chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SARS-COV-2 TEST POSITIVE; DRAINAGE IN THROAT; CONGESTION IN THROAT; CONGESTION IN SINUS AND NOSE; This spontaneous report received from a parent concerned a 34 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, and mold allergy. 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 26-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021, the subject experienced drainage in throat. On 26-APR-2021, the subject experienced congestion in throat. On 26-APR-2021, the subject experienced congestion in sinus and nose. On 19-JUL-2021, the subject experienced sars-cov-2 test positive. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) POSITIVE. On 21-JUL-2021, Laboratory data included: COVID-19 PCR test positive (NR: not provided) POSITIVE, and COVID-19 rapid POC test positive (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drainage in throat, congestion in throat, and congestion in sinus and nose on 03-MAY-2021, and the outcome of sars-cov-2 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
On 10/1/18, patient came to the pharmacy and showed me a red, raised, itchy area (about 1 inch in diameter) on her left upper arm at the site of injection. She said it started a few days after she received the shot. Itching was the primary complaint.
Information has been received from a registered nurse concerning a 29 year old female patient who was vaccinated in another country with a dose of MMR. Post vaccination the patient developed a fever for 1 week. Subsequently, within 3 months post-vaccination, the patient became pregnant. It was reported that the patient decided to terminate her pregnancy based on information she was provided at that time and it was noted that the patient was advised to terminate her pregnancy. The nurse planned to titer the patient and check for immunity.  It was reported that the pt had an elevated temp after vaccination with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no reported medical intervention to treat fever. It was reported that pt was advised to terminate the pregnancy. No further information is available. Follow up 03/03/05: Patient has not recovered from the adverse events.
Ten hours after my injection I woke up around 1:30am and had chills, fever, every part of my body hurt - each tooth, eye socket, fingers, toes, every joint and muscle. I was in a lot of extremely painful pain. I had a terrible headache. I was cold. Everything was to the extreme. I texted my doctor and he informed me I could take Tylenol which I did. This lasted from Monday to Thursday I was without fever and went back to work but did not feel great at all. I was exhausted with extreme fatigue. I didn't start to feel better till a little over a week but still had fatigue. I had a bad reaction to the second vaccine and this time had my mother there to help me because I felt terrible. The event was on the 9th 1:30am when I woke up in the middle of the night to go to the bathroom I passed out and hit my head on the bathtub and woke up on the bathroom floor completely disoriented without knowing what happened. I woke up with head and neck pain due to the position my head/neck was in.  I called Telemed at 2:13am and the doctor called me 20min later and said to followup with my doctor. I went to work the next morning and felt off.  I called my doctor around 8 while at school and was told to go to the ER right away. I was to have a doctor's appointment yesterday, but it was rescheduled to this Thursday.  I've had a concussion in the past, a whip lash concussion. I still off today.
Fever, chills, sweating, loss of appetite, headache, diarrhea (5 days), weight loss, severe swelling at injection site, itchy sunburn-like rash on arm.
Patient received  COVID 19 Moderna vaccine first dose on 3/8/2021. Inadvertently, he received Pfizer COVID 19 vaccine as a second dose on 5/18/2021.
Skin reaction near the site of the shot/ Bright red spot on skin that is an irregular heart shape; Skin reaction near the site of the shot/ warm to the touch and itches; Skin reaction near the site of the shot/ warm to the touch and itches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 15:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. Concomitant medication included triamterene taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not pregnant, did not experience COVID and did not receive other vaccine in four weeks. Post-vaccination, the patient has not been tested for COVID. On 27Feb2021 15:15, the patient experienced skin reaction near the site of the shot developed 24 hours after the shot and lasted 48 hours so far. It was a bright red spot on skin that was an irregular heart shape, about 2 inches in diameter, warm to the touch and itches. No treatment was received for the events. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fevers; headaches; stomach pain; schlerosing mesenteritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; FAMOTIDINE. Past drug history included: Neosporin, reaction(s): "Known allergies: neosporin". Vaccination history included: Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "fevers"; HEADACHE (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "headaches"; MESENTERIC PANNICULITIS (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "schlerosing mesenteritis"; ABDOMINAL PAIN UPPER (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "stomach pain". The events "fevers", "headaches", "stomach pain" and "schlerosing mesenteritis" required physician office visit. Therapeutic measures were not taken as a result of pyrexia, headache, abdominal pain upper, mesenteric panniculitis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
After about 30 mins of vavcine, Rash and redness  to eyes then itchy throat. Started benadryl round the clock. Symptoms lasted x 3 days.
