chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN (sinus pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Headache) and PAIN (sinus pain). At the time of the report, HEADACHE (Headache) and PAIN (sinus pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None.  Upon internal review on 21-May-2021, the age was corrected to unknown.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: Patient received her 2nd dose of Pfizer vaccine. About 12-15 minutes after, she reported tingling in lower extremeties and presented with extreme anxiety; extremely diaphoretic, rash noted on chest, hands were icy cold and was very tremulous. Epinepharine was administered IM to left thigh and 911 was called. Patient report chest and throat tightness about 5 minutes later. Fire rescue and ambulance arrived about 5-7 minutes placing the call.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were unknown. On unspecified dates, the patients were vaccinated several doses of improperly stored PROQUAD (dose and frequency unknown, lot # L041627, expiration date: 20-APR-2017). The vaccines were stored at 8.1 Fahrenheit degree for 17 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as the physician would not be contacted.
The vaccine was administered and within a few hours the patient was noted to be tachypneic and tachycardia RR 30s-40s; HR 130s. ABG done revealing hypoxemia to 57.6, blowing of pCO2 25.6. Lactate 6.6. EKG done revealing sinus tachycardia S1Q3T3; D-dimer 3000s; CTA done revealing a large embolus in the right mainstem pulmonary artery area crossing across midline into the left main pulmonary artery compatible with a saddle embolus.  New saddle pulmonary embolism with hemodynamic instability Patient started on levophed to manage hypotension. Started tPA,and transferred to the ICU.
Urticaria. BENADRYL in ER. BENADRYL 6.25 mg 1/2 tsp 3 times a day. PREDNISONE 7.5 mg daily x 5 days
2 days after vaccine began experiencing stiffness in neck. Stiffness increases and decreases but never goes away.
Pt developed "spots like chicken pox" over chest, arms, back, and buttocks. Very itchy. No fever. Pt's mom 5 months pregnant- previous varicella HX.
Tinnitus started about 24 hours after initial administration of vaccine. The tinnitus has been going on since the date of administration of the vaccine. I have had continuous difficulty sleeping.
Rt thigh-red, swollen, warm to touch at injection site. Rt thigh swollen. Reaction localized. Benedryl 12.5/5cc PO. F/U with PMD.
Information has been received from a registered nurse concerning a 19 year old female patient with seasonal allergies who on 28, Feb 2007 was vaccinated IM with a 0.5 mL dose of Gardasil lot # 654389/0961F) and has not begun her period. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (AVLANE), as oral contraception, and fluticasone propionate (FLONASE). The nurse reported that the patient took her 3 weeks of active pills and usually begins her period 2 days after beginning the reminder pills. As of 08, Mar 2007 (4 days after beginning the reminder  pills), the patient had not begun her period. The patient sought unspecified medical attention. Additional information has been requested.
Pt received vaccine on 4/4/01. On 4/7 she complained of fever/chills, nausea, and headache. Sx still present on 4/9 when seen in clinic. Given Brat diet to follow and advised to take Tylenol.
Nausea, vomiting, joint pain, diarrhea, exhaustion, stomach pain, itchy all over body, swollen chin.  Most symptoms resolved after 2 days except for itchiness which persisted for another couple of days.
Next  Day Raised or swollen bump at the injection location for just over 1 week. Next Day Headaches or migraines and nausea for two weeks and missed work
EXPERIENCED UNUSUAL HEAVY BLEEDING.  NOT DURING MENSTRAL CYCLE TIME BUT RIGHT BEFORE.
The patient received the rubella virus vaccine on 01/16/06. On 01/27 the patient reported to employee health complaining of generalized body rash, itching, joint pain and swelling of the hands and face. Th patient was referred to a medical clinic and was prescribed ibuprofen. Labs and micro work were negative for polyarthritis. On 2/1 the clinic note stated the arthralgias were improveing on NSAID therapy.
6/10/18 developed a vesicular rash along posterior trunk only and oval patch at site of injection.
This spontaneous report as received from a Medical Assistant (C.M.A.)(also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of oral, ROTATEQ dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This is one of several reports from the same reporter. Additional information has been requested.
I started having a scratchy throat in the morning. In evening I developed congestion, and watery eyes. The next day I had difficulty swallowing and had laryngitis. I took my temperature, and it was normal. My throat had gotten so sore that I was unable to swallow, and I developed a headache. The next day I went into the emergency room and was diagnosed with pharyngitis. I was given Tylenol, and fluids for dehydration. He did a strep test that came back negative.  I was sent to the hospital where they did a CT scan, Electrocardiogram, and blood work. All the tests came back normal. He also tested me for COVID-19 and it came back positive. I was prescribed Paxlovid for 10 days. I am still experiencing a mild sore throat, cough, and low energy.
