chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cold sweat, Feeling cold, Full blood count, Heart rate increased
Clinical narrative: Increased heart rate, increased blood pressure, cold/clammy feeling, urticaria (neck), swelling in neck and chest.   At vaccine clinic area, Benadryl 50mg IM given.  Rapid response called via overhead page. Patient taken to ER from vaccine clinic.  In ED, given  famotidine 20mg IV, methylprednisolone 125mg IV.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Swelling, Urticaria
Clinical narrative: Increased heart rate, increased blood pressure, cold/clammy feeling, urticaria (neck), swelling in neck and chest.   At vaccine clinic area, Benadryl 50mg IM given.  Rapid response called via overhead page. Patient taken to ER from vaccine clinic.  In ED, given  famotidine 20mg IV, methylprednisolone 125mg IV.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphonia, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Tongue tingling, throat tightness @0520 Chest heaviness, lips numb @0525 Voice hoarseness @ 0530  IV Benadryl given approx 0550 PO prednisone given approx 1000  Left side of face still numb after 24 hours
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Tongue tingling, throat tightness @0520 Chest heaviness, lips numb @0525 Voice hoarseness @ 0530  IV Benadryl given approx 0550 PO prednisone given approx 1000  Left side of face still numb after 24 hours
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Employee experienced nausea and headache
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: ain at injection site 8 hrs after injection,   fever, chills, joint and muscle pain, tiredness 16 hrs after infection.  temp reached 101.0.about 20 hrs after injection.   temp down to 99.6 after 36 hrs, just still running some low grade temp.  soreness, joint pain better.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ain at injection site 8 hrs after injection,   fever, chills, joint and muscle pain, tiredness 16 hrs after infection.  temp reached 101.0.about 20 hrs after injection.   temp down to 99.6 after 36 hrs, just still running some low grade temp.  soreness, joint pain better.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood thyroid stimulating hormone increased, Brain natriuretic peptide normal, Fatigue, Full blood count normal
Clinical narrative: 12/17/2020 INJECTION. 12 HOURS LATER, NAUSEA W/ TACCYCARDIA, PROXIMAL. HEARTRATE 150. WENT TO ER.  HAD TESTS DONE. NO HISTORY OF ANXIETY; HAD PRETTY ANXIETY. LASTED ABOUT 45 MINUTES. ATIVAN PRESCRIBED BY ER DOCTOR.  DIAPHORETIC.  I AM WORKING BUT STILL DIAPHORETIC AND STILL FEEL A LITTLE FATIGUED. DON'T KNOW IF RELATED TO VACCINE.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Metabolic function test normal, Nausea, Tachycardia, Troponin normal
Clinical narrative: 12/17/2020 INJECTION. 12 HOURS LATER, NAUSEA W/ TACCYCARDIA, PROXIMAL. HEARTRATE 150. WENT TO ER.  HAD TESTS DONE. NO HISTORY OF ANXIETY; HAD PRETTY ANXIETY. LASTED ABOUT 45 MINUTES. ATIVAN PRESCRIBED BY ER DOCTOR.  DIAPHORETIC.  I AM WORKING BUT STILL DIAPHORETIC AND STILL FEEL A LITTLE FATIGUED. DON'T KNOW IF RELATED TO VACCINE.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Heart rate increased, Nausea
Clinical narrative: Exhausted, dizzy, nauseated, rapid heartbeat, pain in joints all over body, fatigue
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure during pregnancy, Vomiting
Clinical narrative: 1 episode of vomiting and diarrhea 12 hours after administration.  Afebrile.  No other events of nausea/vomiting yet during pregnancy. 4 weeks, 4 days pregnant. EDD 8/27/21.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Dyspnoea, Oropharyngeal pain, Throat tightness
Clinical narrative: Began developing tightness/soreness in his throat, some DOB, and increased blood glucose. NKDA or history of adverse reaction to vaccines. Benadryl 50 mg given IM at clinic site. Noted to improve after 15 minutes. Was sent home with instructions to return to the ED with worsening of symptoms.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Condition aggravated, Cough, Decreased appetite, Fatigue
Clinical narrative: Approximately 65 hours post-vaccination patient felt profound fatigue, no appetite, and had increase in baseline chronic cough, and anosmia. Patient was admitted to the hospital on 12/21 due to worsening respiratory symptoms that required supplemental oxygen-initially 2L via nasal cannula. Patient was upgraded to ICU-level of care at 6:30PM 12/21 to receive high-flow nasal cannula, and has had one episode of fever (100.6) 12/22 at 7:00 AM.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Pyrexia, Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: Approximately 65 hours post-vaccination patient felt profound fatigue, no appetite, and had increase in baseline chronic cough, and anosmia. Patient was admitted to the hospital on 12/21 due to worsening respiratory symptoms that required supplemental oxygen-initially 2L via nasal cannula. Patient was upgraded to ICU-level of care at 6:30PM 12/21 to receive high-flow nasal cannula, and has had one episode of fever (100.6) 12/22 at 7:00 AM.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Lethargy
