chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Entire upper arm is largely swollen, very red, and hot to the touch. She is unable to sleep, and is wakeful, crying and in pain. Later in the morning, I observe the arm is very swollen, hot, and red - taking up her entire arm from elbow to shoulder. She seems fine all day, and even goes to school, complaining of only some discomfort.
STARTED HAVING HEART PALPITATIONS A FEW HOURS AFTER GETTING THE FIRST SHOT. the HEART PALPITATIONS WOULD HAPPEN EVERY FEW MINUTES, THEY FINALLY CLEARED UP AFTER 4 DAYS
Regular viral cold - congestion, coughing, sore throat. Covid test negative, doctor informed me a normal summer cold/flu was going around. OTC treatment.
I have a swollen mass on my thyroid. I currently getting treatment, I got an ultrasound.
Mild fatigue within 2 hours of second shot with some soreness in arm, nausea, hot flashes/cold sweats through the evening into the next day, following day (Thursday and Friday) experienced continued cold sweats, body aches and headache.
Patient states that approx. 3 hrs. after vaccine,suffered from shortness of breath, palpitations, cough. Went to nearby walk-in clinic. States she received a "breathing treatment" that alleviated her symptoms.
A mother reported that her 8 month old son received a dose of Rota Shield in 1999. In 6/99, the infant allegedly developed intussusception. It was reported that on 6/15/99, he was hospitalized and required surgical removal of a portion of his bowel. The reporter alleges that as a consequence of the surgery, the infant was permanently damaged. This report of a serious, labeled event, is being submitted in a 15-day time frame, as requested.
This spontaneous report was received from a registered nurse and refers to a 16 year old female patient. The patient had no concurrent conditions, medical history, drug reactions/allergies and concomitant therapy. On 21-JUN-2018, the patient received the first dose of GARDASIL 9 (lot # N026812 and expiration date 22-JUN-2020) (dose unknown) via intramuscular route for human papilloma virus (HPV vaccination). On the same day, the patient experienced tonic-clonic movements which lasted for 30 seconds. No other side effects were reported. It was reported that no treatment was given for the event tonic-clonic movements and no lab tests were performed. The outcome of the event tonic-clonic movements was recovered on 21-JUN-2018. The casual relationship between the event tonic-clonic movements and GARDASIL 9 was not reported. No product quality complaint was reported. Upon internal review, the event of tonic clonic movements was considered as medically significant.
This patient had a swollen arm, hot, and tender, itchy; first above the elbow now to the shoulder.
around noon - legs went numb and weak - couldnt walk  around 1 - took 2 tylonol and had sharp pains up and down the spine  around 2 - face lips jaw were swollen  around 4 - rashes on neck and back and welts on arms  around 5 - went to emergency room  around 6 - doc claims hes allergic to tylonol  customer does not believe him and things dont make sense - pain in legs comes and goes
Breakthrough Varicella-large outbreak >100 lesions despite vaccination.  Sibling with same, also vaccinated.
Improperly stored administered vaccines; This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided.  On 05-AUG-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038175, expiration date 26-NOV-2021 (exact dose, route and site of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHa)) (M-M-R II) lot # S020160, expiration date 30-JUN-2021 (exact dose, route and site of administration were not reported) for prophylaxis. Administered doses of vaccines were exposured for the temperature excursion as follows:- 6 degrees Fahrenheit (F) to 14F (10F) for 1 hour and 15 minutes; 15F to 46F (44.8F) for 1 hour and 30 minutes; 47F to 77F (50F) for 2 hours and 30 minutes There was no previous temperature excursion. The call was because of a digital data logger.
blurred vision, brain fog, shortness of breath  treatment - ibuprofen time - after 8 weeks symptoms dissipated diagnosis - pericarditis
Approximately three days after getting the vaccination I developed a rash. It started on the neck, as well as bilateral antecubital, popliteal, and ankle areas. It has continued to slowly progress over the course of a week. It is a pruritic rash, raised, maculopapular rash.
Pt vaccinated with DTP experienced inconsolable crying x 7-8 hrs; no fever.
