chrisvoncsefalvay/vaers-outcomes huggingface dataset:
legs swelled up twice as big as normally; Down from 60 to 45 ecogram; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs swelled up twice as big as normally) and WEIGHT DECREASED (Down from 60 to 45 ecogram) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TAFAMIDIS (VYNDAMAX) for Amyloidosis.    Concurrent medical conditions included Sarcoidosis, Aneurysm of heart, Amyloidosis, Leg cramps and Swelling of legs. Concomitant products included METOPROLOL for Heart disorder, UBIDECARENONE (COQ-10) for Leg cramps, PREDNISONE for Sarcoidosis, FUROSEMIDE for Swelling of legs, COLECALCIFEROL (D3), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and MAGNESIUM for an unknown indication.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. and TAFAMIDIS (VYNDAMAX) (unknown route) 61 milligram. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelled up twice as big as normally) and WEIGHT DECREASED (Down from 60 to 45 ecogram). At the time of the report, PERIPHERAL SWELLING (legs swelled up twice as big as normally) and WEIGHT DECREASED (Down from 60 to 45 ecogram) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Down from 60 to 45 ecogram.         Patient had the ecogram and at time injection range was 60 and then noticed, it started in early 2019 and coming forward, strength was kind of diminished and patient went to cardiologist, patient was running out of steam and cannot keep up to on a morning walk and marked it down then COVID yet the offices down nothing else was done. Patient took the third shot and legs swelled up twice as big as normally they are and patient went right over to family doctor, and doctor said you got the heart problem this was not the shot and thought it might be the Amyloidosis and they did a check and heart was 45.  No treatment medications were provided.   Reporter did not allow further contact
Pain, swelling and bruising from armpit toward breast on the same-side as the injection (left), but not at the injection site. Began the morning after the injection. Swelling lasted approximately 1 day and bruising took several more days to fade.
Shortness of breath;   Acute hypoxemic respiratory failure due to COVID-19;   Elevated brain natriuretic peptide (BNP) level; AKI; CKD, stage III;
Upon administration, shots Hep B, IPV, Prevnar, pt with in 1 minute pt broke out in red spots over face and entire body.  MD administered epi penyvin or bump and red spots left.  But pt started vomiting and turn pale, lips blue, oxygen was then given 911 call pt went to hospital stable.
3/5/21 woke with puffiness below right eye 3/6/21 extremely tired, just wanted to sleep 3/7/21 eyelids swollen near nose
Hospitalized 2/23/22-3/3/22 Nausea, vomiting, altered mental status, diarrhea, headache, cough, PNA, respiratory failure, elevated troponin, myalgia, decreased appetite, metabolic encephalopathy, NSTEMI, edema,
Grade 3 Arm pain, Grade 3 rash.  Lasted severe for 3 days and soreness still there 4 weeks later.
3 minutes after injection felt flushed and a rapid heart beat which self resolved within a few minutes .
sore throat; Mild arm pain; Fatigue/tired; This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MYALGIA (Mild arm pain) and FATIGUE (Fatigue/tired) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). 01-Apr-2021, the patient experienced MYALGIA (Mild arm pain) and FATIGUE (Fatigue/tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and MYALGIA (Mild arm pain) had resolved and FATIGUE (Fatigue/tired) had not resolved.            No concomitant medication details was reported.
Patient complained of muscle aches, joint pains, severe headache and fever after the vaccination. She started to have numbness on forehead, eyelid and eye on 3/19/2019. She also complained about blurred vision.
Expected soreness, swelling and muscle weakness for 48 hours resolved to ongoing soreness and muscle weakness in upper left arm. Occasional (2-4x daily) shooting pains down arm. Continues to be sore to touch muscle. Continues to be difficult to lift and carry with this arm.
Body aches; Fever of 99-100 degrees farenheit; Nausea; Extreme Fatigue all stared approximately 4 hours after injection and lasted for approximately 48 hours.
