chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: A lot of pain at the injection site; This is a spontaneous report from a contactable physician pharmacist a Pfizer sales representative.  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced a lot of pain at the injection site. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain redness and swelling at injection site; Pain redness and swelling at injection site; Pain redness and swelling at injection site; This is a spontaneous report from a contactable pharmacist (reporting for his wife) received via a Pfizer sales representative. A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unknown date the patient experienced pain, redness and swelling at injection site, all with unknown outcome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product by child, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: child ingested at least one full dose of Fluzone High Dose vaccine, No AE; child ingested at least one full dose of Fluzone High Dose vaccine, No AE; Initial information received on 29-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a seven-year-old male patient who ingested at least one dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number and expiration date was not reported) via oral route for prophylactic vaccination on 28-Jul-2020.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It is an actual medication error case due to unintentional injestion of product by child. It was reported that the patient ingested at least one dose of Fluzone High Dose and it is possible the patient ingested up to 16 doses of Fluzone High Dose (date of vaccination not reported).  It was also a case of overdose.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Impaired work ability, Lethargy, Nausea
Clinical narrative: Patient Experienced Side effects after vaccine administration the same day. These included, lethargy, nausea, stomach upset, diarrhea, and pain in right arm and fingers. Patient had to miss work for 1 day. Most symptoms listed resolved after 24 hours but lethargy lasted 3 days. Patient states she is fine now.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient Experienced Side effects after vaccine administration the same day. These included, lethargy, nausea, stomach upset, diarrhea, and pain in right arm and fingers. Patient had to miss work for 1 day. Most symptoms listed resolved after 24 hours but lethargy lasted 3 days. Patient states she is fine now.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction. Patient received Kinrix at the age of 1 year.  Will need to follow vaccine recommendation due to receiving before age 4 years.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Erythema, Irritability, Tenderness, Urticaria
Clinical narrative: Within 5 min, developed >2cm wheal, extremely tender. 10cm area of surrounding erythema. Child crying and irritable. Given 5mL Benadryl and monitored for 15 min without worsening of sx. Referred to allergist for evaluation
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Myalgia, Oropharyngeal pain
Clinical narrative: fever, myalgia, headache, erythema at injection site, sore throat, diarrhea, congestion
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: fever, myalgia, headache, erythema at injection site, sore throat, diarrhea, congestion
Age: 60.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: patient complained of pain in right arm after shots unrelieved by ice. shots given on 7/18/20. patient complains of pain not getting better and now cannot "lift" his arm.  I
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Injection site pain, Injection site swelling
Clinical narrative: Pt called on 08/05/2020 to report swelling and pain to the injection site.  She had also complained of some abdominal pain, but that was going on prior to injection.  Pt went to the ER for the abdominal pain and everything checked out fine.  She did take some ibuprofen for the pain.  The swelling and pain have subsided.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Arm muscle sore since vaccination on 03/04/20.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: shortness of breath and swelling at injection site
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Throat irritation, Urticaria
Clinical narrative: Received vaccinations at approx. 1030 on 7/30/2020. Mom states at approx. 2230 on 7/30/2020, he started having some itching and redness to the injection site on his right arm. He noted generalized hives and his throat felt "scratchy" shortly after this, but denies any swelling, difficulty breathing, or further symptoms. Mom gave an initial dose of Benadryl 50mg at symptom onset, then another dose of Benadryl 25mg the following morning (7/31/2020) at approx. 0800. She reports the hives and all symptoms had improved as of 0800 on 7/31/2020.
Age: 58.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Axillary pain, Influenza like illness, Injection site erythema, Injection site pain, Lethargy
Clinical narrative: Patient received two vaccines on 8/4/2020 by this reporter (nurse). Pt requested vaccines to be administered in same arm. Today 8/5/2020, patient called Dr.'s office to report symptoms of lethargy, malaise, fever, flu like sx, and muscle pain at injection site and pain in armpit. This nurse paged Dr. who agreed to have pt take tylenol or motrin to remedy symptoms. Also, pt was told to monitor the redness at the injection sites to make sure it does not spread. Pt was agreeable with this plan and was given direct contact info should any other concerns arise. Dr. offered appointment tomorrow 8/7/2020 if the patient's symptoms are still persistent and pt is aware of this.
