine now". Causality assessment was not reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On 28-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M009766, expiration date 23-FEB-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent lot # N003192, expiration date 05-JUL-2019. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 36 degrees Fahrenheit and 46 degrees Fahrenheit for 14 hours. Data logger was involved. There were no previous excursions reported. Lot number N003192 has been verified to be a valid lot number for sterile diluent. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002070.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warm to touch. Did not see treatment.
Age: 4.0
Sex: F
Vaccine: DTPIPV, DTPIPV, MMR, VARCEL
Symptoms: Eye swelling, Rash generalised
Clinical narrative: Left eye was swollen. Rash all over the body.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 08-MAY-2017 from a licensed practical nurse regarding a 6 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004961: US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1705USA004967: US-009507513-1705USA004952: US-009507513-1608USA012794: US-009507513-1705USA004960: US-009507513-1705USA004962.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 08-MAY-2017 from a licensed practical nurse regarding a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The licensed practical nurse did not know why the excursions occurred but there were no further temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004965: US-009507513-1705USA004952: US-009507513-1608USA012794: US-009507513-1705USA004960: US-009507513-1705USA004973: US-009507513-1705USA004962: US-009507513-1705USA004967: US-009507513-1705USA004961.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 08-MAY-2017 from a licensed practical nurse regarding a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The licensed practical nurse did not know why the excursions occurred but there were no further temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004967: US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004952: US-009507513-1705USA004965: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004960.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacy technician reporting on behalf of a contactable pharmacist communicated to a Pfizer sales representative. This pharmacy technician reported the same event for three patients. This is the third of three reports. A female patient over 65 years old of unknown ethnicity received PREVNAR 13 for Protection against pneumococcal pneumonia via an unspecified route at single dose on unknown date. Relevant medical history and concomitant medication were unknown. On unknown date the patient experienced swelling of injection site. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017231461 Same reporter, same drug, same event, different patients; US-PFIZER INC-2017231547 Same reporter, same drug, same event, different patients.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Local reaction, Pruritus, Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 17-MAY-2017. This case involves a female patient (age not reported) who was vaccinated with dose of IPV (batch number N1F18, expiry date, dose and dose in series, rout and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient was warm to the touch and experienced Itchiness and getting bigger in size at local reaction. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: IPV, MNQ, IPV, MNQ
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 18-MAY-2017. This case involves a 37 years old female patient who was vaccinated with first dose of IPOL (batch number N1A461M, expiry date, dose and dose in series, site of administration were not reported) intramuscularly on right side and MENVEO (batch number M15144, expiry date, dose and dose in series, route and site of administration were not reported) on 12-MAY-2017. Patient's medical history reported as not known allergy and concomitant medications were not reported. On 15-MAY-2017, three days following the vaccination, the patient complained of dizziness, fatigue and nausea. It was reported that the patient required emergency room/doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: IPV, MNQ, IPV, MNQ
Symptoms: Fatigue, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 18-MAY-2017. This case involves a 37 years old female patient who was vaccinated with first dose of IPOL (batch number N1A461M, expiry date, dose and dose in series, site of administration were not reported) intramuscularly on right side and MENVEO (batch number M15144, expiry date, dose and dose in series, route and site of administration were not reported) on 12-MAY-2017. Patient's medical history reported as not known allergy and concomitant medications were not reported. On 15-MAY-2017, three days following the vaccination, the patient complained of dizziness, fatigue and nausea. It was reported that the patient required emergency room/doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Sex: M
Vaccine: TTOX
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 18-May-2017. This case involves 22 year-old male patient who was vaccinated with dose of TETANUS TOXOID (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 17-May-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify)allergies were not known as per reporter. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were not reported. On 17-May-2017, same day following vaccination patient developed fever, headache and soreness of arm at injection site. Laboratory investigations and corrective treatment were not reported. Outcome of the event was unknown. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Initial unsolicited report received from a consumer on 18-MAY-2017. This case involves a patient (gender and age was not reported) who was vaccinated with a dose of YELLOW FEVER VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On 05 May 2017, following the vaccination, the patient fainted and lost consciousness briefly. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the patient recovered from the events. Upon internal review, the case was considered as serious due to important medical event: losing consciousness briefly. List of documents held by sender: none.; Sender's Comments: The patient fainted and lost consciousness briefly after vaccination with YELLOW FEVER VACCINE (MFR UNK). Time to onset was not reported. Loss of consciousness following a vaccination can result due to several factors nervousness and fear of needle resulting in drop of blood pressure being few of them. No information regarding patient's condition at the time of vaccination or occurrance of similar events at the time of vaccinations in past has not been provided. Based on the available information the role of the vaccine can not be assessed.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness(9cm x 9cm), pain, swelling.Ibuprofen, Tylenol, benedryl. Advised pt. to apply ice pack intermittently.
