chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MEN
Symptoms: COVID-19, Coronavirus test positive
Clinical narrative: tested positive for covid.; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a 18-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, less than 2 months after receiving Meningococcal B vaccine, the patient experienced covid-19 (serious criteria GSK medically significant). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent (unknown if father or mother). The age at vaccination was not reported, however it could be 17 or 18 years. The patient was scheduled for 2nd dose on 25th September 2020, but tested positive for covid. The reporter wanted to know, how much time did he had to get the 2nd dose. The follow-up was not required.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Mass, Skin warm, Swelling, Tenderness
Clinical narrative: Red swollen lump, hot to touch, tenderness
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Influenza virus test negative, Nausea, Ocular hyperaemia
Clinical narrative: BECAME SHORT OF BREATH, HAD CHEST PAIN, FACE AND ARM SWELLED, EYES RED, NAUSEA/VOMITING. 10/25 TO CURRENT
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, SARS-CoV-2 test negative, Swelling face, Vomiting
Clinical narrative: BECAME SHORT OF BREATH, HAD CHEST PAIN, FACE AND ARM SWELLED, EYES RED, NAUSEA/VOMITING. 10/25 TO CURRENT
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Migraine, Musculoskeletal stiffness, Paranasal sinus inflammation
Clinical narrative: Evening of flu shot patient describes: Migraine, sinus inflammation, neck stiffness, joint pain
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: Severe Arm & Shoulder Pain, High Fever, Headache and Dizziness
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: The morning after the injection, the patient had severe vertigo for several hours .   It improved during the day but did not completely resolve.  The second day after the injection, the severe vertigo returned, lasting several hours and waning as the day progressed. Since then, the vertigo has been mild, and as of today has almost completely resolved.   The patient is aware of another person who had a flu vaccination at pharmacy around the same time and also experienced vertigo .
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects, there was a vaccine error. Pt was supposed to receive adult Hep B (Energix) and was given pediatric vaccine (Recombivax HB)
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Ocular hyperaemia, Oral pain, Pain in extremity
Clinical narrative: Mouth sores red painful hands, blood shot eyes
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Syncope, Visual impairment
Clinical narrative: Client received Td vaccine at 0857 in the right arm. Client stated he was fine. At 0900 client received TST in left arm. Client stated, " everything is going black," and fainted.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: arm was swllen and red and hot and the swelling continued down to her elbow
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Swelling
Clinical narrative: mother had pictures mild redness and swelling day 1 redness and swelling worsening within the 24-36 mark deeper redness and noticeable swelling late Saturday night (lateral view in the photos). Sunday 3, the redness and swelling had improved The redness and swelling is much better this morning (provider did assess the patient) no treatment needed
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Neuralgia
Clinical narrative: patient described a nerve pain like feeling about a day after receiving the vaccine. he is unsure if its related. the nerve pain is still ongoing but comes and goes. it is not constant
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever 101.8 continuing approx 6 hrs Headache Muscle ache
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Peripheral nerve paresis, Swelling
Clinical narrative: Swelling and discomfort followed by clinical ulnar neuropathy
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Patient appeared to have a fluid filled sac under the injection site of the shingrix vaccine. Injection site appeared to be in deltoid, sac was in the bicep area. Patient did not report any serious pain, fever or malaise
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Movement disorder, Musculoskeletal stiffness, Pain
Clinical narrative: severe pain, stiffness, unable to move, unable to get out of bed without struggle. it lasted for 2 days then improved sunday evening (09/27/20). she is using ibuprofen,muscule relaxant,pain med,messager and it improved
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Activated partial thromboplastin time, Blood culture, Blood lactic acid, Full blood count, Injection site erythema
Clinical narrative: Symptoms of redness, swelling in the right deltoid and reports fever Thursday night 09/24/2020 after receiving vaccination at 1433. Pt went to ER on 09/26/2020 at 2228.
