chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unconsolable crying for 6 or more hours.  Tylenol and Ibuprofen giving alternately every 4 hours.
Information has been received from a pharmacist referring to a 73 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were unknown. On 07-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot# M024673, expiration date 17-NOV-2017, dose unknown) intramuscularly for prophylaxis. On the same day, 2 hours after the injection, the patient experienced extreme pain at the injection site with inability to lift the affected arm, and also experienced fever of 102 Fahrenheit degree (F). The patient was advised by pharmacist to take ADVIL and applied ice compresses. No lab diagnosis was performed. The outcome of the events was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The pharmacist was requesting a lot check of lot # M024673. This is one of several reports received from the same reporter. An investigation into the manufacture of lot number: M024673 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information has been requested. Sender's Comments: US-009507513-1609USA005896: US-009507513-1609USA006593: MERCK 1609USA006594:Mfr number.
Patient reported a 102 degree fever, a really sore arm, and was nauseated.
Mild headache after first dose; This is a spontaneous report from a non-contactable consumer (patient). A  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After the first dose, she only had a mild headache. The outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 21-JAN-2019, the patient was inadvertently vaccinated with M-M-R II (therapy type: rHA, lot # M045394, expiration date 14-NOV-2018, one injection, strength and frequency were not reported) subcutaneously for prophylaxis. The patient did not experience any reaction. The outcome of the event was unknown.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment drugs were reported.   This case was linked to MOD-2021-083175 (Patient Link).
Extremely sore arm 1 hour following vaccination  Body aches 6 hours after vaccination  Joint stiffness, headache, chills 9 hours after vaccination
Pt. diagnosed with Guillain-Barre Syndrome. Pt. placed on IGG. Symptoms included: numbness/weakness in upper and lower extremities, difficulty breathing.
Fever, hives, flushed face, general weakness, dizziness, lightheadedness. Took Tylenol but did not really help. Hives on arms and chest.
Assessment  Differential Diagnoses  URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation  Red Flag Symptoms Shortness of breath, fever, chest tightness, chest pain, palpitations, wheezing   Subjective  Chief Complaint Headache and myalgias   HPI  via Virtual visit  24 year old female complains of COVID-19.  Patient is a nurse at the hospital.  Yesterday, she developed a headache along with neck and shoulders achiness.  Last night, she came home with no appetite, has pressure in her chest.  Feels tight and makes her cough.  She has had 1 dose of of the covid vaccine.  Denies fever.  Has no headache currently.  She has not taken anything.
Severe Joint pain; Muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe Joint pain), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Clotting disorder (Clotting concerns) and Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Hypercholesterolaemia, ASPIRIN [ACETYLSALICYLIC ACID] for Thrombosis, SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]), ETHINYLESTRADIOL, NORGESTIMATE (TRINESSA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ESCITALOPRAM OXALATE (LEXAPRO) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Severe Joint pain), MYALGIA (Muscle pain) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Severe Joint pain), MYALGIA (Muscle pain) and HEADACHE (Headache) outcome was unknown.            Treatment information was not provided. It was reported that  Patient when she got the vaccine it was extremely painful and sharp the shot, and she had bleeding on the injection site for +15 hrs there was lots of fresh bleeding. It's starting to bruise underneath.   This case was linked to MOD-2021-366416, MOD-2021-366435 (Patient Link).
Client received first dose of vaccine @ 9:55 am.  Complained of throat tightness @ 10:10 am while in observation.  Client denied trouble breathing, shortness of breath.  Vital signs within normal limits.  Client was given Benadryl 50 mg oral route.  Client reports taking Benadryl in the past for allergic reactions.  Vital signs remained stable, continued observation.  At 10:21 am client reported throat tightness almost gone, 3/10 on scale.  At 10:41 am, client reports no throat tightness, 0/10 on scale.  Client instructed to follow up with primary care and when to call 911.  Client was able to leave observation area @ 10:45am.  At 10:55 am, client returned to site for "residual chest tightness".  RN offered to call 911, client refused, requests to sit in chair and wait to see if symptom resolves.  At 11:09 am, vital signs stable and client reports she feels better.  At 11:14 am, client is able to stand and walk, denies "residual chest tightness" or feeling drowsy.  Client leaves observation area @ 11:15 am with steady gait.