On 1 Dec 2017, patient reported 4 day history of gradually worsening chest pain and shortness of breath. Pt was in significant distress and exam was notable for wheezes bilaterally. Albuterol inhaler was ineffective at relieving symptoms and patient was transferred to local ER where he was diagnosed with acute myocarditis, given a single dose of PO nitroglycerin with significant pain relief, and admitted to the cardiac unit. Medications started on admission were PO colchicine 0.6mg twice daily, IV methylprednisolone 62.5mg, PO Carol-F TID (Ibuprofen arginine 368.9mg, 200mg as ibuprofen), PO Dexlansoprazole 30mg, and PO Legalon 140mg. Symptoms had fully resolved by hospital day (HD)#2. Steroid dose stayed at 62.5mg IV for HD 1-3. On HD#4 he was tapered to prednisolone 30mg PO.  Patient was discharged on HD#5. Per Dr., 4 Dec 2017: Starting Colchicine 0.6mg po BID for 3 months, in addition to Ibuprofen 600mg by mouth TID for 2 weeks with plans to continue steroid taper but knowing his symptoms will likely recur due to steroid use. He should be on a restricted profile (no PT/ or exertional activities of any kind- desk duties) for 3 months. At the 3 months mark he should have a repeat inflammatory markers, cardiac enzymes, repeat TTE and a GXT to assess fitness for duty if his symptoms have not recurred for >6 weeks. On 19 Dec 2017, Patient remains asymptomatic. He is tapering off Prednisone (25 day taper); he continues on Colchicine 0.6 mg twice daily for a total of 3-month course; he is no longer taking Ibuprofen for pain. He is on limited duty and has scheduled Cardiology follow up for March 2018.
Symptoms began 1/30/21, left toes felt numb for weeks.  Then felt numbness on left arm and sometimes left side of my face.  I was prescribed Gabapentin by my PCP, but didn?t help. I later went to Neurologist and had several tests done that came back negative. Today is 7/23/21 and I?m still experiencing numbness.
neuropathy; shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 18-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) at pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a healthcare professional  for shingles and neuropathy (neuropathy peripheral). As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not provided and the causality of the events was related.  Upon internal review, the event neuropathy peripheral was determined to be medically significant.
problem to breathing; blood pressure is low; has dizziness when she gets up; hot and big welt on her arm, injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (problem to breathing), HYPOTENSION (blood pressure is low), DIZZINESS (has dizziness when she gets up) and VACCINATION SITE URTICARIA (hot and big welt on her arm, injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (hot and big welt on her arm, injection). On 22-Mar-2021, the patient experienced DYSPNOEA (problem to breathing), HYPOTENSION (blood pressure is low) and DIZZINESS (has dizziness when she gets up). At the time of the report, DYSPNOEA (problem to breathing), HYPOTENSION (blood pressure is low), DIZZINESS (has dizziness when she gets up) and VACCINATION SITE URTICARIA (hot and big welt on her arm, injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient went to health care professional (HCP) and they prescribed unspecified antibiotic to treat the infection.
On 04/19/2002 9pm fever started. On 04/20, rash started on face, few on neck and legs. Temp max 102.7 deg. F. On 04/22, went to doctor's and chicken pox was diagnosed. On 04/23/2002 fever subsided and treated with Tylenol and Motrin.
On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), FATIGUE (Fatigue) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, PAIN (Body ache), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. fatigue and fever are consistent with the product safety profile.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. fatigue and fever are consistent with the product safety profile.
Initial report received from a healthcare professional on 14 August 2013. A 32-year-old female patient had received intramuscular first dose of ADACEL vaccine. (lot number- C4313AA, expiry date- 22 March 2015) in the right deltoid on 14 August 2013. The patient's last menstrual period date was not reported and the estimated date of delivery was "05 October 2015". The patient's health during pregnancy, risk factors, concomitant medications and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
soreness in my arm; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) intramuscularly on 08Jan2021 (at the age of 65-years-old) as a single dose in the left arm (deltoid) for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bioidentical hormones, levothyroxine sodium (LEVOTHYROXIN), and liothyronine from unspecified date for unspecified indications. The patient reported an allergy to latex gloves with a reaction of rash. On 08Jan2021, the patient experienced soreness in her arm. The outcome of soreness in her arm was unknown.   No follow-up attempts are needed. No further information is expected.
Baby developed diarrhea 2-3 days after immunization on 12/4 which lasted for 5 days and then had vomiting for 1 day.  Treated successfully with oral hydration.
Rash on torso, fever, headache; supportive care; strep screen done due to sore throat and red throat
On 02/20/2001, the patient experienced a pruritic diffuse erythematous papular rash over her face,neck, and upper chest. She had no fever. She also had puffy upper eyelids, dry facial skins,and hypermia. The patient was seen in the nurse practitioner's office on 03/02/2001 and the rash was diffused and red. She had no lesions at the site of the injection or over her arms or vesicular lesions. On exam, she had an isolated nontender palpable left preauricular lymph node. She was treated with 25 mg of Atarax and Lac-Hyrdrin with resolution of pruritus and swelling. On 03/08/01, and she developed an erythematous punctuated papular lesions. On 03/14/01, the patient recovered. Additional information is not expected.
Herpes Zoster - Information has been received from a physician concerning a 2 year old female patient who was vaccinated with varicella virus vaccine live at approximatley 1 year of age.  Subsequently, the patient developed shingles.  By the time the patient was seen by a physician, the shingles had resolved.  Additonal information has been requested.