Age: 58.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient received two vaccines on 8/4/2020 by this reporter (nurse). Pt requested vaccines to be administered in same arm. Today 8/5/2020, patient called Dr.'s office to report symptoms of lethargy, malaise, fever, flu like sx, and muscle pain at injection site and pain in armpit. This nurse paged Dr. who agreed to have pt take tylenol or motrin to remedy symptoms. Also, pt was told to monitor the redness at the injection sites to make sure it does not spread. Pt was agreeable with this plan and was given direct contact info should any other concerns arise. Dr. offered appointment tomorrow 8/7/2020 if the patient's symptoms are still persistent and pt is aware of this.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Diarrhoea, Nausea, Presyncope, Vomiting
Clinical narrative: Mid-afternoon patient started to be nauseated.  Had vomiting and diarrhea and near-syncope.  Family took her to local hospital ER around 4pm.  Have not received report from that visit
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: NAUSEA, TIREDNESS, BODY ACHES, SORENESS IN INJECTION AREA
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore on my bottom lip a few hours after shot
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient received additional dose of Sero groups A, C, W, and Y. Should have received sero group B instead.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Body temperature increased, Dizziness, Fatigue, Migraine
Clinical narrative: My normal tDap side effect is a sore arm for a few days. On Aug 3, about four hours after I received the shot (8:30 am), I was overcome with fatigue and ended up sleeping until the next morning. The next day (Aug 4), I felt fine in the morning (except for the sore arm) and woke up to start my day at 5:30 am. At around 10 am, I started heating up. I took my temperature and it read 98.3. That afternoon, I went to grab dinner around 3 pm (fast food was 5 minutes away from the house). On the car ride home, I was again overcome with fatigue, and a migraine started to form. I drank a glass of cool water when I got home. I sat on the couch because I was a little dizzy (I have balance problems). I ended up falling asleep. My dog woke me up at 7 pm for her dinner. It took a while for me to get off the couch because everything hurt. I fed her and took my temperature and it read 102.7. I took a warm shower, and crawled into bed and slept until 9 am this morning (Aug 5). My temperature this morning was 100.3. I'm feeling better (except for the sore arm), but I'm still achy everywhere -- though not as bad as yesterday. The nurse at my PCP's office instructed me to report this to y'all.   I do not have redness or swelling in the shot area. I do not have nausea, vomiting, diarrhea. My stomach aches are usually IBS or Acid reflux-related.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: My normal tDap side effect is a sore arm for a few days. On Aug 3, about four hours after I received the shot (8:30 am), I was overcome with fatigue and ended up sleeping until the next morning. The next day (Aug 4), I felt fine in the morning (except for the sore arm) and woke up to start my day at 5:30 am. At around 10 am, I started heating up. I took my temperature and it read 98.3. That afternoon, I went to grab dinner around 3 pm (fast food was 5 minutes away from the house). On the car ride home, I was again overcome with fatigue, and a migraine started to form. I drank a glass of cool water when I got home. I sat on the couch because I was a little dizzy (I have balance problems). I ended up falling asleep. My dog woke me up at 7 pm for her dinner. It took a while for me to get off the couch because everything hurt. I fed her and took my temperature and it read 102.7. I took a warm shower, and crawled into bed and slept until 9 am this morning (Aug 5). My temperature this morning was 100.3. I'm feeling better (except for the sore arm), but I'm still achy everywhere -- though not as bad as yesterday. The nurse at my PCP's office instructed me to report this to y'all.   I do not have redness or swelling in the shot area. I do not have nausea, vomiting, diarrhea. My stomach aches are usually IBS or Acid reflux-related.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given at age 1 year and 3 months.  There were know adverse effects from this.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash around vaccine administrated area starting from 08/03/2020  swelling and redness  Observation with no special treatment
