chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: loss of range of motion in shoulder and severe pain in shoulder
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysgeusia, Feeling hot, Rash, Throat tightness
Clinical narrative: Symptoms included metallic taste, hot sensation over entire body, blurry vision, rash on upper body, chills, sensation of throat "getting full" . Noted symptoms approx. 20 minutes after receiving vaccination. Called 911, given epinephrine 1mg/ml 0.3ml IM. Taken to ER via ambulance. Outcome, symptoms resolved after treatment in the ER.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Symptoms included metallic taste, hot sensation over entire body, blurry vision, rash on upper body, chills, sensation of throat "getting full" . Noted symptoms approx. 20 minutes after receiving vaccination. Called 911, given epinephrine 1mg/ml 0.3ml IM. Taken to ER via ambulance. Outcome, symptoms resolved after treatment in the ER.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site infection, Injection site pain, Injection site pruritus
Clinical narrative: Clinic note from 9/24-- "Pt got flu vaccine Friday morning. Friday evening, pt c/o pain and itching at site. Mom treated with tylenol. Saturday, Pt developed small bruising at puncture site with a small red ring around it. Pt still c/o itching and pain. Mom gave zyrtec, tylenol and applied ice. Saturday evening, the red ring was approx 2 inches big and mom called the RN line and was told to watch for 48 hrs and seek care if it was worse when she wakes up. On Sunday morning, area of redness was approx 5 inches and bruised area in the center was larger. Pt was seen at UC and was thought to have an injection site reaction as well as an infection and was started on Keflex. Mom continued with zyrtec, tylenol for comfort and applied ice and hydrocortisone. Pt took 2 doses of keflex on Sunday. Area looked alot better on Monday morning. Today in office, pt is much improved. Area appears normal - no swelling, redness, pain. Pt remained afebrile throughout weekend. This is pt's 4th year to get the flu vaccine. "
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Employee reports shortness of breath approximately 4 hours post vaccine with little relief from inhaler and continued to report shortness of breath the next day (though milder than the day of the vaccine).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported to pharmacy next day with redness around the injection site approximately 3 inches in diameter. Told patient to monitor the area and if it got any larger or no  improvement to seek medical attention. Patient was seen that evening at after hours care where the site had spread to the whole upper arm with itching, swelling and redness. Prescriber treated pt for possible cellulitis and allergic reaction with antibiotic and steroid dose pack.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site induration, Injection site nodule, Injection site pruritus, Skin warm, Swelling
Clinical narrative: Golf ball size swelling and warm to touch. Hard knot at injection site that is very itchy and hasn't gone away. The knot is about the size of a quarter.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Hypoaesthesia, Laboratory test normal, Lumbar puncture normal, Magnetic resonance imaging normal
Clinical narrative: Numbness and tingling to left side on arm, jaw and hand,  and left sided swollen tongue.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Swollen tongue
Clinical narrative: Numbness and tingling to left side on arm, jaw and hand,  and left sided swollen tongue.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fall, Hyperhidrosis, Muscular weakness, Tremor
Clinical narrative: Next day at 7: 30am woke up like usual and ate breakfast.  Around 8am, took shower and got chills that is out of norm.  Started to get dress, went down, started to vomit, and could not get up.  Tried to crawl but could not get footinglegs felt like spaghetti.  Patient was able to get up and felt supper shaky; laid on bed gradually got better.  Patient started to sweat and it took about 24 hours to stop shaking.  Patient has never had an experience like that so was very surprised. She ate the same dinner as the night before to make sure that it was not food poisoning and was not.  Patient has received vaccines in the past with no problem besides a sore arm.  Patient has taken same medicine for years; there was no change. Patient lives by herself.  Today went for a walk as usual but did not walk as many hours as usual.   Patient did not call doctor because it was the weekend.  Patient has follow-up with doctor on Thursday in preparation for surgery to replace pacemaker. Patient is almost back to normal.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Next day at 7: 30am woke up like usual and ate breakfast.  Around 8am, took shower and got chills that is out of norm.  Started to get dress, went down, started to vomit, and could not get up.  Tried to crawl but could not get footinglegs felt like spaghetti.  Patient was able to get up and felt supper shaky; laid on bed gradually got better.  Patient started to sweat and it took about 24 hours to stop shaking.  Patient has never had an experience like that so was very surprised. She ate the same dinner as the night before to make sure that it was not food poisoning and was not.  Patient has received vaccines in the past with no problem besides a sore arm.  Patient has taken same medicine for years; there was no change. Patient lives by herself.  Today went for a walk as usual but did not walk as many hours as usual.   Patient did not call doctor because it was the weekend.  Patient has follow-up with doctor on Thursday in preparation for surgery to replace pacemaker. Patient is almost back to normal.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Tremor
Clinical narrative: A few hrs after shot,  suddenly had both significant difficulty breathing and significant chills, trembling. Super hot steamy bath with menthol, heavy robe, electric blanket on high dissipated in a couple hours. ScareyKindsscarey!
