chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced fever of 99-100, tiredness, soreness beginning about 4 hours after vaccine and lasting about 36 hours 7 days after vaccine, my left arm became  tender/swollen again and there is a red, slightly itchy rash about the size of a donut around the vaccination site. It grew in size and it still present 24 hours after I first noticed it
A report has been received from a Pharmacist concerning a 13 year old, female subject,  who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. It was reported that patient was administered half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Right arm injection site pain which started 11/1/2020 and has resolved; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2020, the patient received the 1st dose of Shingrix. On 1st November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccination in her right arm and on the same day, she experienced injection site pain and had resolved. The patient also received 2 Covid vaccinations (unspecified) in 2021 and her 2nd Covid vaccination was in February 2021.  The reporter did not consent to follow up.
On day one I had a fever 100, 100.3 lasted for 36 hours, treated with Tylenol and cold therapy. On the 3rd day of vaccination, I had whole body sever pain, joint pain, and weakness. Headaches, shortness of breath treated with inhaler and breathing exercise. Still have body and joint pain not tolerable, cough and shortness of breath. Starting January 25th, I had slight numbness and weakness on my lower extremity mainly on the Right side radiating to my back and hands. Couple of incidents tripping and loosing my balance due to the weakness and dragging my right leg lasting for a second or so. I still have the weakness and pain, intermittent lightning headache and continuous pain on my joints. Loss of focus and short memory while having the sudden headache.
Information has been received from a third party claims administrator regarding a case in litigation concerning a female consumer. On 23OCT13, the patient had a flu vaccine (non MSD) and a PNEUMOVAX vaccine lot # J004332 expiration date 26SEP14 and had an adverse reaction (unspecified). The reporter reported it was unclear which vaccine the patient had the adverse reaction to. Additional information has been requested.
rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash all over body). On 08-Mar-2021, RASH (rash all over body) had resolved.            Patient  visited to her dermatologist on 24-FEB-2021  . No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
This spontaneous report was received from the patient's daughter and refers to her mother, an 87 year old female patient. The patient's concurrent conditions included Hashimoto's thyroiditis, an unspecified cardiac disorder, diabetes mellitus, an unspecified blood pressure condition and the patient is allergic to iodine. The patient's medical history included cardiac pacemaker insertion. Concomitant mediations included an unspecified medication to "make her blood thinner", and unspecified medications to treat her cardiac disorder, diabetes mellitus and her unspecified blood pressure condition. On an unspecified date in 1995, the patient received her first dose of PNEUMOVAX 23 (dose, route, lot number and expiry date were not reported) for prophylaxis. After that, on an unspecified date in 2016, the patient received a dose of PREVNAR 13. Later, on 12-OCT-2017, the patient was vaccinated with a second dose of PNEUMOVAX 23 injection, lot # N011867, expiration date 08-NOV-2018 (dose and route were not reported) for prophylaxis. On 13-OCT-2017, the patient's arm was reported as "extreme hard and swollen, dark all the way to the elbow and covered with huge blisters." Then, on the same date, the patient was taken to an emergency room (ER), where a diagnosis of cellulitis was made. It was reported that the patient was treated with clindamycin in the ER. In addition, it was reported that an unspecified health professional stated that the patient's reaction was "bacterial", and unspecified cultures were performed, which results were not available. Also, while in the ER, a line was drawn around the perimeter of the affected area, and on the same date, she was released from the ER and was told that if the reaction expanded beyond the drawn line, she should return to ER. On 14-OCT-2017 at 18:00 hours, the patient returned to ER and then she received treatment with intravenous prednisone (manufacturer unknown) and a new line was drawn around the expanded reaction area. It was also reported that an unspecified healthcare provider stated that the reaction was a "severe allergic reaction." Then, on 15-OCT-2017 at 02:00, she was released from ER with a prescription of two prednisone (manufacturer unknown) 20 mg tablet, orally, daily for 4 days.  After that, on an unknown date in October 2017, the patient's reaction was spread out beyond the second drawn line and the patient stated that "the treatment with prednisone (manufacturer unknown) slowed down the spread, but it was still spreading". At the time of reporting the patient was not recovered from the adverse events. No product quality complaint (PQC) was involved. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Upon internal review, the cellulitis and hypersensitivity were considered to be medically significant events.
This event involved arm flexion and stiffening draws 6-7 seconds after onset. 3 mini seizures post DTaP. Given at 4 mth visit on 1-13-07. Few hours after DTaP, when afebrile had a possible seizure.
general malaise; soreness in injection arm; This case was reported by a consumer via call center representative and described the occurrence of general malaise in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced general malaise and pain in arm. On an unknown date, the outcome of the general malaise and pain in arm were recovered/resolved.   It was unknown if the reporter considered the general malaise and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on unknown arm. Caller is the patient's husband. The patient developed soreness in the injection arm and general malaise following the vaccine. The reporter gave consent to follow up.  The reporter did not provide any additional details.
