chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started a cold on the 15th of May. I tested myself on the 16th of May and I tested positive for COVID. I had phlegm and post nasal drip. I also had a cough and tiredness. I did not have a fever. On May 17, 2022 I called my doctor and she did not prescribe PAXLOVID. I did not have any prescriptions. I felt the symptoms for 5 days. For at least three weeks I had a cough. It was not a small cough. I also had constant phlegm that lasted for about 3 weeks. I did lose my sense of smell for one day.
severe swelling of lymph node below the ear on the neck- pain in head and neck that has lasted for 6 weeks and is on-going
Have tachycardia to 120s when I stand with palpitations. When sitting normal heart rate. Currently being evaluated by cardiologist
Pt. reported "feeling feverish" Friday afternoon through Saturday or Sunday.  Reports temperature 100-100.2 degrees F.  Stated that he did not experience any achiness or other symptoms.
chest pain; Muscle pain; vaccinated left arm swollen; fever; nausea; dizziness; wet cough (phlegm); abdominal pain; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH, formulation: solution for injection, Batch/Lot Number: EN 5318 and expiration date was not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age of 53-years-old) as 2ND dose, single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing hypertension, ongoing irritable bowel syndrome, intervertebral disc protrusion and chronic sinusitis. The patient had no known allergies. Concomitant medication(s) included metformin 750mg; glimepiride 4mg (AMARYL) and enalapril 2.5mg. The historical vaccine included first dose of BNT162B2 (PFIZER BIONTECH, Batch/Lot Number: EK 4176 and expiration date was not reported), via an unspecified route of administration in left arm on 07Jan2021 as single dose for COVID-19 immunisation. The patient did not have COVID prior vaccination. The patient had no other vaccines within four weeks. On 28Jan2021, the patient experienced chest pain, muscle pain, vaccinated left arm swollen, fever, nausea, dizziness, wet cough (phlegm) and abdominal pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Jul2020. Therapeutic measures were taken as a result of the events. The patient was treated with pain reliever and decongestant for the events. Facility type vaccine: Workplace clinic. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient recovered with sequelae from the events.  Follow-up (12Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: No new information updated.   No follow-up attempts are needed. No further information is expected.
Medication error:  ordered for TDAP, was administered Flucelvax in error.  Patient DID desire seasonal flu vaccine and had not yet received it.  This was accepted by both patient and provider.  TDAP also administered as ordered. No adverse reaction.
Chronic/Worsening/Extreme Fatigue, Chronic Muscle cramps in both feet, both hands, and both calves, and intermittent tinnitus mostly in left ear.
04/21/2021:  After my first shot on this date, I had an ache over the injection site within a minute or two, and this subsided after about 10 minutes. The site felt bruised to the touch for about 3 days, and then it was OK.  05/12/2021:  After my 2nd shot on this date, no ache, but same bruised feeling. No other symptoms.
Vaginal infection around 2-15-21 - test results turned on inconclusive, but prescribed fluconizal (sp?) anyway Around April 1, 2021 vertigo (dizziness) started and is worse now, also now it is not just vertigo, but extreme fatigue in whole body, exhaustion, feel like in a fog, weak and shaky, headache, numb feeling throughout body, body feels like it is vibrating, head feels heavy and full, slight ear pain on right side sometimes, sometimes ringing in ears
LARGE, NICKEL TO QUARTER SIZED, HARDENED AREA UNDER THE SKIN ON LEFT ARM AT THE SITE OF INJECTION; BRUISING ON LEFT ARM; NORMAL SYMPTOMS; FEW RASHES ON LEFT ARM; PAINFUL TO TOUCH; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced large, nickel to quarter sized, hardened area under the skin on left arm at the site of injection. On AUG-2021, the patient experienced bruising on left arm. On AUG-2021, the patient experienced normal symptoms. On AUG-2021, the patient experienced few rashes on left arm. On AUG-2021, the patient experienced painful to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from large, nickel to quarter sized, hardened area under the skin on left arm at the site of injection, painful to touch, few rashes on left arm, and bruising on left arm, and the outcome of normal symptoms was not reported. This report was non-serious.
2 1/2 hr p/vax pt started c/o h/a, pain @ site of inj, could not stand up anymore, felt weak, felt like vomiting (did not vomit); mom noted shaking; took to ER next AM p/consulting w/clinic; mom said t105; MD advised no further pertussis;
Information has been received from a pharmacist concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the patient experience an itchy rash.  The patient did seek unspecified medical attention.  The pharmacist also discussed the experiences of three other patients while on therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccinel ive (second generation)(WAES#0207USA02817 to WAES#0207USA02819).  Additional information has been requested.