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Crying, High-pitched crying
Clinical narrative: shrilling inconsolable cry
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: LOCALIZED RASH AND SWELLING
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient called on 9/20/19 and said that her arm was swollen, red, painful and inflammed where she had received the vaccines. When I asked if she was running a fever she said yes. I advised her to alternate between ibuprofen and tylenol and to call me the next day to update me on how she was feeling. I called her back on Saturday and she said she felt much better and that her fever had gone down but her arm was still swollen and red. I advised her if she was still concerned to contact her doctor. She mentioned that it could have also triggered a fibromylagia attack.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Mycobacterium tuberculosis complex test
Clinical narrative: The Patient was known to be pregnant prior to having the vaccines; inadvertently administered properly stored VARIVAX  (lot R029519 & expiration date 10/14/2020 and properly stored M-M-R Il; This spontaneous prospective pregnancy report was received from a nurse regarding a 40-year-old female patient. The patient's medical history and concomitant medications was unknown. The patient's concurrent condition included diabetes. The patient did not have any drug allergy or drug reaction. The patient was pregnant and last menstrual period was approximately on August 2019.   On 06-SEP-2019, the patient was inadvertently vaccinated with properly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R029519, Expiration date:14-OCT-2020), rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHa) (M-M-R II) lot No. R010713 has been verified to be a valid lot number, expiration date reported as 12-APR-2020, but upon internal validation established as 11-APR-2020 (strength, dose number, dose, anatomical location were not reported) subcutaneously for prophylaxis use (reported as immigration purposes) (contraindicated product administered). Both vaccines were reconstituted with properly stored sterile diluent. Other suspect therapy included insulin. The patient was known to pregnant prior to administration of the vaccines (exposure during pregnancy). The gestation period at exposure was at 5 weeks. On an unknown date in September 2019, a Quanti feron- Tuberculosis (TB) gold test was performed and the result was unknown. The patient did not seek medical attention and no treatment was given for adverse events. The Estimated Date of Delivery (EDD) was unknown. The pregnancy outcome was pending. The fetal outcome was unknown. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Pertussis; This case was reported by a consumer via interactive digital media and described the occurrence of pertussis in a child patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown.   It was unknown if the reporter considered the pertussis to be related to DTPa vaccine.  Additional details were provided as follows: The case has been reported by patient's mother. The age at vaccination was not reported. Till the time of reporting, the patient had not received the final TDaP and had contracted. The case was considered as mild because, the patient had been received the vaccination upto the point. This case has been linked with case US2019AMR167031 reported by the same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Pertussis; This case was reported by a consumer via interactive digital media and described the occurrence of pertussis in a child patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown.   It was unknown if the reporter considered the pertussis to be related to DTPa vaccine.  Additional details were provided as follows: The case has been reported by patient's mother. The age at vaccination was not reported. Till the time of reporting, the patient had not received the final DTPa and had contracted. The case was considered as mild because, the patient had been received the vaccination upto the point. This case has been linked with case US2019AMR167025 reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Achiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced fever and achiness after first dose of Shingrix vaccine. The reporter denied to provide any additional information. The reporter did not want to provide his address. The reporter denied permission to follow up.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site injury, Injection site pain, Limb injury, Middle insomnia
Clinical narrative: Apparent shoulder injury.  Felt the needle hit somethin solid (assuming it was bone) during the injection.  No visible signs of redness or bruising on the skin.  Pain was increasing as usual for a flu shot but then it continued until I could not lift my arm above my shoulder.  Woke with shoulder pain in the middle of the night and applied cold packs to the shoulder. This morning, the pain has started to subside.   I am continuing cold pack administration today in hopes that the issue will resolve.  Will seek medical treatment with primary care physician if issue does not resolve within a few days.
