chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (10.3.21);  COVID-19 positive (10.3.21);  fully vaccinated Admission Date: 10/3/2021 Discharge Date: Oct 5, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: This is a 75-year-old male with past medical history significant for coronary artery disease, paroxysmal atrial fibrillation, hypertension, hyperlipidemia, CVA and bladder cancer who presented to the emergency department with shortness of breath, cough and generalized weakness.  In the emergency department, the patient was tachypneic with oxygen saturation stable on room air.  He was found to be COVID-19 positive.  CTA chest was performed and did not show PE but did show findings consistent with COVID-19.  He received a dose of Decadron and was admitted for further management.  Given lack of hypoxia, the patient qualified for monoclonal antibody therapy for which he received on 10/03.  Further Decadron was held and the patient was monitor closely.  The patient did have a small amount of hemoptysis, which was felt likely related to COVID in setting of aspirin and Pradaxa use.  His hemoglobin remained stable.  He did drop his O2 saturations to 89% while ambulating in room to bathroom without supplemental O2 but otherwise feels well and comfortable returning home today. No skilled needs on PT/OT evaluation.
Four days after injection right foot became inflamed and hugely swollen.  Top of foot and all along the outside side of it both on top and at bottom of foot all very painful. Ankle and leg very swollen and painful. Can't walk on foot.  As of 2/26/2021  swelling is not as bad and not so discolored but still some swelling and redness burning and very painful and still cannot use the foot.  Also have noticed places where  I have had surgery or injuries is hurting and being stiff. Am questioning whether or not I should get the 2nd shot. Concerned it will make situation even worse.
Around 9:20 I noticed slight numbness halfway down the left arm.  Around 9:25 my left arm was slightly numb to the hand. A short time later my left side of my back near the shoulder blade area and the back of my neck were feeling  wierd . A few minutes later my left side of my face was slightly numb staying that way until around 10:15 or so. Debated medical attention but decided to wait and see if it would get worse or come out of it.  Didnt seek medical  attention but felt it would be best to report. Will be contacting PCP for advice as to whether or not to receive the second dose.
almost immed upon vax pt became pale, quiet & drowsy; for the next 10 hrs pt was pale, limp, drowsy & cool to the touch; slept almost the entire day, but could be roused to eat & take tempra; nurses felt was rxn to vax;
I had those symptoms in a discontinued manner: slight dizziness during the day, slight headache when I woke up, treated easily with paracetamol.
Pt complaining of left arm muscle soreness and pain, as well as redness and heat at injection site which has persisted for past 4 days. Symptoms have not been relieved with OTC tylenol, ibuprofen, or cold compresses.
DID NOT FEEL GOOD; This spontaneous report received from a consumer concerned a 32 year old male. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 4 decade old. No concomitant medications were reported. On an unspecified date, the patient experienced did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good. This report was non-serious. This case, from the same reporter is linked to 20221230410.
Red itchy mumps like bumps above buttocks stretching across back. Treated with Claritin and calamine lotion. Bumps have since scabbed but still show and sometimes itch.
0920:  Patient noted to be slumping in chair- pale and diaphoretic.  Assisted to floor. EMS and NP in attendance along with other RN staff.  Completely unresponsive and not breathing.  Airway opened (triple jaw maneuver) and turned on side.  She started breathing spontanceously and opened her eyes. Initially confused but became Ox3.  Pt. taken to private observation area. VS: 0925: 125/81- HR 48 (double checked); R 12.  Sat's 98% on RA.  EKG shows sinus bradycardia.  Pt later assisted to seated position on stretcher  and vomited x2 undigested food.  VS#2 @0940:  127/80; HR 52- Sat 94, R 14. Felt better after 2nd set of VS.  Sent home w family member @10:00am.  Teaching:  recommended she inform vaccinator prior to #2 shot she faints easily after injections and perhaps have the injection performed while patient is lying on EMS stretcher. Patient agree to this - brother will follow up with her.
The child was given DPT, IPV, HEP B / Hib), post shots mom gave Apap. Child became unresponsive. The child was taken to the children's ER.
Extremely sore arm 2 hours after injection. Progressively getting worse. To the point I can?t even lift arm. Body aches and severe migraine at about 5pm.  Heart palpitations that entire evening. Chills intermittent. Still experiencing symptoms almost 48 hours later.