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Laboratory test, Metabolic function test, Prothrombin time, Pyrexia
Clinical narrative: Symptoms of redness, swelling in the right deltoid and reports fever Thursday night 09/24/2020 after receiving vaccination at 1433. Pt went to ER on 09/26/2020 at 2228.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Flushing, Pallor, Rash macular
Clinical narrative: Within a few minutes of shot flushed cheeks sparing nasolabial folds, blanching confluent  pink macular rash proximal arms and legs few macules on chest abdomen, stable vitals no wheezing, rash did not appear itchy,  Cetirizine was given, rash resolved within an hour. no other symptoms.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site bruising, Injection site pain
Clinical narrative: Pt reported to pharmacy that less than 24 hours after receiving injection she had a large painful bruise at the injection site. After visiting her physician she reported to pharmacy the severity of the pain and bruising. Pt reported applying heat and taking otc pain relievers. Pt is improving but still experiencing discomfort.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Culture urine
Clinical narrative: Rectal temp to 101.4 in child under 12 weeks. ER visit required.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: CSF test normal, Chest X-ray normal, Disorientation, Encephalitis, Endotracheal intubation
Clinical narrative: Acute encephalitis and seizures.  Patient is currently in ICU sedated and on mechanical ventilation.   MRI is "unremarkable",  lumbar puncture, analysis of spinal fluid is "unremarkable" chest x-rays normal.  Lab results pending.   He has  no known insect bites and has not been near wooded areas, and has routine pest control for the home.  After 24 hours in the ICU  it remains unclear what is causing encephalitis.   I am not certain what flu shot he had, so the information reported above is based on the fact that he advised in regular conversation last week that he had the "high dose flu vaccine"  on Saturday 9/19/2020 at about 11:15 in the morning, and your website lists only the Sanofi one as "high dose".  His wife reports that he was "very cranky and out of character" all day  Saturday, 9/26, and then he was disoriented and incoherent on Sunday morning 9/27/2020 and admitted to the ICU, and having seizures by midday, Sunday 9/27 requiring intubation.  He remains intubated while tests are pending.  I am making this report based on the VAERS guidance "VAERS encourages the reporting of any significant adverse event occurring after the administration of any vaccine licensed in specific country. "
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Incoherent, Intensive care, Irritability, Laboratory test, Magnetic resonance imaging normal
Clinical narrative: Acute encephalitis and seizures.  Patient is currently in ICU sedated and on mechanical ventilation.   MRI is "unremarkable",  lumbar puncture, analysis of spinal fluid is "unremarkable" chest x-rays normal.  Lab results pending.   He has  no known insect bites and has not been near wooded areas, and has routine pest control for the home.  After 24 hours in the ICU  it remains unclear what is causing encephalitis.   I am not certain what flu shot he had, so the information reported above is based on the fact that he advised in regular conversation last week that he had the "high dose flu vaccine"  on Saturday 9/19/2020 at about 11:15 in the morning, and your website lists only the Sanofi one as "high dose".  His wife reports that he was "very cranky and out of character" all day  Saturday, 9/26, and then he was disoriented and incoherent on Sunday morning 9/27/2020 and admitted to the ICU, and having seizures by midday, Sunday 9/27 requiring intubation.  He remains intubated while tests are pending.  I am making this report based on the VAERS guidance "VAERS encourages the reporting of any significant adverse event occurring after the administration of any vaccine licensed in specific country. "
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Mechanical ventilation, Personality change, Seizure
Clinical narrative: Acute encephalitis and seizures.  Patient is currently in ICU sedated and on mechanical ventilation.   MRI is "unremarkable",  lumbar puncture, analysis of spinal fluid is "unremarkable" chest x-rays normal.  Lab results pending.   He has  no known insect bites and has not been near wooded areas, and has routine pest control for the home.  After 24 hours in the ICU  it remains unclear what is causing encephalitis.   I am not certain what flu shot he had, so the information reported above is based on the fact that he advised in regular conversation last week that he had the "high dose flu vaccine"  on Saturday 9/19/2020 at about 11:15 in the morning, and your website lists only the Sanofi one as "high dose".  His wife reports that he was "very cranky and out of character" all day  Saturday, 9/26, and then he was disoriented and incoherent on Sunday morning 9/27/2020 and admitted to the ICU, and having seizures by midday, Sunday 9/27 requiring intubation.  He remains intubated while tests are pending.  I am making this report based on the VAERS guidance "VAERS encourages the reporting of any significant adverse event occurring after the administration of any vaccine licensed in specific country. "
