chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon receiving my first dose of Moderna, I developed a lump on my arm, severe pain in the arm and also a rash. I developed flu like symptoms with exception to the headache. The flue symptoms subsided in about 72 hours, the lump and rash and arm pain took about 7 days. After the second dose of Moderna, the arm pain was more severe, the rash was burning hot, and the lump was significantly larger and the flue symptoms were worse and one again after the flu symptoms and arm rash/lump/pain subsided the headache still remained. Over the past year, general fatigue has increased and the headache pain has increased. In December of 2021, along with the tiredness and headache, I also started getting nosebleeds.  In February I sought medical help from my GP and have been placed indefinitely on migraine medication that comes with a whole list of side effects as well. I was once very active running every day and going to the gym regularly. I would normally run a half marathon a month and now I am lucky if I am able to get the energy to run once or twice a week and only a couple of miles.
3/24/2021: PATIENT SCHEDULED E-CLINIC VISIT.  REPORTS FATIGUE, NAUSEA AND HEADACHE PERSIST FOR 4 DAYS POST INJECTION.  MYALGIA, FEVER RESOLVED 2 DAYS POST INJECTION.
pt recv vax & 3min later pt felt warm, flushed, achy, & devel a h/a;pt went to ER & was noted to have a fever of 101 & orthostatic hypotension (systolic BP dec to 104 upon standing, while heart rate inc to 140 beats/min;
Patient stated that since he has had the vaccine his whole right arm is in pain . The pain starts in the shoulder and works its way all the way  down to the hand. It is most painful in the muscle where the injection was given. The patient also stated that it is had for him to breathe.
Patient received vaccine on 10/4/2019, around 1pm. Patient came back into the pharmacy on 10/6/2019, stating that when she got home later in the evening after having the shot,  she noticed some itching and hives ear the injection site. She states that the hives and itching slowly spread across her back and neck, eventually to the other arm. Pharmacist on duty on 10/6/19 confirmed patient never experienced any breathing issues, was mainly concerned about the itching. Pharmacist recommended patient to take benadryl and contact her primary care provider.  Reporting pharmacist followed up with patient on 10/9/19, patient said the rash had faded and she did not end up contacting her doctor.
Sore arm and lethargy for 24 hours following injection. No fever. Subsequently contracted COVID-19.
Tested COVID-19 positive, resulted in hospitalization. Symptoms include chills, myalgia, cough, wheezing, shortness of breath, chest pain, nausea, abdominal pain, diarrhea, and chest pressure.
Member woke up morning after receiving vaccine with hives, and on 8/17/21 is reporting swollen eyelids and lips.
15 minutes after injection I felt very dizzy. The dizziness and "spacey" feeling stopped around 3:00pm. At 6:00 pm I started to have a horrible headache and could barley lift the arm that received the injection. I went to bed around 9:00pm with my headache getting worse. I woke up at 4:00am the next day with a horrible headache, sweaty but no fever, extreme tiredness, and arm pain. My headache is subsiding, but I have the chills and am sweaty and hot at the same time.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with doses of improperly stored VAQTA (dose, frequency, route and lot# were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm pain immediately after shot; nausea started around 3:30 PM on 3/7/19; vomiting and diarrhea beginning 4 PM on 3/7/19. No fever - tested twice over a span of two hours.
