chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site reaction. Raised red and odd shaped. Very tired. Felt the medication through my system and had pain in airport area. Lymph area. Felt like I was getting a fever hot and cold.
Infection in hand; This spontaneous report has been received from a licensed practical nurse via a lawyer, concerning a 65-year-old male patient.  The patient's medical history included chicken pox. The concurrent conditions included arthritis and degeneration of intervertebral disc. Concomitant medications were not reported.  On 15-NOV-2010 and 02-APR-2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") by a license practical nurse at a physician's office (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for prophylaxis.  On an unspecified date, the patient experienced infection in hand which was considered an adverse reaction or side effect of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The outcome of the event was unknown.  The patient subsequently experienced Ophthalmic herpes zoster, blindness, sudden hearing loss, major depression, vaccination failure, skin infection, back pain, post herpetic neuralgia, chronic, obstructive coronary disease, colonoscopy, auditory disorder, benign, prostatic hyperplasia, restless legs syndrome, and herpes zoster while on therapy with Zoster Vaccine Live (ZOSTAVAX) (litigation case # 1706USA007417).; Sender's Comments:  US-009507513-1706USA007417:
Patient was given Pneumoccal Polysaccharide (Adult) rather then the PREVNAR 13. -No adverse events occured.
2-3hr p/vax in rt deltoid area became red et painful;today rt upper arm has about 4x5in area of induration, is red et swollen et more painful;DPH PO now;DPH po tid PRN;
6/3/09 Came in for office visit - Urticaria on Rt thigh, warm to touch, non-tender.
Narrative: 64 YOM who presents to clinic for Pfizer COVID-19 vaccination. Allergy was reported following administration of second vaccination dose. Patient reports symptoms lasted for lasted 3-6 days. No other details documented.
Pt experienced localized redness + swelling at injection site. Symptoms starting approx. 8-12 hours post vaccination and continuing for approx. 48 hours. Required doses of advil and zytrec. No hospitalization no MD visit or consultation required no fever recorded. No systemic symptoms reported.
This spontaneous report was received from a physician via company representative refers to a 14 year old female patient. The patient's medical history, a drug reactions/allergies and concomitant medications were not reported. The patient was not pregnant. On 02-OCT-2015 at approximately 6:00pm, the patient was vaccinated with dose 2 of GARDASIL, 0.5 ml, intramuscularly. On 02-OCT-2015 (fourteen minutes after administration), the patient became pale and light headed. The physician had the patient lay down on an exam table and a cool cloth was placed on her forehead. Patient's pulse was normal but her lips were pale. The patient was alert. The patient had not eaten all day prior to her appointment. The patient was given water and a lollipop at the office. After 10 minutes the patient felt much better and recovered at the office. The physician then had a discussion with the patient about the importance of eating 3 meals a day and staying hydrated throughout the day. The outcome of the events was recovered. Causality assessment was not provided. The patient sought medical attention. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
p/ pt recv vax approx 3 yr later devel 15-20 lesions.
Breakthrough case admission after two vaccines  Moderna 9/27/21 Lot# 040B21A;  Moderna 10/28/21 Lot# 939904;
Titer came back low; have a patient on immunosuppressing therapy and the patient inadvertently received a dose of MMRII.; This spontaneous report was received from a registered pharmacist concerning a 41-year-old non-pregnant female patient. The patient's medical history was not reported. Her concurrent conditions included multiple sclerosis, and b-cell deficiency. Her concomitant medications included ocrelizumab.   On 14-OCT-2016, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, subcutaneously, lot # M004305, expiration date was not reported, but upon internal validation it was established as 25-JAN-2018, for prophylaxis (injection anatomical location was not provided).  On an unknown date (reported as "recently"), the patient underwent a blood work (unspecified) and her "titer came back low" (Antibody test negative). Therefore, on 26-AUG-2022, after she started immunosuppressive concomitant therapy, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, subcutaneously in her left deltoid, lot # U025199, expiration date was not reported, but upon internal validation it was established as 13-AUG-2023, for prophylaxis (Contraindicated product administered). No other adverse events occurred.
Chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: It was reported that, the patient got the new omicron booster and have had all regular and all boosters Mostly had chills fever But with the bivalent the patient had a little sore arm Maybe tired.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Firm lump at injection site since injection on 1/8/21. Pain at left upper arm  for 3 days after injection.  Today 1/17/21/ 10 days post injection,  injection site became warm, red, swollen and itchy. Cortisone cream applied with no change in symptoms.
