chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; General malaise; feeling really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (weakness), MALAISE (General malaise) and ILLNESS (feeling really sick) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), MALAISE (General malaise) and ILLNESS (feeling really sick). At the time of the report, ASTHENIA (weakness), MALAISE (General malaise) and ILLNESS (feeling really sick) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Treatment medications was not provided.   This case was linked to MOD-2021-196263 (Patient Link).
lump in the left side of my neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump in the left side of my neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK MASS (lump in the left side of my neck). At the time of the report, NECK MASS (lump in the left side of my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Swollen eye, sensation in neck under ears, pressure in head (time (9:20)
Asthma started flairing been bothering me since the day after injection .This is not normal asthma for me .
Redness, swelling and warmth of L mid arm posteriorly, peaking the next day and a little better at time of exam 10/4/13, mid morning.
15 min after vaccine had headache and chest pain requiring EC visit. Evaluated in EC without specific intervention and discharge with follow-up precautions with PCP
Two weeks after the first vaccine had a large circular red area appear around the area of the shot.  The area was tender, especially at the injection spot. The red area was large like three inches by two inches.  sometimes solid red and sometimes just a big ring.  It lasted several days. Unusual in that it appeared two weeks after.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in March 2018). On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced headache, tiredness, injection site erythema and injection site swelling. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the headache, tiredness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the headache, tiredness, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The case number US2019058160 was identified as duplicate of US2019GSK057807. US2019GSK057807 was deleted and all the future correspondence will be added in the present case (US2019058160) which stands as case of record for this patient. The age at vaccination was not reported. After 1st dose it was time for patient to get the 2nd one 2 to 6 month later, patient was unable to find it available anywhere till finally 1 year later. The patient asked had it been too long (1 year), since 1st one, & still need a 2nd one, or was this 2nd one that we just got, going to be just fine even though it had been a year since the 1st one. The patient experienced tiredness, headache, redness, and swelling at the injection site. The symptoms from dose 2 began the next day and had resolved. The reporter consented to follow up.
Following administration of immunizations on 10/15/18, patient felt dizzy as she was walking towards the exit of the office. She lost her balance, but was caught by her sister. She became very pale and sweaty. Her blood pressure was checked, and it had decreased to 90/58 (from 120/70 at start of the visit). She was taken back to her exam room and laid down. She ate a snack and had a drink, and gradually over 5-10 minutes started to feel more like herself. Repeat blood pressure increased to 106/66, and patient was no longer feeling dizzy (just embarrassed). She was able to walk out of the office under her own power, and event was likely related to vasovagal presyncope from receiving her immunizations.
MOC reports pt developed "hives" over entire body, fever (to 103.2 before TYLENOL), headache and diarrhea 4 days after vaccination. States urine output also down on day 4, intake and output now reported per usual temp elevated to touch, hive reduced to trunk per MOC at time of this report.
2/26/23  My sinuses were draining and I had a sore throat. I then got a headache. The symptoms began to slowly get worse. I had fatigue, which was the biggest symptom. I never had lung problems.   On 3/1/23 I took an at home COVID test and it was positive.  On 3/2/23 I saw an APN who suggested I take medication for Malaria and an anti-viral that was not supposed to work.  I did not want to do this.  On 3/3/23 I went to a different APN. I was unable to take Paxlovid because of my blood pressure being elevated.  I was prescribed Lagevrio which I began taking that day. I was also prescribed a Steroid Pack. I began feeling better after the medications. I continued to test positive for COVID for two weeks after that and eventually stopped taking the test.
SEVERE JOINT, MUSCULAR, AND BODY ACHES PAIN; EXCESSIVE TIREDNESS, WEAKNESS;  TEMPERATURE AS HIGH AS 101.5, UNABLE TO PERFORM EMPLOYMENT DUTIES FOR 2 DAYS, INJECTION SITE DISCOMFORT
I got home from the vaccine and within about a half an hour was extremely sleepy. I woke up around 9PM and my tongue, face and neck were swollen on my right side as well as the lymph nodes under my right armpits so I went to the hospital. After being in the hospital 3 days I noticed the area around the injection site was white. Once I was discharged, I continued to have allergic reactions of swelling and itching. It happened under my arms and on my thighs. It was extreme swelling like I had a baseball under my arm. Also on my feet, it looked like I had pads on the balls of my feet. They were sometimes hot to touch as well. It continued for about 2 and a half weeks. The last thing I remember having was itchy rashes. Then I woke up and my tongue again was really big and my throat was close to closing. I came back to the hospital and am currently in ICU. It took the doctors a long time to get the swelling down. More doctors are being called in to see why it happened again and was worse than the first event. I hope to be discharged today. I am just waiting to hear my blood work results.
