chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STROKE; TYPE 2 DIABETES MELLITUS; VACCINATION ADVERSE REACTION/BAD REACTION TO THE VACCINE; PAIN DURING INJECTION/HURTS WHEN TOOK HUMIRA SHOT; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number not reported and expiry: unknown) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   The patient received non-company suspect drug adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis and moderate to severe ulcerative colitis. Age at time of vaccination 48 years old. No concomitant medications were reported. On an unspecified date, patient had a bad reaction to the covid-19 vaccine ad26.cov2.s vaccine (vaccination adverse reaction). The patient also had a stroke. As of 22-APR-2022, patient had type II diabetes mellitus (onset date not specified, reported as 2022). The patient felt hurt when he took adalimumab shot (pain during injection). It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from pain during injection/hurts when took Humira shot, and the outcome of stroke, type 2 diabetes mellitus and vaccination adverse reaction/bad reaction to the vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220458195-covid-19 vaccine ad26.cov2.s -Stroke and Type 2 Diabetes Mellitus . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Body aches, feverish c/o nausea, no vomiting the day. Vaccine administered.
pt recv vax 330PM & devel syncope approx 1hr later @ home;
This spontaneous report as received from a registered pharmacist refers to a 59 year old female patient who on 05-DEC-2013 the patient, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that on 18-MAR-2014, the patient came into the pharmacy with a prescription for acyclovir for treatment of shingles. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional infomration has been requested.
FATIGUE/EXHAUSTION; This spontaneous report received from a patient via a company representative concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included tumor pressing on spinal cord.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced fatigue/exhaustion. Laboratory data (dates unspecified) included: MRI (NR: not provided) MRI highlighted a tumor pressing on subject's spinal cord. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue/exhaustion. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
muscle aches; weakness; lack of appetite; tiredness; fever; feelings of passing out; stomach cramping; nausea; dry heaves; hot flashes; hot sweats; feeling the need to defecate; headache; body ache; A spontaneous report was received from a consumer  concerning a 75 year old, female patient who experienced stomach cramping/abdominal pain lower, nausea, dry heaves/retching, hot flashes/ hot flush, hot sweats/hyperhidrosis, feelings of passing out/loss of consciousness, feeling the need to defecate/defaecation urgency, tiredness/ fatigue, headache, body ache/ pain, fever/pyrexia, lack of appetite/ decreased appetite, weakness/ asthenia and muscle aches/myalgia.  The patient's medical history included esophageal cancer and kidney failure. Products known to have been used by the patient, within two weeks prior to the event, included tylenol and cyanocobalamin injections.  On 20 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in the left arm (deltoid) for prophylaxis of COVID-19 infection.   The patient had sudden onset of stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, and feeling the need to defecate beginning two hours post administration. The episode lasted approximately 4-5 minutes, and she felt better after she was finally able to produce a bowel movement (indicates BM had a horrible odor). The patient began experiencing additional symptoms of tiredness, headache, body aches, and fever during the night of 20 Mar 2021. The patient administered Tylenol to alleviate her symptoms and returned to bed. The patient reported sleeping the entire day 21 Mar 2021 and had little to no appetite. the patient had headache and fever resolved 21 Mar 2021 during the afternoon hours. The patient had continued tiredness and weakness lasting throughout the day on 22 Mar 2021. Her symptoms prevented her from performing her work obligations on 22 Mar 2021. The patient was feeling better on 23 Mar 2021 other than muscle aches. The event feelings of passing out was considered as medically significant. Treatment for the event included Tylenol.  Action taken with mrna-1273 in response to the events was not provided.  The events, stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, feeling the need to defecate, tiredness, headache, body ache, fever, lack of appetite, and weakness, were considered resolved. The outcome of event, muscle aches was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient had reported over the phone she started experience side effect today. Her injection site had lump and was itchy on the surface. Pt had used hydrocortisone to cope with the pain. It may be injection site lymphadenopathy and referred the patient to call her doctor
pt recv vax 23SEP97 & lt arm swollen & itchy @ inj site 24SEP97;advised MOC to contact child PMD ASAP;29SEP97 TC to MOC arm is fine;did not contact child PMD;told MOC to get PMD permission for 3rd hep b;
pruritic rash, recommended to use anti itch cortisone cream. Patient agrees to use cream sometime later today.  Also suggested to see primary provider if symptoms worsen.