pt recv vax  day 1 of life & devel hyperbilirubinemia recurrent & prolonged;bili 18.0; rx phototherapy;31AUG bili decreased to 13.7;
Sorearm; Fatigue; A spontaneous report was received from a consumer, concerning a female patient of  71 age , who received Moderna's COVID-19 vaccine and experienced Pain in extremity/ Sorearm, Fatigue.  History of the patient was not provided. Concomitant product use was not provided by the reporter.  On 13Jan2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot no. unknown) via intramuscular route for COVID-19 infection prophylaxis.  On an unspecified date, after first dose of vaccine, the patient  reports she and the husband developed sore arm and fatigue, but are fine now. She also confirmed that they took Tylenol .    Action taken with mRNA-1273 in response to the event Pain in extremity, Fatigue was unknown.  The outcome of the event Pain in extremity, Fatigue was considered to be recovered/ resolved at the time of this report.  It was reported that she had taken Tylenol as treatment medication.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported
The patient was administered with an expired menactra vaccine with no adverse event reported; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist via Medical Information (Reference number- 00747873) and transmitted to Sanofi on 31-Aug-2021.  This case involves a 35-year-old female patient received an dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was expired in 23-Aug-2021 (expired product administered).  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX).  On 30-Aug-2021, the patient received an expired 0.5 mL total dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Drug Interval Dosage : once,  lot U6690AA, expiry date: 23-Aug-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine use (latency: same day).  The reporter reported " would like to know did they need let the patient know about adverse reactions and if they need to re-administer the dose as the patient received the vaccine yesterday".  At the time of report, no adverse event reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a consumer refers to her 17 year old daughter. On 15-APR-2014, the patient was vaccinated with a fourth dose of GARDASIL (dose, route and lot # not reported). The consumer stated that the patient received her third dose at a previous doctor's visit within the same office. The physician stated to the mother that her daughter was in their computer system twice under two names and that was why he administered her the fourth shot of GARDASIL. There were no Lab diagnostics or studies performed. Follow up information was received stated that: On 15-APR-2014 at 4:00 pm, the patient was vaccinated with a fourth dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016), intramuscular in the left arm for prevention of HPV. The patient received a fourth dose of GARDASIL, but they were not aware that the patient received a previous dose at another physician's office. The patient never had any effects. They had a verbal consent from the parent. Additional information is not expected.
PATIENT PASSED OUT AFTER  RECEIVING THE VACCINE COLLAPSED IN THE CHAIR AND WAS UNCONSCIOUS THEN PHARMACIST ADMINSTERED EPINEPHRINE THEN PATIENT REGAINED CONSCIUOUSNESS AND  HE FELT FINE  DURATION FOR LESS THAN A MIN
Influenza shot administered abnormally high, almost in shoulder joint itself. Injection wouldn't go in so needle had to be repositioned a few times to complete the injection. Patient seen by a provider and then referred to Sports Medicine for ongoing symptoms. Patient receiving PT, shoulder has not improved much and still lacking some ROM.
TICK BITE ( BUG BITE); This spontaneous report received from a patient concerned a male of unspecified age. 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: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced tick bite ( bug bite). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tick bite ( bug bite) was not reported. This report was non-serious.
Headache, muscle pain, dizziness, nausea, constipation, fatigue, dry cough, fever, blotchy vision, clamminess.
No additional AE reported; Consumer received the VARIVAX vaccine intramuscularly; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant therapies were not provided.  On 28-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U019904, expiration date: 24-JUN-2023, administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength was not provided).  No adverse symptoms were reported.
Pt developed redness and swelling around injection site of DTaP on right leg size 4x5inches on right thigh.
Patient beckoned for assistance. Voiced that she was feeling ?light-headed and dizzy. ?Once assessed patient is flushed and sweaty. She remains alert and oriented x 3. States that she hasn?t eaten lunch but does have some snacks in her car. Denies allergic reactions such as hives, itching, or SOB. Vitals signs obtained and WNL. States that she had EPI when she was 5 years old but does not recall the reasoning. Offered bottle of water but denied. Stayed with patient for duration of recovery time. Symptoms subsided at 1340. Patient educated on general side effects of vaccinations and voices understanding. Patient signed report form and was released at 1348.
This spontaneous report was received from patient's mother concerning her daughter, a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 16-DEC-2014 the patient was vaccinated with GARDASIL (dose and route unspecified). Concomitant medications were not reported. On the same day of vaccination, the patient experienced syncope. The patient became pale, light headed and felt like passing away. The outcome of syncope was unknown. The causality of the event with GARDASIL was not reported. Additional information has been requested.
Very large red spot slightly lower than injection site. Not on deltoid muscle but around bicep. Has been about 48 hours since vaccine, Patient did report it feeling warm to the touch (pharmacist also agreed), no itching, no pain, no other symptoms, rash was about 3 inches in length.
FEELING A HEART ATTACK COMING ON; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced feeling a heart attack coming on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling a heart attack coming on was not reported. This report was non-serious.
