chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel like he had the flu; He was achy; couldn't really move much; felt like everything was heavy; had to get up out of bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feel like he had the flu), PAIN (He was achy), HYPOKINESIA (couldn't really move much), DISCOMFORT (felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to get up out of bed) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feel like he had the flu), PAIN (He was achy), HYPOKINESIA (couldn't really move much), DISCOMFORT (felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to get up out of bed). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (feel like he had the flu), PAIN (He was achy), HYPOKINESIA (couldn't really move much), DISCOMFORT (felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to get up out of bed) outcome was unknown.            The reporter declined date of birth of the patient.  No concomitant drug was reported.  Dates of administration and lot numbers were unknown.  After 12 hours of the second dose the patient experienced adverse event.  Next morning on an unknown date of events occurred, patient took Ibuprofen.   This case was linked to MOD-2022-568876 (Patient Link).
This spontaneous report was received from a pharmacist who refers to an unspecified number of patients. The pharmacist reported that the patient's experienced mild injection site reaction (onset date was not provided) after vaccination with ZOSTAVAX (vaccination dates, doses, route, lot numbers were not reported). The outcome of adverse events were not reported. Additional information has been requested. This is one of several reports from the same source.
Upper respiratory infection, followed by severe diarrhea, projectile vomit, fever, herpes like rash spread over left side of back and upper buttocks, followed by rash covering entire lower extremities, arms and back. Followed by eczema on entire body and food allergies to foods he had been eating since 6 months old.
1 month after vaccination with rotarix , pediarix, hepb hib, pcv13 patient presented with bloody diarrhea. Patient diagnosed with the following:  (08/11 2058):,   X-ray showed, "Diffuse moderate to severe gaseous distention of bowel loops throughout the abdomen, consistent with obstruction.   Ultrasound performed the same day demonstrated, "An ileocolic intussusception.  There is an ileocolic intussusception with target sign (approximately 3.3 cm in diameter) noted in the right upper quadrant.  There is fluid trapped in the intussusception.  There is a large echogenic fatty core.  There is a small volume of simple ascites in the right upper quadrant.  Low lung volumes with diffuse hazy opacities.  No focal consolidations."  on 8/12: Ileocecal resection with primary anastomosis.  with ex lap after failure of
I received my second vaccination around 10:00 AM.  I waited 15 minutes in the pharmacy to make sure I didn't have any negative reactions before leaving.  I felt fine at 15 minute mark.  As I was driving home, I did feel a little off and my arm was a little sore on injection side.  All of a sudden, out of nowhere, my vision started to turn black starting from outside and tunneling in while I was driving 35 mph.  I didn't have much warning that I was going to black out but I did.  Before blacking out I tried to put my car in park out of reflex while going 35 then everything went dark.  When I awoke I thought I was going to wake up in bed.  I had a whole dream but realized quickly I was in my car then everything came back to me. Instead of the car being in park it was in reverse and I reversed the car into two other cars on the road.  Luckily no one was hurt.  I am very shaken up.  I am a healthy 36 year old and tolerated first does just fine.  People need to have others drive them after receiving vaccination.  If I was on the highway or had my kids in the car things could have been much different.
itchy hives on inside of left leg, left arm, and back over a  period of several months; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203), administered in arm left, administration date 04Mar2021 15:15 at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pre hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "bladder cancer" (unspecified if ongoing), notes: bladder cancer 15 years remission; "tonsillectomy" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "gall bladder removal" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; TERAZOSIN. Vaccination history included: BNT162B2 (Dose received: 1, Lot number: EL3302, Administration date:10Feb2021, Administration time: 03:15 PM, Vaccine location-Left arm), administration date: 10Feb2021, when the patient was 81 years old, for covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Apr2021, outcome "unknown", described as "itchy hives on inside of left leg, left arm, and back over a period of several months". The event "itchy hives on inside of left leg, left arm, and back over a period of several months" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Fine itchy, red rash all over her back. Itchy 1-2 days, lasted approximately 1 week. Did not take to MD.
