chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hotness at the injection site; Pain at injection site; Redness at the injection site; Swelling at the injection site, to the size of a quarter; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hotness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site, to the size of a quarter) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included IBUPROFEN for Migraine.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hotness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site, to the size of a quarter) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (Hotness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site, to the size of a quarter) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient was prescribed steroids to alleviate her condition.
daughter might have also gotten the vaccine injected in fatty part of her arm because the same person administered it; The daughter is experiencing the same arm soreness as her mother/her arm is extremely sore/sore arm; This is a spontaneous report from a contactable consumer. This female consumer reported for her daughter. This is report two of three. This is a clone report for the first daughter. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0172, Expiration Date was not reported), via an unspecified route of administration, administered in arm on 09Jun2021 (at the age of 17-year-old) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On an unspecified date the daughter experienced the same arm soreness as her mother. Her arm was killing her. It was reported that, she might have also gotten the vaccine injected in fatty part of her arm because the same person administered it. Reporter's daughters both had the first dose and they had sore arms but she didn't see them get the shot and she doesn't think this happened to them. it hurt for a week. They were both sleeping and can't get information from them. Reporter also stated that if she touched it, she thinks her daughter would complain. Adds both our arms are killing us and it looks like this daughter got the vaccine injected from that same tech at pharmacy. She has not had anything happen yet, except that her arm is extremely sore which it was not the first time. The outcome of the event the daughter is experiencing the same arm soreness as her mother/her arm is extremely sore/sore arm was not resolved and unknown for the other event.  Additional information has been requested.
Patient's arm was swollen and very red around injection site extending down the arm in a diameter of about 6 inches.
I watched my daughter change and regress in her behavior right before my very eyes from the moment she was triple vaccinated. For the first month, she was crying and screaming constantly. She then became extremely violent and aggressive toward herself, her caregivers, and animals. Punching, slamming her head into cabinets, biting, etc. Regarding milestone regression, she completely stopped saying the alphabet, numbers, shapes, colors, along with numerous words and phrases she had mastered prior to getting vaccinated. Her hearing became sensitive, she stopped looking at things we are looking it, she stopped trying to attract our attention to her own activities. It has been absolutely horrible going through this and I'm positive it is a result of the vaccines. She continues to need extra therapy and instruction on a constant basis, which costs time and money along with emotional and physical damage.
patient informed me before she got the vaccine is when she got her dose in February she felt numbness in her face and arms and she still feels it. she told that she called Pfizer and nobody paid attention . after I gave her the vaccine she said that she felt the same effect and I told her to stay around , later she said that she is feeling the numbness in her ankle and legs  and she told me not to worry because she had the same reaction in her arms and face before so I asked her to call me back if it does not subside. today 11-10-2021 I got a call saying that she still has the same Side effect so I told her she can report to v-safe and I gave her the site also I told her that I will report it to VAERS she asked me to give her a copy which I will
Client began complaining of shortness of breath, and feeling like his heart was racing. Vitals: 139/90, HR 83-90, 95% RA. Lung sounds were reported as being mostly clear. An ice pack was given.
On 8-9-2010 client was given H1N1 0.1ml. intradermally instead of TB - PPD in the left inner forearm. The eve of 8-9-2010 noted redness at injection site. 8-10-2010 states redness receded with no other symptoms. 8-11-2010 - Area observed - 4 cm area reddened - cool to touch. No c/o discomfort. 8-13-10 - Faded redness c/o sl. itching.
Left trunk rash; internal pain following same route as rash, increasing in intensity with time.  Pain became unmanageable with at-home remedies, necessitating a trip to ER.  Diagnosis: Shingles.
pt recvd vax;sl fever, pain where shot given for 3 days;got worse;pain went further down lt arm;MD felt inflammation & gave anti-inflammatory meds but did not worked;to physical therapy,irritation in muscle;also tinnitus in rt ear which inc
Patient stated that he felt like his lips were swelling about 10 minutes after encounter. After 30 minutes there were no changes or reactions at the site. Patient wanted to go home, take a Benadryl and be observed by a family member/friend and would update us if necessary and follow up with medical provider if needed.
Initial unsolicited report received from pharmacist on 05-Oct-2018. This case involves a [77 years old] male patient who was vaccinated with a 0.5 ml dose of vaccine FLUZONE HIGH DOSE (Batch number: UJ038AB, expiration date: 03-May-2019, site of administration: left deltoid route and was not reported) on 05-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to syringe issue (she screws the needle, it is tight and sealed but there must be a crack or something because it is leaking out) and exposure via skin contact (dose leaked all over him). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
I started developing sores on my chest, thighs, and back on 2/21/2022 and I still have sores and received medication.
