chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymph-nods under left armpit/breast area (side where I received injection)  were enlarged. Went in for a routine mammogram and have been instructed to return in 3 months to ensure  swelling has subsided.  Also, my regular 28 day periods for my entire life (sans pregnancy) have been extremely abnormal, with almost daily spotting and irregular cycles and symptoms.
Indentation at site of shot started out small and is now the size of a golf ball scaling, red and now bruising.
Patient reported 5 days of fever after Prevnar 13 shot.; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported 5 days of fever after pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) shot. The patient recovered from the fever on an unspecified date. No follow-up attempts are possible, information about batch number cannot be obtained.
Pt recvd vax 26MAR92 & c/o being cold states APAP was given; temp during the noc t106; pts MD was notified & was seen on 27MAR92; was told that child had rxn to the shots; mom states child was vomiting s/immun given;
Redness, itching. A red area approximately 2½ - 3 inch in diameter appeared around the site of injection. Originally warm to touch but no longer. Left over darkened area from where the redness was, the location is still itchy.  No rash elsewhere or other symptoms. Recommended to see physician.
Shingles to the left side of my face and left eye; Impetigo to my jaw line on both sides of my back and back of my neck/hairline area; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-years-old male patient received bnt162b2 (BNT162B2),(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1284) dose 2 via an unspecified route of administration, administered in Arm Left on 10Jan2021 as SINGLE DOSE for covid-19 immunisation .Medical history included hypertension from an unknown date and unknown if ongoing , nephrolithiasis from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included potassium citrate (POTASSIUM CITRATE) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; chlorthalidone (CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced shingles to the left side of my face and left eye  on 19Jan2021 15:30 and  impetigo to my jaw line on both sides of my back and back of my neck/hairline area on 19Jan2021 15:30 and The events were considered as non-serious by the other healthcare professional. The outcome of the events was recovered
Patient was given Janssen vaccine and started having a minor convulsion 2 to 3 minutes later. She almost fell of her chair but her husband caught her and gently placed her on the ground. Shortly after, patient started to vomit a lot and 911 was called. Patient claimed she was confused and did not remember where she was. When the ambulance arrived, patient stated that she felt okay and did not want to go to the hospital. Her husband told paramedics that she had an edible (weed) and was really anxious.
covered in spots all over my body and now they are still there and are spots that look like eczema spot in different areas all over my body; When I take a shower they all come all prevalent and then will still be there but not as noticeable some of the spots but others are small or larger dry patches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 12:00 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergies to mold" (unspecified if ongoing); "allergies to birch trees" (unspecified if ongoing), notes: allergies to birch trees. Concomitant medication(s) included: DULERA; LETROZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 28Mar2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 07Mar2021, when the patient was 59 years old, for COVID-19 Immunization.  The following information was reported: ECZEMA (non-serious) with onset 09Jan2022 09:00, outcome "not recovered", described as "covered in spots all over my body and now they are still there and are spots that look like eczema spot in different areas all over my body"; DRY SKIN (non-serious) with onset 09Jan2022 09:00, outcome "not recovered", described as "When I take a shower they all come all prevalent and then will still be there but not as noticeable some of the spots but others are small or larger dry patches". Therapeutic measures were not taken as a result of eczema, dry skin.  Additional information: No covid prior vaccination and post vaccination. No other vaccine in four weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Abrupt onset intractable migraine with leg and arm weakness. Seen by internist and Neurologist and diagnosed with intractable migraine and encephalomyelitis
Within 48 hours: - Severe chest pain - Shortness of breath - Blurred vision - Extreme fatigue - Hair loss - Memory loss - Uncontrolled trembling - Pain above soft palate - Arrhythmia  - Heat intolerance - Exercise intolerance - Dizziness - Loss of muscle control - Headaches  One year later (April 2023) - Transient Ischemic Attack
2 weeks of severe fatigue; Thirst; Nausea; Coldness; pain in left arm continues; Fever; Chills; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 14:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient medical history included thyroid disease, menieres disease, neuropathy, psoriasis, lymphedema, survivor of breast cancer- had an adverse reaction to 1st chemo injection and brain seizure,3 days of a coma, temporary paralysis of left side of body, low tolerance to medications and hearing loss in left ear. The patient had previously taken Neulasta which resulted in a brain seizure. The patient had allergies to sulphate, pen vee k, monosodium glutamate (MSG). The concomitant medications included azithromycin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), Khov-con, vitamin D (MANUFACTURER UNKNOWN) and vitamin B (MANUFACTURER UNKNOWN) all for unknown indication and from unknown dates. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, at 14:15, the patient experienced 2 weeks of severe fatigue, thirst, nausea, coldness, headaches, pain in left arm that continued and 6 hours of severe coldness -nothing kept her warm one week later than vaccine injection 25 hours after receiving injection, fever, chills, headache and nausea. The patient did not receive any treatment for the events. The clinical outcomes of the events, 2 weeks of severe fatigue, chills, coldness, fever, headache, nausea, pain in left arm continues and thirst were recovered with lasting effects on an unspecified date.   No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 12 month old patient of unknown gender. No concomitant conditions or medical history were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L002242 Expiration date: not reported) and with an improperly stored dose of VAQTA (Lot No. L007559 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a physician's assistant concerning a 32 year old pregnant female who was vaccinated with MMR II "several years ago." Subsequently, the pt had a measles antibody titer in the last two weeks that was negative for measles antibodies. In follow-up, the physician's assistant reported that the pt informed her that her obstetrician found "no antibody response when screened for measles antibodies." The pt reported she has had "all the immunization." Unspecified medical attention was sought. No further info is expected.
