chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site pain; body aches; headache; exhaustion; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 25th November 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 25th November 2019, 3 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain, general body pain, headache and exhaustion. On an unknown date, the outcome of the injection site pain, general body pain, headache and exhaustion were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, general body pain, headache and exhaustion to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received dose Shingrix and an unknown flu shot and 3 hours after that dose he developed injection site pain. He states that seven hours after he received his vaccines he developed body pain, exhaustion, and severe headache. All the symptoms have improved, but not resolved. The reporter consented to follow up. The consumer did not have any further information for this Adverse event, did not know details of either vaccine other than those documented.
chills; headache; myalgia; fever; Vaccine 2- 102 days Post BAM protocol; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine 2- 102 days Post BAM protocol), CHILLS (chills), HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 037k20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine 2- 102 days Post BAM protocol). On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine 2- 102 days Post BAM protocol) had resolved and CHILLS (chills), HEADACHE (headache), MYALGIA (myalgia) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not reported.  Treatment information was not reported.   This case was linked to MOD-2021-220827 (Patient Link).
Headache, Arthralgia, fatigue, injection site pain/arm pain Narrative:  Other Relevant History:
My menstrual cycle following vaccination was the most painful of my life.  It was comparable to labor pains. The first day I could not get out of bed from pain, and the following 3 days I had severe cramps.  My menstrual cycles have returned to normal after that first cycle following the second vaccine.  I have also been a breakthrough case, and have been sick with Covid after being fully vaccinated.  I became very sick and weak despite getting the vaccines. My symptoms included chest pain with dry cough and at times phlegm, sore throat, shooting pains in random body parts for a few minutes at a time and then moving to a different body part, fatigue, spaced out, swirly vision unable to focus. sensitivity to sounds, diarrhea, nausea, head aches, dizzy, ear ache, runny nose, loss of smell, and metallic taste in my mouth.  The symptoms seemed to be moving from different body parts as I did not experience these all at the same time but over the course of the 2week sickness.
Parathesia (on/off tingly in checks, arms, legs)  Tired, Body Aches, Headache
Patient developed intense abdominal cramping, nausea, and rapid heart rate (101) as well as high blood pressure (158/88).  EMS was called and one dose of EpiPen was given in the left thigh.  the patient was then taken to a nearby hospital by EMS.
1/8/22 admitted to hospital for AMS and generalized weakness x 3 days; known exposure to COVID; found to also be positive for COVID; acute on chronic kidney injury; did not meet criteria for remdesivir or steroids; on RA; CT of abdomen showed abscess; given ABX; dehydrated; IV Fluids given; NG tube placed; family decided on comfort care and hospice; 1/25/22 pt dc'd to a home care; this is where the pt expired
Patient had anaphylaxis reaction to Pfizer ( LOT#: FF2587, EXP date: DEC2022)first dose. Vaccine administered around 0952, approximately 10 minutes later patient began having generalized itchiness. She then waited another 10 minutes to see if it would pass. After 20 minutes of waiting she returned to the front desk and reported difficulty swallowing along with itchiness. HM3 brought the patient to a patient care room and reported it to the provider. Patient voice hoarse, when provider entered room. Patient also felt her upper lip was swollen. EpiPen 0.3mL (Lot #1F090 Exp: DEC2022) was administered at 1031 and held in patients left lateral thigh for 10 seconds. Patient reported a burning sensation when Epipen was given. EMS was called at 1033 arrived at 1037. Patient reporting that her symptoms were improved. Vital signs taken at 1035 BP: 127/78 HR:90. Patient transported to  Hospital at 1046.
Fever; chills; whole body achiness; transient tingling down bilateral UE/LE; lethargy; lightheaded.
Pain/burning in (L) arm at injection site. Limited motion (L) arm. Weakness (L) arm. TX P.T, MRI, ultrasound guided cortisone injection, Xrays, nerve conduction test x2.
Fever and chills started about 9 hours after vax admin. 3-3-09 was given TWINRIX and ADACEL. Still feverish 24 hours later but feels better. (R) arm is sore, sl. swollen and dime size red area around injection site of ADACEL. Has MD appt 3-5-09 @ 10:00am.
