chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12-month-old patient who on 16-JAN-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (655380/1326F) (rHA). On 26-JAN-2008, the patient came back to the office with a nickel sized lump where the shot was given. It was reported that the onset of symptoms was on 25-Jan-2008. The outcome was not reported. No product quality complaint was involved. Follow-up information has been received from an L.P.N. who indicated that the patient was vaccinated subcutaneously in the right thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (655380/1326F) (rHA) at 10 AM. There was no illness at the time of vaccination. On 25-Jan-2008, the office received a call reporting that there was a quarter sized (previously reported as a nickel sized) lump, and the injection site was reddened. The patient was seen on 26-Jan-2008 and diagnosed with a localized inflammatory reaction on the right anterior lateral thigh. On an unspecified date, the patient recovered. The physician also reported that the patient's twin developed an adverse event following vaccine administration. WAES # 0802USA03128). Additional information has been requested.
Injection site soreness, pain at the injection site. Muddle pain in the arm. Fatigue. Nausea.
Profuse menstrual bleeding that has still not stopped as of this date. I have had an IUD since January 2012 and only have two or three episodes of light spotting each year, only last a day or two each. I have now been bleeding heavily since the night after I received my second dose and it?s not decreasing at all.
1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours,  took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
Pain in right arm radiating at times to elbow no redness swelling at site- patient concerned about nerve irritation.
SEVERE NAUSEA, DIARRHEA, FEVER, CHILLS, DRY HEAVES.
Fever 100.8, shortness of breath, chills, myalgias, weakness, shortness of breath worse with exertion, chest tightness
fever 102F; chills; shakes; vomiting,; flu like symptoms; swelling at injection site; itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102F), CHILLS (chills), TREMOR (shakes), VOMITING (vomiting,) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, OMEPRAZOLE, ATENOLOL, ALLOPURINOL, AMLODIPINE, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (BABY ASPIRIN), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), MULTIVITAMIN FOR WOMEN, CALCIUM and GLUCOSAMINE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (fever 102F), CHILLS (chills), TREMOR (shakes), VOMITING (vomiting,), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Fever and Swelling of injection site, at an unspecified dose and frequency. On 10-Feb-2021, PYREXIA (fever 102F), CHILLS (chills), TREMOR (shakes) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved, VOMITING (vomiting,) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Dizziness; This is a spontaneous report from a non-contactable other HCP via Pfizer sales representative. A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as a dose 2, single for covid-19 immunization. Medical history included confirmed covid prior to beginning vaccine series and was not 90 days from original diagnosis. Concomitant medications were not reported. On an unspecified date, the patient (HCP) experienced some dizziness. The patient underwent lab tests and medical procedures which included SARS-CoV-2 test on an unspecified date, which showed result of confirmed covid. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Severe headache Muscle aches entire body Sharper pains in joints Fever (sweats and chills) Nausea, vomiting Deep fatigue, but unable to sleep for entire night due to pain
Became faint, ashen/pale color to face, approximately 5 minutes after receiving vaccine, fell to floor hitting back of head on floor.
COVID arm, red, hard large red itchy spot at injection site, occurring 8 days after injection
Patient states that site of injection is sore, has firm hard egg-like knob, red and itchy. She states the redness location is large and extends a decent distance away from the site of injection.
Upon waking up the next morning (18 hours after receiving the vaccine) I felt very ill. I had a 100 degree fever, chills/sweating, widespread muscle aches, headache, nausea, joint pain, severe fatigue and an overall feeling of being unwell. These symptoms lasted 24 hours, but I am still experiencing nausea and am now experiencing mild dizziness also.
Vaccine administered 5/17 immediate pain and induration at injection site; by 5/19 fever started (102) controlled with Tylenol for cold; intermittent fever until present, 5/21/07 left deltoid muscle swollen, skin is red and indurated, c/o numbness in upper left arm; Dicloxacillin 500 mg 1 PO qid x 7d called in to pharmacy
No additional adverse events reported; children received 2nd dose of VAQTA but it was the adult dosage not pediatric; This spontaneous report was received from a pharmacist intern referring to a 4 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 30-AUG-2021 (yesterday), the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (adult dose; strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (incorrect dose administered). No additional adverse events reported. No product quality complaints.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000681:
Patient received vaccine Saturday morning 3/20/21. She stated she woke up on Sunday morning 3/21/21 and had a "rash on her arms and chest, and some of the spots looked like blisters." She went to her dermatologist on Wednesday 3/24/21, but they did not give her medication for treatment. Patient states that the rash is improving.
