chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 71 year old female patient with no pertinent medical history or drug reactions/allergies who on 15-MAY-2012 was vaccinated IM with 0.5 mL of PNEUMOVAX 23 (lot # 671607/1169AA). Concomitant therapy included omeprazole, hydrochlorothiazide (+) moexipril hydrochloride, simvastatin (manufacturer unknown) and MIACALCIN. On 15-MAY-2012, the patient developed redness and warmth at the site of the injection on the left arm. On 17-MAY-2012, the patient was diagnosed with cellulitis. No laboratory test was performed. The patient was treated with cephalexin. On an unknown date, the patient recovered from the event. The patient sought medical attention, visited the physician's. This is one of several reports from the same source. Information received from medical records regarding a 71 year old female who on 15-MAY-2012 was vaccinated IM with 0.5 mL of PNEUMOVAX 23 (lot # 671607/1169AA) in her left deltoid. Concurrent conditions reported included: non smoker, esophageal reflux with chronic reflux esophagitis, type II diabetes mellitus, essential hypertension, hyperlipidemia, osteopenia, localized osteoarthritis (vertebral column) and a past medical history of: solitary thyroid nodule an anemia. On 17May2012 the patient was seen by her physician for cellulitis of the left arm. It was reported that the night that the patient received her PNEUMOVAX 23 she noticed some redness and warmth at the injection site. The patient experienced pain and the redness expanded from the injection site to the antecubital fossa. The assessment included: cellulitis with symptoms of skin pain, skin redness, skin warmth and localized edema, but no skin ulceration, no serosanguineous drainage, no purulent drainage and no enlarged lymph nodes. The treatment included: cephalexin 500 mg capsule every 12 hours. It was reported the patient recovered from the cellulitis on 20May2012. Additional information has been requested.
Arm pain after dose 1 from 6-30 hours afterward; Missed period; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 09Apr2021 13:15 (Batch/Lot Number: EW0151) as single dose at the age of 38-year-old for COVID-19 immunisation, administered at hospital.  The patient medical history was not reported. The concomitant medications within 2 weeks of vaccination includes: birth control. The patient was not pregnant. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. In Apr2012 the patient experienced arm pain after dose 1 from 6-30 hours afterward and missed period (scheduled to get 23Apr-25Apr) on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Wheezy before leaving doctors office.  ER visit for wheezing.    Lasted several weeks.  GI problems that consisted of diarrhea that was green foamy/watery at every diaper change 10 or more times a day.  Diarrhea turned into chronic constipation that lasted for nine months.
Fever, body aches, patient fainted and bruised lip on fall, next morning still had fever, body aches. Next morning still mild body aches from fall. October 20, felt "awful" and reported to employee health with symptoms of concussion.
Pt came in for a covid vaccine. He is diabetic and had not eaten  lunch before arriving. I gave him his vaccine and upon standing was a little dizzy/light headed. I asked him to sit down and I asked if he had any other symptoms. He did not. He said he felt ok sitting so I asked him if he wanted an orange juice to bump up his sugar level. He agreed and I gave him a bottle. He drank it down, as I continued to monitor him. After about 10 min or so he said he was feeling better, I asked him to stay another 20min or so just to monitor him. After that time was up I went out to him to check him again. He said he felt fine and left. His wife and family was with him.
Severe diarrhea, stomach cramps, headache, fatigue, sore injection site.
Swelling on my face around my side of my nose and same on both sides; This is a spontaneous report from a contactable other hcp (patient). This 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the right arm on 29Dec2020 12:00pm for Covid-19 immunisation. Medical history included asthma, eggs chicken penicillin. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), omeprazole (PROTONIX [OMEPRAZOLE]), budesonide, formoterol fumarate (SYMBICORT).   The patient stated that experienced: swelling on my face around my side of my nose and same on both sides on 29Dec2020 21:00 with outcome of unknown. No treatment required. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 post the vaccination.   Information on the Batch/Lot number has been requested.
This spontaneous report was received from a nurse and refers to a 30 year old patient (unknown gender). No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (confirmed not GARDASIL quadrivalent) (dose, anatomical site of administration, lot number and expiration date were not reported). No adverse event was reported.