Patient's period started, as expected one week after her vaccine, but was much heavier than normal.  After that period ended, she got her period again on June 7th with incredibly heavy bleeding and painful cramping (the cramping was so bad it had her up all night June 8th).  The second period is a total surprise given the she is taking her birth control regularly.  Also the heavy bleeding and extreme cramping is not normal for her on her birth control.
lethargy, hypoglycemia, decreased feeding, which progressed to brain injury, septic shock and respiratory failure requiring intubation and encephalomalacia. was + parechovirus, but negative bacterial work-up or metabolic, genetic work-up for cause. Still suffering from insult to brain with developmental delay, difficulty feeding, abnormal MRIs.
Information has been received from a health professional concerning a 64 year old male who in October 2005, was vaccinated with a first 0.5ml IM dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (lot # 649693/0456P). Concomitant therapy included atorvastatin calcium and concomitant vaccine administered on the same day included a dose in the left arm of influenza virus vaccine. In October 2005, about 3 hours after vaccination, the patient developed severe pain in his arm and he could barely move it. His arm was swollen and red. The patient went to the emergency room. He was given methylprednisolone and was discharged. It was reported that the patient made a full recovery. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. The event was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Patient came in on morning of 8/19 complaining of severe pain from right shoulder down arm. She explained she was vaccinated on 8/17 and started experiencing symptoms 8/18. Patient did not experience difficulty lifting arm, numbness, or tingling sensation when asked. She explained her symptoms as a severe, dull, ache throughout her arm. She took Advil on 8/18 to help with discomfort. I recommended her use cool compress to alleviate the area and continue using NSAIDs for pain relief, and if symptoms do not begin to resolve in a few days to contact PCP.
hospitilization, syncope, diarrhea, vomiting, unknown symptom onset date  3rd dose Pfizer vaccine given 12/1/21, Lot # FJ8762, IM RUD
severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss intermittent left eye for 5 minutes at a time ( 5 events over one month), continued to this day intermittent diplopia vertical , with blurring vision and eye fatigue , general fatigue with ADL ( missed multiple days of work), bouts of tachycardia and palpitations ( slowly abating over 6 weeks ) , original neck pain and headache severe in first 2-3 weeks especially after second vaccine 1/29/21 lot number EL3246. multiple MRI's done brain ( white matter and demylination dating back to before 2015) and cervical and thoracic spine showing existing disc disease all old , neurology work up was done for MS and it was ruled out. visual disturbances persist and neuro-ophthomologist appointment schedule for mid april .
There was no true adverse event. The vaccine was given in error due to the child only being 12 and having no special considerations for receiving the vaccine before the age of 16.
Not responsive at all; Sleeping; Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups; This morning put her back to bed and then told me she is not herself today; Her eyes kind of closing; Threw up; She was tired about 7 o´clock in the evening and went to bed early; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Not responsive at all) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insulin dependent diabetic. Concomitant products included LISINOPRIL, ATORVASTATIN and INSULIN for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced FATIGUE (She was tired about 7 o´clock in the evening and went to bed early). On 27-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Not responsive at all) (seriousness criterion medically significant), SOMNOLENCE (Sleeping), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups), ASTHENOPIA (Her eyes kind of closing), VOMITING (Threw up) and MALAISE (This morning put her back to bed and then told me she is not herself today). At the time of the report, LOSS OF CONSCIOUSNESS (Not responsive at all), SOMNOLENCE (Sleeping), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Took her to the bathroom at 5 o´clock this morning and she was wet, she is in pull ups), ASTHENOPIA (Her eyes kind of closing), VOMITING (Threw up), MALAISE (This morning put her back to bed and then told me she is not herself today) and FATIGUE (She was tired about 7 o´clock in the evening and went to bed early) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is insulin dependent. Takes blood pressure medication and cholesterol medication. Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's age and medical history of insulin-dependent diabetes mellitus, hypertension and hypercholesterolemia, as well as intake of concomitant medications, are confounding factors that may play possible contributory roles.
1 of 2 pts who was vaxed from the same vial & had adverse event; pt devel erythema (size of quarter), swelling from deltoid to elbow, fever 101, also had asthmatic attack; seen by MD tx w/Epi; presented to ER 5 hrs later; hospitalized;
Pt described having received 3rd HBV 5/25/06 at 4:30PM. Stated "I then worked hard for a few hrs mowing my lawn." At approx 8:00PM onset of Sx: tingling sensation in lips and fingertips with numbness in left fingertips, and chills. Pt did not seek medical care and did not take her temp.