Clinical narrative: Post-dose 1 of COVID-19 Pfizer vaccine, pt started feeling lethargic and lightheaded. Lightheadedness start 12/18(post-dose Day1) and it became more significant 12/19-12/20.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: fever, chills, headache, dizziness, lightheadedness, body aches
Sex: F
Vaccine: COVID19
Symptoms: Respiratory viral panel, SARS-CoV-2 test
Clinical narrative: fever, chills, headache, dizziness, lightheadedness, body aches
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling hot, Hypoaesthesia, Oropharyngeal pain
Clinical narrative: I have a sore throat, runny nose. Also, I am having chest discomfort as my chest feels heavy, the mask did not effect my breathing,  but now since I received the shot it is hard for me to breath while wearing a face mask. I am taking deep breaths to try and catch my breath. My hands are swelling with fluid and going numb. I feel warm/hot but no temperature
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rhinorrhoea
Clinical narrative: I have a sore throat, runny nose. Also, I am having chest discomfort as my chest feels heavy, the mask did not effect my breathing,  but now since I received the shot it is hard for me to breath while wearing a face mask. I am taking deep breaths to try and catch my breath. My hands are swelling with fluid and going numb. I feel warm/hot but no temperature
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Chest discomfort, Chills, Decreased appetite
Clinical narrative: 12/18/20 approximately 10:00am 1st COVID injection administered. within 30 minutes I had a mild headache ( was not throbbing but nerve shooting in nature). later that evening i noticed heart palpitations and rapid heart rate max 130 reps. the heart rate quickly normalized but heart palpitations remained intermittently that night. Saturday morning I woke with stuffy sinuses, chest little tight but chest tightness clear with coffee intake. sinus remained irritated and then as day progressed i began feeling aches/fatigued/temp 99.0F/mild headache with shoots ear pain bilateral/mild chills/loss of appetite. woke Sunday feeling fine with the exception of loss of appetite. As Sunday progressed i attempted to eat lunch approximately 2:00pm (first meal of day). could not eat much, felt heavy on stomach, began to feel aches/chills/no Temp/loss of appetite with stomach pain and nausea after eating solid food/fatigued again. since then these symptoms have remained. reported to necessary provider and Employee Health.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: 12/18/20 approximately 10:00am 1st COVID injection administered. within 30 minutes I had a mild headache ( was not throbbing but nerve shooting in nature). later that evening i noticed heart palpitations and rapid heart rate max 130 reps. the heart rate quickly normalized but heart palpitations remained intermittently that night. Saturday morning I woke with stuffy sinuses, chest little tight but chest tightness clear with coffee intake. sinus remained irritated and then as day progressed i began feeling aches/fatigued/temp 99.0F/mild headache with shoots ear pain bilateral/mild chills/loss of appetite. woke Sunday feeling fine with the exception of loss of appetite. As Sunday progressed i attempted to eat lunch approximately 2:00pm (first meal of day). could not eat much, felt heavy on stomach, began to feel aches/chills/no Temp/loss of appetite with stomach pain and nausea after eating solid food/fatigued again. since then these symptoms have remained. reported to necessary provider and Employee Health.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Palpitations, Paranasal sinus discomfort, Sinus congestion
Clinical narrative: 12/18/20 approximately 10:00am 1st COVID injection administered. within 30 minutes I had a mild headache ( was not throbbing but nerve shooting in nature). later that evening i noticed heart palpitations and rapid heart rate max 130 reps. the heart rate quickly normalized but heart palpitations remained intermittently that night. Saturday morning I woke with stuffy sinuses, chest little tight but chest tightness clear with coffee intake. sinus remained irritated and then as day progressed i began feeling aches/fatigued/temp 99.0F/mild headache with shoots ear pain bilateral/mild chills/loss of appetite. woke Sunday feeling fine with the exception of loss of appetite. As Sunday progressed i attempted to eat lunch approximately 2:00pm (first meal of day). could not eat much, felt heavy on stomach, began to feel aches/chills/no Temp/loss of appetite with stomach pain and nausea after eating solid food/fatigued again. since then these symptoms have remained. reported to necessary provider and Employee Health.