chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Sinus headache, Skin burning sensation, Vaccination failure
Clinical narrative: I had 2 shingles vaccines, I have shingles now/suspected vaccination failure; shingles; extreme sinus headache; head on fire; face on fire; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sinus headache, burning sensation scalp and burning sensation in face. On an unknown date, the outcome of the vaccination failure, shingles, sinus headache, burning sensation scalp and burning sensation in face were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sinus headache, burning sensation scalp and burning sensation in face to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 shingles vaccines as instructed by doctor.  The patient had shingles at the time of reporting. It was started as an extreme and the patient thought was sinus headache on Friday, today on the day of reporting the patient's head on fire, face on fire went to doctor and sure enough shingles. This case was considered as suspected vaccination failure as the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shingles. The patient was treated with antibiotics nos. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that patient had shingles few days ago and still taking antibiotics, just two weeks after he/she took the flu shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the shot hurts. The patient further stated that if vaccine keeps him/her from getting shingles then the patient would be going back for the 2nd dose. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles, the patient said vaccine did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy scalp in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On 17th June 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, an unknown time after receiving Shingrix, the patient experienced itchy scalp. On an unknown date, the outcome of the itchy scalp was not recovered/not resolved. It was unknown if the reporter considered the itchy scalp to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine in the left arm and a month later experienced an itchy scalp. No further information was reported. The reporter consented to follow-up. For 2nd dose tolerance, refer linked case US2021AMR250604, reported by the same reporter for same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR250604:same reporter.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received a dose of Infanrix that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 23rd November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 6th December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a patient received a dose of Infanrix that had expired ,which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter stated that she had heard reactions from the shot and that she knew people who got sick from a shingles shot. The reporter provided limited information. The reporter said that she had heard there were law suits from people who had gotten the shingles shot. The reporter did not wish to provide any contact information. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP, UNK
Symptoms: Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 12-hour-old male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included IMMUNOGLOBULIN for prophylaxis. On 7th December 2021, the patient received Engerix B and IMMUNOGLOBULIN. On 7th December 2021, unknown after receiving Engerix B, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown. Additional details were provided as follows: The pharmacist reported that Engerix-B administered to an infant patient at 12 hours of age, then 4 hours later an immunoglobulin was administered at the same site, which led to vaccine administered at inappropriate site. No other adverse event information were available. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21st September 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site cellulitis, injection site erythema, injection site swelling and injection site pain. The patient was treated with antibiotics NOS. On an unknown date, the outcome of the injection site cellulitis was recovered/resolved and the outcome of the injection site erythema and injection site swelling were unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site swelling and injection site pain to be related to Shingrix. The case was self reported by the patient. The patient received Shingrix in left arm and experienced a red, swollen arm, and cellulitis. The reporter stated that, the redness and soreness in left arm started gradually after the 1st dose and after 4 days she went to the urgent care and had to receive antibiotics for the treatment of cellulitis in her arm (resolved). Cellulitis was confirmed to have occurred in the same arm where the vaccine was received. The reporter also stated that, till the day of reporting her arm was still sore. The reporter could not provide the lot or expiration date of Shingrix vaccine. The reporter consented to follow up by phone. The reporter consented to contact her healthcare professional. For the tolerance of 2nd dose, refer case US2021AMR252661, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE US2021AMR252661:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: past due for dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th May 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient was past due for 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not had lot number or expiration date to provide. The reporter consented to follow-up
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis. Concomitant products included HEPATITIS A VACCINE (HAVRIX). On 8th December 2021, the patient received the 2nd dose of Havrix. On 8th December 2021, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: On 6th November 2021, the patient received 1st dose of Havrix. The patient received the 2nd dose of Havrix in right deltoid, earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product administration error, Product preparation issue