Patient came to pharmacy 07/18/2023 and I routinely chech immunization history especially for elderly and noticed no pneumococcal immunization or shingrix. I told patient's daughter felt more comfortable only administering one of the vaccines Prevnar 20 and I automatically scheduled her first Shingrix 2 weeks out. I also called patient's MD  to make sure she had not gotten either vaccines. I called and spoke to office manager who then transferred me to voice mail wher I left message. The patient routinely gets all her vaccinations st our pharmacy and ones in the area . I did not hear back from doctor office until after I administered the Prevnar 20 vaccine. She stated that the patient had already gotten the prevnar 20 vaccine but not the shingrix. She talked to me in an accusatory tone at which point I stated I followed due diligence, did not see any record of pneumoccocal or shingrix vaccinations and proceeded with prevnar 20 .
Swelling and redness of both eyes. Went away in the morning. Wheezing and tightness of chest and shortness of breath. Took two doses of sulbutanol puffs every six hours for three times. Had sleep disturbance, body ache, felt uneasy and weak.
On left foot and ankle, slight swelling accompanied by a rash, apparently caused by inflammation of capillaries under the skin.  Treated with low dose of Prednisone for 3 days.   Much improved at end of that time; prednisone ceased; resolved (gone) within a few more days.
pt recv vax; adm to hosp due to fever and irritability; found to have an aseptic meningitis; CSF WBC=645, 100% lymphs; RBC=39; culture neg;
itching & swelling w/erythema in peri-orbital region;solumedrol & DPH given;
Nauseated; Dizzy; disoriented; cold sweats; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 59 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 18Mar2021 11:00 (Lot number: EN6204) at the age of 59 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "Nauseated"; DIZZINESS (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "Dizzy"; DISORIENTATION (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "disoriented"; COLD SWEAT (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "cold sweats". Therapeutic measures were not taken as a result of nausea, dizziness, disorientation and cold sweat.  Additional information: Caller reported side effects from covid-19 vaccine. Stated that he took that vaccine on 18Mar and within minutes was nauseated, dizzy, disoriented and had cold sweats. Stated that it lasted like 5 minutes. Stated that he cannot imagine what else could have caused it. Stated that within 2-3 minutes it just slammed him. Stated that it was his first shot. He was concerned about taking second dose based on his experience. Stated that his sister had no issues on the first one and had side effects similar to what he had for the second one. Stated that his sister already did a report. Report reference number not provided. The patient had not received any other vaccine within 4 weeks. Patient had no adverse events prior to vaccination and had not been tested since the vaccination. The patient was not diagnosed with other illness, medical history and chronic health conditions.  No follow-up attempts are possible. No further information is expected.
itching down there (vaginal area); itching anus; vomiting; This spontaneous case was reported by a patient and describes the occurrence of VULVOVAGINAL PRURITUS (itching down there (vaginal area)), ANAL PRURITUS (itching anus) and VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VULVOVAGINAL PRURITUS (itching down there (vaginal area)), ANAL PRURITUS (itching anus) and VOMITING (vomiting). On 18-Jan-2021, VOMITING (vomiting) had resolved. At the time of the report, VULVOVAGINAL PRURITUS (itching down there (vaginal area)) was resolving and ANAL PRURITUS (itching anus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient took pH balance cream (RepHresh vaginal cream), probiotic, and Clotrimazole cream for treatment of the events.
That evening arm ache then lymph nodes in right arm pit , leg, neck and total right side was slightly swollen. Lasted for 10 days.  Headache also for 7 days.  Feeling of coming down with something for first 2 days.  Advil did give relief
8-30-12: Tired, low appetite, sort of "out of it". 8-31-12: 11:00 am high fever, weakness in legs, low appetite 10 pm trouble sleeping through the night and still high fever. 9-1-12: 12 pm slept longer than usual and high fever, crying, low appetite - I gave her liquid generic TYLENOL. 9-2-12: 5 am she woke up screaming with 103 degrees fever; I gave her a cool bath. PM - she broke out with a rash on head, face, neck, chest, back, fever gone. 9-3- and 9-4: Still has spotted rash and more spotted dots, cranky so I have been nursing her a lot more to comfort her.