Severe Chills, Severe Body Aches, Vomiting, Severe Headache
**Pt had 4 Pfizer vaccines ( 2 original, 2 boosters) and didn't experience any reactions. **  Pt had arm swelling first day (more sore than Pfizer - lasted 3 weeks). The following day, experienced extreme fatigue, low-grade fever, unable to care for herself. No change in diet, no gastro issues. Felt "paralyzed", but not long-lasting. Very weak.
After the vaccine - L arm felt numb/"dead" for about 7 days intermittently. Then once that stopped, L calf felt "tense"/painful for about 1 week. No noticeable swelling or redness. After that (approx 10-14 days after injection) woke up with shortness of breath, noticed while climbing stairs but became progressively worse.  Waited about a week - then noticed sob more severe when trying to "hammer". Went to doctor - hospitalized from 9/29 -10/1 with multiple pulmonary embolisms. Chest x-ray  and chest CT scan and blood work completed at clinic prior to admission. While admitted, calf ultrasound, more blood work, and ECHO completed. Started on heparin infusion, discharged on Eliquis for 90 days.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (A stent was put in her leg after receiving the first dose of the Moderna Covid-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The patient's past medical history included Stent placement. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (A stent was put in her leg after receiving the first dose of the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (A stent was put in her leg after receiving the first dose of the Moderna Covid-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that there was no history of Myocarditis/pericarditis and patient was not experienced a similar event in the past. No treatment medications were reported. This case was linked to MOD-2022-566673 (Patient Link).
slight headache; heavy chills; temperature 100.7; tiredness; (This is a spontaneous report from a contactable consumer, the patient. A 80-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWA151) via an unspecified route of administration in the left arm on 10Apr2021 at 13:45 (at the age of 80-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis, thyroid, hypertension and known allergy to pain medications. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP6955) via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 80-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 10Apr2021, 10 hours after vaccine, the patient experienced slight headache, heavy chills, temperature 100.7 and tiredness. The patient underwent lab tests and procedures which included body temperature on 10Apr2021 and the result was 100.7 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event slight headache, heavy chills, temperature 100.7 and tiredness was recovered on unknown date of Apr2021.   No follow-up attempts are needed. No further information is expected.
Flu vaccine rec'd 9/29/23 at 1345 in left arm, at flu clinic.  No issues initially.  On Monday at 0300am, woke up very itchy all over. When woke again at 0600aam, has hives from knees to shoulders over all areas, red raised and very itchy. Seemed to go away on Tues and Wed. Woke up 0300 today, 10/6/23, and hives again in same areas looking the same. Pt took Benadryl around 0700.  Calmed the itch, hives no longer elevated, but still red and patchy.   Does not feel needs medical care at this time, but aware to seek care if sx worsen or new Sx appear.
swollen axillary lymph node on right side.; aggravated arthritis/carpal tunnel in right forearm & wrist; aggravated arthritis/carpal tunnel in right forearm & wrist; soreness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, arthritis and carpal tunnel syndrome. The patient previously took sulfa and experienced sulfonamide allergy, Concomitant medications taken within two weeks of vaccination included levothyroxine sodium (SYNTHROID), bupropion (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and multivitamin (unspecified), all from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced swollen axillary lymph node on right side, aggravated arthritis/carpal tunnel in right forearm and wrist, soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen axillary lymph node on right side, aggravated arthritis/carpal tunnel in right forearm and wrist, soreness at injection site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain in chest, radiating to back. Sometimes on right side and sometimes on left side. Often accompanied by low fever.   Bloodwork over time (ESR and CRP) consistently showed high values indicating Inflammation.  Eventually TRANSTHORACIC ECHO COMPLETE WITH DOPPLER tests showed fluid buildup around the heart and patient was diagnosed with pericarditis and put on the medication Colchicine.