Clinical narrative: Mixed with some volume of a Pfizer vaccine; Mixed with some volume of a Pfizer vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received HBV (Engerix B) (batch number AC397, expiry date 8th August 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication and drug administration error. On an unknown date, the outcome of the inappropriate preparation of medication and drug administration error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. The pharmacist reported that a pediatric patient received a dose of Engerix-B mixed with some volume of a Pfizer vaccine mistakenly, which led to inappropriate preparation of medication and drug administration error. The reporter did not consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis. On 8th December 2021, the patient received Shingrix. On 8th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided are as follows: The age at vaccination was not reported. The patient received an expired dose of Shingrix. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 2019, didn´t received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose with batch number A4B72, on 8th October 2019 on left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient had not yet been administered the second dose of the Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shingrix in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 0.5 ml , on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age  at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administration with liquid component only; administration with liquid component only; This case was reported by a physician 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 an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Physician reported that patient was inadvertently administered a dose of Menveo with the liquid CWY component only,, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. No other adverse event information available at this time as per health care professional. Health care professional provided consent for safety team to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Received vx reconstituted with other diluent; Received vx reconstituted with other diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA585A, expiry date August 2022) for prophylaxis.   On 9th December 2021, the patient received Menveo. On 9th December 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Menveo vaccination that was reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No data available when asked) received Menveo vaccination that was reconstituted with other diluent. The vaccine administration facility was the same as primary reporter. No further information reported. The reporter consented to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis. On 10th December 2021, the patient received Shingrix. On 10th December 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The pharmacist reported that a patient, received only adjuvant component of Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in April 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided are as follows: The age at vaccination was not applicable for this report. No lot number neither expiry date of 1st dose were provided. The Clinic's Vaccine coordinator reported that till the time of reporting, the patient did not receive a dose of Shingrix, which led to incomplete course of vaccination. The patient now wanted to get 2nd dose of Shingrix but did not know how to proceed with schedule. The health care professional provided limited information. The reporter did not consented to follow-up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Swelling in armpit of arm which received shot. Minor swelling in neck lymph node on the same side. No swelling in either area on the other side of the body
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, C-reactive protein, Gait disturbance, Groin pain
Clinical narrative: I started to get aches and pains in my hip girdle down to my knees in both legs. It has varied, but is so severe that I have great difficulty in walking. It subsides only when I am lying on my back. The intense pain is in both groins, and ischium. Walking, stretching, exercises does not make it better or worse.   Note that the same aches appeared 4 days after the second Pfizer shot, but no pains. The aches went away after 3 days. Again, between the hip girdle and both knees.   As of today, more than 10 weeks after the booster, the pain is very severe and debilitating. No medication addresses the pain, not opiods, not IBP, nor Tylenol, nor gabapentum. Note that prior to taking the booster, I was hiking in the mountains with substantial elevation with no issue. At present, I need to use my arms to climb a single set of stairs and I need to use my arms to raise up from a seat. I have lost most of the strength in my legs, and it does not appear to be returning, in fact it appears to be getting worse.   I have not other aches or pains in my body.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Red blood cell sedimentation rate
Clinical narrative: I started to get aches and pains in my hip girdle down to my knees in both legs. It has varied, but is so severe that I have great difficulty in walking. It subsides only when I am lying on my back. The intense pain is in both groins, and ischium. Walking, stretching, exercises does not make it better or worse.   Note that the same aches appeared 4 days after the second Pfizer shot, but no pains. The aches went away after 3 days. Again, between the hip girdle and both knees.   As of today, more than 10 weeks after the booster, the pain is very severe and debilitating. No medication addresses the pain, not opiods, not IBP, nor Tylenol, nor gabapentum. Note that prior to taking the booster, I was hiking in the mountains with substantial elevation with no issue. At present, I need to use my arms to climb a single set of stairs and I need to use my arms to raise up from a seat. I have lost most of the strength in my legs, and it does not appear to be returning, in fact it appears to be getting worse.   I have not other aches or pains in my body.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes simplex, Oral herpes
Clinical narrative: Severe outbreak of Herpes Simplex 1 (cold sores) on lips.  Have not had cold sores in 15-20 years.  Began day 10 after injection and is continuing. Not responsive to OTC Docosonal 10% to current time.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness
Clinical narrative: Persistent dizziness and disorientation lasting one week (so far)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: High resting heart rate for 12+ hours. Resting heart rate up to 163 in my sleep.  Heart rate was in 85-95 range the hour of the shot then began rising after I went to sleep. stayed in 117 -136 range from 1 am Dec 12 to 11 am Dec 12.  This is the most severe of the other side effects I experienced -  body aches, head aches, short fever (99.3 F - 101 F) & cold sweats, fatigue, dizziness, nausea, diarrhea.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pain, Pyrexia
Clinical narrative: High resting heart rate for 12+ hours. Resting heart rate up to 163 in my sleep.  Heart rate was in 85-95 range the hour of the shot then began rising after I went to sleep. stayed in 117 -136 range from 1 am Dec 12 to 11 am Dec 12.  This is the most severe of the other side effects I experienced -  body aches, head aches, short fever (99.3 F - 101 F) & cold sweats, fatigue, dizziness, nausea, diarrhea.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Headache, Vertigo, Visual impairment
Clinical narrative: Dizziness; vertigo; Nonintractable headache, unspecified chronicity pattern:  ear fullness   Sought diagnosis/treatment from Ear, Nose and Throat physician (12/1/21)- prescribed Motrin 200 mg -- 2 tablets three times with food a day for next two to three days. If symptoms are not improved, needs to have neurology evaluation   Symptoms have not improved, have appointment with Neurologist physician (first available) 02/01/22
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Pain in extremity
Clinical narrative: Two-three days after first shot I feel pain across the palm at the base of all fingers. Both hands effected, started weak, advances with time. Feels like touched by hot iron stick, pain last 1-3 minutes, repeats 20-30 times a day. After second shot on 4/19/21 symptoms progresses for the next few weeks to almost unbearable in June. From July intensity of pain started decreased , now happens occasionally and is tolerable. Additionally two days after second shot I started to suffer sharp pain at arm, elbow, forearm, wrist on my left hand. In any given moment one, two or three area were effected. This mostly resolved after two month of PT and five weeks of medication. I am not certain but I think I was vaccinated in the left arm.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives that come and go on both forearms as well as sometimes legs
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lump in left under arm, presumably a swollen lymph node, for approximately four days
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Penile swelling
Clinical narrative: Swelling of patient genitalia (penis).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face, Urticaria
Clinical narrative: Broke out into hives on chest. Left side of face and eye started to swell.  Friend who is an RN immediately had me take 3 Benadryl.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Injection site pain, Injection site paraesthesia, Nausea
Clinical narrative: Pain at injection site - consistent severity weeks later and causes waking up in the middle of the night. At injection tingling traveled down the arm and hand, with numbness in hand for 20-40 minutes. Was light headed and nauseous for 30 minutes after dose. Only half the side effects as first dose but shoulder pain is more severe and didn't vanish after 1 hour.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: Pain at injection site - consistent severity weeks later and causes waking up in the middle of the night. At injection tingling traveled down the arm and hand, with numbness in hand for 20-40 minutes. Was light headed and nauseous for 30 minutes after dose. Only half the side effects as first dose but shoulder pain is more severe and didn't vanish after 1 hour.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Swelling and pain in axillary region.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cough, Fatigue, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: On the morning after receiving vaccine, experienced injection-site arm pain. Later this same day, experience severe fatigue and bilateral leg pain which made it difficult to ambulate. On Nov. 13, 2021, developed a non-productive cough that lasted 3 1/2 weeks.  Fatigue and lower body pain and imbalance continued for 3 days.  I was unable to accomplish any of my activities of daily living. I did have nausea for 2 days after receiving vaccine (no emesis). No symptoms of fever or chills were noted during this time. I self-administered OTC analgesics and cough decongestion.  For the 1st vaccine dose-no symptoms whatsoever. On the 2nd vaccine dose- developed severe injection-site arm pain-lasting 1/2  a day.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: On the morning after receiving vaccine, experienced injection-site arm pain. Later this same day, experience severe fatigue and bilateral leg pain which made it difficult to ambulate. On Nov. 13, 2021, developed a non-productive cough that lasted 3 1/2 weeks.  Fatigue and lower body pain and imbalance continued for 3 days.  I was unable to accomplish any of my activities of daily living. I did have nausea for 2 days after receiving vaccine (no emesis). No symptoms of fever or chills were noted during this time. I self-administered OTC analgesics and cough decongestion.  For the 1st vaccine dose-no symptoms whatsoever. On the 2nd vaccine dose- developed severe injection-site arm pain-lasting 1/2  a day.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site reaction, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: Swollen, painful lymph nodes under arm on injection side.  Tenderness began a few hours after injection.  Large swelling 2 days after. Injection.   Hot, blotchy rash and swelling  (approx 2.5 inch c 3.5 inch) on the injection arm (a couple of inches below the injection site) began 2 days after injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash macular