Patient presented for 1st dose Moderna. She was erroneously given a Moderna booster dose. When the patient was informed of the error, she declined the additional 50mcg dose. She is returning to country in the coming weeks and will let her physician there decide what to do. She was informed that her dose received today was inadequate and was offered to return today for another 50mcg dose or at another day for a full dose.
Arm is still in pain as of 6/7/21. Noted weakness compared to the left side.
hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (hives all over the body). At the time of the report, URTICARIA (hives all over the body) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
This spontaneous report as received from a nurse via a company representative and refers to a 59 year old male patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in August 2017 (reported as "on an unspecified date last week"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date in August 2017 (reported as "sometime after receiving ZOSTAVAX"), the patient came down with ophthalmic shingles, diagnosed at an urgent care facility. At the time of the report, the event was ongoing. The relatedness between the event and suspect therapy was not provided. The reporting nurse considered ophthalmic shingles to be disabling. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Pt call pharmacy Mon 9-26-11 to report a round, red, warm circle at injection site, about the size of a silver dollar.
My infant rec'd 6 vaccines on 8/21. i have her vaccine record but do not have the specifics on the manufacturer/sites etc.  The evening of 8/21 she developed a fever. The afternoon of 8/22 she had a tonic clonic sz that was dx as febrile in nature.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 46-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
SEVERE HEADACHE; MUSCLE ACHE; CHILLS; This spontaneous report received from a patient 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: 041A21A,  expiry: 27-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle ache. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, severe headache, and muscle ache on 08-APR-2021. This report was non-serious.
The fast after I received my dose, the symptoms  began with slight nausea, then I got chills. Started aching in joints and was exhausted. Slept on-and-off the whole day, fever got up to 102.5. Took tylenol that night. Woke up achy, was still exhausted, slept almost all day. Third day only minor aches, tired but able to function a few hours at a time.
Information has been received from an RN concerning a 22 year old male with no past medical history and no known drug allergies who on 7/30/80 and 7/90 was vaccinated with the 1st and 2nd dose of MMRII. There was no concomitant medication. On 8/27/01, it was reported that recent titers done for work were found to have no antibodies for mumps and measles. The pt sought unspecified medical attention. Additional information has been requested.
Pt is concerned about her persistent vaccine side effects. Pt states today is the fourth day S/P 2nd dose of covid vaccine. States she still has low grade fever 99.0, chills and HA , feeling upset stomach (denies cramping states discomfort), nauseated and feeling of no appetite and states feels " my lymph nodes are swollen." 2nd dose on 05/10/21 at MTVW clinic. Scheduled appt with Urgent care on 05/14/21.
Patient in clinic on 02/14/2007 for MMR, but received MMRV in error.  Patient returned on 02/16/2007 with redness and induration measuring 80mm x 65mm.  Patient reports no other adverse reactions such as fever, hives, pain, etc.  Patient had no history of chickenpox or previous varicella vaccinations.
I just had the normal sting that you would get from any vaccine. I sat down for a few minutes just to let the sting go away not thinking much about it. I took some Tylenol, but the pain continued hurting through the night. The next morning whenever I woke up it was red around the injection site, and it spread over the next couple days. The redness and rash spread all the way up to the shoulder and to the end of my elbow. I took Benadryl for the next 3 days, but it wasn't helping. My skin felt like I had hives, it was itching and burning. I scheduled an appointment with doctor and she just said I may of had a mild reaction and just advised me to get the 2nd dose of the vaccine and gave me a prescription for an EpiPen. She wasn't much help and didn't explain anything to me.
-Constant sharp and stabbing pain in left Biceps muscle experienced between hour 18 and hour 54 post vaccination administration. He states his left biceps muscle "feels like it is tearing". -In hour 70 post vaccination administration, after 3 hours of continuous sedentary working, upon standing experienced immediate and sudden onset of excruciating, sharp, and stabbing pain in left posterior mid-tibial area. Followed by sudden onset of marked edema in this area described as "the size of a baseball, cut in half". Immediately following, he developed dizziness, lightheadedness, became diaphoretic and felt near to syncope (No LOC). The pain felt, was the same pain he has felt in his Bicep in the past 3 days since receiving the Janssen vaccine.   No obvious damage to surrounding tissue suggestive of contusion. No puncture marks to suggest insect bite. No reported trauma, no vigorous activity, no history of clots. No pertinent Family History of clotting or bleeding disorders. No changes to medications, aside from the Janssen COVID-19 vaccine, or diet/supplements. Nothing obvious to trigger the onset of these symptoms. No recent travel by airplane, or Cardiovascular history. Young, active, otherwise healthy patient without obesity. Powerlifter, even took precautions by resting muscles and abstaining from health supplements for 5 days ahead of vaccine to return body to baseline.
