chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician assistant who is also the patient's sister refers to a 27 year old female patient. No medical history or drug allergies were reported. On 01-MAY-2013, the patient was vaccinated with a dose of GARDASIL (lot#, expiry not reported), intramuscularly. No concomitant medications were reported. Since an unknown date in May 2013, after receiving GARDASIL, the patient experienced viral symptoms such as: nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs. Patient has also experienced tingling of the hands and migraines. The reporter also stated that in the last three months since May 2013, the patient has missed a lot of work due to exhaustion. Patient sought medical attention. On an unknown date in 2013, the patient visited her primary care physician in which laboratory work was conducted, such as complete blood count (CBC), Lymes, lupus, thyroid and other autoimmune diseases, but all results were negative. The patient then saw a gastrointestinal doctor and had an upper endoscopy completed, results were normal. The patient then saw a neurologist who stated these symptoms may be from the GARDASIL, but did not treat it. Reporter stated that two weeks ago, patient felt 50 percent better for four days, then relapsed. The outcome of nausea, fatigue, weakness, muscle aches, weakness and spasms of the legs, migraines, tingling of the hands, muscle and missed a lot of work due to exhaustion was reported as not recovered. Causality was not reported. The reporter considered the event missed a lot of work due to exhaustion as disabling. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored GARDASIL (dose, route and lot number not provided) on unknown date "within the past 13 months". No other co-suspects were reported. Concomitant medications were reported. No adverse effects  reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Lymph node under jaw / ear on right side became swollen and painful for 7 days. Lower back pain in muscles that has spread to upper buttocks and down left leg. Still currently in pain over three weeks now. Went to doctor and received a steroid  and pain injection into left buttock region, no positive effect yet, injection received Monday 08/30/2021
I received Vaccine on 12/23/2020.  On 12/30/2020 I started to get a red welt on my arm at the site of the injection.  It was warm to the touch but didn't hurt really bad.  Thursday the 12/31/2020, the welt got bigger and warmer, I started to draw lines around the redness and monitor the progress, each day it grew a bit bigger.  Started itching and burning.  I took motrin and used ice on this.  I don't use OTC medicated stuff as I am allergic to a lot of it, and seemed like it was cellulitis.  Monday 1/4/2021, I got to work my arm was just red, inflamed and I was just miserable, the redness and pain were worse, painful to touch.  I went to a walk in clinic that told me they suspected cellulitis, and gave me prednisone, and Keflex.  I continued to ice the area, it started to feel better late Tuesday 1/5/2021 & redness went down.  I have pictures if this is helpful.
Ulcerative Colitis flare-up, observable bloody stools on 15 and 16 March 2021.
Information has been received from a physician concerning a 4 year old female with no past medical history and no known drug allergies who on 8/29/02 was vaccinated with a second dose of MMR (second generation) (lot # 638598/1305L and diluent lot # 636173/1305L). There was no illness at the time of the vaccination and no concomitant medication. Within one minute of receiving the vaccine, the patient experienced a seizure with eyes rolled back and body stiffening, lasting less than one minute. No treatment medication was required. Following the seizure the patient was sleepy and returned to her home. She was scheduled for an electroencephalogram on 8/30/02. It was noted that the patient had no history of seizure activity and that there were no adverse symptoms after the first dose of MMR (second generation) given a few years ago. The physician was unsure if the patient might have become anxious before the injection and that had precipitated the event. Upon internal review, seizure was determined to be an other important medical event (OMIC). Additional information has been requested.
Reaction was to the MMRV. My daughter woke up with a SEVERE rash from head to toe 12 days after MMRV vaccination. The rash hurt and was itchy. It lasted 4 days.
chills; throwing up; diarrhea; small headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), VOMITING (throwing up), DIARRHOEA (diarrhea) and HEADACHE (small headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills), VOMITING (throwing up), DIARRHOEA (diarrhea) and HEADACHE (small headache). At the time of the report, CHILLS (chills), VOMITING (throwing up), DIARRHOEA (diarrhea) and HEADACHE (small headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The local Public Health District, per guidance from the local Department of Health (DH), Centers for Disease Control and Preventio (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Immediately extremely pale, sweating, could not hear, breathing difficulty, threw up several times, lasted thirty minutes
Moderna COVID-19 EUA.  Shot site sore for 2 days.   Muscle and joint aches and pains.  Headache, dizziness, nausea and vomiting, diareahea, upset stomach, loss of appetite., Symptoms started about 20 hours after the 2nd shot, and have lasted for 3+ days.  Am now on day 4 and starting to feel somewhat better.   Still have aches and pains and headache and not eating yet.  Vomiting and diareahea have stopped.  Stomach is still quezy and still get dizzy if I move to fast.  Basically have drank liquids and taken OTC pain pills and peto bismol for treatment.