Age: 11.0
Sex: M
Vaccine: HIBV, HPV9, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Hib vaccine given instead of Meningococcal. Pt will have to come in to get another meningococcal vaccine. no s/s of adverse event
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Autoimmune thyroiditis, Blood test, Fatigue, Gastrointestinal disorder
Clinical narrative: Inflammation . hair loss, gut issues, chronic fatigue mother has autoimmune disease suggested i go see a endocrinologist and was diagnosed with hashimotos within a year after vaccine.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inflammation
Clinical narrative: Inflammation . hair loss, gut issues, chronic fatigue mother has autoimmune disease suggested i go see a endocrinologist and was diagnosed with hashimotos within a year after vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Patient was given vaccine a few seconds after the vaccine was given patient told mom she was not feeling well, per mom patient passed out in her arm and mom laid her down on the floor and yelled to have a staff member help her.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain
Clinical narrative: Patient states her rib cage hurts on the left side 2 days after getting the vaccine
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: body ache, fatigue, head ache, nausea
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Headache, Myalgia
Clinical narrative: Got shot at 8:30 am on 8/3/2020 First side effect ay 6:30 pm fever 101.7 then at 10 pm additional side affects headache,  stomach ache and small hive on my right wrist.  On 8/4/2020 at 2:30 am my body began to shiver for about 15 minutes and muscle pain, my temperature was 101.5 Wife gave me one tablet of Tylenol 500 mg . At 6:00 am my temperature subsides to 99.8 At 12:00 pm my temperature subsides again to 98.9 without side affects. At 8pm took a second dose of 1000 mg of Tylenol with temperature at 99.7 On 8/5/20 @ 10 am woke up without any side affects and my body temperature returned to normal 97.8
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Got shot at 8:30 am on 8/3/2020 First side effect ay 6:30 pm fever 101.7 then at 10 pm additional side affects headache,  stomach ache and small hive on my right wrist.  On 8/4/2020 at 2:30 am my body began to shiver for about 15 minutes and muscle pain, my temperature was 101.5 Wife gave me one tablet of Tylenol 500 mg . At 6:00 am my temperature subsides to 99.8 At 12:00 pm my temperature subsides again to 98.9 without side affects. At 8pm took a second dose of 1000 mg of Tylenol with temperature at 99.7 On 8/5/20 @ 10 am woke up without any side affects and my body temperature returned to normal 97.8
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: An additional meningococcal vaccine was administered on 08/04/2020.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient said Arm Swell up "like a baseball"...NA..told to go to er
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Menactra given was expired by 2 days. No adverse effects were noted
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Electrocardiogram, Laboratory test, Syncope
Clinical narrative: fainted while driving after discharged
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Very achy all night, lethargic all day.  800 mg ibuprofin helped a bit.  At 4pm, i have a 99.2 fever (my normaln8uscabout 97.8)
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Encephalopathy, Fatigue, Headache, Nausea, Photophobia
Clinical narrative: On morning of 8/5/2020, patient developed fatigue, headache, fever, photo-phobia, and nausea. He vomited three times before being seen at the clinic in the afternoon.  No known injuries or recent illnesses. Received Dtap #2 vaccination on 8/4/2020. This patient may be experiencing encephalopathy post vaccination. Recommended supplements to support patient's immunity.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: On morning of 8/5/2020, patient developed fatigue, headache, fever, photo-phobia, and nausea. He vomited three times before being seen at the clinic in the afternoon.  No known injuries or recent illnesses. Received Dtap #2 vaccination on 8/4/2020. This patient may be experiencing encephalopathy post vaccination. Recommended supplements to support patient's immunity.