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site pain, Injection site warmth
Clinical narrative: No pain or abnormalities upon administration.  Pharmacist covered with bandage.  The next day the patient noticed a bruse underneath the bandage.  It was a little achy and slightly warm.  It didn't bother her otherwise had no pain or sensation.  Kept moving her arm.  Has no pain/sensation like a normal bruise.  Bowling didn't irritate it.  Just has a visual bruise and it feels a little bit warm.   Patient has tried icing but it didn't change the size.  It is however turning yellow (healing) and starting to get slightly smaller.  As long as it continues to get smaller, no further medical action is necessary.  If patient develops a fever, or experiences pain/tenderness advised her to be checked out.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever, body aches. 24 hours
Age: 81.0
Sex: F
Vaccine: FLUC4
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: PATIENT FELT LIKE HER THROAT WAS GETTING ITCHY AND HER TONGUE WAS SWELLING,  WITHIN 5 MINS OF RECEIVING VACCINE ,  PT WAS GIVEN 25MG BENEDRYL BY MOUTH, WITH NO SIGNS OF IMPROVEMENT, PT WAS  GIVEN 75MG OF SLOUMEDROL BY IV,  10 MINS LATER SHE WAS GIVEN 50MG OF BENADRYL BY IV.  HER SYMPTOMS DID APPROVE AFTER 30 MINS OF OBSERVATION PT WAS ABLE TO LEAVE.  PATIENT'S CAREGIVER CALLED  THE OFFICE AT 2:14PM STATING THAT THE PATIENT'S SYMPTOMS HAVE RETURNED AND THEY HAVE GOTTEN WORSE PT WAS TOLD TO GO THE ER. PATIENT WAS ADMITTED TO HOSPITAL
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Mother states around 1600 that evening she starting to get red and warm to touch to injection site.  By 1830 that evening she was sick feeling with a headache and the arm was very tender, red, swollen and hot.   She did take Benadryl, Tylenol and Motrin for symptoms.   09/24/2019- Her Dr. was out of the office.  Left message to return phone call. 09/25/2019- 0920- Dr.'s nurse called and updated on above information.  Will notify Dr.   09/25/2019- 0930- Pt's mother called and states she is better but her arm is still red, warm and swollen and very tender.  States she still doesn't feel great but is getting better feeling every day.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Mother states around 1600 that evening she starting to get red and warm to touch to injection site.  By 1830 that evening she was sick feeling with a headache and the arm was very tender, red, swollen and hot.   She did take Benadryl, Tylenol and Motrin for symptoms.   09/24/2019- Her Dr. was out of the office.  Left message to return phone call. 09/25/2019- 0920- Dr.'s nurse called and updated on above information.  Will notify Dr.   09/25/2019- 0930- Pt's mother called and states she is better but her arm is still red, warm and swollen and very tender.  States she still doesn't feel great but is getting better feeling every day.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture urine negative, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: 9/16/19: Patient noted fatigue and nausea, a tingling sensation across the abdominal wall which  improved within 48 hours.  Left sided headache, worse on 9/16 evening-gradually resolved within 48 hours.  Insomnia.  Nocturia and frequency developed on the night of 9/18/19.  Symptoms resolved spontaneously on 9/22/19.  She experienced transient increas in her chronic peripheral neuropathy which resolved back to baseline by 9/23/19
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Nocturia, Paraesthesia, Pollakiuria, Urine analysis normal
Clinical narrative: 9/16/19: Patient noted fatigue and nausea, a tingling sensation across the abdominal wall which  improved within 48 hours.  Left sided headache, worse on 9/16 evening-gradually resolved within 48 hours.  Insomnia.  Nocturia and frequency developed on the night of 9/18/19.  Symptoms resolved spontaneously on 9/22/19.  She experienced transient increas in her chronic peripheral neuropathy which resolved back to baseline by 9/23/19
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: PATIENT HAD FLU LIKE SYMPTOMS (BODY ACHES, FEVER, SORE THROAT) THAT STARTED MORNING AFTER VACCINATION.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Dyskinesia, Injection site nodule
Clinical narrative: Knot developed in right leg and patient had "jerky-like" movements for 2 weeks after vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Joint swelling
Clinical narrative: Patient states that she has had swelling start in her knee that is bothering her.  She had normal adverse reactions to the injection site, but nothing significant.  She is not sure if this is due to Shingrix, but is unaware of what else could cause this for her.  Recommended to follow up with MD.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Full blood count, Intussusception, Irritability