Narrative:  Patient received the Modern vaccine (first dose on 3/9/2021 and second dose on 4/6/2021). He developed upper respiratory symptoms on 9/2/2021 and presented to an Urgent Care, where he tested positive COVID-19. Symptoms worsened over the next 7 days and he presented to the ED on 9/10/2021. Biomarkers were significantly elevated (CRP 28.16, d-dimer 1.2, ferritin 390.9). CT angiogram was negative for PE but did reveal diffuse bilateral infiltrates. ABG revealed hypoxic respiratory failure (pH 7.44, pCO2 30, pO2 70) on 2LPM. Patient was deemed to not be a candidate for remdesivir due to acute on chronic renal failure. He was given tocilizumab 800mg (8mg/kg) IV x 1. He was initially admitted to ICU and placed on dexamethasone 6mg PO daily. He rapidly improved and was weaned to room air on 9/12/2021. He was discharged home on 9/14/2021.
This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced inflammation and redness in the injection site on an unspecified date with outcome of unknown.
HEADACHE, PHOTOPHOBIA, BODY ACHES; FATIGUE; LEFT AXILLARY ADENOPATHY
Patient fainted about 2 minutes after receiving the vaccine. Lost consciousness for approximately 30 to 60 seconds. Paramedics were called, they recommended she see a doctor due to hypotension. She walked out of the store with the paramedics under he own power. Prior to administration patient had reported a history of fainting after vaccines.
Patient had diffculty breathing and had trouble speaking . Patient had to receive epinephrine on site and 911 was contacted.
Information was received from a licensed practical nurse regarding a female patient of unknown age, who on 23-SEP-2014, was vaccinated with a dose of M-M-R II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Abdominal pain and cramping after eating. Seen per PMD-Surgeon on 12-2003. Started on Zantac 150mg po 2xdaily and simethicone as needed.
Sore throat, inflamed tonsils, cough, runny nose and post nasal drip, headache, difficulty swallowing and breathing, chills, overall weakness.
rash; Feels crummy; Feels like the flu; Extreme arm soreness; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels crummy), INFLUENZA LIKE ILLNESS (Feels like the flu), PAIN IN EXTREMITY (Extreme arm soreness), PAIN (Body Aches) and RASH (rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included SIMVASTATIN for Cholesterol, HCTZ for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Feels crummy), INFLUENZA LIKE ILLNESS (Feels like the flu), PAIN IN EXTREMITY (Extreme arm soreness) and PAIN (Body Aches). On 18-Feb-2021, the patient experienced RASH (rash). On 23-Feb-2021, RASH (rash) had resolved. At the time of the report, MALAISE (Feels crummy), INFLUENZA LIKE ILLNESS (Feels like the flu), PAIN IN EXTREMITY (Extreme arm soreness) and PAIN (Body Aches) outcome was unknown.            No treatment medications were provided. Action taken with the product mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-140696, MOD-2021-030892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up included: Reporter demographics, and concomitant medications added.
01/30/22 presents to ED for "generalized weakness". PMHx of "ESRD on HD MWF, OSA, SLE"
Received first dose of vaccine around 5:40p. A few hours later, I experienced sleepiness and minor fatigue. Fatigue subsided after a nights sleep. Additionally, I experienced an intermittent headache for approximately 36 hours.  I continued to drink fluids to stay hydrated and I did NOT take any OTC medicine for headache or fatigue, it went away on its own and I feel back to normal.
Dizziness, feeling faint, tingling in the arm of the vaccination site, chills, waves of tingling from head to toes.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and on 19May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild/sports induced asthma" (unspecified if ongoing), notes: Mild/sports induced asthma. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim; Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Vicodin, reaction(s): "Known allergies: Vicodin", notes: Known allergies: Vicodin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had 2 Pfizer's first then 2 modernas. Anti-viral details product-COVID 19 Treatment, brand-Paxlovid, treatment start date-05Jul2022, treatment stop date-09Jul2022, indication-Treatment of COVID-19. The patient did not receive other medication in 2weeks. Adverse event-Began to cough and remained winded with chest tightness. Then congested, aches, sweats, chills, and slamming headache. Adverse events start date: 13Jul2022, AE resulted in: [None of the above]. If patient recovered was not Recovered. If treatment Ae was yes. Ae treatment: Consult.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.