Age: 35.0
Sex: M
Vaccine: MEN, PNC10, TDAP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Pt was to have 3 vaccines administered from the 317 stock. Meningococcal, Pneumococcal, and TDap. I did not intake the patient. However, was asked by my co-worker if I could give the vaccines, since she needed to attend another patient. I responded, "Yes, but tell me which goes where, because I don't know," and she pointed out that Pneumo. and TDap were IM, and Meningococcal was SubQ, she had them separated in a tray. Vaccines were administered by me. Pt did not have any reaction to the vaccines.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Deltoid muscle soreness, stiffness, achy. not chronic, comes and goes.
Age: 0.58
Sex: M
Vaccine: HIBV, PPV
Symptoms: Skin infection
Clinical narrative: Skin infection, started with one lesion, then spread over face and trunk.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia
Clinical narrative: Patient reported experiencing numbness in arm and fingers.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Per patient, he has shooting pain on his right arm. Pain is mainly on his under arm, armpit, and going toward his rib cage. His arm barely showed any signs of swelling when he came in to the pharmacy today.  He stated that he will continue to take ibuprofen 800 mg every 8 hours.  If his shooting pain does not go away in a day or two, he will have to go to the emergency room.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pruritus, Rash erythematous
Clinical narrative: Red rash with swelling and heat at site of reaction. Patient states itchy occurring >24 hours post vaccination. No anaphylaxis s/sx. Use ice, diphenhydramine, HC cream, and call 911 if any swelling of face or throat or go to urgent care if worsens.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling on the left arm -tricep area from ZOSTAVAX, about Palm-sized in nature.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Discoloured vomit, Haematemesis, Haematochezia, Mucous stools
Clinical narrative: Bowel movement containing significant amount of dark green mucus and black, string-like blood. Also vomit containing pinkish, dark brown blood.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Patient received BEXSERO vaccine 5/25/17 at 1340. Called into office 5/26/17 at 1445 with symptoms of soreness, tiredness and joint pain. Information was given to office RN triage.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Localized reaction to MMR; redness warmth and tenderness to injection site.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Shoulder area of vaccine site with severe but localized large area of circular erythema with fever 2 cm dia area of induration and minimal bruising.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Local reaction around injection site as well as redness, warmth. Treated with Methylprednisolone 4 mg.
Age: 16.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: Vomiting/nausea 1 day after vaccines. Treated with ZOFRAN and clear fluids. Redness/tenderness/ swelling at site of Varicella vaccine.
Age: 45.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Antibody test negative, Pyrexia, Varicella post vaccine
Clinical narrative: Employee called me to report having chicken pox. C/O lesion on back. 2 other lesions, then a few on her groin. Also reported fever of 100.9
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Gaze palsy, Musculoskeletal stiffness, Pallor, Seizure like phenomena
Clinical narrative: Patient had seizure like activity which included being stiff, jerking, eyes rolled in the back of head, pale, and unresponsive.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient had seizure like activity which included being stiff, jerking, eyes rolled in the back of head, pale, and unresponsive.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Wound
Clinical narrative: Diffuse redness around injection site. Burning sensation and itching accompanying the redness. Redness spreads from axillary area to elbow area. Denies scratching at wound. States her son had a previous allergic reaction to an unknown vaccine with a little swollen area on his leg. Not as severe as her reaction, per pt.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Mom noticed pt pulling at clothes last night (5-25-17) and scratching and found rash to top bilateral upper thighs where pt received DTaP and HIB in (LT) and PREVNAR (RT) on 5-22-17. When pt woke up on 5-26-17 rash has spread all over bilateral thighs and up to lower abdominal area. Tx Triamcinolone cream.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest X-ray, Epstein-Barr virus antibody, Fatigue, Full blood count, Malaise
Clinical narrative: Chronic fatigue and malaise. Syncope episode.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Chronic fatigue and malaise. Syncope episode.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Constant pain in upper left arm. Physical therapy 4/24, 5/1, 5/8 and 5/17.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Feeling hot, Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Musculoskeletal stiffness