Clinical narrative: 6 days after vaccination she became fussy.  This progressed and by 8 days after vaccination she had projectile vomiting and bloody/mucosy diarrhea.  She was seen in our office and subsequently admitted where intussception was confirmed and treated.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Metabolic function test, Ultrasound abdomen, Vomiting projectile
Clinical narrative: 6 days after vaccination she became fussy.  This progressed and by 8 days after vaccination she had projectile vomiting and bloody/mucosy diarrhea.  She was seen in our office and subsequently admitted where intussception was confirmed and treated.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Pallor, Rash erythematous, Rash maculo-papular
Clinical narrative: 2x3cm pale erythematous flat rash with central raised red mac-pap rash 1.5x1.5cm; non tender, no increase in warmth, no edema.  No meds needed, expected to improve over the next 1-2 weeks
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Headache, Injection site pain, Myalgia
Clinical narrative: Fever, headache, muscle aches, joint pain, sore throat, pain at injection site, pain throughout arm, weakness
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, headache, muscle aches, joint pain, sore throat, pain at injection site, pain throughout arm, weakness
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Pain, Pyrexia
Clinical narrative: Local reaction last year and needed oral steroids. This year he had local reaction, larger than last year, pretreated with benadryl . Fever for 1.5 days, body aches
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Child started feeling dizzy. Redness and swelling began at injection site about 5 minutes after administering.  Benedryl was administered at the school per the parents request.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Allergy test positive, Asthma, Blood test, Condition aggravated, Constipation
Clinical narrative: Started with severe constipation in a breastfed baby. Sever enough he would have fevers until passing it with assistance (stimulation, suppository, etc). From then on he got worse with every injection. Diagnosed with GERD and eventually suggested to put him on Zyrtec for allergies. Had severe protective vomiting several times per day and some weight loss. Eczema. Has been in the ER mulitple times due to breathing issues, has now (5yrs) been diagnosed with mild to severe persistent asthma.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Croup infectious, Drug hypersensitivity, Dyspnoea, Ear infection, Ear tube insertion
Clinical narrative: Started with severe constipation in a breastfed baby. Sever enough he would have fevers until passing it with assistance (stimulation, suppository, etc). From then on he got worse with every injection. Diagnosed with GERD and eventually suggested to put him on Zyrtec for allergies. Had severe protective vomiting several times per day and some weight loss. Eczema. Has been in the ER mulitple times due to breathing issues, has now (5yrs) been diagnosed with mild to severe persistent asthma.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Eczema, Food allergy, Gastrooesophageal reflux disease, Hypersensitivity, Oral pruritus
Clinical narrative: Started with severe constipation in a breastfed baby. Sever enough he would have fevers until passing it with assistance (stimulation, suppository, etc). From then on he got worse with every injection. Diagnosed with GERD and eventually suggested to put him on Zyrtec for allergies. Had severe protective vomiting several times per day and some weight loss. Eczema. Has been in the ER mulitple times due to breathing issues, has now (5yrs) been diagnosed with mild to severe persistent asthma.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Sleep terror, Streptococcal infection, Vomiting, Weight decreased
Clinical narrative: Started with severe constipation in a breastfed baby. Sever enough he would have fevers until passing it with assistance (stimulation, suppository, etc). From then on he got worse with every injection. Diagnosed with GERD and eventually suggested to put him on Zyrtec for allergies. Had severe protective vomiting several times per day and some weight loss. Eczema. Has been in the ER mulitple times due to breathing issues, has now (5yrs) been diagnosed with mild to severe persistent asthma.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Dropped head syndrome
Clinical narrative: Head drop with shoulder shrug with full cognition several times a day and it escalated to several times an hour.  Symptoms worsened significantly by 1 month post vaccine and resolved completely 2 months post vaccine.  No vomiting, no diarrhea, no seizures, no fever, no illnesses after vaccine.  No loss of developmental milestones.  Growth NL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Vomiting
Clinical narrative: Patient had redness and pain. Vomited liquid once on 8/30. No fever, chills or decreased appetite.