This case was reported by a nurse via call center representative and described the occurrence of headache in a 57-year-old female patient who received FLULAVAL Quadrivalent (batch number 93T79, expiry date June 2016). On 4th November 2015, the patient received FLULAVAL Quadrivalent (intramuscular) .5 ml. On 5th November 2015, 1 days after receiving FLULAVAL Quadrivalent, the patient experienced headache. In November 2015, the patient experienced increased blood pressure. The patient was treated with IMITREX. On an unknown date, the outcome of the headache and increased blood pressure were not recovered/not resolved. It was unknown if the reporter considered the headache and increased blood pressure to be related to FLULAVAL Quadrivalent. Additional details were received as follows: The patient experienced headache every day since she had received a dose of FLULAVAL Quadrivalent. In November 2015, less than a week after receiving FLULAVAL Quadrivalent, the patient also experienced blood pressure elevated.
Developed COVID-19 on 03/04/2023. Diagnosis based on two consecutive positive results using government-supplied self-test.
Initial much worse pain at site when compared to any other vaccines, incuding prior hx flu vaccines.  Following day pain improved but noticed erythema.  Today, 9/29 noticed swelling.  On PE, no fever. Tender (on deep palpation), indurated mass abt. 6X8 cm.  Overlying skin erythematous but smooth, non-tender and intact. C/W cold abscess.
First flu vaccine, ever. Evening of vaccine, approx 7:30, sudden onset of fatigue, aches and joint pain (wrists, ankles, hips,knees, shoulders...all over). Tightness in chest, breathing discomfort, and coughing when trying to take deep breath. Feeling like heart flutters. Headache (inc neck and ears). Symptoms have continued for 6 days now with a little improvement. Seeing Dr Thursday: 11/17.
Patient received her first dose at another Hospital and she received  at that time. Due to a scheduling glitch (resolved soon thereafter), she was only able to schedule an appt at Hospital for her second dose. She was inadvertently given other vaccine as her second dose. No adverse effects noted.
72 days since my first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (72 days since my first shot) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (72 days since my first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (72 days since my first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided  For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
A non-serious spontaneous report of 67-year-old received a dose of H1N1 LAIV was received from registered pharmacist/other health care professional concerning a 67-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Patient received his first and second dose in Jan and Feb. He scheduled this app as a "first dose" so was given a third dose in error.
Dizzy, started to feel feel better. refused transport. 137/86, 91,
dizzy; bones hurt; Feels weak, Low energy; States she also feels very emotional; joint pain; Feels very achy in all her muscles, especially in her legs and arms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional) and ARTHRALGIA (joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional), ARTHRALGIA (joint pain), MYALGIA (Feels very achy in all her muscles, especially in her legs and arms) and HEADACHE (Headache). At the time of the report, DIZZINESS (dizzy), BONE PAIN (bones hurt), ASTHENIA (Feels weak, Low energy), EMOTIONAL DISORDER (States she also feels very emotional), ARTHRALGIA (joint pain), MYALGIA (Feels very achy in all her muscles, especially in her legs and arms) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. No concomitant medications were reported.
Initial report received from a healthcare professional on 13 May 2013. A 66-year-old female patient, had received a dose of ADACEL vaccine (lot number: U4567AA, route of administration was not reported) in right deltoid on 06 May 2013. The patient had no relevant medical history or illness at time of vaccination. The patient had not received Tetanus vaccine since 1950. Concomitant medications were not reported. On 08 May 2013 i.e. 2 day after administration, the patient had developed swelling, redness, minimal itching to injection site that covered her upper arm above the elbow to shoulder and slight fever. The patient laboratory tests were not reported and the patient had received ibuprofen, BENADRYL and ice packs as corrective treatment. At the time of this report, the patient had not recovered. Documents held by sender were none. Follow-up information received from healthcare professional on 24 June 2013. The patient received vaccine intramuscularly in right arm. It was reported that, on 20 May 2013, the patient's arm was back to normal.