Clinical narrative: Client reports feeling warm the evening of the vaccination and the next day. Client says she had a sore arm right after the vaccine. She said the soreness went away and then came back. 3 days later, arm is still stiff and sore (cannot raise above half way). Bruise at site of injection.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Pain in extremity
Clinical narrative: Client reports feeling warm the evening of the vaccination and the next day. Client says she had a sore arm right after the vaccine. She said the soreness went away and then came back. 3 days later, arm is still stiff and sore (cannot raise above half way). Bruise at site of injection.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Blood culture, Full blood count, Pyrexia
Clinical narrative: Fever of 105+ - Seen by Physician 5/19/17 and sent for a CBC and Blood Cx.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to touch. Resolved on its own. No medical treatment needed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: Swelling, redness, warm to touch. Resolved on its own. No medical treatment needed.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: After receiving her PNEUMOVAX 23, in the afternoon, in the evening her arm got very red above her elbow and hurt (round red area) treating with TYLENOL only, applied ice. Spoke with pharmacist 5/17/17 much better.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient started experiencing hives the night of immunizations. Febrile 101.4 R. Hives have continued to next day. Temp 100.2 R today.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Site red, hot, swollen hours after injection. Next day HA, nausea, chills/sweats, loss of appetite, weakness, fatigue, light-headedness. Advised fluids, rest, ibuprofen and TYLENOL. 5/25 fever of 102.4.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site red, hot, swollen hours after injection. Next day HA, nausea, chills/sweats, loss of appetite, weakness, fatigue, light-headedness. Advised fluids, rest, ibuprofen and TYLENOL. 5/25 fever of 102.4.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Pyrexia
Clinical narrative: Site red, hot, swollen hours after injection. Next day HA, nausea, chills/sweats, loss of appetite, weakness, fatigue, light-headedness. Advised fluids, rest, ibuprofen and TYLENOL. 5/25 fever of 102.4.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt given PEDIARIX and Hep B on the same visit. (2 doses of Hep B vaccine.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Patient presented on 5/25//17 with arm redness at injection site. Administered on 5/24/17.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Dyspnoea, Intestinal obstruction
Clinical narrative: Patient said that about one hour after receiving the ZOSTAVAX shot, he had difficulty breathing and his abdomen got swelling. He went to the hospital, got IV treatment for bowel obstruction.
Age: 1.5
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: None (As of 5/26/17).
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Vaccine 5/23/17. Started with 102 degree fever, cough, wheezing on 5/24/17.
Age: 2.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 1.08
Sex: M
Vaccine: UNK
Symptoms: Attention deficit/hyperactivity disorder, Autism spectrum disorder, Injection site reaction, Sensory disturbance, Urticaria
Clinical narrative: Huge welts covering his leg. Told it was normal. Stopped getting vaccines after this.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: She received PCV13 vaccine around 10am and she started to have chills in the afternoon, then fever, fatigue, nausea, body shaking, loss of appetite.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: She received PCV13 vaccine around 10am and she started to have chills in the afternoon, then fever, fatigue, nausea, body shaking, loss of appetite.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's left arm is red and swollen. She believes this is from her ZOSTAVAX vaccination on 5/25/17 administered about noon. She went to the walk-in this morning and was prescribed cefadroxil 500 mg bid for 10 days.
Age: 24.0
Sex: M
Vaccine: YF
Symptoms: Headache, Injection site pain, Photosensitivity reaction, Pyrexia, Rash erythematous
Clinical narrative: Pt started with a low grade fever and headache, pain on injection site. Rash started on 5/19/17 on both arms, legs, chest area(s), and stomach area(s), not itchy, but photosensitive. Pt described the rash as red bumps but not itchy. Pt called 5/19 to inform about the adverse reaction. Pt has taken ZYRTEC for rash. Pt said the fever was gone in 1 day but the rash lingered. Pt was instructed to take BENADRYL for rash for a couple of days for rash, if not improved, then pt can go see dr. No other neurological reactions were reported.
Age: 35.0
Sex: F
Vaccine: YF
Symptoms: Antinuclear antibody positive, Asthenia, Dermatomyositis, Food allergy, Laboratory test normal
Clinical narrative: Dermatomyositis like illness- now chronic - rash, urticaria like, intermittent muscle selling pain, itching.
Age: 35.0
Sex: F
Vaccine: YF
Symptoms: Muscle fatigue, Muscle swelling, Myalgia, Pruritus, Urticaria
Clinical narrative: Dermatomyositis like illness- now chronic - rash, urticaria like, intermittent muscle selling pain, itching.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, X-ray
Clinical narrative: "Pain went down elbow to wrist and went to ER due to severity of pain."