Vaccine administered at 5:45pm on 3/10/10. About 8pm c/o pain, redness, swelling at injection site. Waited 24 hrs and got worse. Went to ER; diagnosed cellulitis. Rx Percocet (pain) and Cephalexin (antibiotic) given. Hospital staff said looked like given in tattoo, was actually given outside ink line.
This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 71-year-old female patient who received BOOSTRIX. Concurrent medical conditions included arthritis. Concomitant products included Aspirin baby. On 7th May 2018, the patient received BOOSTRIX (intramuscular). On 7th May 2018, less than a day after receiving BOOSTRIX, the patient experienced injection site bruising, injection site tenderness, weakness of arms and tiredness. In May 208, the patient experienced numbness and burning sensation. On an unknown date, the outcome of the injection site bruising, injection site tenderness, numbness, weakness of arms and burning sensation were not recovered/not resolved and the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the injection site bruising and burning sensation to be related to BOOSTRIX. The reporter considered the injection site tenderness, numbness, weakness of arms and tiredness to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received a BOOSTRIX injection on Monday on left arm. During vaccination, the patient stated that she felt pain, which she described as a pinch. The patient stated that she thought it was probably the needle, but she was not sure. The patient stated that later that day she noticed bruising at and around the injection site. The patient also reported that she felt more tired and tenderness at the injection site. The patient stated that her upper left arm felt weak and she was experiencing a burning sensation or numbness from her elbow to her wrist (left side).
Information has been received from a mother concerning her 22 year old daughter with no pertinent medical history or drug reactions/allergies who on 06-JUN-2007 was vaccinated with a first dose of Gardasil (lot # unknown) and Recombivax (manufacturer unknown) was administered. On 13-JUL-2007 the female was vaccinated with a second dose of Gardasil. Concomitant therapy included Recombivax (manufacturer unknown) (lot # unknown) for prophylaxis (duration and dose not reported). In July 2007 at an unspecified time after the second dose, her daughter started "breaking out" with red, itchy spots on her arm or arms. She is not sure which are or arms have developed the spots. Medical attention was sought, a dose of At the time of reporting the female patient had not recovered. No further information is available. Additional information has been requested.
within 1hr sx devel:lethargy,vertigo,double vision,muscle spasms of extrem & shuffle gait. pt also had nausea & chills. resp shallow/irreg at times. hands cold, skin pale/dry.  pt. tolerated juice/crackers. to MD office Doc 208487, annual follow up received on 02/21/2001 states that headeaches have resolved in past year. Other neurological problems gone. School performance has returned to normal. She has received other imm. but not the third dose for HepB.
This initial report was received from a 81 year old male patient with drug allergy to morphine (manufacturer unknown), codeine derivatives, penicillin, lisinopril (manufacturer unknown), clindamycin HCL, hydrochlorothiazide and LIPITOR. The patient's concomitant therapies included an unspecified medication and an unspecified flu vaccine applied in his right arm. The patient did not have pertinent medical history. On 04-NOV-2016, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml dose, intramuscular route, expiration date 03-NOV-2017 (strength and lot number were not reported). On 07-NOV-2016, also reported as 3 days after vaccination, the patient experienced swelling on his left elbow and soreness in his left shoulder. The patient did not seek medical attention, received treatment for the events and no laboratory test were performed. At the reporting time, the patient was recovering from joint swelling and musculoskeletal pain. The reporter did not assess the causal relationship between the reported events and therapy with PNEUMOVAX 23. This is one of several reports for the same patient (1611USA004990 and 1611USA004989). Additional information has been requested.
Rebound COVID; Rebound COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FP4554) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). Patient was not pregnant at the time of vaccination had no known allergies. Concomitant medication(s) included: CRESTOR, stop date: 15Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Jun2022 at 20:00, outcome "unknown", COVID-19 (medically significant) with onset 27Jun2022 at 20:00, outcome "recovering" and all described as "Rebound COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received anti-viral for treatment of COVID-19 which included Paxlovid, from 15Jun2022 till 19Jun2022.
