chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Electroencephalogram abnormal, Endotracheal intubation, Enterovirus test positive, Epstein-Barr virus test negative, Human rhinovirus test positive
Clinical narrative: The patient has been admitted due to an apparently acute-onset anoxic brain injury and unresponsive event two days after receiving the Varivax and Havrix vaccines, with leading diagnoses of inborn error of metabolism vs. myocarditis. The night prior to the event she seemed well, and she slept in her parents bed overnight, awakening multiple times for her bottle and behaving normally. The following morning the patient was found unresponsive in the parents' bed. Initial evaluation showed diffuse hypoxic-ichemic brain injury on CT head, EEG with diffuse slowing, hypoglycemia, leukocytosis, myocardial dysfunction on echocardiogram, and hypotension requiring pressors. She was intubated and admitted to the PICU. Started on empiric antibiotics, though LP could not be obtained. Blood viral and bacterial testing was negative. MRI shows small multifocal infarcts. She is now extubated and improving, with underlying etiology unclear
Age: 1.17
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Hypoglycaemia, Hypotension, Hypoxic-ischaemic encephalopathy, Inborn error of metabolism, Intensive care
Clinical narrative: The patient has been admitted due to an apparently acute-onset anoxic brain injury and unresponsive event two days after receiving the Varivax and Havrix vaccines, with leading diagnoses of inborn error of metabolism vs. myocarditis. The night prior to the event she seemed well, and she slept in her parents bed overnight, awakening multiple times for her bottle and behaving normally. The following morning the patient was found unresponsive in the parents' bed. Initial evaluation showed diffuse hypoxic-ichemic brain injury on CT head, EEG with diffuse slowing, hypoglycemia, leukocytosis, myocardial dysfunction on echocardiogram, and hypotension requiring pressors. She was intubated and admitted to the PICU. Started on empiric antibiotics, though LP could not be obtained. Blood viral and bacterial testing was negative. MRI shows small multifocal infarcts. She is now extubated and improving, with underlying etiology unclear
Age: 1.17
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Leukocytosis, Magnetic resonance imaging brain abnormal, Metabolic function test, Myocarditis, Parvovirus B19 test negative
Clinical narrative: The patient has been admitted due to an apparently acute-onset anoxic brain injury and unresponsive event two days after receiving the Varivax and Havrix vaccines, with leading diagnoses of inborn error of metabolism vs. myocarditis. The night prior to the event she seemed well, and she slept in her parents bed overnight, awakening multiple times for her bottle and behaving normally. The following morning the patient was found unresponsive in the parents' bed. Initial evaluation showed diffuse hypoxic-ichemic brain injury on CT head, EEG with diffuse slowing, hypoglycemia, leukocytosis, myocardial dysfunction on echocardiogram, and hypotension requiring pressors. She was intubated and admitted to the PICU. Started on empiric antibiotics, though LP could not be obtained. Blood viral and bacterial testing was negative. MRI shows small multifocal infarcts. She is now extubated and improving, with underlying etiology unclear
Age: 1.17
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Polymerase chain reaction positive, Troponin increased, Unresponsive to stimuli, Viral test negative
Clinical narrative: The patient has been admitted due to an apparently acute-onset anoxic brain injury and unresponsive event two days after receiving the Varivax and Havrix vaccines, with leading diagnoses of inborn error of metabolism vs. myocarditis. The night prior to the event she seemed well, and she slept in her parents bed overnight, awakening multiple times for her bottle and behaving normally. The following morning the patient was found unresponsive in the parents' bed. Initial evaluation showed diffuse hypoxic-ichemic brain injury on CT head, EEG with diffuse slowing, hypoglycemia, leukocytosis, myocardial dysfunction on echocardiogram, and hypotension requiring pressors. She was intubated and admitted to the PICU. Started on empiric antibiotics, though LP could not be obtained. Blood viral and bacterial testing was negative. MRI shows small multifocal infarcts. She is now extubated and improving, with underlying etiology unclear
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS GREATER THAN 1 INCH AND MILD SWELLING/NONTENDER AROUND INJECTION SITE
Age: 34.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Injection site reaction, Myalgia
Clinical narrative: Pt started having a fever, muscle aches, joint pain, diarrhea and poor appetite on 10/3/20. Fever "broke" 10/6/20  with onset of "itchy"  rash on torso, head, arms and hands. Pt states there is a cluster of spots around the injection site of MMR. Highest temp was 101.4. Pt was screened for covid prior to onset of rash and was negative.  Pt plans to go to walk-in clinic today (10/7/20) for further evaluation. Pt does not have PCP. Pt plans to call HD back after visit.