Clinical narrative: Swollen, painful lymph nodes under arm on injection side.  Tenderness began a few hours after injection.  Large swelling 2 days after. Injection.   Hot, blotchy rash and swelling  (approx 2.5 inch c 3.5 inch) on the injection arm (a couple of inches below the injection site) began 2 days after injection.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Patient admitted to facility with atrial fibrillation w/ Rapid ventricular response
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Inflammation, Injection site pain, Nasopharyngitis
Clinical narrative: Three days after the first dose of the vaccine, I noticed that not only did I suffer from pain in the arm where the shot was given (which is common), I also noticed that I was suffering from pain/ inflammation in the chest area. It was hard to breathe at times along with the chest pain. I noticed this especially at night. My symptoms would normally subside when I took pain relievers/anti-inflammatory drugs. This side effect lasted beyond 3 weeks. After my second dose of the vaccine,  I also experienced symptoms like a cold or like I was beginning to get sick.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Heart rate irregular, Myalgia
Clinical narrative: Extreme fatigue Headache Muscle aches Pounding/ Irregular heartbeat Lightheaded
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Extreme fatigue Headache Muscle aches Pounding/ Irregular heartbeat Lightheaded
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS syndrome
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 43 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26. cov2.s (from unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported (dose number in series was 1), administered 1 in total for prophylactic vaccination. No adverse events reported. The patient received half dose of covid-19 vaccine ad26.cov2.s booster dose (suspension for injection, route of admin not reported, batch number: 1822809 or 211A21A expiry: UNKNOWN) dose was not reported (dose number in series was 2), administered 1 in total on 27-NOV-2021 for prophylactic vaccination (RRT: Received half dose for booster, LLT: vaccine under dose, and Off label use) (both events dose number in series was 2). No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for booster and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211202193, 20211201082, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211219871 and 20211220155.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 57 year old adult male with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) unspecified manufacturer, dose not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 or 211A21A and expiry: unknown) 0.25 ml, 1 total administered on 27-NOV-2021 for prophylactic vaccination (Dose number in series 2, Booster dose). No concomitant medications were reported.  On 27-NOV-2021, the patient received half dose for booster dose (Coded as Vaccine under dose and off label use). The reporter stated that something was printed and was disseminated which said to administer 0.25ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211202207, 20211200994, 20211201450, 20211201351, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211219871 and 20211220155.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: This spontaneous report received from a health care professional concerned a 22 year old adult female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on unspecified day for prophylactic vaccination.(Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was 211A21A expiry: unknown) 0.25 ml, 1 total administered on 27-NOV-2021 for prophylactic vaccination. (Dose number in series 2, Booster dose). No concomitant medications were reported.  On 27-NOV-2021, the patient received a half dose for their booster dose (coded as vaccine under dose and off label use) (Dose number in series 2, Booster dose). As by the reporter, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated that Spartan is the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the received a half dose for their booster dose and off label use was not reported.This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871, 20211219926, 20211220155 and 20211201304.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: This spontaneous report received from a health care professional concerned a 52 year old male patient of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (dose number in series 1) and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination (dose number in series 2) (RRT: Received half dose for their booster dose, LLT: vaccine underdose, and Off label use). No concomitant medications were reported.  As by the investigator, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports.(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and received a half dose for booster was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211201443, 20211220152, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211219926.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 33 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s( manufacturer not specified) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 211A21A expiry: Unknown) 0.25 ml, 1 total, administered on 27-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 27-NOV-2021, the patient experienced received half dose for their booster dose (vaccine under dose and off label use). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211204104, 20211202379, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926, 20211220155, 20211200723 and 20211201082.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 28 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 211A21A expiry: unknown) dose was not reported, 1 total, administered on 27-NOV-2021 for prophylactic vaccination. (Dose number in series 2). No concomitant medications were reported.  On 27-NOV-2021, the patient experienced received half dose for their booster dose (vaccine underdose) and had off label use (dose series 2). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from unknown. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201362, 20211204104, 20211202379, 20211201179, 20211202515, 20211200675, 20211201179, 20211201304, 20211201392, 20211201963, 20211202161, 20211200717, 20211200723, 20211200769, 20211202207, 20211202246, 20211202371, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926 and 20211220155.