12 hours after second injection, localized swelling and edema of right arm and shoulder extending to right ribcage. Fourteen hours post-injection (2nd dose only)Fever of 103.5, myalgia, chills, stiff neck, sheadache, and significant sharp pain in joints, muscle cramping in legs and arms. After treating with 600 mg ibuprofren, fever was reduced to 101.0. Fever recurred four hours later with profuse sweating. 600 mg of ibuprofren taken which again reduced fever to 99.8. At 24 hours post injection, swelling of ribcage and shoulder is subsiding, fever of 99.9. Having survived septic shock in 2011, I can say this felt the same. It was extremely painful.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An 84-year-old female patient received PREVNAR 13 single dose via an unspecified route of administration on 21Nov2014. Relevant medical history was not reported and concomitant medications were none. The patient experienced a knot which progressed to redness, cellulitis, and skin peeling on 24Nov2014 with outcome of unknown and a lot of fever on an unspecified date with outcome of unknown. The Pfizer sales representative mentioned that "all reported adverse events were due to PREVNAR-13 as the patient had all reported events after receiving shot and she was not taking any other medication."
Patient received Pfizer COVID vaccine on 3/15/21, 4/5/21, and 12/16/21. On 1/3/22, patient tested positive for COVID and admitted to our inpatient unit with acute respiratory failure and pneumonia due to COVID-19. Patient discharged home today (1/6/22) in stable condition.
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA262531 for patient age 11 yrs. same reporter. This case involves a 9 months old patient (gender unknown) who received vaccine FLUZONE 0.5ml dose, lot UT6259KA, expiry date 30-Jun-2019 via intramuscular route in the left thigh. The patients past medical history, concomitant medication and family history were not provided. No other vaccines given at the time. It was an actual medication error due to incorrect product storage. It was reported that patient received FLUZONE after temp excursion and vaccine unacceptable for use. Temp- 1.64 C for 24 hours. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender- none.
Patient came in for follow up visit and was given Pfizer bivalent as the first covid dose instead of the monovalent. patient tolerated well and had no adverse reaction. No signs and symptoms of any reaction.
See attachment; 11/07/2007, 2:00 p.m. - chills and fever temp 101, 2 tabs tylenlol 500mg every 6 hours; 11/08/2007 - chills and fever temp 101, muscle aches; 11/09/2007 - chills and fever 102, muscle ache and headache, alternating 2 tabs tylenol 500 mg and 2 tabs motrin 800 mg every 6 hours; 11/10/2007 - chills and fever temp 102, muscle ache, headache, hoarseness; 11/11/2007 - chills and fever temp 102, muscle ache, headache, hoarseness; 11/12/2007 - chills and fever temp 102, muscle ache, headache, hoarseness, and small and large hives appearing on hand, arms, and front, back, and sides of body. 11/13/2007, 5:00 a.m. - chills and fever temp 101, muscle ache, headache, hoarsenss; small and large hives connecting which made both arms and hands large and puffy with hives; face and eyes with large and puffy with hives. 8:00 a.m. went to hospital emergency room at Community Hospital. Given pain medication and benadryl through I.V.. Hives subsides. Diagnosed "flu shot side effects,". 11/14/2007 to 11/17/2007 - sick in bed, stayed home, and continued to take medications prescribed by doctor, 2 tabs benadryl every 4 hours, 1 tab motrin 800 mg 3 times daily. 11/18/2007 - fully recovered. 11/19/2007 - back to work.
Swollen lymph nodes, severe headache, body aches, muscle and joint pain, severe cough with mucus and chest pain when coughing, chest congestion, fever, trouble sleeping, vision changes, chills, weak and tired
Right deltoid red, swollen, and warm. Redness looked to be traveling/spreading. Hot flushes. Advised medical attention patient said that she would go see a Dr. on Monday
No additional AEs; A expired dose was inadvertently administered to a patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 31-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 1 time dose, for prophylaxis (lot number S025157 was determined to be vlaid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 13-AUG-2021) (strength, route of administration and anatomical location were not provided).         No adverse event reported.