Age: 34.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Pyrexia, Rash, Rash pruritic, SARS-CoV-2 test negative
Clinical narrative: Pt started having a fever, muscle aches, joint pain, diarrhea and poor appetite on 10/3/20. Fever "broke" 10/6/20  with onset of "itchy"  rash on torso, head, arms and hands. Pt states there is a cluster of spots around the injection site of MMR. Highest temp was 101.4. Pt was screened for covid prior to onset of rash and was negative.  Pt plans to go to walk-in clinic today (10/7/20) for further evaluation. Pt does not have PCP. Pt plans to call HD back after visit.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blood culture, C-reactive protein, Erythema, Full blood count, Metabolic function test
Clinical narrative: Patient went to ER with soreness and redness of arm
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Patient went to ER with soreness and redness of arm
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE/PQC Reported; The patient was administered an improperly stored dose of GARDASIL 9; This spontaneous report was received from a nurse and was referring to patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  On 04-SEP-2020, the patient was vaccinated for prophylaxis with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 ml Intramuscularly (Dosage regimen and anatomical location were not reported, lot number: S062371 and expiration date: unknown).  The improperly stored of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature of 48.2 F with time frame of 121 hours, with a previous temperature excursion of 47 F for 31 hours and 45 minutes; 35 F for 2 hours 5 minutes and was call because a digital data logger. No additional adverse event details available.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: Little vague ache in our shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine Quadrivalent (received yearly for over 30 years).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient was reporting for herself. The age at vaccination was not reported. After receiving Influenza vaccine, the patient had a little vague ache in her shoulder. The patient had been getting the vaccine yearly for over 30 years. The patient was schoolteacher and during that time, she never had the flu. This was 1 of 14 linked cases reported by the same reporter. This case was linked with case US2020AMR196973, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR196983:Husband's case Season 2015-2016 US-GLAXOSMITHKLINE-US2020AMR196984:Husband's case Season 2016-2017 US-GLAXOSMITHKLINE-US2020AMR196973:Husband's case season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196985:Husband's case Season 2017-2018 US-GLAXOSMITHKLINE-US2020AMR196987:Husband's case Season 2019-2020 US-GLAXOSMITHKLINE-US2020AMR196982:Husband's case season 2014-2015 US-GLAXOSMITHKLINE-US2020AMR196986:Husband's case Season 2018-2019 US-GLAXOSMITHKLINE-US2020AMR196967:Season 2014-2015 US-GLAXOSMITHKLINE-US2020AMR196968:Season 2015-2016 US-GLAXOSMITHKLINE-US2020AMR196969:Season 2016-2017 US-GLAXOSMITHKLINE-US2020AMR196970:Season 2017-2018 US-GLAXOSMITHKLINE-US2020AMR196971:Season 2018-2019 US-GLAXOSMITHKLINE-US2020AMR196972:Season 2019-2020 US-GLAXOSMITHKLINE-US2020AMR196967:Season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196971:Season 2020-2021
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: Little vague ache in our shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine quadrivalent (received vaccine yearly for over 30 years).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient had a little vague ache in his shoulder. The patient had been getting the vaccine yearly for over 30 years. The patient was schoolteacher and during that time, he never had the flu. This case was linked with case US2020AMR196945, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR196945:Wife's case season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196967:Wife's case season 2014-2015 US-GLAXOSMITHKLINE-US2020AMR196968:Wife's case season 2015-2016 US-GLAXOSMITHKLINE-US2020AMR196969:Wife's case season 2016-2017 US-GLAXOSMITHKLINE-US2020AMR196970:Wife's case season 2017-2018 US-GLAXOSMITHKLINE-US2020AMR196971:Wife's case season 2018-2019 US-GLAXOSMITHKLINE-US2020AMR196972:Wife's case season 2019-2020 US-GLAXOSMITHKLINE-US2020AMR196986:Season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196982:Season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196983:Season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196985:Season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196984:Season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196987:Season 2020-2021
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Injection site warmth