Age: 23.0
Sex: F
Vaccine: DTAP, FLUC4, HPV9, MMR, VARCEL
Symptoms: Throat tightness, Urticaria
Clinical narrative: Approximately 20 minutes after receiving the vaccinations, patient reported urticaria on her thighs, bilateral.   Patient also reported feeling "tightness" in her throat.    Patient given Epipen in clinic at approximately 12:40pm and Benadryl 50mg PO.    After administration of EPIpen patient reported throat symptoms resolved.  Approximately 30minutes post Benadryl and Epipen Urticaria resolving.     Patient left clinic AMA.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site rash, Injection site swelling
Clinical narrative: red raised rash  allergic reaction at site of injection  treated with prednisone and hydroxyzine for itch and cefdinir for infection
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was given vaccines on 09/23/2019. Patient was given Dtap/IPV and Varcella in the left thy.  Patient presented to the clinic  on 09/25/2019 with a noted swelling, redness, and tenderness the sizes of the palm  around were the vaccines were given on the left thy.  Provider instructed the patients parents to apply warm compresses , Tylenol and antihistamines .
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site pain
Clinical narrative: My right upper arm began aching  more than just from the initial injection a few days from getting the flu shot. I was told this was a better flu shot. The pain just kept getting worse and for the last two weeks I haven?t been able to sleep through the night. It?s been very hard to work as I have to lift some objects that are heavy and some that are not so heavy but now cause me very much pain. I had to leave work yesterday after two hours. Today is my day off, but I don?t know what I?m going to do about tomorrow. Working and  using my arm is excruciating and makes it worse. I have used Aleve in large doses and ice and heating pad for a little relief, but no change.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Paraesthesia oral
Clinical narrative: Pt states her lips were tingling after the vaccine. Took benedryl. Went to ER on the evening of 9/24. Had dizziness but no itching, swelling, or trouble swallowing. Experience mild breathing difficulties. Symptoms started 5-10 minutes after shot was given. Once going to ER the next day, Pt informed staff she has had anaphylaxis in the past (7-10 years ago).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling, Middle insomnia, Swelling face
Clinical narrative: I don't know if I marked the right vaccine.  Al I know is that I received a flu shot.  Severe facial swelling of lips and left eye and cheek.  Swelling started in the middle of the night after the day in which I received the vaccine.  I had the vaccine around lunchtime and woke in the night and felt swelling on my face.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: body itching, at 9:30pm covered in hives armpits, stomach, underwear line, growing, rapidly spreading
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Eczema, Erythema, Skin discolouration
Clinical narrative: When the skin discoloration first began it was also accompanied by red target-like rings on the discoloration marks which led my husband and I to believe that he had gotten ring worm some how. They didn't seem to itch our son though, and we put Miconazole from the local store on it every day. It didn't seem to help though. He didn't run a fever or fall ill from it. We didn't take him to his doc appointment sooner due to those things and his next appointment was 03/18/2019. When we got to his appointment, I asked about what the ash and discoloration was. Dr. said it was eczema, not ring worm and that's why Miconazole didn't work. I asked how he could pick up eczema because that doesn't run on either side of our families. He was not sure. I looked within the vaccine insert under post market-experience on page 17 and found that his last visit and vaccine DTap/IPV/hib fit the time frame perfect.   Eczema is a particular type of inflammatory reaction of the skin in which there is erythema (reddening), edema (swelling), papulles (bumps), and crusting of the skin followed  finally, by lichenification (thickening) and scaling of the skin. Erythema occurs with any skin injury, infection, or inflammation.   Erythema multiforme is most often caused by Herpes Simplex Virus. He received the Varicella vaccine 09/24/2018.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Nerve injury, Pain
Clinical narrative: The injection itself was extremely painful.  Felt like a nerve was being hit.  Within hours, had bad pain in my right arm and could not move it.  Range of motion was limited.  Could not lift arm above shoulder level.  Next morning, same.  Called pharmacy and spoke with pharmacist, who said that is normal and to call him in another 2 days if no better.  He said if no better, he would contact my physician.  Range of motion is a bit better, but still painful to raise arm above shoulder level, and still painful to try to put on clothing.  I am concerned and worried that this may not get better.  It is now 12 days since the vaccine was administered.  I just tried to contact the pharmacy again, but I cannot get a "human."