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: 12/18/20 approximately 10:00am 1st COVID injection administered. within 30 minutes I had a mild headache ( was not throbbing but nerve shooting in nature). later that evening i noticed heart palpitations and rapid heart rate max 130 reps. the heart rate quickly normalized but heart palpitations remained intermittently that night. Saturday morning I woke with stuffy sinuses, chest little tight but chest tightness clear with coffee intake. sinus remained irritated and then as day progressed i began feeling aches/fatigued/temp 99.0F/mild headache with shoots ear pain bilateral/mild chills/loss of appetite. woke Sunday feeling fine with the exception of loss of appetite. As Sunday progressed i attempted to eat lunch approximately 2:00pm (first meal of day). could not eat much, felt heavy on stomach, began to feel aches/chills/no Temp/loss of appetite with stomach pain and nausea after eating solid food/fatigued again. since then these symptoms have remained. reported to necessary provider and Employee Health.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: 12/18/20 approximately 10:00am 1st COVID injection administered. within 30 minutes I had a mild headache ( was not throbbing but nerve shooting in nature). later that evening i noticed heart palpitations and rapid heart rate max 130 reps. the heart rate quickly normalized but heart palpitations remained intermittently that night. Saturday morning I woke with stuffy sinuses, chest little tight but chest tightness clear with coffee intake. sinus remained irritated and then as day progressed i began feeling aches/fatigued/temp 99.0F/mild headache with shoots ear pain bilateral/mild chills/loss of appetite. woke Sunday feeling fine with the exception of loss of appetite. As Sunday progressed i attempted to eat lunch approximately 2:00pm (first meal of day). could not eat much, felt heavy on stomach, began to feel aches/chills/no Temp/loss of appetite with stomach pain and nausea after eating solid food/fatigued again. since then these symptoms have remained. reported to necessary provider and Employee Health.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: 12/18/20 approximately 10:00am 1st COVID injection administered. within 30 minutes I had a mild headache ( was not throbbing but nerve shooting in nature). later that evening i noticed heart palpitations and rapid heart rate max 130 reps. the heart rate quickly normalized but heart palpitations remained intermittently that night. Saturday morning I woke with stuffy sinuses, chest little tight but chest tightness clear with coffee intake. sinus remained irritated and then as day progressed i began feeling aches/fatigued/temp 99.0F/mild headache with shoots ear pain bilateral/mild chills/loss of appetite. woke Sunday feeling fine with the exception of loss of appetite. As Sunday progressed i attempted to eat lunch approximately 2:00pm (first meal of day). could not eat much, felt heavy on stomach, began to feel aches/chills/no Temp/loss of appetite with stomach pain and nausea after eating solid food/fatigued again. since then these symptoms have remained. reported to necessary provider and Employee Health.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Palpitations
Clinical narrative: 12/18/20 approximately 10:00am 1st COVID injection administered. within 30 minutes I had a mild headache ( was not throbbing but nerve shooting in nature). later that evening i noticed heart palpitations and rapid heart rate max 130 reps. the heart rate quickly normalized but heart palpitations remained intermittently that night. Saturday morning I woke with stuffy sinuses, chest little tight but chest tightness clear with coffee intake. sinus remained irritated and then as day progressed i began feeling aches/fatigued/temp 99.0F/mild headache with shoots ear pain bilateral/mild chills/loss of appetite. woke Sunday feeling fine with the exception of loss of appetite. As Sunday progressed i attempted to eat lunch approximately 2:00pm (first meal of day). could not eat much, felt heavy on stomach, began to feel aches/chills/no Temp/loss of appetite with stomach pain and nausea after eating solid food/fatigued again. since then these symptoms have remained. reported to necessary provider and Employee Health.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Chest discomfort, Chills, Decreased appetite
Clinical narrative: Reported received the vaccination at approx. 10am on 12/18. Developed headache during her 12 hour shift at the hospital. At 830pm after getting home from work, she developed  elevated heart rate 130s, heart palpitations, body aches, severe nausea, muscle pain, and fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: Reported received the vaccination at approx. 10am on 12/18. Developed headache during her 12 hour shift at the hospital. At 830pm after getting home from work, she developed  elevated heart rate 130s, heart palpitations, body aches, severe nausea, muscle pain, and fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Palpitations, Paranasal sinus discomfort, Sinus congestion
