chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored ROTATEQ vaccine was administered to a patient from temperature excursion; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for the vaccine.  On 26-APR-2022, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally for use as directed to prevent rotavirus infection (lot # 1742415, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and validated as 12-OCT-2022) (product storage error).
pt recv vax & devel a prodrome of inc temp & mild general malaise approx 24hr prior to an eruption of lesions;pt devel a rash which was macular papular vesicular;
Information has been received from an investigator concerning a child who received a 1st dose of Prevnar as a part of a trial. On 06/27/00, the child was taken to a local clinic after waking from a nap with a red face, rubbing eyes that were closed. A diagnosis of possible seizure was made. The events were considered medically important. As of the date of this report, the investigator and the medical monitor assessments were unknown. Follow up information received on 04/19/2001 from the study investigator revealed the events were "outside the reportable window" and therefore, not related.  A follow up report received 12/03/2001 adds: Seen 07/05/2000 for follow-up to an ER visit on 6/27/00 for possible seizure. "Pt woke up from nap, seen rubbing eye, face red, eye closed. Dx'd possible seizure." Child born at 40 3/7 weeks (by dates). On day of discharge=breast fed well, good urinary output, passing stools, birth weight 8lbs 5oz. Exam of head at this time overlapping sutures, noggizal and coronal, very small anterior fontanel, only fingertip in size. Discharge note indicates pt to be observed closely for head circumference and resolution of overlapping sutures, otherwise, rule out craniosynostosis. 1/17/00 negative skull X-ray for premature synostosis. 6/26/00 11AM seen in ER (registered 6/27/00) for "At 2230 child rubbed his eyes then he appeared to pass out (mother) yelled and shook him and he gasp(ed) for air. Had just awakened ..ago." Review of symptoms: Temp 97 at ER. Pulse 124, Resp 28, O2 Sat 98%. Tugging at ears. TM's red, neck supple. "Gasped for air 2 wks ago." Neg for nausea/vomiting/diarrhea. Neg for hx of seizures. Eating well. Dx at this visit Acute altered level of consciousness-possible seizure. Acute OM. 7/5/00 seen for f/u in clinic. States: ER f/u seen 6/27/00. Just woke up from nap, seen rubbing eye, face red, eye closed slowly, fell forward, seemed alert afterward. No hx of seizure in family. Hx of ingestion. Negative CT and labs by report; no fever but said to have OM in ED, given shot. Well appearing at this time. Assessed ? seizure. 7/10/00 EEC done: Tracing within normal limits in the brief interpretable periods of the tracing, and a repeat tracing should be considered if the child's spells recur. Child has more visits, all without recurrence of above event or similar. 8/3/00 mentions normal EEG above without discussion of seizure like events. 11/24/00 well care, normal exam. 2/26/01 well care, recent OM otherwise normal exam. 9/20/01 well care, normal exam, normal development.
Inflamed, itchy hives showed up approximately 24hrs after the first dose of moderna was administered.  Have  lasted about 10 hrs now and no reduction in swelling or itching.
Rashes and hives on the entire body. Lip and eye swelling. Very itchy all over.
Got sick every time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick every time".  Additional information: I got sick every time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was given her 3rd dose of the pfizer vaccine early in her treatment day, before infusion began. Completed full infusion (2hrs) w/o incident. After infusion completed, PICC line dressing was changed and pt went to the restroom. Upon returning to the room (approx 30 min after completion of infusion), pt c/o SOB, scratchy throat and RN could hear audible wheezing. HR 79, BP 153/113 O2 in low 90s. O2 2L applied. Given 25mg diphenhydramine, 4mg dexamthosone, and an albuterol nebulizer treatment per covering provider orders. VS returned to baseline within 30 min, O2 weaned off. pt monitored in clinic for 1hr, discharged home in the company of friend/family member. Nurse coordinator checked in with patient the next morning, no further trouble breathing overnight. Covering provider felt symptoms were most consistent with reaction to oxaliplatin infusion, but reported to VAERS per clinic protocol.
approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals:  112/78, HR 69, 16 RR,A/0x3, As time progressed c/o achiness when she turns head side to side.  7:12pm c/o head felt foggy, improved chest tightness, heaviness in abdomen, achiness in R) arm pitdenies SOB, BP:110/78, Hr 66,  7:25: felt HR flutter occasionally, heaviness in legs increased and cont. light headed. but ROM WNL, Denies numbness/tingling, denies SOB, no swallowing problems during entire time.  Couldn't go back to work and went home with nursing instructions if heaviness were to increase or other symptoms worsen to call 911 or go to ER.  Taken home by mother and brother.  called next day and symptoms improved.
This spontaneous report was received from a registered nurse referring to an unspecified adult patient. The patient's concurrent conditions and medical history were not provided. On 13-NOV-2015 the patient was inadvertently vaccinated with pediatric RECOMBIVAX HB lot # K018180, expiration date on: 17-SEP-2016 (route and dose were not provided) instead of an adult dose of VAQTA, (dose, route, strength, lot number and expiration date were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
On the 17th, I developed sciatic pain on my right side, and I had cramping and tightness on right lateral aspect of my thigh and also tingling in my foot, and these symptoms would come and go. I had right back pain above buttock sporadically. It was the same situation if I ran far distance and it felt like I ran many miles. I did have a low-grade fever, headache, and I did see my PCP on 06/25 and I still had lingering symptom from 2nd dose at that point as well as vaginal paresthesia. My leg felt very tight, and my right foot was numb off and on. 2 hours after vaccine I got a headache; 6 hours after vaccine I developed fatigue; at the 12-hour mark I was sweating with fever and chills but took Tylenol and drank liquids. I also felt nauseated. The day after the right leg tightness started. I had been doing extra stretching exercises, but my leg was tingling, and I had that right foot numbness. On the 3-day mark was the vaginal paresthesia. The inner arch of my right foot and 4th and 5th toe were numb, almost like a pinched nerve. I was using ice on inner ankle that seemed to help a bit but my right glute area to thigh was very tight. I did have twitching again but this time it was right thumb on 06/22, and it was positional and since I do computer my finger would really twitch, but I had resumed life as normal and got used to it. I did start getting dry mouth on 06/21 and I do hydrate very well but I felt I was constantly not able to keep hydrated. Aside from that, I feel fine.
Muscle pain at left arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle pain at left arm) 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 MYALGIA (Muscle pain at left arm). At the time of the report, MYALGIA (Muscle pain at left arm) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information were reported.
Sudden hearing loss in my right ear. Complete hearing loss in a matter of seconds. Went to ENT next day, they put me on a steroid for 12 days, then I had a series of 3 steroid shots into my eardrum. I recovered some hearing, but still major loss. The steroid pill was: predniSONE (DELTASONE) 10 MG tablet, 60mg po QDx3 days, 40mg po QDx3days, 20mg po QDx3days, 10mg po QDx3days, Disp: 39 tablet, Rfl: 0
Painful (L) arm from injection site to neck and down arm. Has increased pain with mvt and c/o numbness/tingling of (L) forearm. Consistent with local hypersensitivity reaction.
I had severe muscle and joint pain on the day following the Booster. I woke up around 2 a.m with severe back pain. I laid on a heating pad, took a hot shower, and took Tylenol. Nothing relieved the pain, which progressively got worse. It became so severe that I wound up hunched over my bed on my knees almost in the fetal position due to being unable to straighten my back. I went to the ER the pain was so intense and severe. They examined me, said my back muscles had strained and siezed up. I was given a shot of tramedol(?) And sent home with a prescription for anti-inflammatory meds, and a muscle relaxer. The shot helped for roughly 6 hours, then the pain and stiffness in my back returned.  The following day the pain was lingering, but not as severe. It took over a week for me to be able to return to regular routine due to lingering pain and muscle stiffness. (Roughly 10 days from onset to completion)  The joint pain will now randomly hit me when the weather changes, as well as the back pain.