After the second dose, I had a high fever/chills/body aches/soreness at the site of injection for three days. After three days of the second dose, started feeling pain/pulling of chest muscles on the left side. After continued feeling of chest pain/muscle pulling for two days, I contact a doctor on the third day, who advised me to go to ER and have examined by a physician. I went to the ER where a lot of blood tests were done and an x-ray of the chest was taken. But the ER doctor ruled out any heart-related problem. This pain started gradually reducing and reappearing every few days along with the injection site becoming sore. I started reappearing every week, then every 10 days and now it appears every two weeks. After about two weeks had the first gout attack. The doctor did not advise taking any medicine(s) to reduce uric acid before - had annual physical in Jan. Now taking Febuxostat 40 mg once daily. Also, blood work showed giant/big platelets suggesting BSS (to be investigated by a specialist on August 9)
1130AM immun administered; 1215PM mom returned w/pt, raised whelps noted over face, torso, & extremities; no resp distress; 1230PM taken by car to hosp; seen in ER 1 given DPH; 230 mom called clinic states still has rash; no other problems;
Received second vaccine on 2/2/21 and on that same day starting having fatigue, nasal drainage, muscle aches. Went to ICC on 2/6/21.
9 hours after administration of vaccine ( high pitched cry began). It lasted on and off for 4 days. Accompanied by moderate fever 100.5-101 F, Excessive sleepiness. Next day, agitated, irritable, and restless. Excessive spitting up. Tylenol given seemed better on 5th day.
After first injection on 02/05/2021,  the only event was a 24 hour soreness at injection site.  No adverse effects after second injection on 3/5/2021.  During the first few days of June 2021, I noticed that my skin became hyper-sensitive to sunlight and it was like I got sunburned in as little as 30 minutes to sun exposure.  I'm a red-haired person (grey now) and have always sunburned easily but prior to the vaccine I could tolerate 3-4 hour sun exposure with little or no effect.    Now I'm a noticeable redness to my skin after exposure of 30 minutes or less and my skin (face mostly) feels sunburned.   This skin sensitivity has not abated since I became aware of it.
Patient because flush and hives appeared on chest and face.  Patient reported palpatations.  Denied respiratory distress.    Diphenhydramine and EpiPen given.  Patient taken to the ED and was improving when she arrived.  Monitored in the ED with continuous BP, pulse ox and cardiac monitoring.
Nurse called to report PROQUAD had been administered to a 40 year old patient on July 21, 2023. Nurse notes no side effects or symptoms noted.  No additional AE/no PQC.; Nurse called to report PROQUAD had been administered to a 40 year old patient on July 21, 2023. Nurse notes no side effects or symptoms noted.  No additional AE/no PQC.; This spontaneous report was received from a nurse referring to a 40-year-old patient of unknow gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, when the patient was 40-year-old, they were vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered as prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W029552, with expiration date: 14-MAR-2024 and therapy type  rHA) (product administered to patient of inappropriate age). No additional adverse event was reported.
I had a hoarse voice, cough, fatigue. The provider prescribed PAXLOVID for treatment. I was in isolation for 11 days.
I developed symptoms on 12/31 which is probably two or three days after I was in the presence of someone who at the time didn't know they were contagious. I felt mildly sick, lethargic, slight fever, achy, congested. I did call my PCP immediately to ask about Paxlovid. He was mildly discouraging, feeling like it probably wasn't necessary but I insisted on taking it anyways. The symptoms went away 2-3 days, but I kept testing positive after two weeks. I tested every day thinking "today will be the day" but didn't test negative until I believe it was the 15th of January.
3 prefilled syringes of hepatitis A vaccine adult have residue, cloudy color  liquid
This case was reported by a consumer via call center representative and described the occurrence of listless in an elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced listless, fever, injection site pain and influenza. On an unknown date, the outcome of the listless, fever, injection site pain and influenza were recovered/resolved. It was unknown if the reporter considered the listless, fever, injection site pain and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 83 or 84 years. Within approximately two hours after receiving SHINGRIX, the patient experienced pain at the injection site. The evening after receiving SHINGRIX, the patient began to feel listless like he had a mild flu, and a low-grade fever. All of the symptoms were resolved within two to three days. The reporter gave permission to contact their physician. The reporter was unable to provide additional information. This case has been linked with cases US2018153593 and --, reported by same reporter.
Information has been received from a physician concerning a 10 year old male who on an unspecified date was vaccinated with a dose of MMR II (lot#, dose and route not reported). The physician stated that a patient received MMR II injection and had anaphylaxis. She stated that the child also had anaphylaxis after he had eaten cheesecake and at another time after he had eaten a hot dog. After both episodes related to the foods his mother realized that the reactions from the foods were the same reaction he previously had after receiving MMR II. On an unspecified date, the patient sought medical attention at another physician's office. Upon internal review, anaphylaxis was determined to be an other important medical event. Additional information has been requested.
Headache & Myalgia Narrative: 12 hours after second experienced flu-like symptoms and missed one day of work.