Clinical narrative: Reported received the vaccination at approx. 10am on 12/18. Developed headache during her 12 hour shift at the hospital. At 830pm after getting home from work, she developed  elevated heart rate 130s, heart palpitations, body aches, severe nausea, muscle pain, and fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Reported received the vaccination at approx. 10am on 12/18. Developed headache during her 12 hour shift at the hospital. At 830pm after getting home from work, she developed  elevated heart rate 130s, heart palpitations, body aches, severe nausea, muscle pain, and fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Reported received the vaccination at approx. 10am on 12/18. Developed headache during her 12 hour shift at the hospital. At 830pm after getting home from work, she developed  elevated heart rate 130s, heart palpitations, body aches, severe nausea, muscle pain, and fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Reported received the vaccination at approx. 10am on 12/18. Developed headache during her 12 hour shift at the hospital. At 830pm after getting home from work, she developed  elevated heart rate 130s, heart palpitations, body aches, severe nausea, muscle pain, and fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Palpitations
Clinical narrative: Reported received the vaccination at approx. 10am on 12/18. Developed headache during her 12 hour shift at the hospital. At 830pm after getting home from work, she developed  elevated heart rate 130s, heart palpitations, body aches, severe nausea, muscle pain, and fatigue.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula
Clinical narrative: swelling to uvula seen in Emergency department observed for 4 hours in Tele unit sent home on 12/21/2020
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Slight tingling in injection arm
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE; A 12 month old received 4th dose of Rotateq; A 12 month old received 4th dose of Rotateq; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patient was vaccinated with three doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (exact dose, routes of administration, lot#, expiry dates were not provided) for prophylaxis.   On 25-NOV-2020, the patient was vaccinated with the 4th dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml orally, lot # 1684154, expiry date: 24-JUN-2021, for prophylaxis (product administered to patient of inappropriate age and extra dose administered). No other adverse events were reported.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: the temperature excursion happened on 11/14/2020. On 11/16/2020, MMR II and VAQTA were administered to one patient before evaluation; This spontaneous report as received from a medical assistant refers to a 1-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant drug, and drug reactions/allergies was not reported.   On 14-NOV-2020, there was temperature excursion happened with hepatitis A vaccine, inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II). On 16-NOV-2020, the patient was vaccinated with the improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot # T014835, expiration date 17-JUL-2021; dose and route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) (lot # S029454, expiration date 19-SEP-2021; dose and route of administration were not reported) for prophylaxis (product storage error). It was reported that the hepatitis A vaccine, inactivated (VAQTA) was exposed to a temperature of below 2 Celsius degree (1.9 C) for 1 hour 15 minutes and 0 seconds. There was no previous temperature excursion. Digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: there were no adverse effects from the administration; they administered MMR II that was expired to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided. On 14-DEC-2020, the patient was vaccinated with expired 0.5 ml dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R030807, expiration date 24-OCT-2020, albumin status recombinant human albumin (rHA) (route of administration was not reported) for prophylaxis. There were no adverse effects from the administration at this time.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain, Pain in extremity, Pyrexia, Sinusitis
Clinical narrative: received dose 1 /10 months ago / received dose 2 /November 20, 2020; arm soreness; fever; chills; body aches; currently experiencing a sinus infection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose of Shingrix received about 10 months ago, refer case US2020236598).   On 20th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, fever, chills, general body pain and sinus infection. On 20th November 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, chills and general body pain were recovered/resolved and the outcome of the sinus infection was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, general body pain and sinus infection to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient experienced arm soreness, chills, fever, and body aches. The patient also reported that she was currently experiencing a sinus infection.  