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test positive, Culture throat negative, Erythema, Local reaction, Streptococcus test negative
Clinical narrative: Local reaction only.  Redness, hives near where vaccine administered, onset the following day,  which then faded to small bumps-to-flat rash in 12-24hrs..  No systemic symptoms.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Local reaction only.  Redness, hives near where vaccine administered, onset the following day,  which then faded to small bumps-to-flat rash in 12-24hrs..  No systemic symptoms.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: On right shoulder all the way down to her elbow, she is experiencing hot temperature, swollen and pain. It had occurred that same day 6 hours alter. No shortness of breath. She had low grade fever on 9/27/2020 but it had subsided.  Arm had a little bit of itching. Symptoms are still present, but not as strong as on Saturday.  In the back of the right arm is sore.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site scab, Pain
Clinical narrative: patient called the day after  complaining of soreness and a scab forming about the size of a pencil eraser.  After a follow up call on 9/28 the patient reports that the pain is gone but there is a crystalline scab where the injection was given.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Headache, Oropharyngeal pain, Viral upper respiratory tract infection
Clinical narrative: Mild sore throat, headache, and cough consistent with viral upper respiratory symptoms ~3 days after receiving vaccine. Duration 5 days.
Age: 9.0
Sex: U
Vaccine: FLUC4
Symptoms: Eye irritation, Nodule, Pruritus, Rash, Skin reaction
Clinical narrative: Box 17 Manufacturer - Sequrius   Box 18 - Arm is big, round red within 24 hours Hives Applied cream and  steriod cream Rash  Golf ball knot on arm Itching and burning  Went to urgent care clinic prescribed steriods
Age: 9.0
Sex: U
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Box 17 Manufacturer - Sequrius   Box 18 - Arm is big, round red within 24 hours Hives Applied cream and  steriod cream Rash  Golf ball knot on arm Itching and burning  Went to urgent care clinic prescribed steriods
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pallor
Clinical narrative: Pt turned white and nearly passed out immediately after injection.  The school called her parent and they picked her up.  No other reports were made by the parent
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain
Clinical narrative: About 10 minutes after she received the flu vaccine on 9/28/2020, the patient returned to the pharmacy counter complaining of a severe lower back pain that she described as "stabbing."  We had her remain seated and our floater pharmacist gave her a cold pack to place on her back.  After remaining seated for about 10-15 minutes, her back pain was starting to feel better enough for her to stand up and walk out of the store.  Her neighbor picked her up since she was unsure if she could drive home, and we recommended she follow up with the emergency department or her primary care physician.
Age: 68.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Patient had some redness and swelling appear on the forward aspect of her upper arm, a little below the deltoid in the evening following vaccination. By the next day, when she reported to me, the "rash" was extending from the armpit to the elbow. The skin was pink-red and swollen. She had been taking acetaminophen to help with pain.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Eating disorder, Muscle twitching
Clinical narrative: mom reported on 9/24/2020 that baby had decreased bottle intake on 9/24/2020 and left leg "twitching" per mom's observation.  MD spoke with mom on 9/25/2020 and baby was doing well.  Eating was back to normal.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Hyperhidrosis, Movement disorder, Nausea
Clinical narrative: Pt said she went home and started working in the yard. She said she collapsed, and could not move. She was sweating profusely and had severe abdominal pain, nausea and diarrhea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Pt said she went home and started working in the yard. She said she collapsed, and could not move. She was sweating profusely and had severe abdominal pain, nausea and diarrhea.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Reports arm started to ache the day after.  It has remained sore and has affected mobility.