Rash developed near injection site 1 wk after injection. Consisted of 2 urticarial type lesion with warmth and erythema. Low grade fever. Treatment with BENADRYL, Hydrocortisone cream.
The following morning and for the next three days, I experienced severe SOB, chest pain and rapid heart rate.  Once those symptoms started subsiding, I had extreme nausea and diarrhea for 2 more days, and subsequently spent the next 3 weeks with lethargy, palpitations and intermittent tachycardia.
Patient experienced fatigue and soreness at the site that improved. This morning developed uticaria - all over .
I did not have much of a reaction after the first dose, just a sore arm.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 05Mar2021 11:00 (Lot number: EN6205) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Sulfa meds" (unspecified if ongoing); "Allergy: Egg" (unspecified if ongoing); "Allergy: cheese" (unspecified if ongoing); "Allergy: milk" (unspecified if ongoing); "Allergy: wheat" (unspecified if ongoing); "Allergy: gluten" (unspecified if ongoing); "Allergy: ragweed." (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I did not have much of a reaction after the first dose, just a sore arm.".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336700 same patient/drug and different dose/event.
Patient experienced vasovagal response 10 minutes after dose given. Diaphoretic, vital signs remained stable. Patient stated "feel like I could pass out". Observed for 30 minutes with full resolution of symptoms.
This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 30-SEP-2015, the patient was vaccinated with an expired and improperly stored dose of PNEUMOVAX23 lot # K004542, expiration date: 19-AUG-2015 (dose and route were not reported). No adverse effect reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of three reports received from the same reporter. Additional information has been requested.
Large red, itchy patch appearing 12 days at injection site.  Irregular oval shape. About 2.5 inches in diamdter
Moderna vaccine was expiring at 4:22AM on 5/19/21 (but it was till in the refrigerator), on the same day at about 10:45AM the pharmacist inject patient with the expired vaccine. Attention was brought to patient the following day, no adverse side effect per patient. A pharmacist spoke with a representative at Moderna, we were advised against revaccination. We will follow up with patient in the next week.
acute concern for rash 2days post immunizations from 12mo vaccines. Mother reports that rash began one day after her 12 mo immunizations on 8/9. Rash began as small bumps, pictures sent in to nursing staff and documented. Rashes stayed in the same place but began to grow larger, new rashes also started as well. Pt believes the rash started on her R leg but then spread to the rest of her body. Rash is now larger flat round with central clearing. Pt has not seemed ill at all, no itching, no irritation, no fevers or chills.
Initial report received on 12/29/05 from a consumer. A seven month old female with no significant past medical history had received an administration (route not reported) of FLUZONE (lot number not reported) in the thigh on 12/2/05. Per the reporter, on 12/3/05, it was noticed that the patient was opening her arms wide, her mouth wide and shaking, not violently but noticeably. This was reported to have occurred approximately six times this day. These behaviors have continued but at the time of this report, they are more frequent but less noticeable. The episodes occur approximately 24 times a day. Per the reporter, the patient's arms are less extended when she spreads her arms open but she continues to open her mouth wide. At the time of this report, the reporter had noticed that the patient was now frequently opening and closing her hands. This occurs when the patient is active as well as when she is inactive. The patient was seen by a pediatrician on 12/9/05 and he referred the patient to a pediatric neurologist. The patient was seen by the pediatric neurologist on 12/12/05 and per the reporter, the pediatric neurologist did not feel the episodes were seizures as the patient was cognitive of her surroundings during these episodes. No treatment was recommended. At the time of this report, the patient had not recovered from these events. (OMIC)
Fatigue after the first and second Moderna Covid-19 vaccines in the primary series; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the primary series) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the primary series). At the time of the report, FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the primary series) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.  The reporter stated no other adverse reactions for her Son in law.  No treatment information was provided.   This case was linked to MOD-2022-580291, MOD-2022-580295 (Patient Link).
