chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm is sore) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm is sore). At the time of the report, MYALGIA (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Has cold, shiver, aches, the fever up to 102. Stayed in bed. Nausea, R rib pain.
Information has been received from a mother concerning her son who about a year or two ago was vaccinated with a dose of MMR II. It was reported that a day after receiving the vaccine her child developed autism. He was about to start reciting his ABC's and that all stopped after receiving the vaccine. Unspecified medical attention was sought. Blood work was performed. The patient's status is not recovered. No product quality complaint was involved. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Patient received an subcutaneous injection of yellow fever vaccine for a trip, on 9/2/09.  On 9/8/09 he states that he started to experience fatigue, malaise, lower back and hip myalgia which progressed to shooting pain down both legs, no fever was ever present.  All symptoms resolved by 9/11/09.  Pt had a history of a nonspecific back injury and mild sciatica five years previously with no subsequent problems until receiving the yellow fever vaccine.
The first night, I had very bad nausea - and that went into all the next day. After that - upper respiratory  symptoms- cough, nasal congestion, sore throat - Tuesday - Saturday after the vaccine. I had a very sore arm - couldn't lift my arm up for about four days. Advil - cold and flu for symptoms. It helped manage the symptoms.  I went on an antibiotic for the respiratory symptoms - I had contacted my doctor and they prescribed it.
Fever 102 oral with hallucinations. Tylenol given and patient not hallucinating now; he feels better and is playing. Still has fever 101.3 orally.
Came down with a bad case of shingles 4 days after getting vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 28Mar2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunization. The patient has not reported any other health issues. The patient did not have any allergies to food, medications, or other products. Concomitant therapy was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of COVID vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 14:30 (at the age of 42-years-old), as a single dose for COVID-19 immunization. On 31Mar2021 at 12:00, 3 days after the vaccination the patient had come down with a bad case of shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with steroids, creams, anti-viral medications. The clinical outcome of the event shingles was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from healthcare professional on 12 DEC 2014. A 70-year-old female patient, whose medical history and concomitant medications were not reported, and received an intramuscular dose of FLUZONE HD (lot number: U5063BA, expiry: 06 JUN 2015) in the left deltoid on 15 OCT 2014. It was reported that on 16 DEC 2014, the patient experienced generalized numbness of the right side back part of her body intermittently. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None.
I suffered a stroke on March 16, 2021, with the only symptom being complete numbness on my left side.  Emergency room in hospital, then overnight for observation.  CT scan and MRI of brain, Ultrasound on Carotid arteries and heart.  All tests were negative and no reason for the stroke was found. I now have a loop recorder implant to check for AFib
Information has been received from a company representative and a physician concerning a 10 to 11 year old male who was vaccinated with the three does series of RECOMBIVAX HB as an infant. A recent titer was negative so the patient received one additional 0.5 mcg (0.5 mL) dose of RECOMBIVAX HB (LOT# not reported). A repeat titer was still negative. The patient sought unspecified medical attention. At this time of reporting, the patient was reported as not recovered. Additional information has been requested.
The mother stated that the child's left thigh started swelling and turning red on 11/15/01 at 10:00. The child complained of leg being tight and itching. Told mother to give the child Benadryl and apply cold compresses. IF the problem persists or worsens, advised pt to go to PMD or ER.
Client left clinic after receiving 2 shots, drove home and tripped over a metal plate as she got out of her car, lightly bumped her head, scraped her head & knee as she fell, felt dizzy, light headed, nauseated.
The injection was given about 2 inches higher than any previous injection I have received (between two boney areas) high on my left shoulder. Normally when I receive vaccine injections, the injection site is  tender to touch for 2-3 days. This time, pain started less than an hour after the injections and hurts  constantly, even when not touched. The pain increases whenever I move my left arm, especially when I  move my arm/shoulder to my left side away from my body.
Patient became very faint and nauseous 5-10 minutes after receiving the Pfizer COVID vaccine. When supplied with a bucket, paper towels, and a cold compress pack, patient began to vomit and complained that he couldn't see. Patient may have also passed out during this time period. The store manager was contacted  and emergency medical services were also contacted  due to severity of the reaction. the patient was taken to a local medical facility as of the writing of this report.