This spontaneous report was received from a physician via company representative and refers to a 12 year old female patient. There was no information regarding patient's medical history, concomitant medications, drug reactions or allergies provided. On approximately 04-APR-2017, (reported as 2 weeks ago), the patient was vaccinated with unidentified Merck HPV vaccine administered (name and lot number not provided) (reporter was unable to determine which vaccine was used) (exact dose, route of administration, lot number and expiration date were not provided) in immunization series for prophylaxis. On an unknown date in April 2017, after receiving vaccine, the patient experienced emotional outbreaks. Due to the event, the physician was contacted by the patient's parents. The physician advised not to treat the event as related to the vaccine. The patient was fine at the time of the report and that there was no call back from parents of the patient, that the emotional outbreaks continued. There was no product quality complaint involved in this case. Additional information has been requested.
Redness, heat, and mild itching around injection site.  Symptoms subsided after about 3 days
Blistery Rash (similar to shingles); This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 56-year-old 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, unknown after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was recovered/resolved.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comments: The pharmacist stated that the patient received first dose of Shingrix (unknown date) and developed a Blistery Rash (similar to shingles) in the abdominal area. The reporter stated that the patient was due for the 2nd dose, not administered yet and wanted to know if there were contraindications on receiving the 2nd dose.  The reporter stated that the patient did not had symptoms as of the day of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
I was positive for COVID-19 on 17MAR2023, I was tired, I had some body aches and coughing. I also, had nasal congestion.  I contacted my doctor and he prescribed me paxlovid, I started feeling better 5 days later.
High fever, shaking, chills, body aches, bad headache(like COVID headache), thirst.  Sore arm, raised-hot half dollar size red spot.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2017 [reported as shortly after receiving ZOSTAVAX], the patient suffered a stroke. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: Patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the stroke was considered to be not recovered. Upon internal review, stroke was determined to be medically significant. Stroke was considered to be disabling. Additional information has been requested.
I have the side effect because I have allergy, the pimples grow on my body and is itchy; allergy on my skin; I have the side effect because I have allergy, the pimples grow on my body and is itchy; allergy on my skin; I have allergy/allergy on my skin; This is a spontaneous report from a contactable consumer (patient). A  patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose  via an unspecified route of administration on 17Jun2021 at unknown dose single for COVID-19 immunization. Medical history was not reported. No concomitant medication was reported. Patient have the side effect have allergy, the pimples grow on  body and is itchy; allergy on my skin: (From: Unspecified To: Unspecified) the pimples grow on my body and is itchy; allergy on my skin. Consumer stated, "I would like to say I received Covid-19 Vaccine first dose vaccine on 17Jun2021 and I think I have the side effect because I have the allergy because the pimples grow on my body and is itchy, that never happened but I have now." The outcome of event was unknown.  Information about lot/batch number has been requested.
A report has been received from a Health Professional via medical rep. concerning a adult male patient. No information regarding relevant history, concurrent disease and concomitant medications of the patient was provided. The patient had been receiving FLUMIST (intranasal) started during year 2013. The patient experienced asthma attack which started during year 2013. Action taken with FLUMIST (intranasal) was unknown. The patient recovered from the event of asthma attack during year 2013. The report was considered to be non-serious by company physician.
A red and hot-to-the-touch rash developed on right elbow. Sore joints on right arm. Headache. General mental fogginess.
Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Patient was here on Monday, January 27.  While she was here she got the Pneumovax 23 in the left deltoid muscle.  By Monday night it was red, hot, swollen, hard, and very tender.  By the next morning it was even worse.  She developed pain radiating down her arm past the elbow and down into the hand.  She developed ringing in her ears.  She also noticed that with some red streaking going down to the elbow, pain in the left axilla, and pain radiating into her anterior chest. As it progressed she developed tightness in her chest and had trouble breathing.  She also complains of headache, fatigue, myalgia, arthralgia.     When she woke up this morning the chest pressure was gone, but everything else was worse so she presented to the clinic for evaluation.  She rates her pain as a 6 when she is holding the arm still and a 10 when she moves it at all  It hurts bad enough that she cannot tolerate having any clothing touch her arm.  She still has pain in her left axilla and from the deltoid all the way down her left arm into her fingers.  She also still has ringing in her ears.  She can see red streaking down her arm to the elbow.  She currently denies any shortness of breath or respiratory distress.  She denies any chest pain.   1. Cellulitis of arm  She has red streaking down her arm and into the lymph tissue.  This may just be as a sensitivity reaction but in order to cover for potential cellulitis I am going to treat her with cephalexin 500 mg every 6 hours for 10 days.  I have asked her to apply ice and heat off-and-on.  Advised her to wear a sling and elevate her arm as much as possible.  If the symptoms do not improve or if they worsen she has been instructed to seek immediate medical care.  2. Hypersensitivity reaction at injection site, Drug-induced hypersensitivity reaction    4. Injection site reaction   Patient has obviously developed a hypersensitivity reaction at the injection site from the Pneumovax?23 injection.  We will document this in her medical record.  We will also report this.  5. Radiculopathy of arm   I have asked her to elevate her arm, use ice and heat.  6. Headache   She will use Tylenol as needed.  She deferred a prescription for narcotic.  7. Fatigue   I recommend she rest as much as possible until this passes.  8. Myalgia   She will use Tylenol as needed.  She deferred a prescription for narcotic.  9. Arthralgia   She will use Tylenol as needed.  She deferred a prescription for narcotic.  10. Ringing in ears   She will let me know if the ringing in her ears does not resolve.
I had fever starting about 12 or 15 hours after the vaccine was given. The fever lasted for about 24 hours. Now I am very tired and sluggish and still don?t feel well five days after the vaccination was given. I felt very well, except for back pain, before being vaccinated.
Received 2nd dose of Moderna COVID-19 vaccine EUA. Caused central nervous issues similar to other allergic reactions I've had from some antibiotics. Heart racing, shortness of breath, panic attacks. Physically unable to control shaking. This started Tuesday a couple hours after the vaccine and lasted until Saturday (4 days).
Patient developed supraclavicular lymph node nodule 7 days post vaccination on left side of body.  CT scan and biopsy completed 8 days post vaccination.  Biopsy was normal/non-cancerous.
pt rcvd vax; pt devel severe febrile reaction; tx APAP; office visit;
I have had an IUD for a few years and I no longer have period symptoms or the symptoms around periods but I had a serious hormonal disruption and I read other people who had Moderna experienced this.   I found the whole experience so odd but for a couple days I awful diarrhea, acne and fatigue that was noticeable by my boss. I felt like I had been hit by a bus and it was tough to function for a few days. Some of these were familiar period symptoms I hadn?t felt for years but this fatigue was on another level. I kept sleeping and never felt totally rested. It hit me during the week but by the weekend I had snapped out of it. My face is still recovering, though.
Pain at injection site immediately upon injection and then followed by swelling, redness, and heat in the area of injection.  Patient reported a hard lump.  Swelling and redness still visible 4 days later over large area on upper arm.
4 hours after vaccination onset pain (L) upper arm constant, pain level 3-10/10
tinnitus constant ringing in my ear 6 days post my second vaccine on 4/11.
Bladder infection; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Mar2021 15:40 (Lot number: EN6205) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NITROFURANTOIN MACROCRYSTALS taken for cystitis, start date: 15Mar2021.  The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headaches"; CYSTITIS (non-serious) with onset 10Mar2021, outcome "recovering", described as "Bladder infection". Therapeutic measures were taken as a result of headache, cystitis.   Additional information: Concomitant Medications: Caller reports that she thinks the previous antibiotic she was on, was probably the same thing that she was on now, the Nitrofurantoin macro, just a different dose, because they started her on a stronger dose and then lessened the dose. Patient had no prior vaccinations within 4 weeks of suspect administration. Patient had no family medical history relevant to adverse events. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Caller states she had a little headache after the first dose of the vaccine. The headache lasted into the first week after the first dose of the vaccine; 11Mar2021 or 12Mar2021. Caller does not know start date of the headache and does not know exact end date. Patient took Ibuprofen headache.  No follow-up attempts are possible. No further information is expected.