Following vaccine administration, patient c/o "tonsils feeling swollen". VS were checked. BP was elevated. ERT was called. Patient was assessed. Plan determined to monitor patient in clinic for additional 30 minutes. If no change, patient able to leave. Recheck of vitals shows lower BP, patient stated she is feeling better and less of a feeling in her throat. She decided to leave. She was provided instructions to return to the ED if symptoms got worse.
Walk-in patient reports left upper arm pain that stated late in the evening on 8/6/14 and have continued to get worse each day. He reports he was unable to sleep last night due to the pain, shivering & night sweats. He received a Tdap vaccine on 8/6/14. Currently the pain is in the arm & radiates throughout the left arm into his upper chest & antecubital area. Left upper arm is red, firm to palpation & slightly swollen. Explained to patient that to treat with ibuprofen & ice, but also the option of ER precaution is available for treatment to help with symptoms. Records provided to patient if he desires to go to ER.  Patient verbalized understanding.
Given at 2:10pm. Patient returned to work. Called back with tongue swelling. Told to take 2 Benadryl. She then called the ambulance. She will go to hospital.
I have been having muscle aches, join pains and stiffness for more than 2 weeks now - never have this problem prior ever. It is persistent
Urinary Tract Infection and infection in right ear. Treatment: antibiotics for urinary infection and antibiotic oil for ear infection. I got a terrible case of hives from the antibiotics. I had to go to the emergency room 11/23/2016 for a possible ITA and overall weakness in my body. Today I am taking pain pills for overall distress in my body. Before the shots (flu and pneumonia at the same time) I was swimming laps every day and was in excellent health.
Information has been received from a health professional concerning a female with a history of coeliac disease who on 18-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot # 655154/1210U). Concomitant therapy included SEASONIQUE. On 17-MAR-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot # 655327/1287U). On 17-MAR-2008, the patient experienced pain in left arm after administration in her left deltoid. The patient described the pain as "shooting down her arm to her fingers". The pain initially lasted 1-2 days and resolved. Subsequently the patient experienced reoccurring pain in arm and burning sensation in arm a couple of days later. The pain gets worse when she opens and closes her fist. When she closes her fist she gets a pain in her ring finger, little finger, and top of thumb. She also is experiencing a burning sensation down her arm. She is not able to use her arm and can not lift. The patient is being referred to a neurologist. The patient sought unspecified medical treatment via a telephone call to the office The patient's reoccurring pain in arm and burning sensation in arm persisted. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Follow up information received on 02-JUN-2008. The patient called the physician's office reporting that she had pain with injection which shot down to fingers. Sore 2-3 days. Reported burning sensation on left arm from shoulder to finger tips. No fever or redness at injection site. No pain relief with ibuprofen. The patient was referred to neurology for evaluation. On 28-MAY-2008 the patient was contacted. It was reported that the pain improved within 3 to 4 days and that the patient did not see the neurologist. The patient's outcome was recovered. Additional information has been requested.
This spontaneous report was received from a physician assistant refers to a female patient of unknown age. The patient has no pertinent medical history. Concomitant therapy included sterile diluent. The patient had drug allergy for pork. On an unknown date the patient was vaccinated with VARIVAX (dose, units and frequency were unknown) (lot # and expiry date was not reported) for prevention of chicken pox. On an unknown date the patient had a varicella titre, with the result that showed a low titre (viral titre decreased). It was reported that no treatment was given for the event low titre. It was also reported that the patient sought treatment from reporter. It was reported that no intervention was performed to prevent the serious criteria. The outcome of the event low titre was not recovered. The casual relationship between the event low titre and VARIVAX was not provided. There was no product quality complaint (PQC) reported.
Patient came in to Arexvy vaccine and given Arexvy and Boostrix.
Headache, nausea, high fever, muscle pain, nerve pain, diarrhea, vomiting, exhaustion