Patient received 0.25ml instead of 0.5ml of Moderna Bivalent booster dose
Adult received Engerix-B Pediatric; Adult received Engerix-B Pediatric; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   On 13th October 2022, the patient received the 2nd dose of Engerix B pediatric (intramuscular). On 13th October 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
On 3/29 at 6 PM, vocal hoarseness. On 3/29 at 7 PM, headache, and low grade fever. On 03/30 at 7 AM, hives and itching. On 03/30 in the afternoon,  University hospital ER. Treatment with steroid injection and Benadryl. On 04/01, pus in throat. On 04/02, prescribed Amoxicillin. On 04/02 in the PM, no fever, no headache, rash almost totally gone.
patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very strong jaw tightness with lightheadedness/muscles feel so tight; Right away very strong jaw tightness with lightheadedness; the tight jaw with Very tight full deep ache all over body/whole body hurts/feeling more pain; Headache lasting over 59 hours; Very very fatigued/feeling more fatigue; Chills worse at night; her hands feel swollen and cramping but they do not look swollen; her hands feel swollen and cramping but they do not look swollen; On and off lip/face tingling; On and off lip/face tingling; she felt like her lymph nodes were swollen; shaking; This is a spontaneous report from a contactable nurse (reported for herself). This nurse reported information for both mother and baby. This is the maternal report. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ec1284), via an unspecified route of administration on 11Jan2021 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included low vitamin d and patient is currently breastfeeding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc (PRENATAL S), vitamin d [vitamin d nos] (VITAMIN D), and calcium. The patient was administered with first dose of bnt162b2 (Pfizer brand) on 21Dec2020 at 10:00 on her left arm (lot number: EJ1685) for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 10:15, the patient experienced right away, very strong jaw tightness with lightheadedness. The lightheadedness feeling improved 2 hours later, but the tight jaw with very tight full deep ache all over her body. She had headache  lasting over 59 hours. Her whole body hurt. Her muscles felt so tight and she was "very very" fatigued. She had chills (worse at night). She was shaking both nights after 2nd vaccine. Her hands felt swollen and cramping, but they did not look swollen. She also had on and off lip/face tingling. She felt like her lymph nodes were swollen. She can't even do a load of laundry without feeling more pain and fatigue. It was unknown if treatment was given for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious. The patient was not hospitalized due to the events. The patient has not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021038485 baby case
Patient fully vaccinated and died due to Covid related causes. Patient was a resident at a Nursing and Rehabilitation facility
TDAP 6/28/06 about six hours later, c/o not feeling well, fever, dizzy and vomited a few times that evening. 24 hours later, symptoms resolved; left only with large local reaction at injection site.
Redness in left leg from thigh to foot with swelling - unconsolable crying for 3 hours 08/09/2004 - temperature 103.  08/10/2004 and another episode of unconsolable crying for 3 hours.  Temperature not relieved by Tylenol, 2 doses.  Physician notified - Tylenol and Benadryl advised.
Both HPV (IM) and Varicella (SC) given in (L) upper arm on 5/15/07. Developed slight redness and tenderness and a little blister the day after the vaccine. On 5/17/07 (2 days after vax) developed warm, erythematous, indurated area around injection site-given Rx of Benadryl and Ibuprofen and Calendula cream.
Rash on right breast and lower right scapular area. Prescribed prednisone and valtrex
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergy: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: Positive 3 days after negative test after Paxlovid treatment; (Dec2022) Positive, notes: Positive 3 days after negative test after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfzier, Treatment start date: 09Dec2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
During routine inspection, extra vial of diluent found in pharmacy. Investigation determined that powder vial was dispensed without manufacturer-supplied diluent. An alternative diluent was likely dispensed and used to reconstitute vaccine to administer to patient. MD notified and patient notified to return to clinic to receive full dose as prescribed.
Mother called the health department on 9/26/13 stated the child had nausea, vomiting and fever. Also had pain down the left side of body. Mom reported the patient had TDaP and HPV on 7/22/13 and thought the symptoms were from TDaP. Now she is concerned that it was from HPV shot.
Patient came in yesterday 2/5/2020 for a TB test. I inadvertently used Typhoid vaccine (.1cc intradermally) and applied it to her R forearm. I realized my mistake when documenting the injection. I told her what happened and then proceeded to do another TB test on her Left forearm using the correct ppd fluid. Patient wasn't very upset at the time. I told her that more than likely she would have a reaction at the site of the Typhoid injection. I received a call from the patient this morning. The site of the Typhoid injection was inflamed and painful. The site of the ppd (Left forearm was also reactive). Patient seemed more concerned about the ppd site as this was her 2nd test in a few weeks and her first test was completely non-reactive. I explained to her that we would wait until Friday 2/7/2020 to read the TB test. I encouraged her to put ice on the site of the Typhoid injection and also possibly take some Benadryl to help lessen the inflammation. She stated that she took Benadryl last night but it didn't seem to help. She stated she had a headache but no other adverse symptoms.