Had cold symptoms in Nov - Dec. Flu symptoms 1st Jan. Saw P.C. 1/5/09, showed signs of choking often, called paramedics 1/18/09 - could not stand after a fall. Hospitalized that night 21 or 22nd Spinal tap done, treatment started.   4/3/09 MR received for DOS 1/27-2/23/2009 with D/C DX:  Dysphagia. Guillain-Barre Syndrome.  Hx of alcoholism and dementia.  Respiratory insufficiency.  Pt initially presented to local hospital 1/19/09 with profound progressive weakness and dx with GBS.  Intubated following a choking episode which resulted in acute respiratory distress. Developed LLL pneumonia and a small PE. TX with IVIG.  Transferred to current facility for vent mgmt 2' to increasing hypoxia and O2 requirements. Trach, IVC filter and PEG placed. Transferred to long term rehab 2/23/09
Injection site swollen, red, burning; injection site swollen, red, burning; Injection site swollen, red, burning; She was feeling bad; Chills; Chest pain; Flu like symptoms; She started to feel sick; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9265) via an unspecified route of administration in left arm on 06Feb2021 14:00 as dose 2, single (at the age of 47-years-old) for COVID-19 immunization. Patient medical history was not reported. The concomitant medications were  reported as none. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3249) via an unspecified route of administration in left arm on 20Jan2021 10:30 as dose 1, single for COVID-19 immunization. Vaccination Facility type was reported as School/Student Health Clinic. Vaccine was not administered at military facility. Consumer stated she was calling to report her side effects. She had the second shot on Saturday afternoon (06Feb2021 14:00) and was sick all day Sunday. She felt better on Monday and Tuesday. Added on Sunday when she was feeling bad (07Feb2021) she also noticed chest pain (07Feb2021). Clarified she received the first dose of the Pfizer COVID 19 vaccine on 20Jan2021 at 10: 30 in the left arm. Then she received the second dose of the Pfizer COVID 19 vaccine on 06Feb2021 at 14:00 in the left arm. She started to feel sick Saturday night (06Feb2021) with flu like symptoms (06Feb2021) and chills (07Feb2021). She also felt chest pain (07Feb2021) coming and going. Chest pain was one of the last symptoms. It lasted from the afternoon to the evening and went away. She was asking was this an expected side effect. Added she also had swelling, redness and burning at the injection site on 09Feb2021. She took some Benadryl at work from a co-worker but it did not help. She does not have any product or information for the Benadryl to provide UPC, lot or expiration date. The adverse events did not result in a visit to physician or ER. Description of complaint included consumer reporting an AE for the Pfizer COVID-19 vaccine mentioned she took some Benadryl at work from a co-worker but it did not help. She did not have any product or information for the Benadryl to provide UPC, lot or expiration date. The outcome of the event chills and chest pain was resolved on 07Feb2021, that of flu like symptoms was resolved on 08Feb201, that of feeling bad and feeling sick was unknown, while the outcome of the events injection site swollen, red, burning was resolving.   Follow-up attempts are completed. No further information is expected.
expected soreness at place of shot. around 12:30am Tuesday woke up sick to stomach and threw up multiple times and had diarrhea. This happened about every 3 hours from 12:30am Tuesday- 6:30pm Tuesday. It happened 1 more time Tuesday @ 10:30pm.  Felt nausea, tired and feverish the whole time.
MMR -> pt with measles rash starting approx 8/5 or 8/6. Presented 8/12/11. No fever. Cough which is resolving. Patient non toxic. Maculopapular non-blanching rash face/trunk/extremities/diaper area. Decreased appetite but drinking. Stable but rash 8/12/11.
Maculopapular vesicular rash on trunk, face, extremities, fever, pneumonia. Acyclovir from 05/08/02 to 5/20/02.
"milder" right arm rash/COVID Rash (arm); This spontaneous case was reported by a physician and describes the occurrence of RASH ("milder" right arm rash/COVID Rash (arm)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer and Thyroidectomy (10 years ago). Concurrent medical conditions included High cholesterol and Blood pressure high (Patient reported high blood pressure). Concomitant products included AMLODIPINE, VALSARTAN, CALCIUM, VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], SIMVASTATIN, LEVOTHYROXINE and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH ("milder" right arm rash/COVID Rash (arm)). On 08-Apr-2021, RASH ("milder" right arm rash/COVID Rash (arm)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was reported.   This case was linked to MOD-2021-053984, MOD-2021-053984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received and contain Non-significant information. On 11-Aug-2021: Non-Significant follow-up. Contact updated. On 13-Aug-2021: Non-Significant follow-up. Reporter type was updated to physician. Consent to follow-up given through email.
Patient reports that since yesterday (3 days after 2nd dose) he developed shortness of breath upon exertion and while at rest. Intermittent CP left side lasting seconds. Unknown modifiers. Intermittent lightheadedness.
