chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching all over her head, neck and arms/Extreme itchiness; Runny nose; Felt like she had a mild cold; Muscle pain; Underarm swelling of her lymph nodes; Raised red spot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain) and PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Right arm with Severe swelling, redness, tenderness, patient states it is "hot" to touch in deltoid region where Anthrax vaccine was administered. Pt has limited mobility in Right arm. Pain is radiating down right arm and shoulder.
PATIENT INDICATES THAT HE BECAME BLOATED, HE WAS A SKINNY MAN - NOW HE IS VERY BLOATED
About 5 minutes after injection patient injection site started burning, itching and became painful. About 5cm area around the injection site was red, warm  and tender to touch. She started to feel dizzy so I had her lay flat on examination table. I placed pulse ox on her it it showed o2 of 98 and pulse of 82. I applied ice pak to injection site to help with discomfort. At about 15 minutes after injection she started to have tingling around her mouth. She denied any SOB or throat irritation. SHe was taking with out any problems. I gave her 25mg IM benadryl. I recommend ambulance being called but she declined as she was starting to feel better. Her husband was with her. She left the clinic about 1010 walking on her own feeling better. Her husband was to drive her home. ER precautions discussed. Patient agreed to proceed as planned. Advised her not to get dose 2.
fever, muscle ache, change of menstrual cycle and heavier menstrual bleeding. My menstrual cycle started unexpectedly and immediately following the vaccination on both 1st and 2nd dose.
Pocket of swelling under left arm, fever over 101 (started at 1am Sunday morning), allergy effects (runny nose, sneezing, coughing-all day Sunday), swelling of the cheeks, swelling of both eye lids and surrounding area (left eye worse), stabbing pain all over face in waves, starting at sinus area, going down to the teeth, back up to the jaw and ears and down the throat, and hit and cold sweats (all the last symptoms were from 8pm Sunday night to 5am Monday morning).
Information has been received from a mother, for GARDASIL, a Pregnancy Registry product, concerning her 20 year old daughter with penicillin allergy and no pertinent medical history, who on 09-AUG-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # not reported). There was no concomitant medication. The patient told the physician that she was not pregnant before she received a shot. The mother reported that the patient became pregnant 4 or 5 days prior to getting the shot. On an unspecified date, the patient had blood tests taken (the results not reported). The patient did not seek medical attention. Follow-up information has been received from an administrator reporting from the patient's chart that the patient (LMP: on approximately 28-JUL-2010, EDD: on approximately 05-MAY-2011) delivered a healthy female baby on 01-APR-2011 via C-section (cesarean section). The neonate weighed 7 lbs. 0 oz. at 35 weeks gestation. There were no congenital anomalies noted in the patient's OB/delivery record. Upon internal review, the C-section was determined to be an other important medical event. The baby's experience has been captured in WAES1009USA00163B1. Additional information is not expected.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N001533, expiration date 16-OCT-2019 (dose and route were not reported) for prophylaxis. No adverse effects reported. The temperature involved was 32 degrees Fahrenheit up to 35 degrees Fahrenheit (33 degrees Fahrenheit) for 15 hours 30 minutes. A previous temperature excursion was reported as below 32 degrees Fahrenheit (30 degrees Fahrenheit) for 10 minutes. A data logger was involved.
" Called to vaccine table for pt feeling faint. Pt reports similar response to vaccinations in the past. No hx of allergies. Patient presents to the peds ED after experiencing dizziness, vomiting, and vision changes after receiving her first dose of the COVID vaccine (pfizer). Pt states she normally gets lightheaded with needles, but never to this extent in the past. Pt states that immediately after receiving her COVID vaccine, she became lightheaded, had tunnel vision, and vomited. Pt states that she was taken to another room where she vomited. In that room, she was noted to be cold and clammy. EMS notes pt's systolic BP was in the 80's, but improved to a high of 116/69. Pt noted vomiting x3.   Pt notes she did take plan B on 3/21 and LMP was about 5 days ago. Pt denies any PMHx, medications, allergies, family history, or surgeries.    In the ED, pt noted that she was feeling a lot better and was no longer dizzy/lightheaded. Reports Nausea, dizziness and weakness. Pt transferred to triage area. Pt had uncontrolled vomiting. Transferred care to onsite EMS for transport to local ED."
Shingles vaccination: Next few days had increased swelling hardness, heat (hot) Redness cont to spread also itching + aching + soreness - spoke with a pharmacist 2 days after vaccination. She encouraged me to see MD or nurse if not better the next day - not better in am - used ice packs at nite (on+off) no relief first two nights - Then 4 days later had decreased symptoms - only slight red now (12 days later) no relief with ice the first nite + minimal the next nite.
Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB. Subsequently the patient experienced an adverse event. Additional information has been requested.
described as feeling crummy; the lymph nodes swelled; being hard to breathe; Initial information regarding an unsolicited valid non serious case was received from physician via Medical Information (Reference number: 00840271) and transmitted to Sanofi on 03-Nov-2021.  This case involves a 38-year-old female patient who experienced described as feeling crummy (feeling abnormal), the lymph nodes swelled (lymphadenopathy) and being hard to breathe (dyspnoea) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious described as feeling crummy (feeling abnormal), the lymph nodes swelled (lymphadenopathy), being hard to breathe (dyspnoea) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient was treated with PREDNISONE.  It was reported "A Physician reporting on behalf of a female receiving Fluzone Quadrivalent 2019/2020 experiencing a delayed reaction, after getting the vaccine, described as feeling crummy, the lymph nodes swelled and being hard to breathe. The Physician reported that the consumer went to urgent care; that she underwent a 6-day prednisone course."  It was unknown if the patient experienced any additional symptoms/events.  At time of reporting, the outcome was unknown for the reported event.  On an unknown date, patient recovered for the feeling abnormal, lymphadenopathy, dyspnoea.  There will be no information available on the batch number for this case.
Little aching in the shoulder part; Little soreness in the muscle; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Jan2021 to Jan2021 at a single dose for COVID-19 immunization. Medical history included pain in her leg from a surgery; she said that she was taking Tylenol for it. It was reported that the patient just took the first dose of Covid 19 Vaccine yesterday and felt a little aching in the shoulder part, also Little soreness in the muscle; she wants to know as well if it's fine to take her daily medication Tylenol. She said that it is a little soreness in the muscle. The outcome of the events was unknown. Information on the lot/batch number has been requested.
arm rash; itchy eyes; itchy throat; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced rash, eye pruritus and itchy throat. On an unknown date, the outcome of the rash, eye pruritus and itchy throat were recovered/resolved.   It was unknown if the reporter considered the rash, eye pruritus and itchy throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Aftter receiving Shingrix, the patient experienced a rash on the arm, itchy eyes and itchy throat. The reporter consented to follow up.
This spontaneous report was received from a currently 28 year old male patient reporting on himself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient reported that after receiving GARDASIL 9 on an unspecified date, he was diagnosed with acoustic autism (autism spectrum disorder). He stated that the health care provider who diagnosed was from the trailer park. During the report the patient made "hic hic hic" noises. At the time of the report, the outcome of autism spectrum disorder was unknown. The patient did not mention the causality assessment between the event of autism spectrum disorder and GARDASIL 9. Upon internal review, autism spectrum disorder  was determined to be a medically significant event.
p/vax pt tried to red, but couldn't focus-vision blurred, vague discomfort & pressure about ocular area;
Noted some redness of right leg within 30 minutes of vaccine. Swelling started later that night, worsening the following morning in same thigh. Pain with walking, limping. No fevers. Not complains of itching. No streaking. Normal oral intake and uop. No vomiting or diarrhea, no breathing problems. Given Allegra the evening that the swelling first started. When seen in the office had induration of 12X10 cm on right lateral thigh, centered around injection site, indurated area is warm, extremely tender to palpation, minimal erythema of right thigh compared to left, but diffuse, and not localized to injection site.  Right thigh circumference at site of injection 30.5 cm. Full passive ROM of right and left thigh.  Walks favoring right leg, but can bear weight on right leg. Swelling does not cross hip or knee. Swelling improved over the next 48 hours on Benadryl/Allegra, never developed worsening redness or fevers. Had same reaction to flu shot last year.
Immediate onset of-Headache, fever, chills, nausea, tiredness, sore arm, upset stomach still 1 week after
major headache for three days, first night felt like there were hot electrodes zapping through my hand joints these were severe enough to bring tears to my eyes. night sweats for three nights with 102 temp.  shoulder joints, knee joints and left hip joint were also affected
I have had Paroxysmal AFib since 2012 and had an ablation in 2016.  It cured the Afib about 90-95 percent, but I still get intermittent episodes, ALWAYS brought on by some catalyst, (alcohol, sexual relations, drinking a cold beverage, exercise).  However, appr. two weeks after the vaccine, I began getting random bouts of Afib, longer in episodes, but shorter in duration.  Since the vaccine, I have had appr. 12+ episodes of Afib, occurring at various times, even at rest.  Since the ablation, I got about 12 episodes per year, now it's been 12 episodes in 2 months.  Sometimes, I'll get several episodes a day, at random times for no reason.  This has been totally opposite of what I was experiencing pre-vaccine.  What concerns me is that the episodes are random and there are not catalysts to bring them on.
Six hours after receiving booster, began feeling hot/cold. Fever 39 C. Except for the most basic of bodily functions, spent 24+ hours in bed. Sweaty, stomach/abdominal cramping. Ultra sensitive to everything.  Began feeling somewhat "normal" on Saturday, 02 October at about 1130 hours.  Symptoms are gone, though I still feel a bit weak.
there was no adverse reaction. vaccine was given to a 17 year old. no reaction. pt is aware. pt will come back in 28 days for 2nd vaccine of moderna per cdc recommendation
headache, body ache, chills started 8 hours after 2nd dose and lasted almost 24 hours with occurring headache still today.