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Interchange of vaccine products
Clinical narrative: her son has been dealing with runny stool for quite a long time; pediatrician gave my son the ROTATEQ vaccine and only gave 1 dose and then they gave ROTARIX / He was supposed to get 3 doses of ROTATEQ; pediatrician gave my son the ROTATEQ vaccine and only gave 1 dose and then they gave ROTARIX / He was supposed to get 3 doses of ROTATEQ; This spontaneous report was received from a patient's mother and refers to a currently 9-month-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 10-FEB-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (exact dose, dose number, vaccination site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 12-APR-2020, the patient was vaccinated with rotavirus g1 p1 vaccine live (89-12) (ROTARIX).  The patient's mother stated that she was in panic that her pediatrician gave her son rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and only gave 1 dose and then they gave rotavirus g1 p1 vaccine live (89-12) (ROTARIX). She wanted to know if there were any adverse reactions that could happen by doing that. The patient was supposed to get 3 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  Since an unknown date (reported as for quite a long time), the patient has been dealing with runny stool. The outcome of the event was unknown.  The causal relationship between the event and the suspect vaccines was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles rash presented on Sunday on both sides of her torso; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she received the vaccine on Saturday and a shingles rash presented on Sunday on both sides of her torso. The reporter consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Illness, Pain in extremity
Clinical narrative: left arm was sore; sick; felt off; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix. On 2nd November 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, sickness, feeling abnormal and fatigue. On an unknown date, the outcome of the pain in arm, sickness, feeling abnormal and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, sickness, feeling abnormal and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on left arm. Next day after receiving Shingrix, the patient's left arm was sore from the injection and he felt sick, felt off and fatigue which lasted for a few days. The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cholecystectomy, Escherichia infection, Escherichia sepsis, Organ failure, Viral infection
Clinical narrative: bacterial infection (ecoli); bacterial infection (ecoli), not a viral infection and became septic; organ shutdown/gall bladder removed; This case was reported by a pharmacist via call center representative and described the occurrence of escherichia coli infection in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced escherichia coli infection (serious criteria hospitalization and GSK medically significant), septicemia due to escherichia coli (e. coli) (serious criteria hospitalization and GSK medically significant) and organ failure (serious criteria hospitalization). The patient was treated with prednisone. On an unknown date, the outcome of the escherichia coli infection, septicemia due to escherichia coli (e. coli) and organ failure were recovered/resolved.   It was unknown if the reporter considered the escherichia coli infection, septicemia due to escherichia coli (e. coli) and organ failure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix and two months after receiving the dose, the patient had a viral infection (pharmacist did not know what virus), organ shutdown and was hospitalized for 2 months.  The patient recovered but he has been taking Prednisone since, 9 mg daily. The patient has not received the 2nd dose of Shingrix till the time of reporting. Upon follow up it was stated that the patient had a bacterial infection (ecoli), not a viral infection and patient became septic. The patient underwent gall bladder removal.