About 3 hours after vaccine was given I began to vomit intractably for 2 1/2 hours.  Also had mod abdominal pain at the same time.  I have continued to have abdominal pain at intervals for the past 5 days following vaccine.  No treatment has been done at this point.
Left arm swelled large and red.  It remained swollen until Monday morning.  He had a low grade fever that began the evening of 6/28.  On Sunday evening, July 1st, the fever was over 103.  On Monday 7/2, his fever was over 104 and we returned to the doctor's office.  They said he would run a fever for a few more days.  On Tuesday 7/3, he vomited at 9:00 am and his fever reached 106.5 at 6:00 pm.  I called the doctor to inform her and she said to keep giving him Motrin and Tylenol.  He continued to run a fever through the night of 7/3 of over 105.5 degrees.  He also had a loss of appetite from Sunday night, 7/1 through 7/3. It appears his fever broke at 4:00 am on 7/4.
Noticed a hard red knot first about the size of a quarter.  Then, the red place was still hot and as big a tennis ball.
On 09/22/21, his chest was hurting when breathing. Stabbing pains with every breath.  Within the next 5-10 minutes the condition worsened and he was taken to urgent care. He was evaluated with a chest x-ray and EKG (both looked normal). Diagnosis was pluerisy. Treated with oral steroids and pain ceased by the next day. Was put on activity restrictions until 9/27/21
Approximately 6 weeks after Johnson and Johnson vaccine, patient broke out in a shingles like rash on abdomen front and back that has remained for over 4 weeks.  Rash was red, highly itchy, with a burning sensation and slight stabs of pain with movement.  Treatment was to refrain from itching or scratching, calamine lotion to contain the spread and to refrain from any close physical contact with other persons.
Intradermal injection given to left forearm but did not wheal. Repeat subcutaneous injection given to back of left arm successfully.
Low blood pressure, beginning approx 24-36 hours after injection. Kept lowering meds until I had stopped all medications for blood pressure. In the meantime suffering effects of the low pressure. 1 month later I am still on half dose, not sure when I can go back to follow doses. Meanwhile taking my blood pressure reading up to 3 times a day.
Information has been received from a health professional concerning a female in her 30s, with no medical history and no allergies, who was vaccinated with a first, second, and third dose of MMR. Subsequently a recent titer was negative for measles. The patient received a fourth dose of MMR (Lot# 653750/0498F). There was no concomitant medication. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the patient only received one dose of MMR at the facility after which she was not titered. The patient had stated to the reporter that this was her fourth dose. No other information was provided. Additional information is not expected.
pt states he has altered sense of smell.  Says he has a constant smell of burnt molasses.  Pt called his physician friend and was told just to keep an eye out for any other symptoms.
About 1 minute following administration of all three vaccines, client stated that she was going to "pass out."  Eyes rolled back into head, exhibited decorticate posturing of right arm and leg, deep raspy breathing, and some tremors of legs.  Episode lasted approximately 10-15 sec.  Client startled and appeared scared and unable to recognize parents immediatly following episode.  Supportive and reassuring measures provided.
Started getting blisters across rt. upper torso- breast, and  then my back & down  right arm where I received my shot in.  Sharp pain in shoulder. Went to emergency room, was diagnosed with Shingles. I was given pain meds & antibiotics. Spots are healed but nerves & itching still occurs. Not as bad   But still is bothersome. Still take  Gabapentin now for nerve pain. & soreness. Nerve damage & pains seem permanent. I was already disabled.