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: The injection itself was extremely painful.  Felt like a nerve was being hit.  Within hours, had bad pain in my right arm and could not move it.  Range of motion was limited.  Could not lift arm above shoulder level.  Next morning, same.  Called pharmacy and spoke with pharmacist, who said that is normal and to call him in another 2 days if no better.  He said if no better, he would contact my physician.  Range of motion is a bit better, but still painful to raise arm above shoulder level, and still painful to try to put on clothing.  I am concerned and worried that this may not get better.  It is now 12 days since the vaccine was administered.  I just tried to contact the pharmacy again, but I cannot get a "human."
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complains of pain in the arm and she has hard time lifting her arm up. MD said the needle might have hit a nerve to cause the pain and it will eventually go away over time
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: PAINFUL SWOLLEN ARM PATIENT REPORT OF DIFFICULTY LIFTING ARM
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Crying, Diarrhoea, Disability
Clinical narrative: Couldn't get out of bed; Was Achy / Pain throughout her body/Pain upon movement; Crying with the achiness; Light headed; Nausea; Vomiting; Fever; Chills; Hot feeling; Diarrhea; Incapacitated for 2 days; This case was reported by a consumer via call center representative and described the occurrence of disability in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Afluria quadrivalent with an associated reaction of nausea (received the year before the date of reporting and experienced nausea, vomiting,  itching, fatigue, flu like symptoms and achiness) and Benadryl (pre-medicate with 50mg.). Concurrent medical conditions included chronic idiopathic urticaria. Concomitant products included cetirizine hydrochloride (Zyrtec) and fexofenadine hydrochloride (Allegra).   On 18th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea. On an unknown date, the outcome of the disability was recovered/resolved and the outcome of the bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea were unknown.   It was unknown if the reporter considered the disability, bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient was incapacitated for 2 days. The patient could not get out of bed.  The patient was achy, cried with achiness, light headed, nausea, vomiting, fever, chills, hot feeling, diarrhea, pain throughout her body. It was reported that  it hurted upon movement. For tolerance of 2nd dose of Shingrix, refer case US2019AMR165478.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling hot, Influenza like illness, Nausea
Clinical narrative: Couldn't get out of bed; Was Achy / Pain throughout her body/Pain upon movement; Crying with the achiness; Light headed; Nausea; Vomiting; Fever; Chills; Hot feeling; Diarrhea; Incapacitated for 2 days; This case was reported by a consumer via call center representative and described the occurrence of disability in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Afluria quadrivalent with an associated reaction of nausea (received the year before the date of reporting and experienced nausea, vomiting,  itching, fatigue, flu like symptoms and achiness) and Benadryl (pre-medicate with 50mg.). Concurrent medical conditions included chronic idiopathic urticaria. Concomitant products included cetirizine hydrochloride (Zyrtec) and fexofenadine hydrochloride (Allegra).   On 18th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea. On an unknown date, the outcome of the disability was recovered/resolved and the outcome of the bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea were unknown.   It was unknown if the reporter considered the disability, bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient was incapacitated for 2 days. The patient could not get out of bed.  The patient was achy, cried with achiness, light headed, nausea, vomiting, fever, chills, hot feeling, diarrhea, pain throughout her body. It was reported that  it hurted upon movement. For tolerance of 2nd dose of Shingrix, refer case US2019AMR165478.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Vomiting