This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug/reactions allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K008334 with expiration date 09-JUN-2016 and lot # K002327 with expiration date 07-FEB-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. Second excursion for RECOMBIVAX HB: Temperature/time: 34.7F for 15 minutes. Previous excursion: 34.4F for 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a female with on approximately 22 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. On 22 Nov 2006 the patient fainted. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Dizziness, Headache, Myalgia, Diarrhea, NauseaVomiting, diarrhea, fatigue Narrative:
After the awcond vaccine:  Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent.  I had malaise and fatigue.  I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day.  It was painful to touch and tender once the lymph node decreased in size.  The only other reaction was the site pain and tenderness and warmth.  That lasted a few days.
15 mins after the patient had the vaccine she began to have metallic taste in her mouth, pain in left side of the neck with lymphnode swelling, and nausea. PT also began to have lightheadedness and nausea. Pt was asked to stay an additional 20 mins for observation. Pt denies sob or difficulty breathing. PT throat was not swollen. PT dizziness improved but she began to have a headache.
Patient was given Pfizer Covid booster that was drawn up on Friday 12/3/2021 (more than 6 hours after drawn up), no symptoms noted
Information has been received from a licensed visiting nurse concerning a 28 month old female with a pcn allergy and an Amoxil allergy who on 04/27/2000 was vaccinated SC in the right thigh with a first dose of varicella vaccine. There was no concomitant medicaiton. There was no illness at the time of vaccination. The licensed visiting nurse reported that on 09/08/2001, the pt "developed a mild case of chicken pox." The pt had 20-25 pustules, no fever and no other symptoms. It was noted that the pt recovered on 09/18/2001. The licensed visiting nurse reported that the pt was being treated with cefaclor for a sinus infection which was diagnosed on 09/07/2001. Unspecified medical attention was sought.
During vaccine administration by pharmacy technician, after inspection to ensure needle was securely attached, the vaccine suddenly sprayed out as the plunger was being pushed in and patient did not receive the full dose. The piece attached to the vial containing vaccine came off suddenly. Patient was instructed to wait in lobby to monitor for adverse events. The patient left after discussion we would report the incident to VAERS and follow up with the manufacturer to determine how and when to proceed with a subsequent dose. Patient left pharmacy without reporting any serious adverse effect.
No adverse events, sx or signs noted. Pt. given KINRIX & HIB in place of PENTACEL due to PENTACEL being out of stock. Misread age limitations on KINRIX.
Infant began crying non-stop for more than 3 hours. Vaccine given on Monday and crying began Thursday and continued until Friday evening.
Muscle and joint pain in my hips. Burning sensation in my legs that lasted about 5 hours through the night
Seven days after the 2nd Pfizer shot, I began experiencing discomfort and pain outside the vaginal area which gradually worsened over the next week.  Then I began having severe pain in my left lower back that moved to my hips and finally to my legs.  Thinking that it was related to an earlier diagnosed prolapsed uterus, I returned to my gyn.  By this time, I had also developed a rash in the area.  He diagnosed it as shingles, and I took Valtrex for a week.  Even tho the shingles area seemed to be better, the area closer to the vagina was much worse with rawness, burning, and itching.  Out of desperation, I sought help from my dermatologist.  She and her PA diagnosed me as having lichen sclerosus.  I'm using Corbetasol ointment to treat this, but still suffering from this problem. Even tho the scientists and medical professions may not be willing to admit any relationship of my problems to the Pfizer Covid vaccine, I'm convinced that it IS related, especially since I have had neutropenia for about the last twenty years, and I know that my immune system is somewhat compromised.  Since I'm not a scientist or medical doctor, I'm unable to explain how this could have happened, but I know my body and combined with my excellent common sense, I'm convinced there's a relationship to what I've been experiencing since receiving the 2nd Pfizer Covid shot.  I've never expressed this to my gyn, or my dermatologist.  Neither even asked about if I'd received the vaccine, and I didn't bother to tell them because I don't believe they would have acknowledged any relationship because the medical field, as well as everyone else were assured of its safety.  I report this only to perhaps save someone else for the extreme suffering and misery that I've gone through.
After receiving the vaccine the patient stood and walked to the restroom, she returned minutes later reporting feeling light headed.  Sweaty and eyes fluttering. Assisted to sit in chair. BP checked 73/39.  911 called at patients request.
Migraine headaches, extremely bad for six straight weeks. Did not see a doctor for it. Eventually they went away on their own.
Per pt, she received a covid-19 pfizer vaccine at middle school on 4/14/21. Pt c/o fever(104F) and slight pain in lower lungs. Had a UC visit with MD on 4/16/21 during which symptoms had resolved. Pt advised to follow-up or go to ED if symptoms return..
Patient presented to EC on 5/3/12 with complaints of red raised nickel-sized nodule and rash at site of immunization on left thigh and small pea-sized nodule on right thigh.  Unclear as to when these appeared.