Erythema Multiforme and swelling of arm. Diphenhydramine 25 mg PRN.
DVT Right femoral vein on left leg. Blood clot behind left knee in popliteal vein that wont go away.  Was on blood thinners. Then put on  blood thinners again after appearance of clot behind the knee. Possible new blood clot having another ultrasound this week. Been 2 years off and on blood thinners. Never had this until the covid vaccine. Left arm will hurt, left elbow pain and shoulder. Left arm feels weaker.
My left arm was sore a couple of hours after the injection. It continued to get worse throughout the day. That night had a hard time sleeping as it was painful and kept waking me up. I believed it would just get better on its own. It is now 2 days after the vaccine and again another restless night of pain. It is not getting better but seems to be moving down my arm. The injection was at the top of my shoulder, it is uncomfortable about 3 inches down my arm. I broke my shoulder In April of 2019,  It feels just like that  as I try to move my arm around.
Developed macular papular rash to chest, back and upper arms. Total of 15-20 pustules with obvious signs of recovering.
One week after the vaccine: Large, red welt on my left arm at the injection site that is very itchy.  I'm tired, a little loopy, achy and just generally not feeling that great.
Initial and follow up information has been received from a physician and a physician's office concerning a 60 year old retired female with a history of allergies to erythromycin, acetaminophen (+) propoxyphene napsylate (DARVOCET), doxycycline (DOXYCLIN, as reported as doxycline). On 07-DEC-2007, between 10 and 10:30 am, the patient was vaccinated subcutaneous in the left arm with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 658450/1380U). On 07-DEC-2007, between 10 and 10:30 am, the patient experienced a site reaction following pneumococcal 23v polysaccharide vaccine. A knot formed and there was swelling, redness and tenderness at the site. Follow up information indicated that the patient stated "having a great deal of pain". The left arm did not appear to be particularly swollen. The patient stated "it hurt to move: move muscle". No relevant diagnostic studies or laboratory tests were performed. Physicial illness at time of vaccination included: hyperlip, GERD, arthritis, and leg pain. In follow up it was reported that the patient recovered on an unspecified date.
Extremely fatigue , restless sleep at night, headache, running fever periodically, but that went away, I felt like i had the flu, I also have brain fog, trouble concentrating.  Went to my psychiatrist and asked if my meds were too strong. He said  Medication was fine.  My Primary care doctor suggested a sleep study and a cardiac work up because I was having excessive night time sweating  which i didn't have prior to my vaccine, and extreme fatigue. I am falling asleep  behind  the wheel and at my desk at work while someone is talking to me.  My anxiety and depression has gotten worse and i am contributing it to everything  that is going on.
My son was given Moderna and he wasnt supposed to because he is under the age of 18.  i didnt realize this until we went to get his second vaccine shot.    when they saw that he had moderna and he shouldnt have because it hasnt been approved for minors yet, they informed me that they will not give him any vaccine because of liabilities.   they asked me to talk to his pediatrician.    I did and he said lets wait.    so, when he did get his initial moderna shot,   He started complaining of indigestion and his stomach hurt.   he couldnt eat and he had stomach distention.   he looked like he was four months pregnant and he normally has a flat stomach.  he is thin.   along with that.....his face was swollen, eyes and lips looked puffy and a little distorted.    his throat wasnt swelling, so i just kept giving him benydryll and allergy meds.        this lasted a week and a half.     Because my son had this adverse reaction, We are all afraid to give him any second dose of the vaccine.