Shingles, including any and all of its sequelae/the patient had been caused to suffered severe personal injuries; Shingles, including any and all of its sequelae; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a 62-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 04-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). In 2014, as a result of her received zoster vaccine live (ZOSTAVAX), the patient was caused to suffered shingles, included any an all of its sequelae. As a result of her received zoster vaccine live (ZOSTAVAX), the patient had been caused to suffered severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. This action was also brought on her spouse and who suffered loss of consortium damages. The outcome of shingles and ill-defined disorder were not recovered. The reporter considered shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).
ripped my rotator cuff mechanism apart; muscle bruising; fell; severely injured my right should which is where I go the shot; booster; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Sep2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On the morning of the 21Sep2021 the patient fell and severely injured his/her right should which is where the patient went the shot. It was reported that his/her fall has nothing to do with the booster and everything to do with his/her clumsiness. In any event there was a lot of muscle bruising, and the ripped rotator cuff mechanism apart for which the patient will need surgery. The outcome was unknown.   The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of event fall is assessed to be unrelated and is more likely due to patient's condition of clumsiness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Presented to the Medical Center ED after an unwitnessed fall at the assisted facility where patient resides. Patient had another fall 2 days prior. Family reported, that patient looked more weak and confused when they visited her of1/2/21.  Patient was hypoxic with O2 saturation of 74% on room air but appeared without any respiratory distress. Started on 6L of Oxygen.Patient was observed to have right flank/abdominal pain. CT of the chest abdomen and pelvis revealed hazy peripheral lung infiltrates and small fluid collection next to right renal pelvis concerning for hematoma. Urinalysis for occult blood was negative. Trauma surgery and Urology were consulted from emergency department and recommended to continue to monitor hemodynamic status. Since admission, patient has had very high O2 needs, requiring NHF therapy.  Patient did not have much PO intake.  Na levels rising requiring IV free water replacement. Patient has been followed by infectious disease and pulmonary has been consulted as well. Patient was treated with IV remdesivir, Decadron and baricitinib.  Patient's blood sugars remain elevated. Patient had General surgery as well as Urology consult for perinephric fluid collection after recent fall. Geriatrics and palliative care were consulted. Patient with an extremely poor prognosis and had increasing O2 needs, increasing agitation, and increased need for IV medications to control symptoms. Family meeting resulted in transition of care to that of comfort focus.  Hospice consulted.  Patient was admitted on 1/12/14 to Hospice from Hospital for end-of-life care, with a terminal diagnosis of acute hypoxemic respiratory failure secondary to COVID19 pneumonia. Patient died 1/14/22
NEEDLE ISSUE (NEEDLE OF THE VACCINE ITSELF WAS CAUSTIC, THERE WAS SOMETHING IN THE INOCULATION THAT WAS CAUSTIC); TERRIBLY ITCHY; ARM ACHE; WOUND WITH SCAB (THAT COMES OFF, DOES NOT HEAL  AND LARGE IN DIAMETER); LOT OF DISCOMFORT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: kidney problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced wound with scab (that comes off, does not heal and large in diameter). On APR-2021, the patient experienced lot of discomfort. On APR-2021, the patient experienced terribly itchy. On APR-2021, the patient experienced arm ache. On 08-APR-2021, the patient experienced needle issue (needle of the vaccine itself was caustic, there was something in the inoculation that was caustic). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from wound with scab (that comes off, does not heal and large in diameter), arm ache, lot of discomfort, and terribly itchy, and the outcome of needle issue (needle of the vaccine itself was caustic, there was something in the inoculation that was caustic) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217470.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On 16-AUG-2017, the patient was administered a dose of VAQTA, lot reported as: M016191, expiration date: 26-MAY-2017, for prophylaxis. No adverse effects were reported in the patient. Lot number M016191 has been verified to be a valid lot number for VAQTA.
No additional AE or PQC reported; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from a registered nurse referring an patient of unknown age and gender. The patients pertinent medical history, drug reactions, allergies and concomitant medications were not reported.    On 01-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W018836 that had been verified to be a valid number with expiration date 14-JUN-2024 (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) (product storage error)  The administered dose of the vaccine experienced a temperature excursion of 12.7 degrees Celsius (C). It was reported that a previous temperature excursion happened. Time frame unknown. There was no additional adverse event reported.
chest pain, dyspnea, and what she describes as congestion shortness of breath, constant nonradiating central chest pain that she describes as "sharp" in nature that began Monday and has not changed in nature but has been persistent. Pericarditis
p/vax pt exp a lack of seroconversion;lab tests collected on 7/6/98 indicated a negative varicella antibody titer;
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received FLUARIX QUADRIVALENT (batch number 35F5F, expiry date 30th June 2016). On 16th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced sore arm after vaccination. This case was created on follow up of case US2016019415 and was reported by the same reporter.
swelling at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingirx and experienced swelling and pain at the injection site that has improved but has not resolved. The reporter did not consent to follow up.