Vaccine administered 10/05/2008. Symptoms started on 10/09/2008 with PERSISTENT NAUSEA, VOMITING AND DIZZINESS. Chlorpheniramine has reduced part of the symptoms, but the vertigo still persists, Diazepam was also prescribed.  NOTE: I am the injured-person's PCP completing this report. Patient is a pharmacist: if you need the lot number, please contact him at his place of work.
Headache (lasting 3 days after), Body aches (lasted 2 days after), Neck Stiffness (lasting 3 days after), Chills (lasted 2 days after), Sweating (lasted 2 days after), Dehydration (lasting 3 days after), Nausea (lasted one day on second day after), Pain at Site of Injection (lasted 2 days after), Difficult Taking Full Breaths Nausea (lasted one day on second day after), Fatigue (lasting 3 days after)
Per mother's report patient developed fever and rash on 8/24.  Vesicular rash to hands, torso, face.  No fever when pt evaluated in PCP office on 9/1.
Patient's husband called on Saturday 09/30/2017 to ask if anyone else had reported muscle pain due to the flu shot. He stated patient was having shoulder pain and pain in/and around the upper breast area. He stated she didn't recall pulling a muscle but it felt that way. He also stated that he had his shot the same day at a later time, I also administered his, and he was feeling fine without any pain. I asked them to call me if they needed anything and offered to follow up Monday. I called on Monday 10/02/2017 and husband answered the phone. He stated patient had a bad weekend but didn't go to a urgent care even though he suggested it. He stated she went to school (she's a teacher) on Monday and was going to try to make it through the day. I asked him/them to please call with anything they needed and to follow up with me. No one called between Monday 10/02/2017 and Thursday 10/05/2017. I tried to reach them again this evening, no one answered.
Information has been received from a 61 year old female consumer with wheat, rye and barley allergies, crohn's disease, coeliac disease and "PSC" who on 01-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included ursodiol (URSO) and mesalamine (ASACOL). On 02-MAY-2007 the patient developed swelling, itchiness, redness and soreness on her arm around the injection site. There was no laboratory tests performed. Unspecified medical attention was sought. Subsequently, the patient recovered on 08-MAY-2007. No product quality complaint was involved. No further information is expected.
Within 24 hrs of administration, fever, abdominal pain, generalized rash, headache, stiff neck, hypotension requiring dopamine drip and boluses. In ICU on CPAP leaking fluid from intravascular compartment into extracellular space. Dx: serum sickness-like reaction; (in ICU and present very ill); Was c/o severe head ache 8/10 prior to vaccine gave 2 Tylenol 4 dizziness prior day. 7/1/08-summary received for DOS 2/8-2/18/08-DX:Bacterial meningitis or other invasive bacterial disease. Likely causative agents include Streptococcus pneumoniae, Neisseria meningitidis, Group A Streptococcus, Staphylococcus aureus (either MRSA or MSSA). Other possibilities include ricettsial disease (RMSF, Ehrlichia and Anaplasma-these are quite unlikely given that it is wintertime) and sexually-transmitted diseases (disseminated Neisseria gonorrheae, acute HIV infection). Toxin-mediated disease including toxi-shock syndrome (menstrual-associated or nonmenstrual-associated) are also high on differential diagnosis. Day of vaccination developed tactile fever, rash over (diffuse, macular, sparing palms and soles), lethargy, abdominal pain, headache and neck pain. Hypotension. Temp 102,
pt reported extreme fatigue, sleepy and foggy for several days (5 days) after given hep B vaccine booster in the afternoon on March 2, 2022.
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 15 month old female who received Infanrix for prophylaxis. On an unspecified date in April 2003, the pt received the fourth injection of Infanrix (589A9) packaged in a prefilled syringe. The injection was made into the left thigh. The pt was also received an injection of IPOL in the right thigh. On 4/23/03, "within a couple of days" post-immunization, the pt developed an injection site reaction on the left thigh. The pt was seen by the physician, who noted an area of erythema, swelling, and inudration measuring three to four centimeters in diameter. The physician made a diagnosis of injection site cellulitis and prescribed a 7-day course of Duricef. The event resolved on 4/30/03. The nurse considered the event to be serious (OMIC) because it jeopardized the pt or required intervention. The nurse considered the event was possibly related to vaccination with Infanrix.