For four hours: nausea, shivering, can't eat, very tired, injection site pain Still feeling: tired, injection site pain
Patient presented for 12 month well exam. MMR, Varicella and Havrix  was ordered. Nurse gave MMR, Varicella and Kinrix.  30 minutes after the visit, while I was signing off the note, this was noted. Patient had received MMR and Kinrix in the left thigh. called GSK rep for advice on further actions. was advised to report to VAERS. Called parent and informed that Dtap-IPV combination was given instead of Hep A. reassured parent that Hep A  can  be given at 15 months.  Also informed parent, Patient may not need  Dtap booster at 15 months. Advised parent to call with concerns of any side effects
GOT IN A CAR ACCIDENT AFTER TAKING IT; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced got in a car accident after taking it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got in a car accident after taking it was not reported. This report was non-serious.
significant side effects with the pain in the underarm on the side of the shot; fever; headache; trap muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 18Mar2021 14:15 (Lot number: ER2613) at the age of 23 years as dose 1, single and intramuscular, administered in deltoid left, administration date 13Apr2021 11:45 (Lot number: EW0151) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY PAIN (disability), outcome "recovered", described as "significant side effects with the pain in the underarm on the side of the shot"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "headache"; MYALGIA (non-serious), outcome "recovered", described as "trap muscle pain". The patient underwent the following laboratory tests and procedures: body temperature: unknown results. Therapeutic measures were taken as a result of axillary pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101828758 Same patient, same vaccine in different dose, partial same event
3RD COVID VACCINE GIVEN 10/26/21, PFIZER, LOT #FF2590; pt admitted to hospital with AMS/aspiration pneumonia, UTI; was recently tx in hospital for pneumonia and UTI, given ABX; pt is DNR/DNI; 9/14/22 pt had diarrhea x 3days; found to be positive for C.Diff and COVID; givn tx for C.Diff. 9/19/22 pt tachycardic with dyspnea; given corticosteroids and breathing tx; refused feeding tube; transitioned to comfort measures; pt passed away
Area of injection hurt for about 2 weeks.  Approx. a week after injection, shoulder pain began and worsened over time.  Can't raise arm above shoulder level.  Very painful to move.  Can't reach behind back, or high overhead.
pt with an new onset single episode of tonic-clonic seizure on 4/9 (3 weeks after vaccination) that lasted 60-90 seconds. patient with no predisposing trauma, no recreational or illicit drug use or alcohol use, no history of seizure disorder or family history of seizure disorder. pt with postictal state lasting 10-15 minutes. Patient went to ER following episode and treated with Ativan. Patient with no reports of seizure like activity or episodes since the event.
Next day after flu vaccine noticed rash on legs. Next day rash spread trunk and extremities office visit 11/15/06 DX with Erythema multiforme. No treatment. Not sure if this is related or not to Fluzone.
Caller reporting giving an expired dose of Menactra; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a16 years old patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation.  On 21-Aug-2019, the patient received a 0.5 ml single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U594AC (expiry date: 14-AUG-2019) via unknown route in the right deltoid.  It was of actual medication error case due to expired vaccine used.  It was not reported whether adverse event was experienced by the patient or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  List of documents held by sender: none.
Swollen arm; Pain at arm; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got shingles vaccine two days ago, a bit swollen and pain at arm but all was good. The contact details of patient was not reported hence follow-up not possible.
No adverse effect; inadvertently administered a dose of MMR II, that was expired; This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 13-MAY-2019, the patient was inadvertently vaccinated with a dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (also reported as M-M-R III) injection, lot # N013868, expiration date 04-MAY-2019, for prophylaxis (exact dose, route of administration and injection site were not reported). Concomitant therapies included sterile diluent. No adverse event was reported.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment  medications were provided. Time from first puncture was 3.5 hours.
Later in the evening after receiving the flu shot my daughter ran a fever and started crying uncontrollably, which she had never done, for hours.  She refused to eat, and fell asleep.  Around 10:00 pm she woke up and began vomiting food that she had eaten earlier in the day, emptying her stomach completely until she was vomiting only mucus, and eventually dry-heaving.  It required a visit to the emergency room.  She was fine the next day.
w/in 7-10min p/MMR/HIB vax, pea-sized welt appeared approx 1/2" above inject site w/lime/sized reddened area; By 20 min p/inject, 1.5" reddened area remained only; Mom advised to contact MD or go to ER it site worsened or problems devel;
Chills, sweating, headache, body aches, 103.5 fever (highest), fever over 100 for 15 hours.
Pt was given Hep A #2 immunization an then got HPV #2 vaccine. At that point she became limp & pale. The nurse laid her down & called for her. She was doing fine when I checked into the room. The nurse said  it appeared she had a mini seizure that lasted approx 10-15 seconds. No treatment needed. Pt recovered spontaneously.
Redness and swelling at injection site and surrounding tissues 10 days from injection. Cellulitis of right upper extremity causing fever and body aches.