I had had dizziness a few days before that resolved on March 8th. On March 12th I got the vaccination. That evening, the dizziness came back but got much much worse so that over a day or two I was unable to get out of bed. What had been lightheadedness became fullon tilt-a-whirl, cannot safely walk, could only lie in bed for 10 days. I was finally able to get out of bed starting March 22nd.
pt recv vax 19OCT95 & 25MAR97 pt devel chickenpox consisting of 50-100 lesions;f/u info reported that no addl details were available d/t pt tracking method used @ MD office;
her heart began to race / have palpitations; felt very anxious for a couple of hours; reports having arm pain within 5 minutes of the vaccine; felt her chest tightening; This case was reported by a consumer via call center representative and described the occurrence of heart racing in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received Influenza vaccine (intramuscular). On an unknown date, 60 sec after receiving Influenza vaccine, the patient experienced heart racing, anxiety, pain in arm and chest tightness. On an unknown date, the outcome of the heart racing, anxiety, pain in arm and chest tightness were recovered/resolved.   It was unknown if the reporter considered the heart racing, anxiety, pain in arm and chest tightness to be related to Influenza vaccine.  Additional details were reported as follows: The patient received flu vaccine approximately 3 years ago in 2017 in her left arm at a pharmacy and within 60 seconds her heart began to race she had palpitations and she felt very anxious for a couple of hours. The patient reported arm pain within 5 minutes of the vaccine that was on and off for approximately 4 to 6 hours. She also described a moment when she sat in her car to call her physician and felt her chest tightening but eventually everything subsided. The reporter did not consent to follow up.
Possible transverse myelitis, i.e. sudden onset of weakness, decreased sensation, numbness of upper and lower extremities, up to sternum with urinary retention. Sudden onset 10/12/03. States got influenza vaccination 10/08/2003.  Nurse follow up on 07/27/04 states: "chest pain; nausea; vomiting; constipation; back pain; balance impaired. Per annual report-Pt has hyper reflexion, mild spasticity, gait disturbance and urinary incontinence. Pt work up at hospital with neurologist and neurosurgeon.  Neurologist thinks it secondary to cervical myelopathy secondary cervical stenomi-pt underwent surgery care.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) patients antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that office manager called in and stated that they got 10 vials Moderna vaccine (037C21A) delivered in on 24May2021 and immediately placed the vaccine into refrigerated storage. The indicated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator. The caller stated that they administered this vaccine to patients after this 30-day mark.   This case was linked to MOD-2021-415889 (Patient Link).
dizzy, sweating, clammy skin, light headed about 5 minutes after getting vaccine, lasted less than 10 min, he got a ride home just to be safe
Complains of numbness and tingling down Right arm from shoulder to fingers along ulnar distribution since vaccination. Exam completed by Occupational Health physician. Employee with continues symptoms referred to her own provider.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive again after previously testing negative; Negative, notes: Tested positive again after previously testing negative; Positive, notes: Tested positive again after previously testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid-19 treatment was done with paxlovid from 23Jul2022 to 28Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Severe muscle aches, shaking chills, fever, severe pain at injection site all started 12 hours after immunization. Not relieved by Tylenol or ibuprofen.
Localized arm pain, under arm swelling, headache, tiredness. Fever, chills, and SEVERE abdominal pain with diarrhea. Started within 24 hrs of booster and has continued for 3 days (still happening).  Taking electrolyte drinks for dehydration caused by diarrhea.
Pain in arm swollen lymph node with shooting pain. Joint pain as well. Leg cramps.