Pt states that she felt like she passed out after injection. Incident not witnessed. She states she has " seized up"  in the past after blood draw. Pt declines EMR assistance. Pt left site in no distress without complaints
it's been over 4 months since receiving the 1st dose; It was 2nd worst migraine I've ever had; severe vomiting; started to get migraine-like symptoms headache/severe pain in the head; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting), HEADACHE (started to get migraine-like symptoms headache/severe pain in the head) and PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (preservatives) and Migraine (pretty bad).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting) and HEADACHE (started to get migraine-like symptoms headache/severe pain in the head). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose). At the time of the report, MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting) and HEADACHE (started to get migraine-like symptoms headache/severe pain in the head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Chills, headache and body ache that started approx 12 hours after vaccine admin
On 9/19 the pt developed myalgias, fever, pharyngitis, On 9/22 the pt developed varicella rash, on 9/23 the pt was seen at the MD's and has a moderate case of varicella.
p/vax pt began c/o pruritus & urticarial wheals to back approx 30min p/vax;
Received 2nd dose of Pfizer COVID vaccine on 1/20/21.  On 4/3/2021 developed headache and sore throat.  Tested positive for COVID.
24 hours after injections felt dizzy, had arm pain, looked pale, was very fatigued. Tylenol and ice packs used which helped.
Patient was given a 0.25 mL injection (booster dose amount) and did not receive the correct 0.5 mL amount.
Several hr p/vax pt devel screaming,ecchymosis @inj site & fever 101.4.
Lt arm red, raised, hot to touch area approx 1 1/2 in x 2 in on left posterior of arm. Cellulitis per Dr.
12 mo M received routine Hep A and MMR vaccines 8/28/15. On 9/1/15 parents noted drooping/weakness of right side of mouth. No other symptoms. Eye not involved. Confirmed weakness/lower segment (R) 7th nerve in office 9/8/15.
Pt. was administered PediFlu at 5 wks of age in a misidentification medication error on 11/23/07. No adverse reaction detected at time of administration. Mother advised to watch for fever by M.D. Pt was reportedly admitted to hospital for evaluation. Unknown to health center if directly related to vaccination.  1/22/08 Reviewed hospital medical records which reveal patient experienced 3 episodes of becoming limp, floppy, pale, arching of back, abnormal movements of extremities, w/eyes rolling back followed by period of lethargy, decreased activity & reduced oral intake.  Seen at outlying ER & transferred to higher level of care.  Admitted 11/25-11/27/2007 for sepsis w/u.  Tx w/antiviral & antibiotic.  Neuro exam was WNL on admit.  (+) Gr III systolic murmur present.   FINAL DX: none provided on d/c summary. Follow-up: No contact with pt / mother since shortly after event.
This case was reported by a healthcare professional and described the occurrence of chest rash in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 4 May 2011 the subject received 1st dose of ENGERIX B at 0.5 ml in the left arm. On 6 May 2011, 2 days after vaccination with ENGERIX B, the subject experienced chest rash and back rash. At the time of reporting the events were unresolved.
Patient is a 42 YO female who presents for evaluation of a possible skin infection located left upper arm. Patient was given PPCV 23 and influenza shots in the left upper arm on 1/17/2018. Symptoms include moderate pain, erythema located, mild itching over the immunization site and low grade fever that was managed at home with ibuprofen; last dose was at 0800 AM and currently afebrile. Patient denies chills, fever greater than 100 and N/V. Treatment to date has included OTC analgesics and warm compresses with transient relief.
Reddened warm area to right upper arm with slight tenderness and previous increased swelling.  Prescribed Omnicef 250/=1 tsp for 10 days and Benadryl PRN.
Patient received the flu shot while being seated and reported no discomfort.  Patient stood up and was watching her mom receive the flu shot.  While applying the bandaid on the mom the daughter(patient) started losing consciousness and fell to the floor with her back against the wall. When the patient fell she hit her head. The parents assisted the daughter up and seated her in a chair. We provided the daughter with water, and upon visual and verbal inspection the patient was able to answer and was visibly alert and aware of her surroundings. She did tell us her head hurt where she had bumped head.
Patient (parent) came in for pediatric  dose #2, but we noticed the pt was not of age yet. patient had gotten first dose at age 4 due to incorrect input of dob at time of making appointment at the call center for the first dose. dob originally inputted into system was 8-15-2016 (putting the pt age to 5), when they got here for first dose, system was able to push it through the pharmacist to administer because dob was incorrect and this pt had already been entered into our system. when pharmacist noticed dob was incorrect, the technician corrected the dob in the system but it was allowed to go through anyway without a hard stop and it was administered. we called pfizer to get further information on next steps as this pt lives in another Country. According to Pfizer, they told us not to administer the second dose until the pt reaches the approved age of 5.