Pt. was called back in reference to a call that was placed by this pt, to our call center.   This nurse called back the pt. and asked the pt. if can please explain the reason for his call... The pt. stated he called because he got the shot on 10 OCT 2022 at Facility and he noticed when he woke up the next morning it looked like a pimple that may have fluid in it , pt. then stated that it appeared to be dried up now so there is no fluid present.  The pt. stated that he may have overreacted ( I asked patient, how did he feel in general? He stated he felt fine, no pain anywhere, there's absolutely nothings hurting on me!) Like I said I think I over reacted about this whole thing.) I assured the pt. that in his case its important to continue to monitor the site for any changes or anything abnormal around the access site and to keep it dry and try not to allow anything to come in contact with it . He was instructed to contact his PCP or call us back should any if the above was to occur.  The pt. agreed and verbalized  he understood the verbal directions/instructions that were given to him by myself. The pt. stated he had to end the call because he had someone in his office.  This nurse call ended.
Question 9: Fenofibrate 54mg, Acid Controller-famotidine 20mg, Aspirin 81mg.  Question 18: TIREDNESS, MUSCLE PAIN, SLIGHT NAUSEA, FEELING UNWELL, SEVERE HEADACHE. HEADACHE CONTINUES BUT IS NOW ONLY MILD.
Patient is under the age of 18 and received a dose of the Moderna COVID19 vaccine.
Itching; Arm got swollen; Sore injection site; Warm injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE WARMTH (Warm injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Arm got swollen) and VACCINATION SITE PAIN (Sore injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Allergy NOS and Seasonal allergy. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) and IPRATROPIUM BROMIDE for Allergy NOS, GLUCOSAMINE, METHYLSULFONYLMETHANE (GLUCOSAMINE/MSM) and FISH OIL for Arthritis, CALCIUM for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm injection site), VACCINATION SITE SWELLING (Arm got swollen) and VACCINATION SITE PAIN (Sore injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Jan-2021, VACCINATION SITE PAIN (Sore injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (Warm injection site), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Arm got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Medical history added, event details updated, concomitant medication details updated
This spontaneous report was received from a registered nurse concerning an adult female patient (age not provided, described as being in her teens) who on her childhood, on unknown dates, completed the full vaccination series of RECOMBIVAX HB or hepatitis B vaccine (manufacturer unknown) (route and lot number was not proved). Secondary suspect or concomitant medications were not provided. The register nurse reported that the patient, had a negative or low titer test following completion of hepatitis B vaccine (manufacturer unknown) but RECOMBIVAX HB could not be ruled out at the time of the call. No other adverse events were reported. At the time of the report the patient's outcome was not provided. This is one of several reports received from the same source. Additional information is not expected.
Fever 100.4, chills, joint pain, fatigue, Diarrhea
within 24 hours: shakes, chils. The injection site was  warm to touch, tender, red with :bullseye"  marking which lasted for several days over time: the injection site was dime sized, and took on a tan-brown color, which is still evident today 10/10/21
This literature marketed report as received from a physician who is also an author of the literature article refers to a 59 years old healthy female patient. The patient was vaccinated with 3 doses of GARDASIL (lot#s not reported) in her arm in July 2010, September 2010, and January 2011, respectively for treatment of recalcitrant plantar warts. The patient presented in October 2009 with a 5-year history of recalcitrant plantar warts, Four large warts were present on her feet; the largest measured 4.6 cm in diameter. She had previously been treated with numerous therapies, including liquid nitrogen cryotherapy, topical iminiquimod 5%, 40% salicylic acid, pulsed dye laser, and oral cimetidine without improvement. A shave biopsy was performed and findings confirmed the diagnosis. On the basis of the classic and histopathologic findings, human papillomavirus (HPV) typing was not performed initially. Treatment was initiated, with aggressive liquid nitrogen cryotherapy in conjunction with topical tretinoin 0.025% with the plaques occluded by 40% salicylic acid tape for several weeks without improvement. Subsequently, a series of 12 intralesional bleomycin 1% injections were administered approximately every 2 weeks. Minimal improvement was observed; the largest wart still measured 4 cm after the final injection. On the basis of isolated literature reports of cross-protection of the GARDASIL, this vaccine was administered in the patient's arm in 3 doses at 0, 2, and 6 months (July 2010, September 2010, and January 2011, respectively). Other treatments were discontinued at that time for lack of efficacy. When the patient returned for follow-up in November 2010, the largest wart had decreased in size and thickness, measuring 2.5 cm. By February 2011, only 2 warts left remained, the largest measuring 0.5 cm in diameter. By April 2011, the warts had completely regressed. Given the patient's response to the vaccination, HPV in situ hybridization studies were performed on paraffin-embedded tissue sections from the original biopsy specimen. They were negative for HPV types 6, 11, 16, and 18 but positive for a general probe for HPV. In July 2011, the patient's feet remained wart free with no evidence of recurrence. Spontaneous regression of warts independent of treatment certainly occurred, and this might have occurred in this patient. However, HPV vaccines had been proven to show cross-protein against other strains, and it was possible that this was the mechanism for resolution of the long-standing, recalcitrant walls in this patient. Further clinical trials might be warranted. Additional information has been requested.