Patient was admitted with ischemic colitis and hypoglycemia.  She also tested positive for C.diff during her hospitalization, unclear if this was from prior antibiotics in March.  She did not receive DVT prophylaxis for 2 days.  She developed  a nonocclusive DVT in the right internal jugular and subclavian veins and a Nonocclusive superficial thrombosis in the right basilic vein on 4/18.  She went into PEA and was revived, intubated, and transferred to the ICU.  She went into PEA again and was revived after 5 rounds of CPR.  The family decided to make the patient comfort care and expired on 4/19
pt was fine upon leaving the pharmacy, developed shoulder pain late at night along with some numbness in arm which prompted a visit to the emergency room. US right upper extremity venous duplex Doppler was performed and showed a 7.2x5.2x5.6cm fluid collection in the subcutaneous soft tissues of the lateral upper arm. Pt was given rx for Norco for pain relief.
The night of the vaccine, I awoke with severe liver pain like a knife going through my liver and my kidneys were aching.  The severe liver pain came and went often for about 1 hour.  I nearly went to the emergency room but never did.  The rest of the night I would be woke by the sever liver pain off and on.  This continued the next day until eve.  As of bedtime only my kidneys ached then the day after that those symptoms were gone.  I had many of the other typical symptoms also they were very bad also.
Felt flushed and hot about 20 min after injections. Next A.M. went to urgent care for cough, feeling hot and shaky. Next day went back to urgent care and given Rx Z-Pak Dx bronchitis.
a mass grew within the muscle at the forearm region; minor pain; swelling; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 22Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included shellfish allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had first shot of BNT162B2 on 22Dec2020 09:00 then two weeks later a mass grew within the muscle at the forearm region, no ecchymosis with minor pain on 04Jan2021 11:45. The patient had heat pad applied to lower the swelling 04Jan2021 11:45. The outcome of the events was recovering. No treatment was given to the patient for the events minor pain and mass in forearm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number and expiry date for the suspect product will be requested in follow-up attempts.
After 1st shot- twitching/muscle spasm in left tricep  After 2nd shot- twitching/muscle spasm now in chest/ribs and stomach muscles  *no pain.  Just twitching/spasm all day non-stop
Dizziness, Headache, Pain @ injection site Narrative:  Other Relevant History:
Sat. 1/2 dollar size red area at injection site. By Sunday, four finger size wrapped around arm. Severe headache Sunday with vomiting.
Fever - temp up to 104.2 degrees per patient. Only able to get down to 102.0 degrees at home with ADVIL 600 mg. Arm red and painful. Advised to ER. Pt was admitted to rule out cellulitis. Infectious disease evaluated patient. Diagnosed with injection site reaction with serum sickness type reaction.
Back pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was recovered/resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The reporter was the patient.  The reporter reported patient received dose of Shingrix approximately two months ago. The reporter reported that patient experiencing back pain for approximately one week, after dose of Shingrix. The reporter did not consent to follow up.
Rapid, pounding pulse >120 bpm, able to hear heartbeat and rushing of blood  with heart pumps in ears when lying on side.  Resolved after 5 hours, now at 60 bpm.
Rash on the neck /chest/ back/ belly; Fever; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and RASH (Rash on the neck /chest/ back/ belly) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced RASH (Rash on the neck /chest/ back/ belly). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and RASH (Rash on the neck /chest/ back/ belly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient went to urgent care and received unspecified steroid shot and pills as treatment for the symptoms.
Patient complaints of wheezing at night and fells pressure on the chest and coughing starts about 2 weeks after vaccination but reported to me on 1/12/2009.
Became very tired at 7:30 pm - to bed by 9:30. Fell asleep right away. Woke at 1:00 a.m. unable to move.  My arms legs and body were too heavy to move. I had to call out to my fiance' to wake him to help me. He had to physically move my body, set me up with pillows. I was not able to swallow so it took a bit to get three ibuprofen down. I could breath ok but incredibly scary to not be able to move or swallow. Still very tired. Fell asleep sitting with head tipped to the side as I was afraid to throw up but couldn't speak to my fiance' to get a bucket. Woke up at 7:00 a.m. able to move all body parts. Throat still swollen but eventually I was able to swallow. Tired throughout the day. Light headed, weak, and dizzy.