Fever to 104 F, shaking chills, nausea, generalized aches, fatigue, intractable hiccups, tongue blister, diarrhea. Seen at urgent care 3/12 and had negative rapid COVID test. Given prescription for zofran and taking Tylenol for fever. Returned home that afternoon and developed intractable hiccups  and noticed tongue blister. Again seen at urgent on care on 3/13 and given baclofen for hiccups.
Patient developed rash on lower arm below the injection site, the area itched, was red, and hot patient went to her doctors office. Patient couldn't remember what the doctor diagnosis her with. She was given an antibiotic and course of steroids.
Post vax, the pt developed red blotches around injection site. Area was hot to the touch. Generalized swelling, no defining edges. Only verbal complaint was that arm felt numb. Watched child for 40 minutes. Blotches faded. No respiratory distress.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB, (dose number, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 19-DEC-2016 the vaccines experienced a temperature excursion of 29.8 Fahrenheit Degrees for 30 minutes, and, on 03-APR-2017 experienced a temperature excursion of 49 Fahrenheit Degrees for 15 minutes. The digital data logger was involved. No side effects were reported by the reporter. Concomitant therapies included sterile diluent, however, the registered nurse did not provide any lot number or expiration date for the properly stored sterile diluent. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012148: US-009507513-1704USA012149: US-009507513-1704USA011906:
Waking up on the morning of 10/29 at approximately 8am, there was a localized reaction of a painful swollen lump, heat and a 2 inch area of redness around the injection site. The area was very sore and continued to be so throughout the day. As the day went on I began to feel worse with a cough developing, headache, heat and redness in the face and body and a low grade fever of 99F. The temperature was taken at 7PM that night. I then proceeded to take 2 ibuprofen tablets at a total of 400mg to relieve the symptoms. As of today (10/30/13), at 10:45AM, the injection site is still red, swollen and painful.
Patient stated she had severe GI discomfort including nausea and diarrhea, extremely painful arm at injection site, and numbness of the legs including feet.
loss of taste; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of AGEUSIA (loss of taste) and FATIGUE (Fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On 05-Mar-2021, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.
No additional information; Expired dose of PQOQUAD was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 17-FEB-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), 0.5 milliliter, (Lot# T028297 and expiration date 16-FEB-2022) (exact dose, frequency, route of administration were not reported) as prophylaxis. (expired product administered). There was no previous temperature excursion. No additional adverse event reported, no further information provided.
Continuous Tinnitus new onset post vaccine starting in February of 2021. Unknown if this will be permanent at this time, therefore I checked permanent to item 21 until this stops i have no way of determining permanence
12/30/2021: Event occurred after 2nd vaccine. Presenting with 4 days of fevers, chills, fever and cough. She took blood sugar at home was found to be 1200 at which time she presented to the emergency department. She has not had a peritoneal dialysis today. She has had occasional nausea and vomiting but denies any chest pain or shortness of breath. Patient denies: Diarrhea, fever, urinary symptoms, blurred vision, back pain, palpitations, dizziness, shortness of breath, and rash. 01/06/2022: Completed remdesivir therapy. Remains in hospital.
Around 1 pm on 3/31 my wife developed an extremely high fever of 105.2 and sustained this for 90 minutes until I treated her with 1000 milligrams of Tylenol 2× over a 3 hour period. I also applied a cold compresses to her for head for 2 hours until fever gradually dropped to 101.5. Continued use of Tylenol every 4 hors after that kept her fever below 99. She also developed severe diarrhea  for 2 days after recovering from her fever. She was in a delirious state of mind during the 24 hour period 1 day after her 2nd Moderna dose.
Patient became flush red, started feeling sick and complained that she felt like she was having trouble breathing. Administered EPIPEN to patient and then called 911. After a few minutes patient felt better and was able to breath. EMS came and evaluated her and she said she felt much better and that she didn't want to go to hospital.
Noticed this a.m. that Left arm was red swollen and warm to touch. Ice pack applied last night due to pain and fever. Noted. Has history of seizures had one last night. no meds for seizures, was told by md that h would outgrow them.