31 year old with onset of arm and leg urticaria 10 days after first Pfizer COVID-19 vaccine.  No immediate reaction.  No prior history of allergy or urticaria.  No other suspected recent food, medication, illness, or environmental trigger identified.  Managed with standard antihistamine for urticaria.  Advised to get second vaccine as normally recommended.
pt recvd flu vax & devel warmth, redness, & induration @ site of inject; 22OCT92 inject site began itching & was painful to touch;
Headache for 3 days after vaccination, sore arm for  a few days theses symptoms started the next day.  approximately 5 days I later notice a rash in the abdominal area.  Rash slowly spread to chest, arm pits, groin and now next and shoulders.  The rash has been getting progressively worse.  I went to urgent care on 9/13/21.   I was told to wait on getting the second dose unitl can see my primary physicians and/or to set an appointment with dermatology.  I was seen by dermatology on 9/21/21 and given a  Diagnosis of Pityriasis Rosea. The doctor indicated that this is a rare finding however there are reports of this post vaccine.  Ias of today the symptoms or rash continue to worsen.  The rash is now very itchy and covers most of my body with the exception of my lower legs and lower arms.
This case was reportd by a pharmacist and described the occurrence of drug dose administration intreval too short in a 43-year-old male patient who received HAVRIX adult (batch number PC527, expiry date 8th June 2015). Concomitant products included HAVRIX (adult). On 29th September 2014, the patient received the 2nd dose of HAVRIX adult. On 29th September 2014, an unknowntime after receiving HAVRIX adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the drug dose administration interval too short to be related to HAVRIX adult. Additional information: On 29 September 2014, the patient received a 1st dose of HAVRIX. On 29 September 2014, a 2nd dose of HAVRIX was given by mistake which led to maladministration "drug dose administration interval too short". The local recommendation was 6 to 12 months between the 2 doses.
Clinical Summary Patient is a 81 y.o. female with a history of HTN, IDDM2 w/ neuropathy, HLD, COVID-19 infection (11/5/20) and hypothyroidism who presented to hospital Observation 4/21/2021 from AL s/p fall with right knee/hip pain. Admit Hgb 12.0, COVID-19 +. CT right knee showed large hematoma in the prepatellar region measuring up to 16.4 cm. Evaluated by ortho, recommended supportive measures.    1. Traumatic Hematoma of Right Knee: s/p fall as detailed below. Patient endorsed immediate pain to her right hip/knee, described as sharp/aching with muscle spasms. Denied numbness/tingling. Admit CT pelvis non-acute, CT right knee as above. Held ASA. Pain control, ice, elevation. CBC remained stable. Ortho followed, recommend continued monitoring of skin integrity and local wound care.   2. Left Forehead Hematoma: s/p fall. Admit Hgb stable. CTH on admit with noted hematoma, otherwise unremarkable. Encouraged ice, pain control.  3. Mechanical Fall: Patient tripped and fell in the hallway at her AL facility while participating in fire drill. Denied LOC, did strike head on a nearby shelf. Initially reported dizziness that has since resolved, continued gentle IVF.  4. COVID-19 Infection: asymptomatic. Patient initially tested + for COVID-19 11/5/20, and received her 2nd vaccination 2/10/21. Denied dyspnea, chest pain, fevers/chills, cough. Discussed with infection prevention, will require additional 10-day isolation (last day 4/30/21). Isolation precautions, supportive care.
Patient states she had vaccination on Thursday, February 25, 2016 and states that side effects consisted of headache, nausea, chills, fever redness/swelling at the injection site. Patient states she had taken ibuprofen, TYLENOL, and BENADRYL prophylactically or the side effects would've been worse. Patient states she's back to normal now (3/1/16).
This report has been received from an registered nurse who reported that an unspecified patient. On an unknown date in February 2012, on an unknown date in September 2012 and 09-AUG-2013 (today) the patient was vaccinated with the first, second and third doses of GARDASIL (lot#, dose, route, indication not reported). No known adverse effect reported. Additional information has been requested.