Age: 52.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site vesicles
Clinical narrative: symptoms: redness, itching, inflamed and blistered at deltoid injection site (probably caused by Pneumovax 23) Time: 6 days Treatment: tylenol OTC, hydrocortisone cream, symptoms has not been resolved after 6 days
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Hypoglycaemia, Syncope
Clinical narrative: Patient had hypoglycemia and got syncope right at the moment he received M-M-R.  Patient took 4 tablets of glucose, sat for about 20 minutes.  He confirmed that he felt better and I let him go.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Pain
Clinical narrative: PATIENT SAID EXPERIENCED  HOT/COLD AND ACHING. SAID DID NOT CHECK FOR A FEVER. SAID LASTED UNTIL 3am. SAID THING SUBSIDED AND JUST ACHING NOW. WANTED IT DOCUMENTED. WE INFORMED HIM IT WAS THE SIDE EFFECTS.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Pt developed red blotches beneath the injection site.  She received the injection on 08/03/2020. She reported it to the pharmacy on 08/05/2020. Recommended oral benadryl  and to follow up with her physician if symptoms do not resolve or worsen.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Musculoskeletal stiffness, Mydriasis, Syncope, Urinary incontinence
Clinical narrative: Patient receives Menveo in Left Deltoid and Bexsero in R Deltoid at 10:45 am. Walks to front to checkout with mother. Patient collapses into wall and lands on laminate floor @ 10:50. 911 called immediately.  Mother stays at patient side. Patient eyes are dilated and arms stiff for approximately 1 min 30 seconds, patient looses bladder control. EMT arrives. Patient arouses. Ambulance takes patient to ER for further evaluation per mother's request.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal discomfort, Pyrexia, Rash macular
Clinical narrative: Red spots all over body for over 72 hours, 72 hours of a fever, 72 hours of an upset stomach
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Asthma, Autoimmune disorder, Hypersensitivity, Irritable bowel syndrome, Vitiligo
Clinical narrative: Vitiligo IBS  allergies asthma auto immune
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Patient called the pharmacy to inform us that he had broken out a few days after receiving the shot and has presented with shingles on his body. There is some itching and the patient is in mild pain
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Myoclonus, Tic
Clinical narrative: Tic myoclonus began 6 days post MENACTRA. TAPERED OVER 3 WEEKS AND NOW RESOLVED.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain
Clinical narrative: On 8-4-20 pt. came to clinic to speak to doctor re: syx. Was advised to use cold compressions and take Tylenol, Ibuprofen or Advil. On 8-5-20 I called pt. to follow up. Per pt. went to a doctor and was prescribed Ibuprofen 600mg x 6 hr d prn for pain. Advised to take until pain is better.
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: - 101F two hours after vaccine, then chills that night - continued fevers @ night only x 3-4 days - fatigue, headache, achey
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: - 101F two hours after vaccine, then chills that night - continued fevers @ night only x 3-4 days - fatigue, headache, achey
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Apparent life threatening event, Diplegia, Foreign body, Inflammation, Paraesthesia
Clinical narrative: Pt  history of tingly hands about a month after vaccinations. Mother allergic to flu vaccines.  March 16: rash break outs. Tingling feet & hands. March 28: sudden paralysis of legs while walking. Loss of bladder control. Symptoms increased over next 2 weeks to life threatening paralysis. Pt sheltered in place since early March afraid of exposure to coronavirus and afraid of ventilators. Said goodbye to family and friends. Current: spinal pain & inflammation at T12 and L1.  A magnet collected a visible clump of metal in vein near wrist. Possibly from accumulation of vaccines.
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash, Spinal pain, Urinary incontinence
Clinical narrative: Pt  history of tingly hands about a month after vaccinations. Mother allergic to flu vaccines.  March 16: rash break outs. Tingling feet & hands. March 28: sudden paralysis of legs while walking. Loss of bladder control. Symptoms increased over next 2 weeks to life threatening paralysis. Pt sheltered in place since early March afraid of exposure to coronavirus and afraid of ventilators. Said goodbye to family and friends. Current: spinal pain & inflammation at T12 and L1.  A magnet collected a visible clump of metal in vein near wrist. Possibly from accumulation of vaccines.
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Amenorrhoea, Dysgraphia, Dyspnoea, Feeling abnormal, Gait inability
Clinical narrative: Pt  history of tingly hands about a month after vaccinations. Mother allergic to flu vaccines.  March 16: rash break outs. Tingling feet & hands. March 28: sudden paralysis of legs while walking. Loss of bladder control. Symptoms increased over next 2 weeks to life threatening paralysis. Pt sheltered in place since early March afraid of exposure to coronavirus and afraid of ventilators. Said goodbye to family and friends. Current: spinal pain & inflammation at T12 and L1.  A magnet collected a visible clump of metal in vein near wrist. Possibly from accumulation of vaccines.
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: General physical health deterioration, Grip strength decreased, Guillain-Barre syndrome, Ill-defined disorder, Laboratory test
Clinical narrative: Pt  history of tingly hands about a month after vaccinations. Mother allergic to flu vaccines.  March 16: rash break outs. Tingling feet & hands. March 28: sudden paralysis of legs while walking. Loss of bladder control. Symptoms increased over next 2 weeks to life threatening paralysis. Pt sheltered in place since early March afraid of exposure to coronavirus and afraid of ventilators. Said goodbye to family and friends. Current: spinal pain & inflammation at T12 and L1.  A magnet collected a visible clump of metal in vein near wrist. Possibly from accumulation of vaccines.