Case number PHEH2011US02596 is an initial spontaneous report received from a nurse on 11 Aug 2011. This report refers to an adult female patient. The patient was vaccinated with MENVEO vaccine (batch number: 10051) intramuscularly on 10 Aug 2011. On the same day, she experienced vomiting, nausea and headache. These symptoms persisted whole night, until she was was able to get TYLENOL down. The outcome of the events were not reported.
Rapid heart rate, severe sweating, inability to breathe, narrowing vision, fainting, anxiety
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), in right arm, on 09Apr2021 as dose 2, single (Lot number: EN6206), in left arm, on 11Oct2021 as dose 3 (booster) single (Lot number: FF8839), in left arm and on 22Apr2022 as dose 4 (booster) single (Lot number: FJ4989) at the age of 72 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 from 15Jul2022 and 20Jul2022.  Clinical course: The patient had no known allergies. 5 days after taking a 5-day regimen of Paxlovid the patient started having sore throat, runny nose and mild fatigue.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 2/18/98; on 2/19/98 pt exp vax site rx of pain & swelling; Typhoid vax expired on 5/97 & administered IM-should have been administered SC or intradermal
Behavior changes. Tingling and numbness in left arm and both legs. Cold sensations throughout body. Pressure headaches as well as being lethargic. Trouble remembering things and trouble making decisions. Feeling distorted, trouble concentrating. Needs to have directions repeated. Muscle twitching and lower back pain. Weak pulse and low blood pressure.
Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided. Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient vaccinated on 8/31/13 with FLUZONE HD. On 9/2/13, patient reports itching and rash on arms only.
This spontaneous report was received from a pharmacist regarding a 66 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date in June 2015 (also reported as 10 months ago), the patient was vaccine with ZOSTAVAX 19400 PFU, dosage regiment and route unknown. Concomitant medications were not reported. On an unknown date the patient developed shingles. The patient sought medical attention by contacting pharmacist. The patient was treated with VALTREX. The outcome of shingles was reported to be recovered/resolved. Product quality complaint (PQC) was not filed. Causality assessment was not provided.  Additional information has been requested.
After she got the vaccine this pain in her knee increased; sore arm; This is a spontaneous report from a contactable consumer, the patient.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date in Jan2021(at an unknown age) as a single dose for COVID-19 vaccination. Medical history was reported as arthritis, hip and knee pain which she attributed to the cold weather. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on an unspecified date for COVID-19 immunization. Concomitant medications were not provided. The reporter stated that, on an unspecified date in Jan2021 (reported as "last Monday") she got the second dose of "the COVID shot." Prior to this she had arthritis and hip and knee pain which she attributed to the cold weather. After she got the vaccine this pain in her knee increased and she also experienced a sore arm which went away two days after. The clinical outcomes of knee pain increased was reported as unknown. The clinical outcome of sore arm was reported as resolved on an unspecified date in Jan2021.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 09-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had four temperature excursions: 336, 232, 1172 and 80 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 47 (8.333333333 Celsius degrees) and 59 (15 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented mild pain at injection area, dizziness and nausea
3/18/2023: Patient presents ED for evaluation after falling off the toilet and experiencing generalized weakness and nausea. Patient states she woke this morning usual state of health without complaints. Shortly after dinner however, the patient started to feel unwell. Upon trying to get up from the toilet, she became very weak and had a slow controlled fall.  She is extremely weak and unable to stand without great assistance. She is unable to ambulate independently. No focal deficits.  She was admitted for further management. Her COVID-19 infection was felt to be mild, she was afebrile and was not hypoxic. She was placed in airborne isolation with supportive and symptomatic management. Will resume home BP meds with as needed for mild blood pressure elevation. PT and OT were consulted for generalized weakness, recommendation was for rehab.  Stroke alert was called 3/19/2023 due to suspected left hemiparesis. On evaluation, patient gave history of having chronic trouble using her left upper extremity because of left shoulder pain. We completed stroke work-up, and MRI brain ruled out acute stroke.  A.m. of 3/20/2023, she was found to be increasingly lethargic. She became increasingly hypotensive and bradycardic. She received atropine. She became pulseless. Her CODE STATUS was clearly DNR, so no attempt at CPR was done. She went into asystole at 1019 on 3/20/2023. Her daughter and spouse were informed of her passing. Death notice indicates immediate cause of death Covid 19 infection due to or as a cause of bradycardia  Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital:
This spontaneous prospective pregnancy report as received from a nurse refers to a 29 year old female patient. No concurrent conditions, medical history or allergy/drug reactions were reported. The patient had come for pre-natal care and reported that on 07-JAN-2016, she had been vaccinated with VARIVAX (Merck) (dosing details, route, expiration and lot# were not reported). No concomitant medication was reported. She was 9 weeks and one day pregnant as of 08-FEB-2016. The LMP and EDD was not known. The pregnancy outcome was pending. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Pt was given Rota vaccine in error. Error reported asap to provider.  Noted upon pt's depature.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
approx 20 minutes p/vax pt devel red fine rash around mouth; mom denies hx of allergy to med or vax; DPH given w/in 30 mins rash began to fade;
She states that she had a deep pain in her chest which began on Wednesday August 25th.  She felt the sensation start on Wednesday August 25.  She felt it coming on.  The severe pain hit her Friday August 27th.  She came to our facility for evaluation and treatment and required dopamine to keep a blood pressure of for 48 hours.  She states that that the pain is resolving.  It lasted longer more on the right.  She states that when it was occurring initially on Friday August 27th she could not really take a deep breath in.  She states that this pain was worse than labor pain.  She has atypical pleural pain or atypical pleuritis with no pleural effusion.