10-15 second episode of eyes rolling up and outward, fixed with tonic-clonic shaking of extremities. Then became very sleepy afterwards. Pt was taken by ambulance to local hospital for evaluation and transferred to another hospital.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 02-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 920 hours and 0 Celsius degrees for 168 hours with lowest temperature recorded of 34 and 32 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
within 10 minutes of vaccination, patient c/o feeling warm and nausea.  symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands.  HR in '70's initially then progressed to tachycardia in 130's.  EMS called for ED transport.
On 1/13 I started with a small area of hives. On 1/14 I woke up with hives and significant itching all over my arms, legs, and torso. I called my doctor and began a Medrol Dosepak. The hives and itching continued. I went for an in-person doctors appointment on 1/18 and was given a Triamcinolone injection and prescribed Prednisone and Hydroxyzine. The hives and itching slowly went away.
Body aches; Swollen lymph nodes under armpit in the arm that was injected; Swollen lymph nodes above clavicle in the arm that was injected; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm on 18Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Apr2021 the patient experienced body aches and swollen lymph nodes under armpit and above clavicle in the arm that was injected. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches and swollen lymph nodes under armpit and above clavicle in the arm that was injected were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
After first shot developed chills, headache, body aches, and chest pain with yawning or stretching. Occurred within 24 hours. Had Covid in January of 2021. Positive covid antibodies based in previous bpood donations.
injuries resulting from Zostavax use: Herpes Zoster; injuries resulting from Zostavax use: Herpes Zoster; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 68 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2011, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: Herpes Zoster.  The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received a single dose of PREVNAR 13 and a high dose of FLUZONE, both in Oct2016, one in each arm for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date, after vaccinations, the patient experienced headache, chills, body ache and flu-like symptoms. The patient recovered from all the events on an unknown date.
Breakthrough case admission after 2 vaccines Moderna 6/24/2 Lot# 011D21A;  Moderna 7/22/21 Lot# 007D21A
Sweats and muscle aches within 2 hours, chills all night long, fever ranging from 101.5-103.5 fahreinheight throughout the night and day Saturday, chest discomfort, fluttering heart, general feeling of unwellness, sore throat, severe body and joint aches, trouble breathing in small spurts self reaolving witj burning feeling in chest. Symptoms ongoing.
Patient began itching this am. She went to a urgent care where they gave her oral Benadryl tablets  then was transported to ER. There she received IV steroid. The provider thought she had an allergic reaction to the Covid vaccine. She was not given any additional meds for home use.
Swelling, redness, itching near the vaccine injection site. Symptoms first appeared 8 days after injection
Hives began appearing on torso within 2 hours of shot.  Within 9 hours hives spread to limbs.  By 18 hours post-shot entire body was covered (thousands of hives.)  Patient started on Benedryl after Dr. visit 11/05/07.  Hives did not fully disappear for 2 weeks.
High blood pressure; vertigo; This case was reported by a pharmacist via call center representative and described the occurrence of blood pressure high in a male patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date unknown) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 29th September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than an hour after receiving Shingrix, the patient experienced blood pressure high (serious criteria hospitalization) and vertigo (serious criteria hospitalization). On an unknown date, the outcome of the blood pressure high and vertigo were unknown.   It was unknown if the reporter considered the blood pressure high and vertigo to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comments: Pharmacist reported that the patient received the first dose of Shingrix on 7th July 2021. The patient informed by email to the pharmacist that minutes after receiving the 2nd dose of Shingrix he was hospitalized due to vertigo and high blood pressure. The health care professional requested follow up by phone as soon as possible.
Administered adjuvant suspension only - without reconstitution of lyophilized antigen. Pt reported injection site (left arm) tenderness and chills for one day post admin. Pt also noted small rash on opposite arm (right arm), but noted may be from recent insect bites. Consulted with GSK for guidelines and monitoring parameters - none. IAC recommends repeating dose in 4 weeks. Notified prescriber and recommended follow up if appropriate. Instructed pt seek medical attention if symptoms persist or worsen.
During administration of VAQTA, patient felt dizzy and lightheaded. Prior to vaccine patient had labs drawn. Patient slumped to the side and was assisted to lie down. I walled, called in, he was alert and stated he had not eaten. Gave him a popsicle. Left 30 min. later w/ guardian.
Started feeling very tired and dull headaches in approximately July.  Headaches grew worse in August.  I thought I was going to have a stroke.  Contacted Dr and he said to go to either a urgent care or E/R.  Went to the hospital on August 26.  He prescribed HBP but never called in the meds so ended up in the E/R that evening.  E/R doctor did blood test, EKG and head scan.  Prescribed Lisinopril 10mg.
I woke up in the night with severe  ear ringing and continue to have issues. I have never had ear ringing problems previously.
Pain in left shoulder joint noticed same day before exercising. Pain felt when lifting arm to side. Joint pain is still present