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At the site pt said red and swollen.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Constipation, Crying, Dyschezia, Faeces hard, Infrequent bowel movements
Clinical narrative: Had minor side effects after PC and HIB in November 2015 and January 2016 of fevers and rashes on face and foot. After DTAP and ROTA in December 2015 had less frequent bowel movements. February 2016 he had DTAP again and the following day his bowel movements got worse. The entire next 2 months he only had a bowel movement once per week after we wpuld give him a suppository. Large hard stool that hurt him and made him cry. For months we tried over the counter remedies and nothing worked. Went to pediatric gastro intestinal doctor with no help. Severe constipation. Finally started him on magnesium supplementation in August 2016 which has helped.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash
Clinical narrative: Had minor side effects after PC and HIB in November 2015 and January 2016 of fevers and rashes on face and foot. After DTAP and ROTA in December 2015 had less frequent bowel movements. February 2016 he had DTAP again and the following day his bowel movements got worse. The entire next 2 months he only had a bowel movement once per week after we wpuld give him a suppository. Large hard stool that hurt him and made him cry. For months we tried over the counter remedies and nothing worked. Went to pediatric gastro intestinal doctor with no help. Severe constipation. Finally started him on magnesium supplementation in August 2016 which has helped.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Shortly after receiving vaccine, got a severe headache that lasted several days.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Localized reaction (pain, redness, and swelling at injection site. Swelling and redness measure about 10 cm).
Age: 61.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Dizziness, Vertigo
Clinical narrative: I experienced severe vertigo (the room seemed to be spinning) when I first got up from bed the morning after taking the first dose of VIVOTIF. The vertigo lasted about 2 or 3 minutes. I have experienced nothing that severe since, but for the following 4 days have experienced brief, moderate dizziness most of the time after getting up or lying down.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: I got a tetanus shot. Itching, mass swelling, tender to touch, redness, blotchy rash 3inches by 3inches. Dull muscle pain, difficulty lifting arm and tingling.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash macular, Swelling, Tenderness
Clinical narrative: I got a tetanus shot. Itching, mass swelling, tender to touch, redness, blotchy rash 3inches by 3inches. Dull muscle pain, difficulty lifting arm and tingling.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Vaccination complication
Clinical narrative: Pt complained of severe decrease arm mobility. She went to see MD who gave Pt naproxen and stated vaccination given properly and had reaction to vaccine.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Patient developed red rash around injection site. She claims the area is tender, burning and inflamed.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Early a few (5-10) small raised red dots on waist, upper thighs and chest. By evening several more dots on trunk and low grade fever (99-100.5) with general fussiness. Day 2 rash less raised and less red but more generalized all over below neck, low grade fever. By end of day rash all over including face, more fussy, low grade fever.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Altered state of consciousness, Blood pressure decreased, Burning sensation, Pain in extremity
Clinical narrative: As vaccine was being administered, instantly arm was aching and burning. One minute or less later, my blood pressure dropped very low. The doctor said I was having a vaccine reaction. Every couple minutes either the doctor or nurse was repeatedly taking my blood pressure. I felt like I would pass out. This lasted about an hour and then my blood pressure started to go back up.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever up to 102 by 9pm (9 hrs after administration). 5/28/2017 morning had fever to 103.7 with nausea and vomiting x1.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Computerised tomogram, Infection, Malaise, Migraine
Clinical narrative: The day after the Tdap I got a bad migraine. Then I started having 2 or 3 severe migraines every week after that. I went to several doctor appointments for it and it was so bad I went to the hospital and had a CT scan which didn't show any reason for the migraines. I also started having frequent illnesses and infections at the same time.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: 24-year-old female was in normal state of health until approximately 30-45 minutes after she had the flu vaccine. She began to feel dizzy, lightheaded with nausea and approximately 6 episodes of vomiting. Vomitus is nonbilious and nonbloody. She did not have wheezing,shortness of breath, or feeling of her throat closing. Her dizziness was worse on standing. She has not had hives, urticaria, or tongue or lip swelling.  Of note, she had the AFLURIA flu vaccine five years before, but has had the intranasal flu vaccine every year since until this year.  This year she had the AFLURIA vaccine again.  Time of vaccine was approximately 1030, onset of symptoms approximately 1100-1115.  Patient was seen in clinic at approximately 1400.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Bedridden, Biopsy colon
Clinical narrative: Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy kidney, Biopsy small intestine, Biopsy stomach, Blood cholesterol increased, Blood test
Clinical narrative: Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Bronchitis, Diarrhoea, Eyelid oedema, Feeding disorder, Fluid retention
Clinical narrative: Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Gastrooesophageal reflux disease, Hypertension, Immune system disorder, Impaired work ability, Infection
Clinical narrative: Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Nephrotic syndrome, Peripheral swelling, Protein urine present, Rash