The patient had a pneumo vaccination on Tuesday. On Wednesday her arm was sore and tender, called "nurse first". Had a temperature of 101.6.  Thursday morning 2 inch area, Thursday evening it spread to a 4 inch area. Friday, 12/08/ 2000 large area on upper arm. The patient was put on Augmentin, no fever, extreme tenderness.
Frequent new frontal headaches few times a day. Frequency and urgency in urination. Loose bowel movements. Seizure.
pain, followed by swelling,loss of arm movement, shrinking muscle in arm, discoloration of digits and hand and arm. final diagnoses 2 bloodclots in left arm, dimished pulse. diagnosed dec 28. ER visit dec 30 for severe swelling, pain, radiating pain to chest and shoulder
SORENESS AT INJECTION SITE, REDNESS AND SWOLLEN, SLIGHT HEADACHE,  AND CHILLS  FOR ABOUT THREE DAYS.
Adverse Event: PT c/o headache, nausea, arms and hands tingling. RN responded, called for aid at 0900. EMTS arrived at 0903 and began assessment. RNs also responded at this time. PT then stated "I feel nauseated and my head hurts." At 0924, PT c/o upper chest discomfort. VS were assessed again (see below). At 0936, PT reports feeling better and back to baseline.   Treatment: Water and juice provided, EMTs assessed PT, obtained vital signs (0905: BP 138/88, HR 105, T 97.6, SPO2 100%. 0936: 126/84, HR 104, CBG 130. 0938: BP 134/92, HR 97, SPO2 99%). Outcome: PT medically  cleared by EMTs at 0938, exited facility with husband. Husband to drive home.
Information has been received from a medical assistant and a nurse via a company rep, concerning an 82 yr old female with hypothyroidism, gastroesophageal reflux disease, hyperglycaemia, osteoporosis, irritable bowel syndrome and glaucoma and a history of hypertension and skin lesion who on 18Apr06 was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651321/1036P). Concomitant therapy included levothyroxine Na (synthroid), therapy unspecified (Timidol), ascorbic acid, calcium carbonate (Os Cal), glucosamine, acetaminophen (Tylenol), vitamin E and therapy unspecified (Maxaid Hydrid Cholithiax). On 18Apr06 the pt called the doctor's serve stating the she had redness and swelling at the injection site of left deltoid. The doctor office called the pt yesterday (19Apr06) and the pt was improving, but had not yet recovered. Treatment ice pack for comfort measures. The nurse mentioned that the pt had a local reaction and developed swelling down to her elbow. The pt's present status was reported as improving. No product quality control was involved. Additional information has been requested.
approx 1AUG92 pt recvd 1 dose of Engerix-B & the day p/dose had generalized redness on the arms, chest, abdo;  there was no itching or hives present, pt did not exp any resp problems;
Sore arm with red rash below injection site, ongoing as of 3/30/2021) Night of vaccination; muscle and joint aches, chills, upset stomach, "feeling feverish" (no actual fever).  Excessive fatigue upon waking, tired muscles, some of the ache subsided after I did a short cardio and weight workout.  Tired for most of the day 3/29/2021 but by bedtime most of the muscle and joint pain had subsided.  Took 1 Aleve at bedtime, aches gone the morning of 3/30/2021 though still a bit fatigued.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dryness, skin peeling at sight of injection-Mild, Additional Details: Patient experienced a large bruise, dry skin peeling, and soreness at the site of injection. It has mostly resolved by the date of her second dose.
Within 10 minutes of receiving the vaccine patient was feeling dizzy and light headed. We gave her a juice and pretzels. She had a few pretzels and then began complaining of throat tightening/feeling congested.  She started to get a rash on her neck, sides of face, and down her back. (ARNP) gave her a shot of 25mg Benadryl. After about 15 to 20 minutes patient gave another dose of Benadryl.  We waited at our location until 4:45 pm and then I (Office Manager) drove her to our local urgent care. Urgent care observed her for 30 minutes and then sent her home. She is doing well.
04/14/2021 Vaccination; 4-6 Weeks after, I started to experience all over body hives. My hands had the hives the worst, started on my left hand, swelling. Outbreak on my L knee. I went to the dermatologist and allergist first; He prescribed me some Allegra from his office. I told him I was allergic to dye. Then I had to go on the steroids to clean that out. I was on the Allegra 4x a day, 3x a day, 2x a day for a total of 14 days. It did clear up the hives; 24 hour Allegra.
Varicella vaccine breakthrough.  Mother called to report chickenpox.  Exposed at school.  Had 25-30 lesions on face, trunk, and legs, some fluid-filled.  No fever.
Per witness Patient seemed to pass out while checking out and hit her head. I observed patient lying on ground unresponsive with bilateral hands contorted and neck jerked to right side. Md on site within minutes patient sat up with minimal assist within minutes of my arrival then appeared to begin breathing rapidly, paper bag used to help slow down breathing and prevent hyperventillation. Patient able to respond to commands within minutes but unable to speak coherently. EMS was called and patient taken to Emergency room.