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Erythema, Fatigue, Skin ulcer, Swelling, Swelling face
Clinical narrative: Both arms got very red/face and neck became very red; Neck started to swell; Face started to swell; Afluria TIV and Gardasil 9 were administered into the same (right) arm on the same day; The patient felt very run down; Ulcer like burns on his face and nose; Information was downloaded from Agency (US-SEQIRUS-202000368).  This spontaneous report as received from an other health professional refers to a 13-year-old male patient. The patient's concurrent conditions included asthma, allergy to dogs, seasonal allergy, food allergy and drug allergy.     On 08-OCT-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial, right arm (lot #, expiration date, route of administration and dose were unknown) for prophylaxis.  Other suspect vaccination included influenza virus split virion 3v vaccine inactivated (AFLURIA) (lot #, expiration date, route of administration and dose were unknown) administered on the same date, in the same (right) arm (product administration error) for prophylaxis. Concomitant therapies included children vitamins (unspecified) and amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL TABLETS).     On 08-OCT-2019, patient's both arms got very red, face and neck became very red, his neck started to swell, and his face started to swell. On an unspecified date in October 2019, he experienced ulcer like burns on his face and nose and felt very run down. The outcome of the events was unknown.  The reporter did not provide relatedness between the events and the vaccinations with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and virus split virion 3v vaccine inactivated (AFLURIA).  The agency considered the events of swelling face, ulcer like burns on his face and nose, and neck swelling to be medically significant.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: Bruising on right arm
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Ear discomfort, Hyperhidrosis, Insomnia
Clinical narrative: aches over entire body by 11pm couldn't sleep, stuffy congestion in upper head including blocked ears by 5am, severe migraine headache by 7am and wouldn't ease up to half the pain til following day, chills during night and  sweating during day, severe dizziness when moving head down with nausea when did that, otherwise no nausea - no fever or other covid symptoms and felt fine that day.   I wear Oura ring which indicated I was well that day, next day it dropped in half indicating immune system was struggling, next day it's come up some to say need more rest.  Took advil, tramadol, mucinex dm, and relpax at separate times in effort to find relief.  Today (2 days afterwards) taking mucinex and relpax and feel about 50% better.  Never had a reaction to flu shot before.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Nasal congestion, Nausea, Pain, Sinus congestion
Clinical narrative: aches over entire body by 11pm couldn't sleep, stuffy congestion in upper head including blocked ears by 5am, severe migraine headache by 7am and wouldn't ease up to half the pain til following day, chills during night and  sweating during day, severe dizziness when moving head down with nausea when did that, otherwise no nausea - no fever or other covid symptoms and felt fine that day.   I wear Oura ring which indicated I was well that day, next day it dropped in half indicating immune system was struggling, next day it's come up some to say need more rest.  Took advil, tramadol, mucinex dm, and relpax at separate times in effort to find relief.  Today (2 days afterwards) taking mucinex and relpax and feel about 50% better.  Never had a reaction to flu shot before.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient reported localized swelling, redness, tenderness, and heat in her right shoulder which started almost immediately following immunization and has gotten progressively worse over the last three days.  It has extended down to the right elbow and over to the right underarm and breast.  Patient using ice and acetaminophen to manage the symptoms, and she is planning on seeking further medical attention if the condition worsens significantly or does not improve within 24 hours.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Cough, Diarrhoea, Ear pain, Headache
Clinical narrative: COUGH, EARACHE, FEVER, HEADACHE, JOINT PAINS, RUNNY NOSE AND DIARRHEA.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: COUGH, EARACHE, FEVER, HEADACHE, JOINT PAINS, RUNNY NOSE AND DIARRHEA.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash, Skin warm
Clinical narrative: Fever of 101 F. Gave Infants Motrin at 1200AM 28 Sept. Woke up at 0230 still feeling warm. Gave Infants Tylenol. Woke up at 0430 with no fever. Gave Motrin at 0630. Daycare called at 11AM to pick up child because of 100.8F fever and irritability. They also noted a wrash on his butt.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt came to clinic to report ADR to flu vaccine. He noticed some "redness and stinging" around right deltoid injection site about 24 hrs after clinic visit. He states his wife "just wanted to let clinic know" that this had happened. Pt does not wish to be seen for full visit at this time, states he has been using neosporin at home and that seems to help. Apologized for ADR and pt discomfort. Discussed pt case with NP, clinical care lead -- will report to vaers, create pt safety event, and encourage pt to seek evaluation with clinic or PCP for any worsening symptoms per her advise.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site reaction, Injection site swelling, Irritability, Rash macular, Screaming