Clinical narrative: warm on the injection site; 3rd dose of Shingrix was administrated; fist dose  was administrated October 29 2019 / second dose administrated December 13 2019; This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th December 2019, the patient received the 2nd dose of Shingrix. On 6th July 2020, the patient received the 3rd dose of Shingrix. On 13th December 2019, unknown after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On 6th July 2020, the patient experienced injection site warmth and extra dose administered. On an unknown date, the outcome of the injection site warmth was recovered/resolved and the outcome of the extra dose administered and drug dose administration interval too short were unknown.  Additional details were reported as follows: The age at vaccination was not reported. On 29th October 2019, the patient received 1st dose of Shingrix. On 13th December 2019, the patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. Less than a day after receiving 3rd dose of Shingrix, the patient experienced warmth on the injection site. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Malaise
Clinical narrative: Issues with her stomach; Doesn't feel great; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced stomach discomfort and feeling unwell. On an unknown date, the outcome of the stomach discomfort and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the stomach discomfort and feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient experienced stomach discomfort and was not feeling well after receiving the Flu vaccinein the past.  The reporter consented to follow up. The case is linked with the case- US2020AMR199016 and case- US2020198047, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198047:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Doesn't feel great; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 90-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The case was reported by patient's daughter. The patient was not feeling great after receiving the dose of Flu vaccine. No further information was provided. Follow up was requested. The case is linked with the case- US2020198044 and case- US2020AMR199016, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198044:same reporter US-GLAXOSMITHKLINE-US2020AMR199016:same reporter
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Swollen tongue, Syncope
Clinical narrative: a few minutes after the injection the patient exhibited signs of a syncope reaction. but not typical. after about 10 minutes she appeared to be having difficulty breathing and tongue appeared  to be swelling. called 911 and administered an EpiPen. ems arrived. she had stabilized somewhat. they transported her to hospital.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: From Day 1, swelling at shot site, fever/chills, nausea and vomiting Day 2, fever continued through Day 4.  Arm extremely sore, red, swollen from site down to elbow, very limited range of motion.   By Day 5, Fevers gone b it not much Arm improvement. Cefalexin  500mg/3x day started for possible cellulitis.  Day 6, improving range of motion, but very hard lump at point of injection, erythema and some pruritus underside of upper arm to below elbow. DEFINITE POUCHES OF EDEMA UNDERSIDE OF ARM NOW EXTENDING DOWN HALFWAY TO RIGHT WRIST.  INJECTION SITE STILL EXTREMELY PAINFUL.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Joint range of motion decreased, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: From Day 1, swelling at shot site, fever/chills, nausea and vomiting Day 2, fever continued through Day 4.  Arm extremely sore, red, swollen from site down to elbow, very limited range of motion.   By Day 5, Fevers gone b it not much Arm improvement. Cefalexin  500mg/3x day started for possible cellulitis.  Day 6, improving range of motion, but very hard lump at point of injection, erythema and some pruritus underside of upper arm to below elbow. DEFINITE POUCHES OF EDEMA UNDERSIDE OF ARM NOW EXTENDING DOWN HALFWAY TO RIGHT WRIST.  INJECTION SITE STILL EXTREMELY PAINFUL.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Vomiting
Clinical narrative: From Day 1, swelling at shot site, fever/chills, nausea and vomiting Day 2, fever continued through Day 4.  Arm extremely sore, red, swollen from site down to elbow, very limited range of motion.   By Day 5, Fevers gone b it not much Arm improvement. Cefalexin  500mg/3x day started for possible cellulitis.  Day 6, improving range of motion, but very hard lump at point of injection, erythema and some pruritus underside of upper arm to below elbow. DEFINITE POUCHES OF EDEMA UNDERSIDE OF ARM NOW EXTENDING DOWN HALFWAY TO RIGHT WRIST.  INJECTION SITE STILL EXTREMELY PAINFUL.