A mother reported that her 26 month old daughter received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed and developed cellulitis. This case was also reported by a nurse. The patient's medical history was notable for allergies to tomatoes and other unspecified foods, asthma, and febrile seizures. The patient underwent a tonsillectomy and adenoidectomy in February 2004. Concurrent medications included fluticasone and mometasone. On 3/2/04, the patient received the fourth dose of Infanrix (lot DTPA630A2) in her left thigh. On the same day, the patient received an injection of Haemophilus influenzae type B vaccine in the left thigh approximately one half inch apart from the Infanrix injection site. The mother reported that on the same day, the patient experienced injection site warmth and redness of approximately a quarter size. Approximately three days following the administration of Infanrix, on 3/5/04, the patient experienced a swollen face and was not acting right, and was seen at an emergency room. Examination revealed that the facial swelling had resolved and that the thigh was red. The mother also stated that the reaction site was larger than before, extending down and around the thigh. The patient was diagnosed with cellulitus and was treated with cephalexin and diphenhydramine. The patient's mother stated that as of 3/9/04, the local reactions have resolved but there is some discoloration at the injection site. The discoloration was described as, four inches long and goes half way around the front and back of the thigh. The patient's mother reported also, that as of 3/9/04, she noticed, a larger saddlebag on the left inner thigh compared to the right thigh. The reporting nurse considered the events to probably be related to vaccination with Infanrix and due to something with the lot number. The events were assessed as medically serious (OMIC). Follow up: This report was confirmed by a nurse with the following exceptions. The nurse stated that the injection site cellulitis accompanied by injection site warmth, discoloration and swollen thigh onet on 04MAR2004 and resolved on 09MAR2004. No biopsy was performed. The facial swelling and not feeling well resolved (date of resolution not provided). The nurse felt that the events jeopardized the patient or required intervention to prevent a serious outcome.
Pt got her shot on august 9th. she got a high fever of 103 on august 14th and it continued till the 16th of august. i took her to the emergency room to be checked out. she was ok only the fever was her sympthon.
Fainting/syncope, drop in blood pressure. BP lying down after syncope 80/59, pulse 88. Patient unable to rise up for 20 minutes without experiencing faintness. After consuming 32 ounces of water, blood pressure came back to normal limits. Patient was not dehydrated at time of event. Pt did not fall or sustain injury. Upon recognizing symptoms, pt. immediately tried to get to sofa, but had to sit on floor then lie down. LOC very brief. After 10 minutes, BP 97/61 standing. After 30 minutes, BP 116/69, pulse 78 sitting. After 50 minutes, BP 96/65 standing, pulse 94. at 60 minutes, BP 102/67, pulse 92. Pt. able to stay up and move around. Total episode lasted about 1 hour.
Shortness of breath started before chest pain. Chest pain was on the left side. Could not make it to urgent care but I am going for a check up 11/18/2021. No treatment other than hydrating, resting, monitoring blood pressure and oxygen saturation.
This spontaneous report was received from a other reporter, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided. On 13-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter, by oral route as prophylaxis (concentration was not reported; lot number 1742457 and expiration date 16-FEB-2022). According to the reporter, the temperature excursion was 1.3 degrees Celsius for a time frame of 19 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
hip joint pain on the left side; This is a spontaneous report received from a contactable consumer (reporting on herself). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266; Expiration Date: 31May2021) via an unspecified route of administration in Arm Right on 18Feb2021 13:15, as 2st dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) taken for an unspecified indication from 2019 and ongoing. Patient received first dose of BNT162B2 on 28Jan2021 for COVID-19 immunization. Patient received the second dose of the Covid-19 vaccine and has been having hip joint pain on the left side. Is there anything that she can do. She was concerned that it was from the vaccine. Physician address and zip code are unknown to patient. She received the vaccine on Thursday (18Feb2021) at 1:15pm. The pain started on Friday (19Feb2021). Yesterday it was worse but it is a little better today. The outcome of the event was recovering.
Starting on the day of the vaccine (2nd dose)- I felt really spacey, hallucinated at night and fever. I took ibuprofen.  I woke up the next day and noticed blurry vison in my left eye. Also had pain when moving the eye.  I developed left sided weakness and notice declining cognitive functions.  I felt extremely fatigue, difficulty swallowing,  tinnitus, difficulty walking and my left leg was wek and my balance was definitely  off.  After about 2 weeks, I decided to go to the Hospital Emergency Room. I had an MRI with and without contrast and diagnosedwith optical neuritis.  I saw opthamology on 2/9/2021 and they did all sorts of visual tests and referred me to neurology.  I saw my PCP on 2/12/2021 and was referred to Neurology.  I went to see a neurologist and was diagnosed with clinically isolated syndrome (precuror to multiple sclerosis) and had numerous MRI, blood work and EMG.
Information has been received from a registered nurse concerning a 16 year old female who on 15-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
This spontaneous report was received from a medical assistant referring to a patient of unknown age. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 for prophylaxis, 18 days earlier than specified in the prescribing information. No adverse event.