Clinical narrative: Vaccines were given at 9:45am. Parents called our office at 2:00pm claiming that the patient had been screaming uncontrollably for 1 hour. They came in to our office at about 2:20pm. Parents said that during the previous hour, the patient's legs and feet swelled up and developed a splotchy rash. These were both resolved and unapparent when we examined him in office. Temperature was 98.0 and O2 was 100% in office. We offered Tylenol for the fussiness, which parents declined.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Feeling abnormal
Clinical narrative: I wanted to let you know I had a very unusual and adverse reaction to the flu shot.  I received it Friday Sept. 25 about 2:45pm in an outdoor drive thru.  I was not feeling badly that evening but could not go to sleep (that is unusual for me on a Friday). I fFell asleep about midnight and at 3am work up with a massive case of chills.  Shivering so hard the next day I knew I strained muscles.   I woke up Sat. at about 7am feeling terrible.  I took my temperature and it was 101 and stayed that way all day. I had a terrible headache, nausea joint ache and body ache.  The rest of the day I kept napping 2-3 times and ate bread and crackers.  I took Tylenol and by late evening my temp was a little less than 100.  I felt the symptoms at that time did not warrant a visit to a doctor, however had they not gotten better in 24 hours I would make that decision to go to a Dr.    I slept well Sat. night and Sunday am my temp was 99 and is still 99 at 10:30am on Sunday 27th.    I have been taking the flu shots (yes I know each year the compositions changes) for 25-30 annually. I have had very minor reactions sore arm, elevated temp but this was debilitating.  Back to normal temp 98.4 by Sunday evening.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Initial insomnia, Muscle strain, Nausea, Pain
Clinical narrative: I wanted to let you know I had a very unusual and adverse reaction to the flu shot.  I received it Friday Sept. 25 about 2:45pm in an outdoor drive thru.  I was not feeling badly that evening but could not go to sleep (that is unusual for me on a Friday). I fFell asleep about midnight and at 3am work up with a massive case of chills.  Shivering so hard the next day I knew I strained muscles.   I woke up Sat. at about 7am feeling terrible.  I took my temperature and it was 101 and stayed that way all day. I had a terrible headache, nausea joint ache and body ache.  The rest of the day I kept napping 2-3 times and ate bread and crackers.  I took Tylenol and by late evening my temp was a little less than 100.  I felt the symptoms at that time did not warrant a visit to a doctor, however had they not gotten better in 24 hours I would make that decision to go to a Dr.    I slept well Sat. night and Sunday am my temp was 99 and is still 99 at 10:30am on Sunday 27th.    I have been taking the flu shots (yes I know each year the compositions changes) for 25-30 annually. I have had very minor reactions sore arm, elevated temp but this was debilitating.  Back to normal temp 98.4 by Sunday evening.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient states her arm became sore a couple of days after injection and has gotten worse over the past days to the point she cant even lift it
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, body aches and low-grade fever - mid 99's
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Shock symptom
Clinical narrative: Shock-like feeling in left upper back region, happened a few times today (9/28) the date after vaccination
Age: 8.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: One hive just below the site of injection approximately 2" x 2", red, slightly swollen and tender.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: When administering the immunization -the plunger would not inject-  I pushed as hard as i could-  After disposing of the faulty shot-  I administered one that worked.  Patient recieved no vaccine from first syringe
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Middle insomnia, Mobility decreased, Muscle spasms
Clinical narrative: nerve pain; stabbing pain; spasms; fatigue / is still continuing now.; difficulty going up the stairs; wakes her up at night, and states she feels like "Frankenstein"; This case was reported by a pharmacist via sales rep and described the occurrence of nerve pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number T2CS3, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In March 2020, the patient received the 2nd dose of Shingrix. In April 2020, 1 month after receiving Shingrix, the patient experienced nerve pain, pain, spasms, fatigue, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the nerve pain, pain, spasms and fatigue were not recovered/not resolved and the outcome of the mobility decreased and difficulty sleeping were unknown.   It was unknown if the reporter considered the nerve pain, pain, spasms, fatigue, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In December 2019, the patient received the 1st dose in left deltoid muscle. In March 2019, the patient received the 2nd dose in left deltoid muscle The patient started experiencing out of the ordinary symptoms one month after receiving her second dose of Shingrix. The symptoms were described as stabbing pain, spasms, nerve pain, fatigue that was still continuing.  She had difficulty going up the stairs, wakes her up at night, and stated she feels like Frankenstein. She has already gone to rheumatologist for a work up and has an appointment with a neurologist soon for another work up.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain
Clinical narrative: nerve pain; stabbing pain; spasms; fatigue / is still continuing now.; difficulty going up the stairs; wakes her up at night, and states she feels like "Frankenstein"; This case was reported by a pharmacist via sales rep and described the occurrence of nerve pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number T2CS3, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In March 2020, the patient received the 2nd dose of Shingrix. In April 2020, 1 month after receiving Shingrix, the patient experienced nerve pain, pain, spasms, fatigue, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the nerve pain, pain, spasms and fatigue were not recovered/not resolved and the outcome of the mobility decreased and difficulty sleeping were unknown.   It was unknown if the reporter considered the nerve pain, pain, spasms, fatigue, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In December 2019, the patient received the 1st dose in left deltoid muscle. In March 2019, the patient received the 2nd dose in left deltoid muscle The patient started experiencing out of the ordinary symptoms one month after receiving her second dose of Shingrix. The symptoms were described as stabbing pain, spasms, nerve pain, fatigue that was still continuing.  She had difficulty going up the stairs, wakes her up at night, and stated she feels like Frankenstein. She has already gone to rheumatologist for a work up and has an appointment with a neurologist soon for another work up.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: standard pain; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number P7HK7, expiry date unknown) and (batch number 275KY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced standard pain, redness and swelling. The permission to follow-up was denied. This was 1 of 5 cases, reported by the same reporter. The discrepancies were observed regarding batch number, two different batch number was reported as 275KY and P7HK7 into the source document and correct batch number was unclear, hence both reported batch numbers was retained.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189449:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: redness that extended from the leg injection site to the knee; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 275KY, expiry date unknown) or(batch number P7HK7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Tetra 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. The patient received FluLaval tetra 2020-2021 season with batch number either P7HK7 or 275KY. It was reported that the Immunization Consultant from the Immunization Program provided a high-level overview. It was reported that one clinic site got call and patient reported that after he vaccination with FluLaval experienced redness that extended from the leg injection site to the knee. It was stated It is possible that these were administration technique errors and not related to vaccine product quality. They are currently evaluating the administration technique and retraining. The reporter did not consent to follow up. This case is one of the 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189449:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Anxiety
Clinical narrative: the anxiety from the 1st dose; This case was reported by a consumer via call center representative and described the occurrence of anxiety in a 36-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received the 1st dose of RabAvert. On an unknown date, less than a year after receiving RabAvert, the patient experienced anxiety. On an unknown date, the outcome of the anxiety was not recovered/not resolved.   It was unknown if the reporter considered the anxiety to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Rabavert for post-exposure prophylaxis. The patient experienced some anxiety prior to receiving the RabAvert vaccine and since the administration of it, the anxiety had become worse, which led to anxiety aggravated. The reporter consented to follow-up. For tolerance after 2nd dose, refer case US2020187878.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187878:2nd dose
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Patient had a non febrile seizure on 9/20/2020.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: after injection developed pain at site of injection and then yesterday developed redness, feels hot to site to tetanus injfecton.  reports lymphnodes hurt in axilla feels tired    cellulitis vs vaccine reaction  treat for infectoin, cephalexin twice daily, take probiotic cautioned risks  use ice, tylenol, ibuprofen as needed  call if not improving as expected not a guarantee you will have this happen in the future with vaccines  Med Current    :  Cephalexin 500 mg 1 by mouth twice a day
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain
Clinical narrative: after injection developed pain at site of injection and then yesterday developed redness, feels hot to site to tetanus injfecton.  reports lymphnodes hurt in axilla feels tired    cellulitis vs vaccine reaction  treat for infectoin, cephalexin twice daily, take probiotic cautioned risks  use ice, tylenol, ibuprofen as needed  call if not improving as expected not a guarantee you will have this happen in the future with vaccines  Med Current    :  Cephalexin 500 mg 1 by mouth twice a day
Age: 31.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Feeling of body temperature change, Loss of consciousness
Clinical narrative: pt passed out at the parking lot and then become conscious. he said that he was feeling chill and hot.  called pt on 9/28  and he said he is feeling better and there was no explanation why he passed out.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Headache, Nausea, Syncope, Vomiting
Clinical narrative: Vasovagal syncope, prolonged recovery with nausea, vomiting, headache X4 hours
Age: 25.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Erythema, Laboratory test, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Patient received flu and pneumonia shot on 9/24. Started having fever and pain in the arm the next day. Continued until 9/27 when patient decided to seek medical treatment. Continued with fever  (103) and muscle pain/weakness/redness in the arm.