Age: 52.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Headache, Impaired work ability, Pain, Pyrexia
Clinical narrative: PATIENT REPORTED FEVER, HEADACHE, JOINT & BODY ACHES THAT STARTED THE DAY AFTER VACCINATION AND WORSENED OVER THE COURSE OF THE DAY, RESULTING IN BEING SENT HOME FROM WORK. PATIENT MISSED THE DAY AFTER THAT AS WELL, ALTHOUGH PATIENT REPORTED SYMPTOMS HAD CLEARED BY THE SECOND DAY POST VACCINATION. NO FURTHER MEDICAL CARE OR AFTER CARE WAS NEEDED ONCE SYMPTOMS CLEARED.
Age: 50.0
Sex: F
Vaccine: FLUN4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client was accidentally given FluMist vaccine at age 50.  No adverse signs or symptoms have been reported to my knowledge.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Influenza injection administered, within 5 minutes itching at site, at 10 minutes redness and heat noted, ice applied. At 15 minutes 6cm hive at site with nausea and dizziness, 20 minutes felt "woozy". 30 minutes looking pale and having difficulty breathing.  Taken to Emergency Room for treatment.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Nausea, Pallor
Clinical narrative: Influenza injection administered, within 5 minutes itching at site, at 10 minutes redness and heat noted, ice applied. At 15 minutes 6cm hive at site with nausea and dizziness, 20 minutes felt "woozy". 30 minutes looking pale and having difficulty breathing.  Taken to Emergency Room for treatment.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Influenza like illness, Migraine, Nausea, Pain
Clinical narrative: Was well at time of vaccination and had no immediate problems. The following day she developed nausea, vomiting and a headache. She reported a low grade temperature and body aches as if she had the flu. She stated there was no pattern with the migraines or any association with events. They would last a couple of hours and she would have some light sensitivity. Other than the occasional headache she denied any previous hx of headaches. She reported the headaches lasted approx 6 months and spontaneously resolved in May 2019. Did not seek formal evaluation other than a pcm visit and never received a diagnosis of migraines.   Symptoms: HEADACHE(R51).
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Photophobia, Vomiting
Clinical narrative: Was well at time of vaccination and had no immediate problems. The following day she developed nausea, vomiting and a headache. She reported a low grade temperature and body aches as if she had the flu. She stated there was no pattern with the migraines or any association with events. They would last a couple of hours and she would have some light sensitivity. Other than the occasional headache she denied any previous hx of headaches. She reported the headaches lasted approx 6 months and spontaneously resolved in May 2019. Did not seek formal evaluation other than a pcm visit and never received a diagnosis of migraines.   Symptoms: HEADACHE(R51).
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Limb discomfort, Myalgia, Pain
Clinical narrative: A feeling of heaviness from right shoulder into hand.  Soreness and muscle ache given prednisone metro dose pack.  Observation for 2 hours
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Nausea
Clinical narrative: The client reports that her arm swelled up at the site of injection to the size of a tennis ball. The site was red, painful, she was nauseous  and in general she did not feel well. She reports that she was taking regular doses of BENADRYL, but she reports no trouble breathing or rash occurring. The client did not seek medical care or call the pharmacy when the reaction occurred. The incident was discovered by the pharmacy when call the client to get her second dose of SHINGRIX.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Neck pain
Clinical narrative: pain at injection site & referred pain down arm & into hand - onset <1 hr - treatment none nausea & lightheadedness - onset ~3 hrs - treatment none headache & neck pain, severe - onset ~12 hrs - treatment 400mg ibuprofen, 50mg tramadol, 500mg methocarbamol fatigue, slept 14.5 out of 16 hrs beginning 2pm 10/6 - onset~24 hrs fever 101.5 - onset ~34 hrs - treatment none throat constriction - onset ~34 hrs - treatment none
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Throat tightness
Clinical narrative: pain at injection site & referred pain down arm & into hand - onset <1 hr - treatment none nausea & lightheadedness - onset ~3 hrs - treatment none headache & neck pain, severe - onset ~12 hrs - treatment 400mg ibuprofen, 50mg tramadol, 500mg methocarbamol fatigue, slept 14.5 out of 16 hrs beginning 2pm 10/6 - onset~24 hrs fever 101.5 - onset ~34 hrs - treatment none throat constriction - onset ~34 hrs - treatment none
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing, Hypertension, Swollen tongue
Clinical narrative: Flushing, SOB, tongue swelling, hypertension Given 50mg of diphenhydramine and taken to ED for eval