Did not complete the vaccine series; Rotator cuff tear. Have surgery to get it repaired; Pain at the injection site; Pain reached his shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 28th May 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On 2nd June 2018, the patient experienced rotator cuff tear. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain, shoulder pain and rotator cuff tear were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, shoulder pain and rotator cuff tear to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Reporter was patient who called to get additional information on side effects with Shingrix.  He stated he received his first dose of Shingrix and on the same day post vaccination the patient reported pain at the injection site.  His primary care physician referred him to an orthopedic specialist because the pain reached his shoulder and a week after vaccination a Magnetic resonance imaging (MRI) showed a rotator cuff tear.  Patient stated he did have surgery to get it repaired at the time.  Patient stated he did not complete the vaccine series and did not get the second dose.  Referred to health care professional (HCP) and provided medical advice disclaimer.  Provided information on side effects per package insert (PI). The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
16AUG96 rash over trunk, upper extremities + face, itching x 3-4 w/ ER visit & tx hydrocortisone cream & DPH;20AUG96 pain in both arms & fingers rx Ibuprofen;21AUG96 rash & arm pain w/tingling, numbness in fingers;27AUG96 lt arm numb w/pain
ER visit for abdominal pain, muscle pain, and fevers on 7-13-18 and 7-14-18. Admitted to hospital 7.14.18 for workup. On 7.21.18 I was unresponsive and transferred to the another hospital for additional testing. Results: HSV-2 menigoencephalitis, arachnoiditis, and hydrocephalus which resulted in spastic para-paresis, venous insufficiency, and a neurogenic bladder. 8.16.18 transferred to the facility for skilled nursing care, physical and occupational rehabilitation. Discharged to home on 10-20-18 Hospitalizations: Medical Center Dates: 7-14-18 to 7.22.18 transferred to: another Hospital Dates: 7.22.18 to 8.16.18 transferred to: Skilled Nursing facility Dates: 8.16.18 to 10-20.18
When pt's wife came to the clinic for her second dose on 3/11/21 she informed staff that her husband had passed away on 3/7/21 of a brain tumor.  Death does not appear to be related to the vaccine - reporting only because death occurred within 30 days of first dose of vaccine.  .
Pt received a PNEUMOVAX - 2 days later she called and stated the injection site was ok but the outer portion of her arm was red swollen warm to touch and painful. Pt was bought into office the Dr. looked at it and treated it for cellulitis.
Erythematous 4 1/2 x 5" swelling at (L) area
shivers, fever 100.3  excruciating headache nausea  omitting and very weak feeling
Patient received expired vaccine. Expired 3/26, received 3/30; patient opted for no revaccination.
Initial misuse report received from a healthcare professional on 24 October 2013. The cases were received on 21 March 2014. A patient under 65-years of age had received a dose of FLUZONE HD on an unspecified date. No adverse event was reported. List of documents held by sender: none.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In December 2017, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received 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 pain in arm, circumstance or information capable of leading to medication error, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the pain in arm, circumstance or information capable of leading to medication error, incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient stated that, she received her 1st dose of SHINGRIX and experienced a sore arm. The patient also reported that her 2nd dose would be due on 3rd July 2018, but her pharmacy was unable to get it due to the backorder, which was the circumstance or information capable of leading to medication error of incomplete course of vaccination. No follow-up information was requested from the patient. No further information was provided.
Chills, fever, pain in lower back. Fever occured during sleep, broke a sweat. Next morning no adverse affects and none since
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 64 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not provided. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
BODY ACHE; DIZZINESS; HEADACHE; This spontaneous report received from a consumer concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal pollen allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 19:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, and dizziness. This report was non-serious.
A week or so before Easter I thought I had a sinus infection, with headache and congestion. a nurse practitioner gave me antibiotics and it seemed to help but symptoms didn't go away. I took a covid 19 home test and tested positive. On Easter I went to a covid clinic and tested positive again. there was a lot of congestion and coughing and fatigue. my symptoms lasted for about a week and a half. A week after testing positive for covid 19 I tested again and it was negative.
Intense fatigue; Losing train of thought mid sentence frequently, forgetting questions right after theyre asked; slow cognitive function; Sleeping for several hours at time; Brain fog days after injection; Not feeling rested; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included GERD, pernicious anemia, migraine and seasonal allergies. The patient did not have any allergies to medications, food, or other products. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), levomilnacipran hydrochloride (FETZIMA), nasal allergy spray (MANUFACTURER UNKNOWN) and famotidine (PEPCID); all from an unknown date and for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced intense fatigue and brain fog days after injection; sleeping for several hours at a time but not feeling rested; losing train of thought in mid sentence frequently, forgetting questions right after they were asked; slow cognitive function. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the events fatigue extreme, foggy feeling in head, sleepy, restlessness and cognitive function abnormal were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt's arm (R) had redness and erythema following pneumonia vaccine injection. Pt used BENADRYL and compresses. Symptoms resolved by the next day.