Age: 25.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient received flu and pneumonia shot on 9/24. Started having fever and pain in the arm the next day. Continued until 9/27 when patient decided to seek medical treatment. Continued with fever  (103) and muscle pain/weakness/redness in the arm.
Age: 72.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: patient was being seen on 9/28/20 for a rash that developed on 9/23/20 following IMZs (Shingrix and Fluzone HD) administered on 9/16/20. Patient had recalled rash was on right side and suggested topical cream (VAGISIL for itching and pain) for some relief while patient was waiting to be seen on Monday by provider to double check rash. Pharmacist did not recall prior vaccines when patient asked for recommendation on Saturday 9/26/20.  Patient  was waiting til Monday because did not feel an ER trip was necessary. Provider gave patient Valtrex and Prednisone for treatment on 9/28/20.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site swelling, Joint swelling, Pain, Pain in extremity
Clinical narrative: Pt began to have normal arm pain later that night. Over the next 48 hours the pain worsened,swelling occurred at the site and down the arm to the wrist.  She became unable to lift the arm due to pain and swelling, It worsened over 8 days,Did not respond to NSAIDS , ICe or rest.  then decreased a small amount at the visit on 9/28/2020. At times of visit she is unable to use an active ROM to lift the left arm at the shoulder joint. PROM is painful but possible. There is visible swelling from left mid deltoid to the AC joint, ROM is limited similar to a significant Rotator cuff tendonitis type event.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Peripheral swelling
Clinical narrative: Pt began to have normal arm pain later that night. Over the next 48 hours the pain worsened,swelling occurred at the site and down the arm to the wrist.  She became unable to lift the arm due to pain and swelling, It worsened over 8 days,Did not respond to NSAIDS , ICe or rest.  then decreased a small amount at the visit on 9/28/2020. At times of visit she is unable to use an active ROM to lift the left arm at the shoulder joint. PROM is painful but possible. There is visible swelling from left mid deltoid to the AC joint, ROM is limited similar to a significant Rotator cuff tendonitis type event.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion; This spontaneous report was received from an office manager and refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JUL-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S004554, expiration date 14-FEB-2021 (formulation, strength, exact dose and route of administration were not reported) for prophylaxis. The temperature excursion was reported as: temperature range of 6 degrees Fahrenheit (F) to 14 degrees F for 80 hours. There was no previous temperature excursion. A data logger was used to capture the temperatures. The outcome of the event was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA007311: US-009507513-2009USA007316: US-009507513-2009USA007304:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administration; This spontaneous report refers to a currently 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) dose 0.5 ml,  lot# S031703, expiry date: 06-APR-2021, for prophylaxis (dose number, route of administration were not provided).  Administered dose of vaccine experienced the temperature excursion of -9.5 degrees Celsius for 8 hours and 53 minutes and -10.1 degrees Celsius for 6 hours and 40 minutes. There were no previous excursions related. Data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine in use; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-SEP-2020, the patient was vaccinated with improperly stored vaccine, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot#: T013540 has been verified to be a valid lot number, expiration date 17-OCT-2021, albumin status rHA (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (6 to 14 Fahrenheit degree (11.7 F)) degrees Fahrenheit for 25 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine in ude; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-SEP-2020, the patient was vaccinated with improperly stored vaccine, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot#: T013540 has been verified to be a valid lot number, expiration date 17-OCT-2021, albumin status: rHA (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (6 to 14 Fahrenheit degree (11.7 F)) degrees Fahrenheit for 25 minutes. Data logger was involved. There were no previous excursions reported.