Events had resolved, except for the sinus infection which was still present at time of report.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236598:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: received dose 1 /10 months ago / received dose 2 /November 20, 2020; arm soreness; fever; chills; body aches; currently experiencing a sinus infection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose of Shingrix received about 10 months ago, refer case US2020236598).   On 20th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, fever, chills, general body pain and sinus infection. On 20th November 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, chills and general body pain were recovered/resolved and the outcome of the sinus infection was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, general body pain and sinus infection to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient experienced arm soreness, chills, fever, and body aches. The patient also reported that she was currently experiencing a sinus infection.  Events had resolved, except for the sinus infection which was still present at time of report.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236598:same reporter
Age: 48.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pain in extremity, Underdose
Clinical narrative: sore arm; GAVE AN ADULT PATIENT, PEDIATRIC DOSES FOR / HAVRIX; GAVE AN ADULT PATIENT, PEDIATRIC DOSES FOR / HAVRIX / Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 48-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HAV (Havrix pediatric) for prophylaxis.   On 24th November 2020, the patient received Engerix B pediatric and Havrix pediatric. On 24th November 2020, unknown after receiving Engerix B pediatric and Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, underdose and adult use of a child product were unknown.   It was unknown if the reporter considered the pain in arm to be related to Engerix B pediatric and Havrix pediatric.  Additional details were received as follows: The age at vaccination was not reported.   An adult patient, pediatric doses for both Havrix or Engerix, which led to underdose and adult use of a child product. The patient had sore arm. Medical assistant stating she gave a pediatric dose of the Havrix and the pediatric dose of Engerix B to an adult patient on 24th Nov 20 .  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020237652:FU1 deleted
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: feels like they have injected a brick into my arm; feels like they have injected a brick into my arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingles vaccine. On 1st December 2020, immediately after receiving Shingles vaccine, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient just got the shot and it felt like they have injected a brick into arm.  The reporter wanted to know was there anything could do to alleviate the pain like warm/cold and compresses.
Sex: M
Vaccine: MEN
Symptoms: Headache, Hyperacusis, Incomplete course of vaccination, Photophobia, Pyrexia
Clinical narrative: 104+ fever spikes; his head hurt so bad that he thought it was going to explode / felt like a ton of bricks hitting his head; head hurt / slightest/ ounce of light made 10 times worse; head hurt / slightest sound / made 10 times worse; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient exposed to Men B NVS (Meningococcal B vaccine) in utero. The parent received the product for prophylaxis.   On an unknown date, the mother received the 1st dose of Meningococcal B vaccine. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to  at an unknown time during the pregnancy. The patient was diagnosed with fever, headache, photophobia and sound sensitivity increased. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, photophobia and sound sensitivity increased were unknown.   It was unknown if the reporter considered the fever, headache, photophobia and sound sensitivity increased to be related to Meningococcal B vaccine.  Additional details were received as follows: The age at vaccination was not reported.  The patient had very bad reaction, fever with 104 degree F spiked that Tylenol did very little for. He said his head hurt so bad that he thought it was going to explode. The slightest sound or ounce of light made 10 times worse even though he didn't think it could get worse. Me touching his head to place a tempered cloth felt like a ton of bricks hitting his head. I seriously thought we were going to be heading to the ER. I didn't sleep a wink that night as I was so afraid that he was going to die in his sleep. Needless to say he did not get the 2nd dose even though the pediatrician office keep trying to get use to schedule the second dose. My daughter refused after witness the side affects her brother
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Feeling hot, Incomplete course of vaccination, Influenza like illness, Pyrexia