Have been running low grade fever accompanied with chills off and on since 1/13  noon.  Up to now, today  only normal fever. Had ingested 2 Extra strength Tylenol at 5:30 am and 11:30 am.
almost fainted felt lightheaded & dizzy, nauseated; up all noc w/school activity & only last ate @ 6AM; BP 102/60, cool washcloth given applejuice & crackers;
Information has been received from a physician concerning a 2 month old female who on 18-DEC-2006 was vaccinated with a 2ml oral dose of Rotateq. Concomitant vaccinations administered that day included a dose of Comvax, ad dose of Dtap, Polio and a dose of Prevnar. Later the day the patient experienced on or more episodes of vomiting. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
22 Jan 2021-Friday-Tired,SOB 23 Jan 2021-Saturday-Tired 24th Jan 2021-Sunday-folding laundry-winded & tired 25th Jan 2021-Monday-winded, tired-climbing stairs 26th Jan 2021-tired & winded, 27th same, 28th Tired & winded 29th Today January-2021-Tired & winded-Reminded patient to GO to ER if his SOB get worse, or see his PCM Took naproxen for his tiredness
On July 9th, 2021 around midnight I had a fever of 102, I called my OBGYN hotline around 3:00AM  for a appointment and they advised me to take Tylenol. The fever continued until Saturday , July 10, 2021 and fluctuated to 100 to 101 and by the afternoon it was gone.   I also had an appointment on July 9th , 2021 with my Dr. and he told me to continue to take the Tylenol.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and unknown gender. Information about concurrent condition, concomitant medication or medical history was not provided. On or about 23-JUN-2014 the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a pharmacist for the long term prevention of shingles and/or zoster-related conditions. At the time of pt's vaccination, pt relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the pt to be vaccinated.  On an unspecified date (reported as subsequent to inoculation), the pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live(ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered as not recovered. The causality was assessed as related by the lawyer and the patient.
p/vax swelling lt leg; took pt to ER due to inc swelling; was given benadryl & swelling subsided; also noted red rash at inj site; mom  told incident was allergic react to shot
Information has been received from a physician to a 19 year old female patient with immunosuppression. On 16-JUN-2016, at 11 am Mountain Time, the patient was vaccinated with VARIVAX (lot # L046885, expiration date 23-NOV-2017, in the right arm; route unknown) while on HUMIRA (which the physician reported to be an immunosuppression medication, which was other-than-indicated in the Prescribing information) (product use issue). The patient had not experienced any adverse effects. Additional information has been requested.
1/24/21 sx Red & sore at site for 2-3 days.  1/28/21 sx worsen Palm size rash and edema, hot & itchy for 4-5 days and subsided.  Asx now.  apap PM at HS and cortisone cream used.  Plan to follow-up with PCP and if risk > 2nd vaccine benefits.
Rash/bumps on body, no temps, was advised during conversation with mom at 1;45pm regarding her sons Sx's (see VAERS report number E-77414). Advised she should take her daughter to PCP for further evaluation today. Mom did note daughter had previous rash unrelated to vaccination. seen a dermatologist previously.
Neon green poop. Non stop screaming and crying. Belly pain. Fussiness days later.
Diffuse macular papular rash beginning on face, edematous hands/feet, tonsillitis, fever to 103.3.  CBC: wnl; Symptomatic care; Rapid strep: neg; Follow up in 3 days-RR if course s/s.
Tenderness; More than half solution leaked; Leaked out of arm; This case was reported by a physician via call center representative and described the occurrence of accidental underdose in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix. On 10th October 2020, unknown after receiving Shingrix, the patient experienced accidental underdose and exposure via skin contact. On 11th October 2020, the patient experienced tenderness. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and tenderness were unknown.   It was unknown if the reporter considered the tenderness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician reported that while giving 1st Shingrix more than half solution leaked out of arm, which led to accidental underdose and exposure via skin contact. The patient had some tenderness next day of vaccination. The reporter consented to follow up. This case has been linked with the case US2020206895, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206895:same reporter, different patient
A lot of pain in the neck and arm appearance of balls in the neck chest pain tingling in the left arm. The pain is also in the back on the left side, headache.
AE started on Jan/3/2022 as a cramp in calf of righ leg which resolved in a day without treatment. Cramp re-started in calf of the same leg on Jan/12/2022, and extended to upper leg muscles on Jan/13/2022 which did not resolve. In the morning of Jan/15/2022 I felt short of breath and weakness after minor physical activity and went to seek emergency care and was immediately hospitalized with bilaterlal pulmonary embolism and deep vein thrombosis in right leg.
HIGH BLOOD PRESSURE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported. Per-procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high blood pressure was not reported. This report was non-serious.