Intense erythema circumferentially around entire upper arm in 3 inch wide band with burning sensation.
she has a box of ROTATEQ in which the foil pouches containing ROTATEQ are unsealed; Caller reports that patient did not have any adverse effects or symptoms following administration of the ROTATEQ.; three doses have been given out of that box /caller reports the dose of ROTATEQ was administered on 27-APR-2022; This spontaneous report has been received from a Registered Nurse referring to a 3-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.   On 27-APR-2022, the patient was vaccinated with a possibly unsealed rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter (ml) orally (strength and vaccination scheme frequency were not provided; lot number 1742077 has been verified to be a valid lot number with and expiration date reported and established as 12-SEP-2022) as prophylaxis (poor quality product administered).   The reporter stated that she had a box of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) in which the foil pouches containing the vaccine were unsealed (product container seal issue ), and that three doses had been administered out of that box. However, this was noticed until 11-MAY-2022; therefore, the reporter did not know whether the foil pouches containing the administered doses were also unsealed.  It was reported that the patient did not have any adverse effects or symptoms following the administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003440: US-009507513-2205USA003247:
Lips, tongue and inside mouth are swollen.  Tastebuds are overly active. Feels like I?ve eaten hot food and burned my mouth. Tongue and lips have a tingle sensation
extreme joint pain, fever and chills, muscle aching, severe head ache (lasting 3 days), excessive full body sweating x3 days, extreme fatigue (sleeping >16 hrs per day x3 days, 1 short bout of nausea, sensitivity to skin on back and legs i.e. a cotton shirt against my skin felt like it was burning me. loss of appetite. multiple doses of OCT analgesics/fever reducers. loss of scheduled work x2 days.
This spontaneous report was received from a healthcare worker refers to a 5 year old male patient. Concurrent conditions, medical history and allergies were not reported. On 22-OCT-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous injection in the right arm (strength, dose number, lot number and expiration date were not reported) which was exposed to warmer temperatures. Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected.
Immediate headache Body aches, sore throat, dizziness Swollen lymph nodes starting 2/18/22 Unable to use left arm
Information has been received from a physician concerning a 24-month-old patient who on 19-APR-2007 was vaccinated with a dose of ProQuad (Lot # 656887/0150U) instead of hepatitis A virus vaccine inactivated (manufacturer unknown). It was noted that the patient was previously vaccinated with ProQuad (at 1-year of age). No symptoms have been reported. The event occurred due to "nursing error", not product confusion. No further information is available. There was no product quality complaint. Additional information has been requested.
Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization.  Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal.  Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg  for allergies, vitamin D at 1000 iU  daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing.  The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021.  The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered.  The information on the batch number has been requested.
received her first GARDASIL 9 vaccine at 36 years old, wants to complete the vaccination series; No PQC or additional AEs reported; This spontaneous report was received from a nurse referring to a female patient of unknown age and gender.      The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in 2018, when the patient was 36 years old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, frequency, lot # and expiration date not reported) for prophylaxis. At the time of the report, the patient wanted to complete the vaccination series. No adverse events were reported.
Back pain leading to MRI with incidental finding of mediastinal and Hilar adenopathy. Biopsy pending.
myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 29-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Had myocarditis from Covid vaccine. It was a very different story. A 29 year old male with a young child, who can't work, limited whole body function, currently looking at blood transfusions, hospitals in disarray because they don't know what to do.  No treatment medications were provided.  Company Comment This spontaneous case concerns a 29 years-old male patient with no medical history reported who experienced the expected seriousness criterion medically significant event of myocarditis unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273.815 vaccine  is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2023: Live follow up received contains new reporter added.
Throbbing pain w/in 1 inch of injection site like someone punched arm really hard a few times (no redness, swelling, bump there). Sore to the point pt can only lift arm 45 degrees then it throbs causing a  pain in her eyes. Left arm (Pneumovax).
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-FEB-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
3 cm x 2 cm firm edematous area lt deltoid; 0 redness, 0 pain, 0 paresthesia, lungs bil clear; 0 chest pain or resp difficulty; t98.5, p80 reg, r 20, BP 160/76; warm pack to lt deltoid region for 20 mins;
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 24Feb2021 at dose 2, single and first dose on 03Feb2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no serious underlying health conditions. The patient began feeling ill with symptoms of coughing, congestion, headache, body aches and fever on 21Aug2021. Patient went for COVID testing on morning of 23Aug2021 and COVID test was positive. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Started with some congestion, dizziness, then quickly progressed to coughing and hoarseness, blurry vision. I was transported via a wheelchair to the ED. I took 2 BENADRYL about 2 hours before the injection with lunch. I took 2 more after the reaction started plus 2 puffs of my albuterol inhaler. Then 50 mg of prednisone followed later by a taper of prednisone for 3 days.
after 25 minutes,  I felt a tingling and numbness on the left side of my face and became difficult to swallow.   I was given benedryl and pepcid by emergency room and things felt normal a couple hours later