No further adverse events; Nurse reporting administered dose of expired DILUENT.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 15-JUN-2022, the patient was vaccinated with one dose of varicella virus vaccine live (VARIVAX) as prophylaxis (strength, frequency, route of administration, and anatomical injection site were not reported; lot number U025791 with an expiration date of 19-AUG-2023). The vaccine was reconstituted with one dose of an expired sterile diluent (lot number S026378 with an expiration date of 15-MAY-2022) (expired product administered). No further adverse events.
Pt presented to Hospital ED for possible blood in stool. Per parents reported currant jelly stool, parents have photo documentation on their phone. Pt discharged from the ED. Seen at Clinic 04/18/2018 by Dr. for r/o intussusception d/t Rotavirus vaccine. Vaccine was GlaxoSmithKline ROTARIX, lot number A41CB554A. Per parents pt never stooled again after initial blood stool. Pt had been irritable but consolable. Parents denied sausage "lump" on stomach wall, emesis, and fever.
This case was received from a family nurse pracitionter on 22 June 2009. A male patient received an injection of influenza vaccine (manufacturer, date of administration, and lot number not reported). He later experienced red, hot, itchy skin, and also complained of being sweaty. He was seen in the emergency room, but was not admitted. No additional information was reported. Follow up information received on 17 July 2009 from health professional. The patient received FLUZONE SV(date not provided). The patient was given a "shot" (medication not known) in the emergency room as treatment. The patient was reported as being treated in the emergency room in "?2007". The patient recovered, date not provided. No further information reported.
Headaches, severe fatigue and muscle weakness,  upper thigh pain prominent,  makes walking and balance difficult, viral-like 'brain fog.  Now, has persisted for 8 weeks and shows no sign of stopping.  Self employed but able to only work 1-2 hrs./day
1/25: woke up with a sore arm, no rash 11:30 - started feeling febrile, was 98.7 (ear); rash on arm; arm VERY sore (hard to raise up). HR 70s-80s. BP 141/98 12:30 - significantly worse chills/aches/fever was 99.1 (ear), took 1000mg Tylenol (can't take ibuprofen due to Von Willebrand's) 1:30 - worse s/s - fever 99.7 (ear); 100.5 behind ear 3:00 - raised red rash over entire upper arm and the previous injection site (left arm); similar to hives, but no pustules.  Arm pain increased on the right side; fever 101.5 (ear) and 102.1 behind ear 4:00 - rash continued, pain continued, chills/fever 101.7 (ear); HR 110s 5:00 - same, 102.8 fever, HR 110-120s. Called my MD - who denied need for ER (to go if fever is 104+); BP ok. Rash continued 6:00 - Tmax 103.2 (ear), 104.6 behind my ear; HR 110s-120s. Tylenol 1000mg again.  7:30 - Fever coming down; feeling a little better, fever 102 (ear) 9:00 - Fever 99.6; other symptoms are the same 10:30 - fell asleep; fever was around 101 11:15 - Fever 101.7 Midnight - fever 102.3; tylenol again; took famotidine 40 mg and benadryl 37.5mg - kids chewable (this combo works well when I have issues with latex exposure)  4:35 AM 1/26:  husband work me up to check my fever - 99.6  8:00AM  1/26:  Fever 102.4; HR 90-100s; took tylenol 1000mg ; rash is less severe - on side of injection: localized to injection site us about 2-3 inches; swelling) and noted the other arm is red and itchy -just below site of the injection - improved though 10:00 AM 1/26: Fever finally broke - 98.8 Called healthcare provider (vaccine was though workplace) and they advised to call which then advised me to complete the form online.
Mild local reactions 18 hours after shot, seen 40 hours after shot, already improving.
fever 102; body aches; chills; shivers; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102), MYALGIA (body aches), CHILLS (chills) and CHILLS (shivers) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (fever 102), MYALGIA (body aches), CHILLS (chills) and CHILLS (shivers). At the time of the report, PYREXIA (fever 102), MYALGIA (body aches), CHILLS (chills) and CHILLS (shivers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Mild pain on my diaphragm Intense stomach cramping Pins and needles in my hand
Approx. 17 hours after receiving 2nd dose (around 4am on 8/2/21): woke up with stomach/gastro issue, and then sudden onset of intense dizziness, nausea and light-headedness (near-syncope?), ringing in ears, sweating, intense feeling of panic/terror/impending doom, vibrational/buzzing felt throughout entire body. Duration - maybe 5-10 minutes  Continued / ongoing effects have been strange intermittent pains throughout body and soreness. In particular lower legs, sometimes felt through my groin / testicular area, fatigue, and night sweats
Breakthrough case after Covid vaccination. Dose #1 4/17/21 Dose #2 5/15/21. C/O fever, headache, fatigue, cough , and chest pain