Patient received second dose on day 47 from first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on day 47 from first dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on day 47 from first dose). On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on day 47 from first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicines was not reported by reporter . Treatment information was not provided . The action taken with mRNA-1273 with the events was considered as not applicable
On the evening of the 21st I had sore throat and tightness in chest. On October of 22 went to urgent care and tested positive for COVID-19. They prescribed PAXLOVID and I began taking it around noon on the 22nd. On the 22nd I also began having fatigue and brain fog. After beginning PAXLOVID I haven't noticed significant improvements in my symptoms.
cold shivers & hot flashes almost fainted several times nausea  All lasted a few hours, then following sleep and rest, all disappeared the following day
Feeling like pens/needles are in your hand and toes; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for a female patient (reporter's colleague)   A female patient of an unspecified age received bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 19May2021 as single dose for COVID-19 immunisation. Medical history included patients that are immunosuppressed that are on biologics (as reported). concomitant medications were not reported. Per the reporter (Nurse), they see patients that are immunosuppressed that are on biologics. They have received the Pfizer COVID-19 Vaccine. Per reporter the individuals came back negative for immunity on the spike test. The reporter reported that all the patients taking imbruvica 450 mg tablets (un-specified indication) also came back negative on antibody testing, enquired whether the patient showing no antibodies were still immune, asked if booster given for negative immunity or what course would you take to get the immunity at a higher level. Response was given from The CDC for the use of Covid-19 vaccines stating that the need for and timing of booster doses for mRNA Covid-19 vaccines has not been established. No additional doses are recommended at this time.  The reporter asked if there have been reports of feeling like pens and needles are in your hand and toes after receiving the Pfizer  COVID-19  Vaccine. She then voiced that she was asking for one of the nurses. She reported the nurse received the Pfizer  COVID-19 Vaccine on 19May2021. Her symptoms started on 24May2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
screamed a high pitched unusual scream regardless of how the parents tried to comfort pt, from 2pm-7pm p/ shot given at approx 1000am
pt devel hives immed on forehead & flat red areas on head p/ 1/2 the OPV;p/ a few min skin cleared;reporter repeated the OPV w/1 drop & the hives recurred & also had redness on arm & trunk;
7 year old female received first vaccination of FLUMIST on 9/30/2010 at 4:30 p.m. At 4:00 p.m. on 10/1/2010 she started vomiting profusely. Child vomited 3 times initially, but continued vomiting due to dehydration and needed to go to the E.R. for rehydration and 2 infusions of ZOFRAN. Child recovered within 15 hours of onset of vomiting with no other symptoms.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 43-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous vaccination included influenza virus vaccine; manufacturer unspecified; details unknown; given on an unspecified date. The healthcare professional reported that the subject "had her flu shot for the season". On 9 January 2012 at 11:30 the subject received a dose of FLULAVAL (.1 units unknown, intradermal, right forearm) and experienced wrong route of administration and extra dose administered. The healthcare professional reported that the subject went to receive TB [tuberculin] injection and received FLULAVAL rather than TB. On 10 January 2012, 1 day after vaccination with FLULAVAL, the subject experienced injection site redness, raised area injection site and injection site tenderness. The healthcare professional reported that the intradermal FLULAVAL injection resulted in an injection site reaction that was red, raised and tender. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow up information received from the healthcare professional on 02 February 2012. The healthcare professional reported that the events were resolved on 24 January 2012. The healthcare professional noted that the events were not serious. The healthcare professional explained that the events could have been associated with the erroneous, intradermal, administration of FLULAVAL.
Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves 10 patients who was administered vaccine ADACEL that was out of temperature range. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect ADACEL lot U6043BA via unknown route. It was a case of actual medication error due to incorrect product storage. No adverse event occurred. 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 and Module VI of the 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.
Hardness at injection site, tenderness around entire shoulder,  red splotchy rash, heat in rash, swelling. Started a couple of hours after vaccination
PLAQUE PSORIASIS FLARE; Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021). On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021) outcome was unknown. No concomitant medication was provided. On 08-MAR-2022 the patient received booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient had a flare after been taking the Covid Vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On 17-JUL-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M042849, expiration date 18-JAN-2018, dose and route were not reported) for prophylaxis ,which was reconstituted with sterile diluent (MERCK STERILE DILUENT). The vaccine was exposed to temperature excursion of -13 degrees Celsius for 8 hours and the data logger was involved. There was no previous temperature excursion. Sterile diluent (MERCK STERILE DILUENT) was stored properly. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA001487:
On Friday I had a sore throat and woke up Saturday with congestion and more coughing.  No fever, no fatigue.  The sore throat only lasted one day.  I had a very gravely voice.  I went to the urgent care Saturday afternoon for the Covid test.
Became lethargic and slept for 18 hours. Then continued to go down hill and experienced diarrhea lethargy and extreme fatigue lasting 12 months. Numerous doctors visits, including returning to the clinic where it was given, my pcp and naturopathic MD.