4/08/2021 @1200 - diarrhea, tired, weak.  At 1700, extreme muscle achiness. At 2300, severe headache, temp 102° F, chills, sore mucous membranes in mouth,  tachycardia (110-120/min), Respiratory expiratory wheezes.  Took Tylenol extended release 650mg po. Drank grape juice & 7up.  Diarrhea twice during night (4/09/2021) 0100 - 0600.  Very sick. By 0700 on 4/09/2021 symptoms slightly better. Still had temp of 100 °F, O2 Saturation 94%,  Took Tylenol every 6 hrs x 3 daily on 4/09/2021 thru 4/11/2021.  Didn't feel better til 4/11/2021.
Shoulder pain got better over time; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain got better over time) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain got better over time). At the time of the report, ARTHRALGIA (Shoulder pain got better over time) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medication was not provided. Treatment information was not reported.
Very sore arm, headache, chills, lower back pain,  tiredness......mostly one day
Respiratory distress; Difficulty breathing; A spontaneous report  was received from a pharmacist concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory distress and difficulty breathing.  The patient's medical history, as provided by the reporter, included heart disease, osteoporosis, osteoarthritis, gastroesophageal reflux disease, hypothyroidism, hypertension and history of anemia. No relevant concomitant medications were reported.   On 26 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number:029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Jan 2021, within an hour of vaccination, patient had respiratory distress and difficulty breathing. The patient was treated with diphenhydramine and epinephrine, the patient was intubated and was taken to the hospital.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, respiratory distress and difficulty breathing unknown.; Reporter's Comments: This case concerns an 84-year-old female patient with medical history of heart disease,  who received their first of two planned doses of mRNA-1273 (Lot 029K20A), and who experienced the serious unlisted events of Respiratory distress and Dyspnoea.  The events occurred within one hour of vaccination.  Based on the current available information and temporal association between vaccine administration and the onset of events on the day of vaccination, a causal relationship cannot be excluded.
Roughly 12-14 hours after receiving vaccine, patient had severe chills, nausea and then passed out. She woke up with rectal discharge. She started to feel better about 36 hours later.
menstrual cycle heavy, painful, and more frequent menstrual the adverse symptoms from the first vaccine got worse
Tiredness w/i 1 hr. of shot 11/2. 11/3 next morning: nauseas, back pain, vomitting 102.5 fever, diarrhea, sick for 3 days.
Developed edema (pitting 2+), erythema, warmth and pain in left deltoid area (3 in x 3 in).
Patient Complain oF Patient alert and oriented x3 complaint oF lightheaded 5 minute aFter receiving 2nd dose of Moderna Covid 19 vaccine. ViTal signs taken as Follows BP 122/74, HR 77, RR 19, Temp 98, O2 Sat 100%. Patient was monitored 80 minutes. Electrolit beverage oFFered and taken tolerated well. Patient stated oF relieF and advised to go to ER For any adverse reactions patient verbalized understanding.
Pain Swelling at site Redness Warm to touch Headache Muscle pain Neck pain Anxiety Insomnia Heart palpitations Fatigue Cramping (foot)
Got influenza vaccine Oct 14, 2011. Within a day, itching which continued a week, followed by severe back pain. Blisters one-sided around trunk appeared Oct 24, 2011. Diagnosis: Shingles. Blisters healed in 3 weeks, but pain extreme for 7 weeks, but slowly abating. (Week 12 now).