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Borrelia test, Full blood count, Laboratory test, Metabolic function test, Streptococcus test
Clinical narrative: urticaria to bilateral arms and legs, chest and back, no other s.sx
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Urticaria
Clinical narrative: urticaria to bilateral arms and legs, chest and back, no other s.sx
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Ongoing nausea and tiredness, headache, shivering.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Neurological examination normal, Paraesthesia
Clinical narrative: Parasthesias R arm starting 1 hour after injection
Age: 87.0
Sex: F
Vaccine: FLUA4
Symptoms: Dyspnoea, Erythema, Immediate post-injection reaction
Clinical narrative: Patient received vaccination  and within a minute was turning red and having trouble breathing. Technician grabbed a 0.3mg Epipen and the pharmacist. Tried to inject one epipen and the needle bent trying to administer through pants. They proceeded to roll up pants and administered 2nd epipen in the thigh. 911 was called.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Seizure
Clinical narrative: Patient passed out within seconds of receiving vaccine and had mild seizure
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Laboratory test, Pyrexia, Seizure like phenomena
Clinical narrative: fever with seizure like activity, was seen in ED and discharged home
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient reports arm and shoulder soreness that has worsened since time of immunization and now reports difficulty moving shoulder
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Pyrexia, Rash
Clinical narrative: fever accompanied with rash 2 days in duration; weakness
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles 10/7/2020 per Dr.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Incorrect route of product administration, Skin warm, Swelling
Clinical narrative: Injection was given SC rather than IM. I had baseball size swelling first day, second  day is 2 inch red and bruised circle that is hot to the touch
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Patient was given a Fluzone HD injection into Left Deltoid on 9/24/2020 through an Inject-Safe barrier bandage. At that time patient was instructed to take off bandage when bleeding stopped in about 10-15 minutes. Patient left bandage on for approximately 24 hours. When she took the bandage off, there was a 'burn-like' mark on her arm where the film had contacted her skin. Patient brought this to my attention on 10/6/2020. I spoke with the manufacturer of the Inject-Safe barrier and they felt that it was a reaction to the Fluzone HD injection because the circular area was where the film was not where the adhesive was.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: Light-headed-ness, headache, mild nausea, increased heart rate with a sudden onset within 5 hours after vaccination. Instructed to contact Primary Care Physician the next morning (07-OCT-2020). Informed that no testing was necessary at this time and to call 911 if symptoms became worse.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Pain in extremity
Clinical narrative: Pt said his arm was sore evening of the injection and the following day. 2 days later, his arm became red/blue bruised in the area around the injection site and down towards the elbow on the inner side of the arm. Pt came into the pharmacy the following day (3 days later) and showed his arm to the RPh on duty and was told to go to the doctor to get it checked out. Pt came back to pharmacy the following day (4 days later) and said the doctor told him it was likely due to the flu shot and told him to come back in a couple days to recheck arm. Pt will update pharmacy once he returns to doctor and pharmacy will call pt to check on him.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Appetite disorder, Behaviour disorder, Decreased eye contact, Laboratory test, Speech disorder developmental
Clinical narrative: speech delay appetite eye contact  behavorial
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Papilloma viral infection, Smear cervix
Clinical narrative: diagnosed with HPV, strain 16 & 18 in July 2019 which GARDASIL is supposed to protect against; diagnosed with HPV, strain 16 & 18 in July 2019 which GARDASIL is supposed to protect against; This spontaneous report was received from a consumer who refers to herself, a currently 25-year-old non-pregnant female patient. Concomitant medication included drospirenone (+) ethinyl estradiol (YAZ) and cetirizine hydrochloride (ZYRTEC). Concurrent condition included birth control and no drug reaction or allergies. There was no information about the patient's medical history provided.   On an unknown date in 2009,  the patient was vaccinated with full series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscularly for human papillomavirus (HPV) prevention (exact dose, lot number and expiration date were not provided).  