Clinical narrative: Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Scan, Swelling, Swelling face, Thrombosis, Ultrasound scan
Clinical narrative: Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Urine analysis, Weight decreased
Clinical narrative: Within a couple weeks of the flu vaccine I started having many symptoms. Infections and needing antibiotics,  bronchitis and needing steroids. Started having a little bit of body swelling. Stomach pain and frequent diarrhea for weeks it would come and go. Started getting weak.  Started having worse body swelling.  Feet swelled so I could barely tie my shoes, hands swelling, face swelling so eyes were almost swelled shut,stomach swelling. Filling with fluid all over my body. Developed high blood pressure and high cholesterol at this time. Couldn't hardly eat anything due to swelling and no room in stomach. Developed a rash over my whole back. No energy to be able to work. Developed acid reflux. Bedridden and hospitalized for a week. Blood clot in kidney.  Losing protein in urine. Lost about 14 pounds from being so sick. Diagnosed with nephrotic syndrom of the kidneys and doctor said it was immune induced. Doctor said I looked like death.  Have tried 3 different treatments,  currently on the 3rd treatment. First 2 treatments didnt work.  If treatments dont work i will need a kidney transplant. Types of treatments include immune suppressor, steroids, infusions in the hospital,  acid reflux medication, blood thinners, cholesterol medication,  blood pressure medication. According to agency, this is rare but nephrotic syndrom following vaccination has been documented.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MEN
Symptoms: Loss of consciousness, Respiratory arrest, Seizure
Clinical narrative: She stopped breathing and lost consciousness for approximately 15 seconds. As soon as she resume breathing on the floor, her body ceased convulsing. I gave her 2 quick breaths. Firemen arrived at around 12:10pm.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash generalised, Rash vesicular
Clinical narrative: Vesicular lesions with a red base scattered throughout the body, face, scalp and back in various forms - approximately 25.
Age: 31.0
Sex: F
Vaccine: HEPA, PPV, TYP, YF
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted after 4 vaccines were administered. Patient gained consciousness. 911 was called and patient was taken to ER.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Dyspnoea, Insomnia, Malaise, Pruritus
Clinical narrative: Rash on arm. Very itchy. Very uncomfortable. Shortness of breath, feeling ill. Trouble sleeping.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash on arm. Very itchy. Very uncomfortable. Shortness of breath, feeling ill. Trouble sleeping.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF test normal, Herpes simplex test negative, Herpes zoster, Polymerase chain reaction, Rash
Clinical narrative: HZV rash to right sided post auricular large skin on face.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: HZV rash to right sided post auricular large skin on face.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Mother alleges pte began with itching, redness and rash in left arm at noon on 05/26/2017. No medication nor emergency visit was required.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Patient developed red, itchy lump at site of injection the day following injection. Said it has not gotten worse but it is not better either. Instructed him to use ice and try BENADRYL and to contact dr.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Patient was given MENACTRA as subcutaneous injection rather than an IM injection; no adverse event reported by patient as of 6:00 PM (approximately 45 minutes after vaccine administration).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641518). This spontaneous report refers to a 12 year old female patient. Information on the patient's concurrent illnesses, medical history, prior vaccinations and other medications were not reported. On 01-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscular route in the left arm for prophylaxis. On the same day, the patient experienced nausea and dizziness. The outcome of dizziness and nausea was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Pallor, Tremor, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641606). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 22-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659 (expiry date: 20-SEP-2017), dose 2, intramuscular route in the right arm for prophylaxis. On the same day, approximately 5 min after vaccine administration, the patient was lightheaded and complained of dizziness. The patient was pale in color, he vomited once- clear emesis. The patient was shaky, he was laid on the exam table with his feet elevated. Water and ice pop were given. The patient was monitored for 30 minutes and the symptoms improved. In the follow-up that evening, the patient was more tired than usual. On 23-JUN-2016, the next morning the patient felt better. The outcome of dizziness, vomiting, tremor, pallor and fatigue was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Dizziness, Vomiting
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient had medical history of allergies to milk, nuts and fish. The patient had no current illnesses. The patient's other medications and prior vaccinations were not reported. On 30-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M003659 and expiration date: 20-SEP-2017, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included MENACTRA dose number 1; vaccinated date: 30-JUN-2016, intramuscularly in the right arm, lot # U5259AA; (dose, frequency and lot expiration date unknown) and BOOSTRIX dose number 1; vaccinated date: 30-JUN-2016, intramuscularly in the left arm, lot # Z9Z4Y; (dose, frequency and lot expiration date unknown). On 30-JUN-2016, after 5 minutes of vaccines administered the patient developed chest pain, vomiting and dizziness. The patient was observed for 10 additional minutes and normal examinations were performed. The patient walked out of office on his own. The outcome of chest pain, vomiting and dizziness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.