Associate has history of asthma was planned to be observed for 30 minutes. at 12:30 patient complained of light headache which fully resolved after 30 minutes. no further intervention.
Arm just under injection site is inflammed. Red, hot, itchy and sore. I have also had pins and needles in my fingers on that arm, which I do not have. No treatment, just allergy medication for the itching. Outcome - still red and sore, no change of yet.
pt. recvd M-M-R II & exp. "mumps-like synd".
12 year old male, that received 2 Pfizer pediatric doses previously presented and was given adult Pfizer booster instead of the Pfizer bivalent booster.
I have a dry cough no product or nothing comes up but it is enough to interrupt conversation , sleep, and daily activities. I was prescribed Cefdinir.
Cough, conjuctivitis, rhinorhea, erythematous confluent macular on face and papular on trunk and extremities.
Large dark red area surrounded by a light red area on right upper arm.  Also small red area on left upper arm.  Both sites very painful and itchy.  Was given EES 2 tsp BID for 14 days.
Temperature at 6:00 am of 100.6 Temperature at 6:30 am of 100.7 Temperature at 8: 15 am  99.6 nausea for a brief period of time headache ongoing
Pt vaccinated with DTP/OPV 2-3 hrs after receiving vaccine, child was reported by mother to have high pitched scream with crying & child was unconsolable.
Jannsen covid-19 vaccine EUA Shortness of breath. Leg swelling. Myocarditis, fluid retention, fatigue, weakness. Heart failure symptoms
Hospitalized 12/24/2021; COVID-19 positive 12/24/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 12/24/2021 Discharge Date: Dec 26, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Mania (HCC) [F30.9] Cocaine abuse (HCC) [F14.10] Hypoxia [R09.02] Acute renal failure, unspecified acute renal failure type (HCC) [N17.9] COVID-19 [U07.1]   HOSPITAL COURSE: 61 year old male w/PMH including CKD3, polysubstance abuse and opiate use disorder, peripheral vascular disease with recent femoral endarterectomy, HTN, T2DM, who presented with mania and altered mental status, reportedly moving his arms erratically, yelling, and raising his voice. He was found to have COVID-19 positivity, a drug screen containing nicotine, cocaine and fentanyl, and an AKI. He was admitted for further management.  Mania/AMS -His mania and altered mental status did resolve and are thought to be secondary to illicit drug use. He returned to his neurologic baseline. He was counseled against illicit drug use and evaluated by social work. He was seen by Psychiatry who did not appreciated any psychiatric or active thought disorder. Of note, he has not had suboxone in over a month and is without a prescriber. Psych recommended discontinuation of suboxone at this time and for patient to re-establish with provider in future if desired. COVID-19 infection - Patient had only mild URI symptoms during admission and did not become hypoxic or require treatment for COVID. Recommended continued 10-day isolation from 12/24/21. He was counseled on signs and symptoms of worsening COVID PNA and when to return to the ED. He is therapeutically anticoagulated with warfarin so DVT/PE is unlikely. No signs or symptoms of myocarditis. Elevated procalcitonin - Patient had elevated procalcitonin with negative culture data and no clear bacterial focus of infection. Observed on antibiotics however no clear infectious focus was identified and he had no further s/sx of infection. Antibiotics were discontinued.  Hypertension -remained stable inpatient on current antihypertensives. One of his antihypertensives is clonidine. Outpatient consideration of switching this agent to another if compliance is an issue but would defer to PCP. AKI - likely prerenal. This resolved with IV fluids. Also noted was a mild nontraumatic rhabdomyolysis which improved with IV fluids.  Peripheral vascular disease, h/o endarterectomy - remained stable. Patient is to continue on ASA/statin/cilostazol. Pharmacy dosed warfarin while inpatient and he should continue on this until otherwise instructed. Counseled on need to make follow up appoints with Vascular surgery and counseled against nicotine/tobacco use.  At time of discharge, patient is hemodynamically and neurologically stable, tolerating diet. He declines need for social work/substance abuse evaluation. No current signs of intoxication or withdrawal for past two days. Discharged in stable condition. Recommended outpatient PCP and vascular follow-ups.
w/in several hrs of vax, vomited x 1, lt work; never felt well but acutely ill w/minimal fatigue, chest "heaviness", non-prod cough; seen by MD 6 wks later tx w/PCN; prob bronchitis & or pneumonia;
Low grade fever, body aches, headache, fatigue,  intermittent chills. Lasted about 24 hours.