This spontaneous report as received from a registered nurse refers to a 66 years old male patient with unknown medical history. On 12-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (lot # 671555/1314AA, exp. date 02-MAY-2013). An administered dose of PNEUMOVAX23 was expired. No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 4 year old patient of unknown gender.  No information regarding the patient's medical history, concurrent conditions and concomitant therapies was reported. On 17-MAY-2017, the patient was vaccinated with GARDASIL 9 (dose, route and frequency were not provided) lot # M041990, expiration date 28-JUN-2019 for prophylaxis. On 17-MAY-2017, the four year old patient was inadvertently administered a dose of GARDASIL 9 (drug administered to patient of inappropriate age).  No adverse effects were reported. A Product Quality Complaint was not involved. Additional information has been requested.
Developed atrial tachycardia with exercise. Patient has never had issues in previously. Underwent cardiac stress test with echo which demonstrated tendency for PVCs. Has had several episodes of brief SVT noted on Fourth Frontier cardiac monitor.
Patient states symptoms started less than 10 minutes after flu injections. Skin level numbness in left forearm and wrist. At times would tingle. By 30 minutes tingling up left side of neck and face. Within 1/2 hours tingling in left collar bone and shoulder blade. Tingling came and went. Mostly in left wrist, jaw and eyebrow. BENADRYL 25mg, second dose 50mg not helpful.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient  has history of anxiety, and admitted to being anxious before vaccine. Shortly after vaccine pt started to feel chest tightness, headache, tingling/numbness and increased heartrate/bp. I took bp was 165/104. Called and ambulance for pt since sx didnt improve and pt went to  hospital. Per friend, shes feeling better but still has some chest tightness.
01/10/22 presents to EC ED for "chest pain and SOB". PMHx of "CAD s/p CABG, ESRD on HD"
This spontaneous report as received from a registered nurse refers to a 60 year old patient of unknown gender. On 16-JAN-2014 the patient was vaccinated with PNEUMOVAX 23, (0.5 ml dose). Concomitant medications were not reported. On 07-NOV-2014, the patient again received PNEUMOVAX 23. No adverse experience was reported. No product quality complaint was involved. Additional information has been requested.
Client came to clinic, stated had an appt for 2nd dose, could not locate appt or client, did not have previously issued vaccination card to verify since unlocated to verify 1st dose date.  Vaccinator went ahead and proceeded with vaccination. While client was waiting in observation area was able to be located  and discovered 1st dose was administered on 1/28/21 and received second dose after 2 weeks on 2/11/21
Severe body pain for ~24 hours, regular OTC painkillers not able to subdue
About 24-48 hours after second dose, sudden leg weakness and inability to walk.  Still recovering
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "74yoF ho coronary artery disease, there is stenosis, hypertension, dm 2, HLD, BPH, MI 2003, paroxysmal SVT presenting on 12/05 for progressive shortness of breath.  Three day duration, never had the past, exacerbated by exertion, relieved with rest, denies chest discomfort, endorses nonproductive cough.  Found to be in atrial tachycardia with rate exceeding 140, CXR suggesting volume overload versus pulmonary edema.  Initial blood pressure 172/113 and hypoxic to 80% on room air.  CTA negative for PE revealed bilateral effusions and ground-glass opacities with mosaic attenuation consistent with pulmonary edema.  Also found be COVID positive.  Troponin/EKG unremarkable for ischemia.  Blood pressure and hypoxia improved with IV diuretics and rate control.  Echo revealed reduced EF 20% with severe global hypokinesis.  Compared to 2021 echo EF 55%.  Cardiology consulted and recommend LifeVest on discharge with repeat echo as NM stress test on 12/01 was negative for ischemia.  Patient discharged without requirements for therapy or home oxygen.    Acute hypoxic respiratory failure due to new HFrEF exacerbation  -transition IV Lasix to oral, GDMT valsartan and beta-blocker.  Selected tartrate for rate control and patient could not afford Entresto.  Life vest given on discharge.  Close cardiology follow-up.  Consider SGLT2.  Multifocal atrial tachycardia with history SVT  -SVT seen on outpatient cardiac monitor and MATseen on tele/EKG while inpatient, amiodarone 400mg q12h 10 days, 200mg daily thereafter, metoprolol tartrate  COVID-19 infection  -likely minimal contribution, respiratory status improved with control of HR, BP, and volume status, continue supportive care outpatient"