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Muscular weakness, Paralysis, Rash, Spinal pain, Urinary incontinence
Clinical narrative: Pt  history of tingly hands about a month after vaccinations. Mother allergic to flu vaccines.  March 16: rash break outs. Tingling feet & hands. March 28: sudden paralysis of legs while walking. Loss of bladder control. Symptoms increased over next 2 weeks to life threatening paralysis. Pt sheltered in place since early March afraid of exposure to coronavirus and afraid of ventilators. Said goodbye to family and friends. Current: spinal pain & inflammation at T12 and L1.  A magnet collected a visible clump of metal in vein near wrist. Possibly from accumulation of vaccines.
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: Pt  history of tingly hands about a month after vaccinations. Mother allergic to flu vaccines.  March 16: rash break outs. Tingling feet & hands. March 28: sudden paralysis of legs while walking. Loss of bladder control. Symptoms increased over next 2 weeks to life threatening paralysis. Pt sheltered in place since early March afraid of exposure to coronavirus and afraid of ventilators. Said goodbye to family and friends. Current: spinal pain & inflammation at T12 and L1.  A magnet collected a visible clump of metal in vein near wrist. Possibly from accumulation of vaccines.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 was stored improperly and administered; Information has been received from a licensed practical nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 28-JUL-2020, 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# 1637651 and expiration date 09-JUN-2022 for prophylaxis (dose and route of administration were not reported).  On an unknown date, the vaccine experienced an excursion temperature of 50 degrees Fahrenheit for 1 hour and 46 minutes. The reporter confirmed that there was no previous temperature excursion. The call was placed because of a digital data logger.   This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA012054: US-009507513-2007USA012060: US-009507513-2007USA012061: US-009507513-2007USA012124: US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307: US-009507513-2008USA000314: US-009507513-2008USA000326: US-009507513-2008USA000367: US-009507513-2008USA000370: US-009507513-2008USA000372:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Gardasil 9 was improperly stored and administered; Information has been received from a nurse and refers to a patients of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On 29-JUL-2020, the patient was vaccinated with a dose of improperly stored haemophilus  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637651 and expiration date of 09-JUN-2022 (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 50 Fahrenheit degrees for 1 hour and 46 minutes. No previous temperature excursion was reported.  No adverse effects were reported.   Digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000316: US-009507513-2008USA000266:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: she was doing okay and had not experienced any side effects from receiving the expired vaccination; On 29Jul2020, she received a Proquad vaccine that expired 23Jul2020; This spontaneous report was received from a certified medical assistant referring to a 5-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On an unspecified date in 2016 (reported as "when she was 1 year old"), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 29-JUL-2020, she received the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) 0.5 milliliter subcutaneous injection for vaccination, lot# S002490, expiration date 23-JUL-2020.  The second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was expired at the time of administration. At the time of the call, the patient was "doing okay" and had not experienced any side effects from receiving an expired vaccine. As of 29-JUL-2020, it was unknown if she would receive another measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2008USA000238:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event reported; expired vaccine used; This spontaneous report as received from a other refers to a 62 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 28-JUL-2020 the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # S007265 expiration date 07-JUL-2020 (dose and route were not provided) for prophylaxis. No adverse event were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: He felt very nauseous; This spontaneous report has been received from a consumer regarding to a male patient of unknown age. The patient's concurrent condition, medical history, concomitant medication, drug allergies or reaction were not provided.   On 30-JUL-2020 around 3:00 pm, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were unknown) for prophylaxis. On the same date, 1 to 2 hours after vaccination, the patient felt very nauseous. The reporter stated that the nausea lasted well into the night, till he went to bed around 9 pm, on the same date. Additionally, the reporter stated     that the patient did not presented this symptom when he received the first and the second dose. At the reporting time, the outcome for the event was unknown.   The causality assessment between nausea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.   This is one of two reports from the same reported.; Sender's Comments:  US-009507513-2008USA000493:
Sex: U
Vaccine: VARZOS
Symptoms: Nervousness, Pyrexia
Clinical narrative: later developed a low grade fever./about 30 hours later developed a low grade fever/31 hours later got a low grade fever.; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. On 28th July 2020, 30 hrs after receiving Shingrix, the patient experienced low grade fever. In July 2020, the outcome of the low grade fever was recovered/resolved.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received shingrix vaccine and had low grade fever, in a covid environment, fevers made patient nervous. The patient asked if someone experienced adverse reactions from the first shot whether they likely to experience adverse reactions from the second shot. The patient also whether he/she get 2nd dose at the same time of receiving annual flu shot and also asked about the guidance for interval of 2 to 6 months for the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Liver disorder, Liver function test increased
Clinical narrative: increased liver function / affect the liver; This case was reported by a consumer via call center representative and described the occurrence of liver disorder in a 87-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced liver disorder. On an unknown date, the outcome of the liver disorder was unknown.   It was unknown if the reporter considered the liver disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced increased liver function and affect the liver.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling of the right index finger/associated fingers on the his right hand also swelled up; Extreme joint tenderness; Injection-site soreness/the pain level was a 7 or 8; The tenderness and swelling of his right index; This case was reported by a consumer via call center representative and described the occurrence of swelling of fingers in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th July 2020, 3 hrs after receiving Shingrix, the patient experienced swelling of fingers, joint tenderness, injection site pain and pain in fingers. On an unknown date, the outcome of the swelling of fingers, joint tenderness, injection site pain and pain in fingers were not recovered/not resolved.   It was unknown if the reporter considered the swelling of fingers, joint tenderness, injection site pain and pain in fingers to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experiencing swelling of the right index finger, extreme joint tenderness, and injection-site soreness after receiving their first dose of the Shingrix vaccine. The patient received the shot at Pharmacy, and around 5pm that same day was when the adverse reactions occurred.  The patient reported that his associated fingers on the his right hand also swelled up but there was no point tenderness that occurred like in his right index finger. He reported that the pain level was a 7 or 8 on a scale of 1 to10. The tenderness and swelling of his right index finger started 3 hours after the injection and the reaction was improved today but still was unresolved. The adverse reactions were not resolved, and had same like that for the past 2 days. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Rash, Rash erythematous, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction; red rash on both arms(in right arm 14 cm by 10 cm and in left arm 4 cm by 3 cm); Initial information was received on 27-Jul-2020 regarding an unsolicited valid serious case from a health care professional, issued from a literature article.    This case is linked to case 2020SA197750( same literature).  This case involves a 11-year-old female patient who experienced Arthus reaction (type III immune complex mediated reaction) with red rash on both arms (in right arm 14 cm by 10 cm and in left arm 4 cm by 3 cm) (rash erythematous), while she received vaccines MENINGOCOCCAL VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in the left and right arm respectively for prophylactic vaccination.  On an unknown date, the patient developed serious arthus reaction (type III immune complex mediated reaction) with symptoms red rash on both arms (in right arm 14 cm by 10 cm and in left arm 4 cm by 3 cm) (rash erythematous) within 12 hours following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and within 12 hours following the administration of MENINGOCOCCAL VACCINE. These events were  assessed as medically significant.  Details of laboratory data were not reported.  Final diagnosis was type III immune complex mediated reaction.   Patient was treated with antihistamines and steroid creams.  At the time of reporting, outcome of the event was not reported.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a 11 years old female patient who experienced type III immune complex mediated reaction within 12 hours after vaccination with MENINGOCOCCAL VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The time to onset was compatible. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.