pt recvd vax & devel a fever of 103-105 10 day p/vax; No further details were provided; MD reported 15 similar pts;
Extreme chills / Fever / Muscle aches / Joint Pain / Nausea / Passed out X3 / Lack of apatite / Restlessness / Constipation
Patient is an 18 year old female with no PMHx that presented with lightheadedness and three subsequent episodes of syncope approximately 3-10 minutes post-vaccination. Patient was found to have an abrasion to the outer corner of her right eyebrow following an unwitnessed. It was unknown if patient was seated or standing at the time. The nurse first on scene states the patient lost consciousness briefly again and experienced approximately 10 seconds of upper extremity muscle contractions (described as convulsions). Patient experienced a loss of bladder control upon loss of consciousness. Patient was lowered to the ground to be in a supine position by healthcare staff. At this time, patient was alert and oriented without agitation or confusion. Patient denies memory of the event. She states she had prior episodes of fainting after blood draw.   Patient has no allergies to medication or food. No past surgical history. No prior hospitalizations. Denies personal and family history seizure disorders, cardiac disturbances, and hypoglycemic or hyperglycemic events.   Patient was hooked up to cardiac monitor and found to be in normal sinus rhythm with a heart rate of 64bpm.  Vitals Orthostatic BP measurements Lying supine - 110/72 Seated - 124/76 Standing - 128/72  HR: 64 bpm RR: 16 breaths/min without distress SO2: 99%  On examination, patient was A&Ox3 without lethargy, agitation, or confusion. Patient has an abrasion to the superior aspect of the right orbit (outer eyebrow) without laceration or bleeding.  Patient was diaphoretic and pale following event. Normal cardiac rate and rhythm. Radial pulses intact, strong and equal bilaterally. No obvious nystagmus. Upon standing, patient steady on her feet without abnormal gait.
Administered 11/7/2017 and patient complained of arm soreness and couldn't move arm. First time getting FLUZONE HD 2017-2018. It has been 2 weeks and still has pain in arms and can't move arm (pain).
Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 28 years old female patient who received a partial dose/less than 0.5 ml of vaccine TYPHIM VI (lot number: N1K81(M), reporter had trouble reading the lot number, expiry date: Oct-2019) via intramuscular in the unknown administration site (also reported as right) on 05-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HAVRIX for Immunisation. It was a case of actual medication error due to vaccine underdose. It was also a case of syringe issue because the administrating pharmacist had difficulty removing the cap off of the prefilled syringe and it stripped the top somehowneedle attached to the top, however the vaccine leaked from  the hub. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 11-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009730, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Lot number J009730 is an invalid lot number for MMR II, upon internal review the lot was valid for (Merck) VARIVAX. Additional information has been requested.
No antibodies secondary to the vaccine; This spontaneous report was received from the patient, a currently 52-year-old female, reporting on herself.  The patient's medical history included sinusitis, deviated septum, partial hysterectomy, and vision problem. The patient's concurrent conditions included multiple sclerosis, headache, cholesterol high, blood pressure high, The patient's drug allergies included lortab, Levaquin, and afrin nasal spray. It was also reported that she had banana allergy. Historical drugs included lortab, levaquin, and afrin nasal spray. Concomitant medications included ocrelizumab (OCREVUS), gabapentin, fluoxetine hydrochloride (PROZAC), nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide (HCTZ), fluticasone propionate (FLONASE) and colecalciferol (VITAMIN D3).  On an unspecified date in January or February 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided) administered for prophylaxis.  On unknown date, the patient had no antibodies secondary to the vaccine (vaccine induced antibody absent).   The outcome of the event of vaccine induced antibody absent was unknown.  The causal relationship between vaccine induced antibody absent and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in a 68-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Treated with blood pressure medications.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) outcome was unknown.        mRNA-1273 (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-100543.
Patient reported feeling nauseous at the end of the observation times (15 minutes). He declined sitting back in the chair longer and said he did not need any help. He also reported that he has not eaten anything today.
Patient came in to receive 4 travel vaccinations (hep b, Heb a, Dtap, Typhoid). Patient reported on informed content form fainting upon blood draws only. I discussed with patient about only receiving 2 vaccination that day and coming back for the remaining 2 shots. Patient refused suggestion because of time crunch with this trip. I discussed with patient all VIS information for all vaccinations and discussed the follow vaccinations for the hep a and hep b. After administering the hep a and hep b shots I checked with patient on how he was feeling, " he said he felt fine and was ready for the other 2 shots". I proceeded with the remaining  2 vaccinations. Patient felt fine after the 4 shots. I asked him to wait for 15 minutes, that is when he stated" that he felt dizzy and was seeing white" shortly after the patient slumped down into the chair and did not respond to my asking questions. I came back into the pharmacy and got the 2nd pharmacist and called 911. In the patient will call line one of the patients was a paramedic and came in to assist with the patient. Patient was diaphoretic and had low blood pressure but was responsive to the paramedic. The medix crew arrived and took the scene with patient care. Patient recovered without and injuries and refused to go with the medix crew to the hospital. After waiting another 20 minutes patient left the store and stated he was " feeling normal again".
Severe persistent muscle weakness and pain. Difficulty going up and down stairs, getting down on floor or up from floor. Legs feel heavy and like they are going to give out. Fatigue. Back pain. Spontaneous nosebleeds.