On an unknown dates, the patient had performed biopsy and pap-smear but the results were not provided.  On an unknown date in July 2019, the patient was diagnosed with HPV, strain 16 and 18 which quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was supposed to protect against. It was reported that the patient sought for medical attention. No treatment was given for the adverse events.   On an unknown date in November 2019, the patient had performed re-pap which came back to normal.  The outcome of the events was reported as recovered on an unknown date in November 2019. The causality assessment was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Administration of an expired PNEUMOVAX 23 vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.  On 30-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 injection form, lot # R034248, expiration date on 07-AUG-2020 (Expired vaccine used) for prophylaxis (strength, frequency, route of administration, and anatomical location were not reported).  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R034248; expirationdate: 07-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 16-NOV-2016, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster-related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provided for shingles. As a direct and proximate result of plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine. The patient had and will continue suffering ongoing injuries, including but not limited to: mental and physical pain an suffering; medical care and treatment or these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages, and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of VARIVAX which was stored at -11.1 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-SEP-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S003447 with an expiration date of 04-FEB-2021, 1 injection (formulation, strength, exact dose and route of administration were not reported) for prophylaxis. The temperature excursion was reported as stored at -11.1 Celsius for 4 hours and 30 minutes. There was no previous excursion reported. A data logger was used to capture the temperature excursion. The outcome was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick for 8 months/walk all tore up; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine 3 years ago and was sick for 8 months had to walk daughter for her wedding all tore up the shot never again.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever; sore/aches; puffy arm; red puffy arm; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain, swelling arm and erythema of extremities. On an unknown date, the outcome of the fever, pain, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the fever, pain, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient had a routine reaction to dose one of Shingrix as fever, sore, red puffy arm, aches. The reporter questioned what should be expected from dose two.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Very painful adverse effects; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced very painful adverse effects.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chills, Feeling abnormal
Clinical narrative: shivering, chills; felt like crap; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   On 1st September 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced chills and feeling bad. On an unknown date, the outcome of the chills and feeling bad were unknown.   It was unknown if the reporter considered the chills and feeling bad to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and flu vaccine on that same day also in his left arm and experienced shivering, chills and felt like crap.  The reporter did not consent to follow up. Both caller and husband both have the same initials ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020197211:Same Reporter
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Very mild rash and self limited; This case was reported by a physician via call center representative and described the occurrence of rash in a 64-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2E3EH, expiry date 31st October 2021) for prophylaxis.   On 27th January 2020, the patient received Boostrix. On an unknown date, less than 9 months after receiving Boostrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Boostrix.  Additional details were provided as follows:  The patient received Boostrix and might had a very mild rash and self limited earlier this year and reporter asked would be able to receive Shingrix.  The HCP reported this would be 1st dose of Shingrix in case patient receives it and was not sure if the rash could be related to any vaccination. The reporter consented to follow up. All patient identifiers were provided as well as Batch Number and Expiration Date.  No further clarifications made.