Information has been received from a pharmacist concerning a pt who on 10/16/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 10/19/01, the pt developed erythema of the arm. Unspecified medical attention was sought. Additional information has been requested.
Hair loss Chest and jaw pain Persistent Eyeball pressure/pain  Throat pressure/fullness Severe debilitating generalized  joint pain followed by bone pain Debilitating hand joint pain in bilateral hands , worsening and more sever pain in thumb joints  Severe low back pain Fatigue and brain fog for months Severe leg fatigue-feeling as if weights are on my legs holding them down especially when attempting to walk upstairs  High abnormal Inflammatory lab tesults Severe asthma flare up requiring me to use my rescue inhaler more than I've used in the last 10 years combined
2 days of low grade fever, chills, night sweats, mild headache, and nausea without vomiting. Treated with acetaminophen and rest without relief. Symptoms resolved by 6pm on 2/1/2021. Also right arm tenderness that is ongoing but improved.
this happened during covid pandemic as pt stating she had redness at side of injection and heavy arm , pt said she became congested hard time breathing
The night of the 19th I had major aches, and freezinng cold and developed a fever.  Next morning woke up extremely dizzy, fell to the floor and threw up, and had a fever for 24 hrs, and with aches.
pt recvd vax 6JAN94 & became lethargic & stop breathing; 911 called & pt taken to ER; mom stated pt was breathing fine upon arrival but not responding to voice;
patient who received a dose of Menveo / was reconstituted on 14May2021   / stored in the refrigerator until 17May2021 when it was finally administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA549A, expiry date 28th February 2022) for prophylaxis.   On 14th May 2021, the patient received Menveo. On 14th May 2021, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: On 14th May 2021, a dose of Menveo was reconstituted and stored in the refrigerator which led to incorrect storage of drug. On 17th May 2021, the reconstituted vaccine was administered to the patient. The reporter consented to follow up via email.
This case involves Neonate female patient who had dermal swelling at injection site (injection site swelling) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious dermal swelling at injection site (injection site swelling) (unknown latency) following the administration of vaccine. It was unknown if the patient experienced any additional symptoms/events. No laboratory data reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the event. There would be no information on the batch number for this case.
The patient had mild chest discomfort 24-48hrs after receiving the second dose of Moderna COVID-19 vaccine dose but attributed it to winter colds, stress, etc. He attempted to sleep and woke up with severe chest pain and went to the ER.Troponin was elevated.  Echocardiogram demonstrated mildly reduced LV systolic function and cardiac MRI was consistent with myopericarditis.  EKG demonstrated Sinus rhythm rate of 57, diffuse ST elevation consistent with pericarditis, no ST depression, peaked T waves. He had elevated troponin at 6473 with a repeat of 8989, with reference range <=45 ng/L.  COVID-19 PCR was negative.  Chest x-ray was within normal limits.  Toradol and aspirin were given with improvement in symptoms. Hemoglobin and white count are normal.  Bilirubin was mildly elevated at 1.6 and AST at 51.  Elevated inflammatory markers: Sed rate 23 with a CRP of 6.8.   Three days prior to his second dose, the patient noted mild dyspnea with running, however he has asthma, it was winter, and he had not run in months, so he felt it was not unusual.  It is unclear if these symptoms could indicate the start of myopericarditis or other viral illness prior to his second dose of vaccine, however he had no other concerning symptoms and was otherwise active walking around his graduate school complex.
Patient received Pfizer COVID-19 2 shot series in March/April 2021. A booster dose was administered on 10-28-21. Patient has been receiving chemotherapy for lung cancer with last chemotherapy doses on 10-25 through 10-27. Patient was given infuenza vaccine on 10-27. Patient was admitted to hospital with neutropenic sepsis and acute pulmonary emboli on 11-3-21.
Information has been received from a physician concerning a 62 day old female patient who on 12-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 664537/1193Y) (Expiration date: 05-FEB-2011) instead of PREVNAR (human error in ordering the vaccine in the office computer system, not PQC). No adverse effect was reported. Follow up information was received via telephone call from a Licensed Practical Nurse concerning the 54 day old patient (previously reported as 62 day old). The nurse reported that she had given the patient a dose of PNEUMOVAX 23 because that was what the physician ordered. The patient had concomitantly received a first dose of ROTATEQ (Lot# 665020/1588Y) and a dose of PENTACEL (Lot# C3265AC). Additional information was received via telephone call from the Registered Nurse indicating that the physician had written the order to give the patient PREVNAR 13. The computer system had computed the physician's order as PNEUMOVAX 23. The patient received the PNEUMOVAX 23 instead of PREVNAR 13 due to a computer problem. The Registered Nurse also stated that the computer problem had been corrected. Follow-up information has been received from a physician who indicated that the female patient with no drugs reactions or allergies no birth defects, no medical conditions and no illness at the time of vaccination was vaccinated on 20-JUL-2010 with a second dose of RECOMBIVAX HB (lot # not reported). The physician also stated that in a telephone call to the child's grand mother on 13-AUG-2010 "the next day", she reported that the child had no fever, no swelling and was eating well. On 09-SEP-2010 the child was fine. No further information is available.