Clinical narrative: Couldn't get out of bed; Was Achy / Pain throughout her body/Pain upon movement; Crying with the achiness; Light headed; Nausea; Vomiting; Fever; Chills; Hot feeling; Diarrhea; Incapacitated for 2 days; This case was reported by a consumer via call center representative and described the occurrence of disability in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Afluria quadrivalent with an associated reaction of nausea (received the year before the date of reporting and experienced nausea, vomiting,  itching, fatigue, flu like symptoms and achiness) and Benadryl (pre-medicate with 50mg.). Concurrent medical conditions included chronic idiopathic urticaria. Concomitant products included cetirizine hydrochloride (Zyrtec) and fexofenadine hydrochloride (Allegra).   On 18th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea. On an unknown date, the outcome of the disability was recovered/resolved and the outcome of the bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea were unknown.   It was unknown if the reporter considered the disability, bedridden, pain, crying, light headedness, nausea, vomiting, fever, chills, feeling hot and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient was incapacitated for 2 days. The patient could not get out of bed.  The patient was achy, cried with achiness, light headed, nausea, vomiting, fever, chills, hot feeling, diarrhea, pain throughout her body. It was reported that  it hurted upon movement. For tolerance of 2nd dose of Shingrix, refer case US2019AMR165478.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Pt became light headed, BP dropped from 128/74 to 70/48
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site streaking, Nausea, Pyrexia
Clinical narrative: Patient states that her left arm had red streaks stemming from the injection site all the way to her armpit. She also feels slightly nauseous and feverish.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient received pneumonia and flu vaccine both given in the left upper arm on 9.20.19--at pharmacy.  Both injections were given in the left deltoid.  Later on Saturday evening  her left upper arm was painful and started to swell and turn red, she states she "was swollen from the elbow to the armpit."  That resolved partially on Monday, but she was unable to lift her arm, it was still very stiff and pain was rated at "15 of 10" on the pain scale.  In addition, pain  had travelled into the left neck and clavicle. She also developed low grade temp on 9/21/19 weekend that increased to 100.0  by 9/24/19.   Patient called Dr.'s office and explained the circumstances, she was advised to see her PCP's office and report the issue to the pharmacy that gave her the vaccines. (Rheumatologist then called the Pharmacy to advise them.) Patient saw her pcp, DR. and patient called Rheumatology on 9/25/19 to report that she did in fact have SIRVA injury related to the vaccine administration.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neck pain, Pain, Pyrexia, Shoulder injury related to vaccine administration
Clinical narrative: Patient received pneumonia and flu vaccine both given in the left upper arm on 9.20.19--at pharmacy.  Both injections were given in the left deltoid.  Later on Saturday evening  her left upper arm was painful and started to swell and turn red, she states she "was swollen from the elbow to the armpit."  That resolved partially on Monday, but she was unable to lift her arm, it was still very stiff and pain was rated at "15 of 10" on the pain scale.  In addition, pain  had travelled into the left neck and clavicle. She also developed low grade temp on 9/21/19 weekend that increased to 100.0  by 9/24/19.   Patient called Dr.'s office and explained the circumstances, she was advised to see her PCP's office and report the issue to the pharmacy that gave her the vaccines. (Rheumatologist then called the Pharmacy to advise them.) Patient saw her pcp, DR. and patient called Rheumatology on 9/25/19 to report that she did in fact have SIRVA injury related to the vaccine administration.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered MA to give DTap due to the patient not ever having vaccines. The patient was to get TDap. I helped with these vaccines and entered them into the chart.  The provider was notified, this event was reported and there were NO adverse reactions.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Morning after receiving vaccine, I was nauseous, injection site was very sore, had headache, back of neck hurt, occasional stomach pain and fatigue. Stayed in bed all day until 5:00 p.m. Following morning I feel fine but have a rash on chest and under breasts.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Rash
Clinical narrative: Morning after receiving vaccine, I was nauseous, injection site was very sore, had headache, back of neck hurt, occasional stomach pain and fatigue. Stayed in bed all day until 5:00 p.m. Following morning I feel fine but have a rash on chest and under breasts.