extremely itchy all over torso, arms, arm pits, palms, face and head; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) from unspecified route administered in left arm on 26Feb2021 at 03:30 PM (at the age of vaccination 54 years) for COVID-19 immunisation. Medical history included breast cancer, fibromyalgia, autonomic neuropathy, peripheral neuropathy and paraneoplastic disorder. The patient had allergies with Penicillin, vancomycin, amoxicillin and nitrofurantoin. The concomitant drugs received by the patient were oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) (MANUFACTURER UNKNOWN), milnacipran hydrochloride (SAVELLA) (MANUFACTURER UNKNOWN), gabapentin (NEURONTIN) (MANUFACTURER UNKNOWN) and bifidobacterium lactis (PROBIOTIC) (MANUFACTURER UNKNOWN) for unknown indication from unknown start date. The patient experienced as extremely itchy all over torso, arms, arm pits, palms, face and head on 03Mar2021 (no rash or hives as reported). The patient underwent PCR test having report result as negative. The patient received Benadryl as therapeutic measures for event itching. The clinical outcome of the event itchy was ongoing (at the time of reporting patient has unbearably itchy everywhere even after 19 days of 1st shot, and face was itchy all day). Prior to vaccination patient was not diagnosed with COVID-19 and Since the vaccination has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient was administered 1/2 dose of DECAVAC due to a cut from metal shelves.  Her last tetanus was in 1993.  The tetanus shot she received in 1993 caused reddness at the injection site so patient asked for 1/2 the dose to be given.  Two days after receiving 1/2 dose of DECAVAC, the patient complained of reddness, swelling, and pain at site of injection.  Patient also had difficulty raising her R arm.  Reddness was about 6-7 cm in diameter and warm to touch.  Ice was applied to injection site and Tylenol given to patient.
Fluid build up in lungs, shortness of breath, dypsnea, coughing, wheezing, inability to sleep flat, edema in abdomen, legs, feet. Heart attack 1, possible 2nd attack.
Mother noted hives on trunk of body (chest, abd., back) when child awoke on August 9th.  A few hives were noted on the neck and face.  The doctor felt the child did not need an appt. for an examination.  Resolving hives noted by writer on August 11th.  Denies changes in food or laundry soaps or environment.
Pt received shot. Several minutes later, pt was standing up in exam room and had syncopal episode. Hit face on exam table and then fell to floor. Pt was awake in <1 min. Vitals stable. Neck pain after event, so sent to ER.
This case was reported by a healthcare professional and the occurrence of swelling in a child subject (4 to 6) of unspecified gender who was vaccinated with combined DTaP+IPV (Glaxosmithkline) for prophylaxis. On an unspecified subject received unspecified dose of DTap+IPV (unknown). At an unspecified time after vaccination with DTaP+IPV, the subject experienced swelling. At the time of reporting the outcome of the event was unspecified. It was reported that two subjects in the same clinic experienced swelling after getting DTaP+IPV. The case number for the second report is A0803171A.
Around 9:15pm while watching tv, I felt a quick kick in my chest. My heart rate increased to 153 bpm, according to my watch. My chest felt tight and heavy. I went to a Trauma Center around 10:30pm. I sat in the Waiting Room after triage until 6am Saturday 3/6/2021. I started to feel my pain subside, never saw a doctor and I left. Notified my Family Doctor and he referred me to see a Cardiologist. I have an appointment for 4/13/2021 at 8:30am.
Arm is very sore; inflamed lymph node in axillary area; complains of generalized symptoms of malaise; continues with these complaints in addition to diarrhea as of 9/28/06.
short winded; cough; runny nose; sneezing; fever; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short winded), MALAISE (didn't feel well), COUGH (cough), RHINORRHOEA (runny nose) and SNEEZING (sneezing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (didn't feel well) and PYREXIA (fever). On 16-Mar-2021, the patient experienced COUGH (cough), RHINORRHOEA (runny nose) and SNEEZING (sneezing). On 17-Mar-2021, the patient experienced DYSPNOEA (short winded). On 17-Mar-2021, MALAISE (didn't feel well), COUGH (cough), RHINORRHOEA (runny nose), SNEEZING (sneezing) and PYREXIA (fever) had resolved. At the time of the report, DYSPNOEA (short winded) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
about 12 hours after the second vaccine dose I had sudden onsets chills with significant rigors which lasted for about 24h. Chills continued after for 1-2 days after this bu the rigors stopped. I had fevers to the 101F range which persisted for about 48h after the vaccine. Also significant myalgias and fatigue. Symptoms partially responded to tylenol and ibuprofen (total of 3.5g tylenol and 800mg of ibuprofen taken over the 48h period).
the Ipol that was used for the dose had been exposed to a temperature excursion prior to the administration to this patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00525796) and transmitted to Sanofi on 18-Mar-2021.  This case involves a 10 month old (also reported as: 11 month old) male patient who received IPV (VERO) [IPOL] [lot: RID973M and expiry date: 17-Jul-2021] via an intramuscular route at the right deltoid on 01-Feb-2021 at 12:03 for prophylactic vaccination which had been exposed to a temperature excursion prior to the administration to patient (product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was a case of actual medication error due to incorrect storage of product. It was reported that, after the vaccination on 01-Feb-2021, in Mar-2021, a data log report was performed and the data log showed that the IPOL that was used for the dose had been exposed to a temperature excursion prior to the administration to this patient. As a result of the excursion, that the IPOL was not suitable for use.   First time product used and still using product was reported as no at the time of reporting.   At the time of report, no adverse event was reported.  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.