NASAL CONGESTION, SORE THROAT, COUGH, HEADACHE, FEVER, CHILLS MAB TREATMENT
During the night, around 10 pm, I was having body aches and would periodically wake up throughout the night. I was also getting hot and cold during the night. In the morning my shirt was soaked with sweat.
Patient came in to Health Unit on 04/27/21 with a complaint of headaches. Post mediacl officer (PMO) examened patient. Vital signs: BP-155/78, 128/83, HR-52, O2-100% on RA, T-36.7 C, RR-16. GCS 15/15, PERL. PMO referred patient to a neurologist - assessment GCS 15/15, PERL, no abnormatities detected. Neurologist ordered blood tests, and prescribed Naproxen 550 mg when suffering from a headache. Patient came back for multiple follow ups with persisting headaches. PMO referred to neurologist who ordered an MRI Head and prescribed UltraCod 500/30 mg BD. Conclusion from MRI: No indication of brain pathologyhas been obrained, relatively large retention cyst in the right maxillary cavity. Patient came back to Health Unit for MRI results. Patient continued to take UltraCod 500/30 mg tablets for 2 weeks. A check up on the 06/14/21 - patient stated that all headaches have subsided now. Has not had any headaches reacently. Spoke to patient over the phone on 04/08/21 - patient has not had any headaches now and said "everything had gone away overnight".
On 8/13/2021, 8/14/21 still feel heart elevated and fatigue.  Fever, chills, elevated heart rate, fatigue, pain at injection sight. Felt like I had covid again.
Dad states that the rash began on back area and progressed to abdomen and chest area. Seen by an MD on 5/17/00 and had slightly red, raised papular rash on trunk of body. Pt experienced irritability and an elevated temperature. Tylenol was given.
SUPPOSED TO ADMINISTER CHICKENPOX VACCINE NOT COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with BNT 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced supposed to administer chickenpox vaccine not covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of supposed to administer chickenpox vaccine not covid-19 vaccine was not reported. This report was non-serious.
I had cold sores; A spontaneous report was received from a consumer concerning a 75 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced oral herpes.  The patient's medical history was provided as sore lips and had breast cancer on her left side. The Concomitant medication reported was Livalo.  On 11 Feb 2021 , approximately 12 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection.   On 23 Feb 2021 tuesday, patient developed cold sores and she took Denavir which was prescribed to her earlier. The patient's second dose is due on 11 Mar 2011.She enquired if she can take the second dose.  The treatment taken for the events was reported as Denavir.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events were considered as resolving.
Clenching jaw and rigid body, lasted about 2-3 seconds and then opened eyes and felt tired. Positive urine incontinence. Pt was tired after for about 3-5 minutes but able to answer questions. Concern for syncope vs. seizure --- transferred to ED for evaluation and discharged home, referred to pediatric neurology for possible seizure.
Elevated Irregular Heartbeat.  Hospital admission on 5/3-5/6 for Tachycardia , cardiovascular testing and electrolytes replacement.  Potential POTS Postural Orthostatic Tachycardia Syndrome
This spontaneous report was received from a registered nurse, and refers to two unspecified patients of unknown age and gender. No information about the patients' medical history and concurrent conditions was provided. On 27-DEC-2017, the patient were vaccinated with improperly stored doses of VARIVAX (lot # N020686 with an expiration date in 13-JUL-2018), for prophylaxis that underwent a temperature excursion from -9 degrees Celsius to 8 degrees Celsius during 1 hour and 30 minutes. The doses underwent a previous temperature excursion from  -9 degrees Celsius to 8 degrees Celsius during 2 hours and 13 minutes, the vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown). Digital data logger was involved. No adverse events reported and no product quality complaint (PQC) was involved. As of 07-JUN-2018, all telephone attempts to obtain follow-up information have been unsuccessful.