Information has been received from a registered nurse concerning a patient who on 26-FEB-2007 was possibly vaccinated with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot# 647538/0784R) instead of a dose of zoster vaccine live (MSD). The patient's chart stated that the patient received a dose of zoster vaccine live (MSD) but the lot number listed was for varicella virus vaccine live (MSD). The nurse could not verify which of the two vaccines that the patient actually received. The patient did not experience any problems or difficulties. A product quality complaint was not involved. Additional information has been requested.
Patient received vaccine on 1/6.  Patient started not feeling well on 1/8 in the evening.  On 1/9 patient had several abdominal pain, nausea, and vomiting.  She was taken to the emergency room where she was admitted to the hospital with a small bowel obstruction.
Thyroid/throat area swelling; Shortness of breath; Tingling in arms and legs; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 15Apr2021 at 18:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, celiac disease and allergies included gluten sensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (ARMOUR THYROID) and naloxone hydrochloride, buprenorphine hydrochloride (SUBOXONE) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Apr2021, shortness of breath began approximately 24 hours after second dose of vaccine and was continuing up to date. Tingling in arms and legs began approximately 24 hours after vaccine and was continuing to date. On 16Apr2021 at 18:15, 24 hours after vaccine patient experienced thyroid/throat area swelling and was continuing to date. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness of breath, tingling in arms and legs and thyroid/throat area swelling was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Not a serious or dangerous event, but my patient developed a photoallergic drug eruption / rash (biopsy proven) 1 week following her second Shingrix shot. Wanted to report this to help our colleagues and patients.
Small patch of red skin at vaccination site.  Not raised, not itchy, not burning.  The irritation has a diameter of 2 inches by 2 inches around the vaccine site.
By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high fever of 102, body aches and extreme fatigue. She had a fever all day on 8th and experienced severe fatigue. She is still  weak, having body aches and a low grade fever on Friday the 9th. Her chest pains stopped on Thursday.
No adverse effects were reported in the patient; A child, received a dose of GARDASIL-9 on 7/23/2019; This spontaneous report was received from a physician via a company representative, concerning an 8-year-old patient, whose gender was not reported. The patient's pertinent medical history, drug reactions, allergies, and concomitant medication were not reported.   On 23-JUL-2019, the patient was believed to be 9 years old and was therefore vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (number of dose and frequency of vaccine scheme, route and anatomical location of vaccination, lot number, and expiration date were not reported). However, records received on a later date revealed that the patient was 8 years old at the time of vaccination (product administered to patient of inappropriate age). No adverse effects were reported in the patient.
pt recv vax & returned about 1 1/2hr later w/pruritic skin rash;
On 03/01/03 had redness, itching, swelling in bicep area moving down left each day for 3 days with swelling increasing to forearm area. Lasted 4-5 days.
(3hours following)  Fever of 103+  Chills and shakes Lethargic, sore
Injection site for Booster shot in left arm, administered on November 4th, still sore when raising arm; can feel a bit of discomfort when pressing on injection site; Injection site for Booster shot in left arm, administered on November 4th, still sore when raising arm; Dose received: 3; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 12:30 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 04Nov2021; VALACYCLOVIR [VALACICLOVIR]; LAMOTRIGINE; BUPROPION; ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021, outcome "unknown", described as "Dose received: 3"; PRODUCT USE ISSUE (non-serious) with onset 04Nov2021, outcome "unknown", described as "Product use for unapproved combination"; MOVEMENT DISORDER (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 05Nov2021 08:00, outcome "not recovered" and all described as "Injection site for Booster shot in left arm, administered on November 4th, still sore when raising arm"; VACCINATION SITE DISCOMFORT (non-serious) with onset 05Nov2021 08:00, outcome "not recovered", described as "can feel a bit of discomfort when pressing on injection site". Therapeutic measures were not taken as a result of movement disorder, vaccination site discomfort, vaccination site pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Lymphadenopathy . A swelling at the intersection of the upper lip and the groove up to my nose. And rigidity of my nose.  Minor pain at the injection site 3 or so hours after, continuing 36 hours until fading away.
Had low back pain 8 hours later then 12 hours after shot, chill, muscle aches, headache and more low back pain.