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: softball size welt at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site wheal in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 1st October 2020, the patient received FluLaval Tetra 2020-2021 season. On 2nd October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site wheal. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site wheal was unknown.   The reporter considered the injection site wheal to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The  Sales representative called response center to report an adverse event.  The reporter was a pharmacy technician at a hospital.  The pharmacy technician reports that the patient received Flulaval shot and had a softball size welt at the injection site.  It was being treated with a cold compress and ibuprofen.  Reporter provided limited information.  The reporter did not had the patient date of birth in front of her but estimates that she is about 25 years old.   No further details were reported such as lot number or injection site. The reporter provided limited information.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: flu; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via social media.  This case involves a patient (with unknown demographics) who experienced flu (influenza) every time he/she received INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu (influenza) (unknown latency) every time following the administration of INFLUENZA VACCINE.  Laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome was unknown for influenza.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Nodule, Pain, Skin warm
Clinical narrative: Patient reported knot forming, turning red, and feeling warm to touch/ being sore until 10/06.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: ARM BECAME SORE WITHIN 2 HOURS OF ADMINISTRATION, CANT LIFT ARM, VERY PAINFUL STILL 3 WEEKS AFTER ADMINISTRATION
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Feeling abnormal
Clinical narrative: PATIENT STATED SHE FELT SEDATED THE DAY AFTER THE VACCINE.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Decreased appetite, Dry mouth, Mucosal disorder, Pyrexia
Clinical narrative: fever > 100* f decreased appetite dry mouth, mucus membranes  All > 2 days
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Dysphagia, Heart rate increased, Nervousness
Clinical narrative: Hot feeling in arm that traveled into chest and neck, rash, dizziness/nervousness, trouble swallowing, increased blood pressure (164/98), increased HR 120. Took 2 Benadryl, 1 Claritin and 1 famotidine, 10 mg decadron shot . the reaction started 15 mins after shot took medications and was monitored for an hour.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Skin warm
Clinical narrative: Hot feeling in arm that traveled into chest and neck, rash, dizziness/nervousness, trouble swallowing, increased blood pressure (164/98), increased HR 120. Took 2 Benadryl, 1 Claritin and 1 famotidine, 10 mg decadron shot . the reaction started 15 mins after shot took medications and was monitored for an hour.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting
Age: 72.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Chest pain, Dizziness
Clinical narrative: After patient received Flublok Quad and Pneumovax23, patient experienced dizziness, then few minutes later patient complained chest pain.  We called 911, paramedics came and assessed patient.  Patient rested in consultation room for 15 to 20 minutes and felt better.  Patient contacted her cardiologist, and also called her friend to come and pick her up.  Patient's friend took patient home.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Injection site erythema, Skin warm
Clinical narrative: patient stated that her arm got very hot and warm to touch and red spots at the sight of the injection and the redness relocated to the lower part of her arm under the injection, there is bruise-like blemishing with small red dots
Age: 13.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered Flublok vaccine instead of Fluvarix vaccine in right deltoid. No symptoms or reactions noted after administering vaccine.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: Developed spreading rash to injection site that extended down to right arm length. Responded to oral Benadryl given by parent at home. No medical visit required.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter referring to a currently 1-year-old patient of an unknown gender. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # S038702, expiration date 01-DEC-2021; strength, vaccination scheme, route and anatomical location not reported) for prophylaxis.   The vaccine administered experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008353: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008520: US-009507513-2009USA008533: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008804: US-009507513-2009USA008870:
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Electrocardiogram abnormal, Fatigue, Heart rate increased, Heart rate irregular
Clinical narrative: My heart started pounding irregularly and rapidly and I felt like I was going to faint/except for tachycardia and irregular heartbeat- a sinus rhythm; I felt like I was going to faint; My heart started pounding irregularly and rapidly and I felt like I was going to faint/except for tachycardia and irregular heartbeat- a sinus rhythm; they feel tired; They had an "immediate allergic reaction, or what I feel was an allergic reaction"; This spontaneous report has been received from a 72-year-old female patient, referring to herself. The patient's medical history and concomitant medications were not provided. The patient's concurrent conditions included an allergy to penicillin and sulfa. The patient did not receive any other vaccine or begun a new medication in the last fourteen days.  On 01-OCT-2020 (in the afternoon), the patient was vaccinated with pneumococcal vaccine PNEUMOVAX23 0.5 milliliter once a year, subcutaneously (lot number and expiration date were not provided) for prevention of pneumococcal disease caused by 23 serotypes contained in the vaccine.  On 01-OCT-2020, the patient stated that had an immediate allergic reaction or what she felt that was an allergic reaction. The reporter stated that her heart started pounding irregularly and rapidly and felt like she was going to faint (dizziness). Due to the patient was in the doctor's office (also reported that the patient was hospitalized), the physician performed a blood pressure check which was normal and an electrocardiogram (EKG) which was normal except for tachycardia and irregular heartbeat related with sinus rhythm. The reporter stated that she was fully recovered, but she felt tired.  The patient did not receive any treatment for the adverse events.  The outcome of tachycardia, sinus rhythm, dizziness and allergic reaction was recovering. The outcome of felt tired was not recovered. The reporter did not provide a relationship between the adverse events and the therapy.