This initial spontaneous case, was received from other health professional (pharmacist) on 05-Oct-2017, concerning a 40-year-old, adult, female patient. The patient had no medical history. The patient's concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number, expiry date, and anatomical location: not reported). The vaccine was administered to the patient under age of 65-year-old (explicitly coded as inappropriate age at vaccine administration). It was reported that, no adverse effects were experienced by the patient. The reporter assessed the events as non-serious. Follow-up received on 08-Nov-2017: Added patient's age (40-year-old). Narrative amended accordingly.
immed p/vax pt fell backwards across exam table & had mild sx lasted less than 1 min; pt regained consciousnesss; VS taken all WNL; MD did neuro exam-was neg; less than 10 mins p/sz had 2 more similar to 1st;
Patient began having cramping of her upper extremities and subsequent swelling of her face and  neck and also shortness of breath, chest pressure and flushed appearance.  She denies any tongue or throat swelling.  She is also complaining of bilateral arm pain.  The initial reaction treatment was started in the conference room and then the patient was transferred to the emergency room.  She continued to has arm and chest pain in the emergency room.  She had muscle tension/rigidity in the upper extremity which caused significant pain.  She also developed a nonspecific rash on the chest and abdomen that  persisted  for through out he hospital stay. Treatment was started with epinephrine 0.5 mg IM x2 and diphenhydramine 50 mg  IM x1, prior to transfer to emergency room.  In the emergency room  treatment was dexamethasone  10mg  IV x 1, famotidine 20mg IV x1, Ketorolac 30mg IV x 1, lorazepam, 1mg IV x 2, morphine 4mg IV x 2, 1000ml Saline Solution.  As an inpatient  the treatment  included scheduled acetaminophen 500mg TID, as need morphine for pain after treatment  with fentanyl, scheduled diphenhydramine 25mg IV q8 and compazine  5mg  IV for nausea, cyclobenzapine 10mg as need for muscle spasms, dexamethasone as a scheduled dose started at 4 mg BID and tapered to 2 mg BID, Naproxen 500mg  BID and Norco 7.5/325 as need for pain. with famotidine 20mg BID .
had to travel overseas for about 3 months.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had to travel overseas for about 3 months.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had to travel overseas for about 3 months.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had to travel overseas for about 3 months.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe dizziness ( started at around 15 minutes after injection),  cold followed by hot burning sensation on upper parts of both arms. Numbness in both hands, low back pain (sciatica flare up, especially on right side). Right side of right leg (calf into foot) numbness, with constant "nerve zaps". Entire right arm and right leg experience complete numbness (and the sensation of sharp "pins and needles"). This has been going on now for over a week (started night one after receiving shot). Deep muscular pain on underside of right leg. Dizziness is recurrent and random. Random itchiness throughout body (hives appeared once on right foot). Pain and tightness of chest (pain occurred 3 days after shot, tightness immediately when reactions occurred).
Fainted; fell and struck head on floor. Was unconscious for approximately 30-60 seconds.
Patient experienced increase desaturations and bradycardia, borderline temp, and abdominal distention after receiving Pediarix & Haemophilus vaccines. Patient also experienced same symptoms when Prevnar was given the following day (10/24/14) at 11:57 am.