Clinical narrative: Achy Joints; Felt Feverish; Flu-like Symptoms; first Shingrix vaccine approximately one year ago; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced joint pain, feeling hot, influenza-like symptoms and incomplete course of vaccination. On an unknown date, the outcome of the joint pain, feeling hot and influenza-like symptoms were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the joint pain, feeling hot and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported for the 1st dose. The age at the vaccination was not applicable for the 2nd dose. The patient received Shingrix vaccine approximately one year ago and had flu-like symptoms, felt feverish and had achy joints. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: MMR vaccine diluent was added to the mix and administered to a patient.; MMR vaccine diluent was added to the mix and administered to a patient.; Wrong solution used in drug reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 1st December 2020, the patient received Menveo. On 1st December 2020, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, incorrect dose administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication, incorrect dose administered and wrong solution used in drug reconstitution were unknown.  Additional information received as follows: The age at vaccination was not reported.  Menveo vaccine was reconstituted using the powder and the approved diluent and then an MMR vaccine diluent was added to the mix and administered to a patient. Addition of another diluent to the Menveo vaccine. This led to inappropriate preparation of medication, incorrect dose administered and wrong solution used in drug reconstitution. The reporter did not consent to follow-up.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired doses of IPOL were administered; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a 12-year-old male patient who had administered expired doses of IPV (Vero) Ipol were administered.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a expired dose of dose of suspect IPV (VERO) (lot P1F54, expiry date 07-Dec-2020) via unknown route in unknown administration site (expired product administered).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not applicable.  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 Disclaimer: 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Palpitations
Clinical narrative: Immunized at 9:15 AM- no symptoms, 2-3 episodes of palpitations throughout the day, resolved spontaneously; 9:00 PM chills and palpitations lasting approximately 1 hour- resolved spontaneously with no further symptoms outside of a sore (expected) injection site.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm pain radiating down extremity, mostly resolved immediately
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: About 4-6 hours after I had the vaccine, I experienced severe tenderness at the injection site. I had a low grade fever of 99.6 for a short period of time. Dizziness, headache, and body aches have continued over the past 9 hours (~2AM - 11:30AM).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nasal congestion, SARS-CoV-2 test negative
Clinical narrative: All started 2 days after injection Severe Headache, Diarrhea , Chills, congestion nose
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Injection site extravasation, Underdose
Clinical narrative: Patient provided immunizations, after injection and retraction of needle, member has some fluid seepage from injection site.  Concern not entire 0.3ml were absorbed.  No pain or redness at site.  Member scheduled for follow up 2nd dose in 21 days.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Ocular hyperaemia, Swelling
Clinical narrative: Pt described eye redness and swelling bilat
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA On 12/21/2020 13:17 the patient received the first dose of COVID-19 vaccine. During monitoring, the patient experience itching skin. Hives and welts were not located. The injection site was read and hot. No wheezing occurred, no tachycardia observed.  The patient report a history of anaphylactic reactions to food (Sesame), but has never had an anaphylactic reaction to vaccines in the past.  Patient also reports anaphylaxis to lidocaine. The patient was treated with ice pack on injection site, 50 mg diphenhydramine, 10 mg cetirizine, and 20 mg  famotidine. Patient was observed for a full hour. Advised to pre-medicate at 2nd dose and to alert vaccinator of this reaction.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA On 12/21/2020 13:17 the patient received the first dose of COVID-19 vaccine. During monitoring, the patient experience itching skin. Hives and welts were not located. The injection site was read and hot. No wheezing occurred, no tachycardia observed.  The patient report a history of anaphylactic reactions to food (Sesame), but has never had an anaphylactic reaction to vaccines in the past.  Patient also reports anaphylaxis to lidocaine. The patient was treated with ice pack on injection site, 50 mg diphenhydramine, 10 mg cetirizine, and 20 mg  famotidine. Patient was observed for a full hour. Advised to pre-medicate at 2nd dose and to alert vaccinator of this reaction.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal mucosal discolouration, Oropharyngeal pain, Productive cough, Respiratory tract congestion