Age: 25.0
Sex: F
Vaccine: FLUN4
Symptoms: Antinuclear antibody positive, Fibromyalgia, Sjogren's syndrome
Clinical narrative: Short explanation: DEVELOPED ALL HORRIBLE SYMPTOMS OF SKOGREN'S SYNDROME, AN AUTOIMMUNE DISEASE-  FLUMIST MADE ME HAVE AN AUTOIMMUNE RESPONSE/REACTION.  ALSO DEVELOPED FIBROMYALGIA
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Mouth swelling, Oral pruritus, Pruritus, Swelling face
Clinical narrative: Patient experiences itching and swelling around the mouth/face. Treated at urgent care clinic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swelling and hot to touch at injection site. I'm taking ibuprofen, this is the day after the injection. I'm hoping it will get better.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vasculitis
Clinical narrative: patient woke up with vasculitis in her lower right leg.  She said she got it a few years ago, but not after a flu shot.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Headache, Nausea, Pruritus
Clinical narrative: itchy sensation in abdomen and head, headache, nausea, and facial flushing
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 6 to 8 hours after injection the injection was raised and swollen, red, and hot to the touch  Patient has arm pain at injection site
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Blisters noted at or near injection site
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Within 12 hours experienced fever, chills general feeling of illness.  Felt exhaustion the next day and slept most of the next 24 hours. The site of injection became red, (a circle approx. 3 inches round.)  A large, hard lump appeared and took almost a week to dissipate.  The injection area was also very itchy.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Malaise, Pyrexia
Clinical narrative: Within 12 hours experienced fever, chills general feeling of illness.  Felt exhaustion the next day and slept most of the next 24 hours. The site of injection became red, (a circle approx. 3 inches round.)  A large, hard lump appeared and took almost a week to dissipate.  The injection area was also very itchy.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased activity, Decreased appetite, Hypersomnia, Lethargy, Somnolence
Clinical narrative: Lethargic 12 hour periods of sleeping reduced appetite and reduced activity level extreme difficulties being woke up
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Phone call from mother, stated child had a fever of 101.2 on 9/24/2019 and had to be picked up from school.  Patient had not had any antifebrile medication today.  Child states head hurting and arm hurting.  No seizures or any other symptoms noted.  Encouraged Tylenol or Motrin for symptoms along with ice pack to arm.  Instructed mother to call pediatrician if patient becomes worse or if symptoms do not improve.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Skin irritation
Clinical narrative: LOCAL SKIN IRRITATION. RED AND LITTLE SORE WHEN SHE MOVES ARM.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood gases normal, CSF culture negative, Full blood count normal, Lumbar puncture normal, Mental status changes
Clinical narrative: Altered mental status. Unresponsiveness. Moans to any stimulus. Symptoms started upon awakening on 9/23/19. Labs including CBC, CMP, lumbar puncture, PCR for viral meningitis, CSF culture all normal. No evidence for infectious etiology. Venous blood gas normal. Provided supportive care and he improved over a period of 24-36 hours. Has no recollection of the event or day following.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Moaning, Polymerase chain reaction, Unresponsive to stimuli, Viral test negative
Clinical narrative: Altered mental status. Unresponsiveness. Moans to any stimulus. Symptoms started upon awakening on 9/23/19. Labs including CBC, CMP, lumbar puncture, PCR for viral meningitis, CSF culture all normal. No evidence for infectious etiology. Venous blood gas normal. Provided supportive care and he improved over a period of 24-36 hours. Has no recollection of the event or day following.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Improperly stored dose of GARDASIL 9 was administered to the patient on an unknown date; no adverse effect; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection lot # N022952, expiration date: 14-JUN-2020 (exact dose, strength and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Improperly stored dose of GARDASIL 9 was administered to the patient on an unknown date; No adverse effect; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date: 14-JUN-2020 (exact dose, strength and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Improperly stored dose of GARDASIL 9 was administered to the patient on an unknown date; no adverse effects; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date: 14-JUN-2020 (exact dose, strength and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36 degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints were involved.