Discharge Provider: DO Primary Care Provider : DO    Admission Date: 11/2/2022 Discharge Date: 11/4/2022 COVID positive Date 11/2/2022 Admitting Diagnoses: Principal Problem:   COVID-19 Active Problems:   Hyperlipidemia   HTN (hypertension)   Type 2 diabetes mellitus without complication, with long-term current use of insulin    OSA (obstructive sleep apnea)   Back pain   Morbid obesity with BMI of 45.0-49.9, adult    Hypoxia PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: 68 y.o. male with past medical history significant for chronic obstructive pulmonary disease, hypertension, chronic back pain, GERD, depression, migraine headaches, insulin-dependent diabetes presents with complaints acute shortness of breath.  When EMS arrived, they reported that the patient was in the low 70% range on room air.  They placed the patient on a non-rebreather mask and the patient only improved to the upper 70% range.  Patient was placed on CPAP prior to arrival to the hospital.  Upon arrival to hospital, the patient was immediately placed on BiPAP.  Patient was admitted to the hospital with acute hypoxic respiratory failure, covid 19 infection, acute copd exacerbation. Patient did well with the addition of steriods. CT did not reveal PE or evidence of pneumonia. He was setup with 2l o2 at home prior to DC. He is to continue course of dexametasone for treatment of copd and covid19.    Patient's discharge was held on 11/3/22 due to hyperglycemia. Endocrinology team was consulted and patient was placed on insulin GTT. This was transitioned off and patient was discharged home on 11/4/22
Patient called the pharmacy on 10/23/2020 to report blotchiness and soreness on her left arm with heat. She was advised that those reactions are somewhat common and to watch and report any worsening to her PCP. She presented to pharmacy on 10/24 with sharpie markings around the margins of the reaction and stated that her reaction had improved. She indicated that there was significant swelling although swelling was not apparent to me. I advised her that she should see MD and that my concern was cellulitis with the description of her worst symptoms. I do not know if she has been evaluated by a healthcare professional.
died a week after getting the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), 1 week after the suspect product(s) administration, outcome "fatal", described as "died a week after getting the Pfizer shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died a week after getting the Pfizer shot
FATIGUE; HEADACHES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headaches on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210400162.
6-month-old patient was given a PENTACEL vaccine today (01Feb2023) but the vaccine expired yesterday; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 month old male patient who had taken DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 01-feb-2023 but the vaccine expired yesterday.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq); Hepatitis B Vaccine (Hepatitis B Vaccine) and (Pneumococcal Vaccines).  On 01-Feb-2023, the patient received a dose 1 of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE for Suspension for injection (Frequency: Once, lot: UJ659AAA, expiry date: 31-Jan-2023) via unknown route in unknown administration site for immunization.  On 01-Feb-2023, (latency: same day) the patient was given a pentacel vaccine today but the vaccine expired yesterday (expired product administered).  No lab data available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hearing loss; This case was reported by a physician via call center representative and described the occurrence of hearing loss in a 46-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number N9A39, expiry date 30th June 2021) for prophylaxis.   On 11th September 2020, the patient received FluLaval Tetra 2020-2021 season. On 11th September 2020, 3 hrs 30 min after receiving FluLaval Tetra 2020-2021 season, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows:  The patient received Flulaval quadrivalent and 3.5 hours after vaccination experienced hearing loss in right ear. No additional information was reported. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
Breakthrough case admission after 3 Vaccines NO Manufacturer listed on any of the vaccines; Moderna listed on form only because form will be rejected if no manufacturer listed; DO NOT SEND FOLLOW UP REQUEST FOR MANUFACTURER; NOT LISTED IN STATE DATABASE  2/26/21 Lot# 001a21A;  3/26/21 Lot# 006B21A;  2/16/22 Lot# 042J21A
Initial report received from a health care professional on 04 August 2011. A 54-year-old female patient received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number C3935AA, on 27 July 2011. The patient had no known allergies (NKA) and denied any illnesses at the time of vaccination. Approximately 7 days later (August 2011), the patient developed a red raised area on the left deltoid which measured approximately 1/2 inch away from the injection site. The red area was 11.5 by 8 centimeters (cm) in size. The patient denied pain but stated she had slight burning sensation at times. The outcome was reported as not recovered. Follow-up information was received from the healthcare professional on 29 August 2011. The patient was seen on 04 August 2011 by a nurse practitioner, complaining of redness and a burning sensation in the left upper arm. She was treated with warm soaks and ibuprofen 400mg PO bid. The next day she noted that the burning sensation continued, but redness was decreased. She was advised to continue the warm soaks, and was prescribed prednisone 20mg PO x 2 days. On 09 August 2011 the left arm erythema was "almost completely resolved". Outcome was reported as recovered. Documents held by sender: None.
COVID infection following COVID vaccine, 03/27 Janssen dose #1 08/02 COVID swab, pre-op,result: positive 08/04 pt denies symptoms
2 days after injection (PNEUMOVAX) pt. complaining with chills, low back pain, headache achy all over and tenderness at injection site.
Client reports soreness began 3-9-12. Next day noted "some" swelling. Now c/o R arm at site of injection with 3 inch diameter swelling and c/o "hot" to touch . Also states had neck pain and headache over the weekend after vaccines received. Denies any hives or Resp distress at any time after vaccines. States has "normal" temperature now and denies any drainage at site. Advised client to see his private MD or urgent care facility to assess above area and C/o of headache and neck pain.
Monovalent Moderna for booster inadvertently given. No symptoms at time of administration.
sore arm for a day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm for a day". Additional information: the patient had memories of all the Pfizer vaccines he got, had no side effects except a sore arm for a day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.