Clinical narrative: My arm was not that sore or anything but Friday morning when I woke up my throat was really really sore and I felt congested.  My nasal mucus was green and I was also coughing up some green phlegm. I went to the walk in clinic because I had to go to work and wanted to make sure I was well enough.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Impaired driving ability, Loss of personal independence in daily activities, Musculoskeletal discomfort, Pain
Clinical narrative: Shoulder pain--patient notes that developed shoulder discomfort after the shingles vaccine was administered; she had the initial vaccine reaction of fever and body aches for 48 hours but now her shoulder is still hurting; tearful on the call; report difficulty dressing and driving due to the pain; reviewed need for patient to do abduction of the shoulder to move the fluid out of the shoulder as that tends to be the major issue; rec she do abduction 20 times, 3 times/day over the next week; if it is not continuing to improve or is not resolve, then she should plan to see us for evaluation; rec naproxen 220mg, 2bid for the next week;
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tearfulness
Clinical narrative: Shoulder pain--patient notes that developed shoulder discomfort after the shingles vaccine was administered; she had the initial vaccine reaction of fever and body aches for 48 hours but now her shoulder is still hurting; tearful on the call; report difficulty dressing and driving due to the pain; reviewed need for patient to do abduction of the shoulder to move the fluid out of the shoulder as that tends to be the major issue; rec she do abduction 20 times, 3 times/day over the next week; if it is not continuing to improve or is not resolve, then she should plan to see us for evaluation; rec naproxen 220mg, 2bid for the next week;
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lip pruritus, Paraesthesia, Pruritus, Tenderness
Clinical narrative: 12/19/20 AM tender arm-- PM arm/ hand tingling numb, itching hands and lips. 12/20/20 Nurse triage line advise to take medication for  Loratadine 10mg, Symptoms have not resolved; not as intense today 12/22/2020.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Pruritus
Clinical narrative: 12/19/20 AM tender arm-- PM arm/ hand tingling numb, itching hands and lips. 12/20/20 Nurse triage line advise to take medication for  Loratadine 10mg, Symptoms have not resolved; not as intense today 12/22/2020.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache and extreme pain in left arm
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Oropharyngeal pain
Clinical narrative: Dizziness, muscle aches, sore throat
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pruritus
Clinical narrative: Itching at medial surface of left upper arm (injection site on lateral L UE). Also reported numbness down ventral surface of L forearm into hand. No weakness. She received Benadryl 50mg po at 10:00am. Itching began to improve during this documentation. No airway compromise. Clear mental status. She is recovering from the itching, but the  numbness in the hand is still present.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Condition aggravated, Fatigue, Insomnia
Clinical narrative: 12/16/2020 around 2300 body aches, followed by chills progressed to rigors, developed a  migraine 6 to 8 hours after fatigue, insomnia, temp was 100.4. Those symptoms progressed and stayed stable for 24 hours until the next night and didn't resolve until the 18th and  late that night I developed lymphadenopathy in left axilla, al nodes very swollen and large. That subsided since then. I took Tylenol and 10mg Rizatriptan  for migraines  and that resolved. **I was in a double blinded study for the AstraZeneca trial and am still unsure whether or not I received the placebo or the actual shot. Nov 30th
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Pain
Clinical narrative: 12/16/2020 around 2300 body aches, followed by chills progressed to rigors, developed a  migraine 6 to 8 hours after fatigue, insomnia, temp was 100.4. Those symptoms progressed and stayed stable for 24 hours until the next night and didn't resolve until the 18th and  late that night I developed lymphadenopathy in left axilla, al nodes very swollen and large. That subsided since then. I took Tylenol and 10mg Rizatriptan  for migraines  and that resolved. **I was in a double blinded study for the AstraZeneca trial and am still unsure whether or not I received the placebo or the actual shot. Nov 30th
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Fatigue, Hyperhidrosis, Hypertension