Age: 84.0
Sex: F
Vaccine: DT
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of DT vaccine/No AE; Initial information was received on 30-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 84 year old female patient who received an expired dose of DIPHTHERIA AND TETANUS TOXOIDS (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  On 29-Jul-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA AND TETANUS TOXOIDS [prefilled syringes, lot number: 46021AA, expiry date: 27-Jul-2020] via an intramuscular route at the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of vaccine/No AE; Initial information was received on 30-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 30-Jul-2020, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE once [vial, lot U6208AD, expiry date: 08-Jul-2020] via an intramuscular route at the left leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Excessive eye blinking, Head discomfort, Nausea, Pain in extremity, Pallor
Clinical narrative: Patient reported heaviness on her head, closed eyes repeatedly, coldness on the face, nausea, paleness, and pain in left arm.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral coldness
Clinical narrative: Patient reported heaviness on her head, closed eyes repeatedly, coldness on the face, nausea, paleness, and pain in left arm.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Pain in extremity, Pallor
Clinical narrative: Dizziness, weakness, paleness, pain on left arm.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Inflammation, Injection site pain
Clinical narrative: Pt came to our clinic requesting HPV vaccine. Risks benefits described. Consent forms signed. By day after receiving HPV9 #1, she felt a dull ache in her deltoid at the injection site. She called our office today 8/6/2020 to report. no fevers, no redness, no swelling. no loss of strength. No sensation changes. Reports dull ache has not improved over 3 weeks and worsens if she rolls on it in sleep or moves or palpates deltoid.  Told her probably prolonged inflammatory response in muscle, perhaps with nerve irritation. Told her to try motrim or tylenol and resting deltoid. Told her we were cancelling her #2 and #3 shots since her risk benefit calculus had shifted for an elective vaccine, and recommended other ways to limit/prevent HPV.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site urticaria, Rash macular
Clinical narrative: Patient presented to pharmacy with red blotchy hive looking appearance near the vaccination site. Patient was advised to contact their medical provider. Provider advised patient to take benedryl, which the patient did and noticed a decrease in redness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature increased, Feeding disorder, Feeling abnormal, Feeling cold
Clinical narrative: Got vaccine the morning of 8/4/20 and had very sore arm for remainder of day.  At midnight awoke feeling cold so got a blanket.  Slept fitfully until 4 a.m. when I got up, took temperature which was 101.9 F.  Stomach upset, heaved up bile.  Forced something to eat so I could take ibuprofen.  Temp gradually started going down, but it took most of the entire day on 8/5 to get to normal.  During the day could not eat and heaved up bile several times.  Regular activities were not possible.  At 6 p.m. forced a slice of bread down, and by 8 p.m.  finally felt some relief from the misery.  Today, 8/6, temp is normal, some stomach upset remains and feel wiped out.  I worked in spite of my sickness yesterday and am forcing it today.  I will NEVER get this vaccine EVER again.  I have foregone Flu vaccines now for several years after getting high fevers both times I did get them.  Related?
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Poor quality sleep, Vomiting
Clinical narrative: Got vaccine the morning of 8/4/20 and had very sore arm for remainder of day.  At midnight awoke feeling cold so got a blanket.  Slept fitfully until 4 a.m. when I got up, took temperature which was 101.9 F.  Stomach upset, heaved up bile.  Forced something to eat so I could take ibuprofen.  Temp gradually started going down, but it took most of the entire day on 8/5 to get to normal.  During the day could not eat and heaved up bile several times.  Regular activities were not possible.  At 6 p.m. forced a slice of bread down, and by 8 p.m.  finally felt some relief from the misery.  Today, 8/6, temp is normal, some stomach upset remains and feel wiped out.  I worked in spite of my sickness yesterday and am forcing it today.  I will NEVER get this vaccine EVER again.  I have foregone Flu vaccines now for several years after getting high fevers both times I did get them.  Related?
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Mom reports swelling, redness to the right leg.  Mom states she feels like child is feverish but is unable to obtain a temperature.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Chills, Fatigue, Headache, Muscular weakness
Clinical narrative: Fever (up to 103), chills, headache, fatigue, weakness, leg  weakness, leg tingling
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Fever (up to 103), chills, headache, fatigue, weakness, leg  weakness, leg tingling
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient received incorrect vaccine. Patient was due for menactra and was administered meningitis B.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Head injury, Heart rate decreased, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: After receiving the vaccine, patient stated she felt dizzy, then passed out.   Patient's side of head hit wall but sitting down on exam table when she passed out.  Nurse in the exam room got patient down onto exam table.  Nurse reports patient had stiffening of both arms without shaking while 'out'.  Patient quickly came to and aware of surroundings.   Heart rate low on initial exam by MD.  Patient observed for several minutes then safely sat up and walked out of exam room / office.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted twice shortly after the vaccination was administered. No signs of anaphylaxis or other allergic reaction. 911 was called by responders determined the patient was fine and able to leave on her own. Patient was not transported to the ER.