When called to follow up regarding missed second dose appointment, patient stated he saw he physician "a couple of weeks ago" regarding tinnitis following his first dose and decided not to get the second dose.
Swelling of lymph nodes in arm pit of left arm. Two days after dose, swelling has increased and ?pit? of armpit is not indented on left side but rather flat with body. Skin is flushed over arm pit and arm pit area is very sore, preventing normal use of left arm.
on 5/19/21 pt experienced "tingling and a rushing feeling" throughout her body. she then could not move the left side of her body. Per ER records, pt suffered an infarct in the brain that day: .ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY   THROMBOSIS OF RIGHT INTERNAL CAROTID ARTERY
She was watching a movie and gradually became dizzy, sweats, and was warm.  She was also very confused.  I didn't take her temp to confirm she had a fever.  She fought bad dreams after that until about 4am.  She has had BAD dreams and confusion 4 of the last 6 nights after that. (continuing)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 1, single (Lot number: Fd0809), in right arm, on 22Dec2021 as dose 2, single (Lot number: Ej1685), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: El1284) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: O46L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies:Sufa" (unspecified if ongoing), notes: Known allergies:Sufa. Concomitant medication(s) included: ALLEGRA, start date: 01Apr2022, stop date: 01Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for Covid-19 from 19Jun2022 to 23Jun2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Gradual increase in fever (started at 99 and went up to 101.8 within 36 hours) Severe leg cramps Chills Fatigue but couldn?t sleep
Cough, but not for long Headache High temperature for 24 hours Given 5 day doses of Pavlovid
First day after my vaccine I experienced an extremely painful headache and diarrhea. Then on 4/6/2021 I started with abdominal pain and severe diarrhea that lasted 3 days and and . still having abdominal pain today 4/14/2021 and extreme fatigue
(L) arm red/swollen/painful. Lump at site of KINRIX. Fever 103 degrees.
3 1/2 weeks after shot, client developed spot on buttocks area.  3 days later it was 2x size with blisters.  Client had shingles 6 years ago.  10/25/07-area healed over but still urticaric. No pain.  Started Acyclovir 800 mg 5x day x 5 days.  Still with healed over blisters, some itching.
Information has been received from a registered nurse concerning an 11 year old male with no known medical history or allergies, who received a first and second dose of varicella virus vaccine live (Oka/Merck), on 12-FEB-1997 (0.5 mL, SC) and on 22-NOV-2005 (lot number "U19355AA), respectively. There was no concomitant medication. It was reported that on 03-MAY-2007 the patient experienced itchiness with a varicella like rash, 34-35 lesions on his face, chest, back and legs. Unspecified medical attention was sought. It was reported that the patient's status is not recovered. No laboratory tests were done. No product quality complaint was involved. In follow-up it was reported that on 04-MAY-2007 the patient developed 34-35 papular lesions on his face, chest, back and legs. The patient recovered on 17-MAY-2007. Additional information has been requested.
A baseball size lump develop under my left armpit 24 hours after my second dose.  The lump is still present after 3 days.
2 weeks after first shot I had heart failure and atrial fibrillation. I could not breathe. 6 days in hospital. On 5/20/21 hospitalized for cardioversion.
Reporting a vaccine administration error.  Patient was given a dose of Moderna vaccine that was expired at the time of administration.  Vial that dose was drawn from was moved from freezer to fridge on 8/30/2021 at 8:45pm, starting a 30 day expiration per manufacturer.   Error was discovered on 10/5/2021 after a subsequent vial from the same box was identified as being expired.  Manufacturer was contacted on 10/6/2021  for guidance.  Manufacturer indicated on 10/6/2021 that they will "conduct an analysis to determine if the vaccine administered past 30 days provided the necessary protection against a COVID-19 infection".   Attempted to contact patient on 10/6/21, left voicemail for patient to call back to discuss error.
NUMBNESS/TINGLING MOUTH, FLUSHING FACE, DIFFICULTY SWALLOWING.