Clinical narrative: within 10 mins of receiving the vaccine I had a burning sensation across my chest, arms and face, developed hypertension, tachycardia and had perfuse sweating.  Blotchiness was noted on my face. I felt like the inside of my body was on fire, only in my torso area. I was given an ice pack, vitals were monitored and the symptoms resolved after 10 mins.  Then within 5 mins, the symptoms returned.  They again last for about 10 mins and resolved enough for me to leave the vaccination observation area.  I was monitored closely for over an 1hr post injection. I did have itchiness in the roof of my mouth, so I took Benadryl 50 mg when I got home and the next morning  had major fatigue and mild soreness in the injection site.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Oral pruritus, Rash macular, Tachycardia
Clinical narrative: within 10 mins of receiving the vaccine I had a burning sensation across my chest, arms and face, developed hypertension, tachycardia and had perfuse sweating.  Blotchiness was noted on my face. I felt like the inside of my body was on fire, only in my torso area. I was given an ice pack, vitals were monitored and the symptoms resolved after 10 mins.  Then within 5 mins, the symptoms returned.  They again last for about 10 mins and resolved enough for me to leave the vaccination observation area.  I was monitored closely for over an 1hr post injection. I did have itchiness in the roof of my mouth, so I took Benadryl 50 mg when I got home and the next morning  had major fatigue and mild soreness in the injection site.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability
Clinical narrative: I would just say not sure if it's from vaccine exp severe headache 12-18 hrs after vaccination. No other symptoms was unable to return to work.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Oropharyngeal pain
Clinical narrative: Headache, Chills, sore throat, muscle weakness, fatigue
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, SARS-CoV-2 test negative
Clinical narrative: Chest tightness and shortness of breath since 12/19/20
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Neck pain
Clinical narrative: Had chills at 3 am, took Tylenol 750 mg PO. Skipped work that day due to unexpected chills. Had a fever of 100.3 F, neck pain, headache and muscle aches around noon the same day. Took another Tylenol 750 mg. At 9:00 PM and next morning at 6:00 AM took Tylenol 750 PO. No more symptoms observed.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had chills at 3 am, took Tylenol 750 mg PO. Skipped work that day due to unexpected chills. Had a fever of 100.3 F, neck pain, headache and muscle aches around noon the same day. Took another Tylenol 750 mg. At 9:00 PM and next morning at 6:00 AM took Tylenol 750 PO. No more symptoms observed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema mouth, Throat irritation
Clinical narrative: Itchiness in throat and edema at the mouth.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity
Clinical narrative: Sore arm, chills but no fever, body malaise
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EAU
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Cough, Diarrhoea, Disturbance in attention
Clinical narrative: 12/18/2020: Pain/heat at injection site, dizziness, muscle aches, nausea, increased mucus production, fever, chills. 12/19/2020: Fatigue, tiredness, headache, nose congestion, muscle aches, injection site was very painful/muscle stiffness left deltoid/applied heat didn't even help, left arm wasn't red, swollen, or hot to the touch. 12/20/2020: Fatigue, tiredness, increased mucus production, cough,. ADHD medication was not taken this day to specifically rest the majority of the day because I thought that would help alleviate the symptoms. 12/21/2020: Cough, headache, nasal congestion and drainage. I did take a short jog (2mile) this day because I was felling overall better. 12/22/2020: Cough (no chest congestion), increased mucus production, headache (sinus), tiredness, slight confusion/unable to focus well, nausea, diarrhea.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Injection site reaction
Clinical narrative: 12/18/2020: Pain/heat at injection site, dizziness, muscle aches, nausea, increased mucus production, fever, chills. 12/19/2020: Fatigue, tiredness, headache, nose congestion, muscle aches, injection site was very painful/muscle stiffness left deltoid/applied heat didn't even help, left arm wasn't red, swollen, or hot to the touch. 12/20/2020: Fatigue, tiredness, increased mucus production, cough,. ADHD medication was not taken this day to specifically rest the majority of the day because I thought that would help alleviate the symptoms. 12/21/2020: Cough, headache, nasal congestion and drainage. I did take a short jog (2mile) this day because I was felling overall better. 12/22/2020: Cough (no chest congestion), increased mucus production, headache (sinus), tiredness, slight confusion/unable to focus well, nausea, diarrhea.