This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 05Oct2017 at single dose for immunization. Medical history included ongoing trigeminal neuralgia, peripheral neuropathy, diabetes mellitus and abdominal migraine and cluster headache because of the damage to cranial nerves. It was reported that the patient took a lot of other medications. On an unspecified date in Oct2017, the patient experienced productive cough, severe cough, low grade fever, sore throat and headache. No treatment was required/provided for the events. Outcome of the events was not recovered (also reported as probably worse than what when he started). No follow-up attempts are possible. No further information is expected.
Observation 4/24/22-4/25/22 abd pain, penile swelling, constipation, SOB, lower extremity edema, a-fib, CHF, pleural effusions, lung mass, small bowel obstruction, PNA, hernia,
Developed reactions to cold in the form of hives, large welts, and swelling of the lips.  First reaction was a softball size welt on June 25th after icing sore elbow.  Now any contact with chilled or iced items produces welts, swelling, and itching.  Contact with cold river water while rafting August 8 produced hives over entire body.  Contact with ice cream on 8/7 produced swollen lips.  Very concerned as my daughter is a competitive swimmer.  While the first notable welt on elbow, was approximately 9 days after 2nd vaccine,  she said she noticed an itchy sensation when exposed to cold at some point prior to this but never before 2nd vaccine.
p/vax pt devel diarrhea, vomiting, lethargy & a severe milk allergy;5/13/99 sx resolved x/milk allergy persisted;
Next day injection site red, painful, sore (arthus reaction) 2 days later a few raised "red dots" with "whitehead" pustules that she tried to squeeze but nothing came out. Resolved after 3 days. Possible varicella-like lesions which have resolved.
Fever of 101 by that evening, treated with Tylenol. 99 by the next morning. Severe body/joint ache. Headache. Severe Diarrhea. Difficulty breathing, treated with Albuterol inhaler. Still experiencing body aches and diarrhea 46 hours after vaccination.
fever; chills; headache; body aches thru the night; arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills, headache, general body pain and pain in arm. On an unknown date, the outcome of the fever, chills, headache, general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, general body pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just got his/her shingles shot. The patient had fever, chills, headache, body aches throughout the night and arm hurt for 3 days.  The patient stated that he/she would take it compared to the horror stories of getting shingles. Additional Supportive information: The follow up would not possible as no contact details were available.
Patient developed a welt on arm and went to doctor about trouble breathing--had bronchitis and was giving antibiotic and inhaler--drew marker around welt to see if it got better/worse 04/02/2017.
Diabetes, Vision, Blood restal, psoriasis  6/8/09 Received medical records from 7/20/2006-6/4/2009. Records reveal patient experienced: exacerbation of psoriasis, low back pain, dislipidemia, hypercholesterolemia, overweight, adjustment disorder w/depression & anxiety, insomnia, sleep apnea, recurrent ventral hernia repairs, GERD, intermittent tinnitis, allergic rhinitis, HAs, sinusitis, plantar fasciitis, intermittent shoulder hip throat pain, elevated FBS.
Pt received shot.  She had to wait 30 minutes since she had an anaphylactic rxtn hx to tree nuts and shellfish.  Pt stated after 30 minute wait that her lips felt tingly.  I looked at her lips and there was no swelling.  She expressed that she has had many anaphylactic rxtns in the past and stated it would be unlikely if this would result in an anaphylactic rxt.  I asked if she would like an antihistamine.  She accepted my offer.  I gave her 50mg of diphenhydramine.  She expressed that she would leave and head to the ED if there was any signs of further issues, but highly doubted there would be any future issue.
Pt recvd flu & pneumococcal vax on 22OCT91 @ 330PM & devel sore throat on 23OCT91 & on 29OCT91 pt saw pvt MD for cough, runny nose, chills, fever & sl achinesss; given antibiotic for "red ear";
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# M041084, expiration date: 04-APR-2018 and lot# reported as M041509, expiration date: 09-APR-2018) (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.29 degrees Fahrenheit) for 44 hours and for 44 hours and 1 minute. Data logger was involved. There were no previous excursions reported. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006443.