The morning after my second vaccine my lymph nodes were so swollen that you could grab them. They were the size of a ping pong ball. And then about 3 weeks after I started noticing hand( fingers) being very swollen and hurting. They were hard to bend my fingers because they hurt so bad and they would go numb throughout the day. As time progressed the pain in my joints ta went from just my fingers to my knees and ankles and toes. My fingers and knees still swell a lot throughout the days and those and my ankles and toes hurt literally non stop. I have tried many different types of arthritis creams and pain releiving creams and muscle rubs. I have also tried peptides (pills and nasal sprays), cleanses like heavy metal detox and and antivax cleanse. My doctor also put me on metacam and gabapentin and nothing has helped. I saw an ortho specialist in 8/21 and just saw  a rheumatoid specialist on 1/3/22 and am waiting for all the blood tests he did to come back.
Patient became lightheaded and lost color in her skin. Patient also complained of ringing in the right ear. Symptoms occured approximately 1 minute later and resolved within 20 minutes.
p/vax pt had several pinhead sized clear fluid vesicles on lt arm near inj site; MD recommended triple ATB cream to area
FLUZONE HD was administered to a 51 year old patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case via health professional and physician. Agency number: 01287082.  This case involves a 51-year-old male patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PCV 20).  On 20-Sep-2022, the 51-year patient received suspect FLUZONE HIGH-DOSE QUADRIVALENT at dose 0.7ml once via intramuscular route in the left arm (lot: UJ904AB, expiry: 30-Jun-2023) for immunization with no reported adverse event (product administered to patient of inappropriate age) a same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC 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.
For a few days following vaccination had very mild flu-like symptoms but nothing special.  Approx 4 w after the shot I developed mild SOB that progressed over the next 4 w into severe SOB so that I had to rest going up 1 flight of stairs.   Had audible wheezing.  Saw my PMD and diagnosed with CHF.   Subsequent w/u revealed severe non-ischemic left ventricle cardiomyopathy with CO < 20%.  Now on 6 meds for the HF and I'm functional but no-where near what I was prior to the symptoms developing (I was very athletic, kyaking, biking to metro every day going to work as a surgeon, open water swimming, long hikes, very physical yard work).
Right arm and hand swollen and pale in color.  Difficulty in breathing.  Mother contacted by school nurse.  Child seen at 11:30 AM.  Symptoms resolved.
"1. End of week1 after dose 1 - Flare up of allergic rhinitis" Narrative:
Rec'd vac. Tues 9-28-10 that pm arm became red, sore, lump, she took BENADRYL and 800mg MOTRIN. States a lot better today (9-30-10). Also warm to touch.
Pt stated she developed a red bump at injection site. She went to doctor told her to monitor she went home next day bump had grown in size MD gave steroid shot bump resolved next day.
mom reports per phone runny nose 9-7; fine rash evening body appears red on buttocks diarrhea, t102.5 on 9SEP92; mom reported to MD who called in an ATB for pt;
1 hour after administration of flu vaccine - developed hives. Took BENADRYL with complete resolution.
Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history and no allergies who on 08-JUL-2007 was vaccinated with the first dose of GARDASIL 0.5 ml IM (lot # 660387/1967U). Concomitant therapy included NUVARING (birth control) and Ibuprofen as needed. The patient developed rash over her back 3-5 days after vaccination. The patient's mother called the office since the rash has persisted and she was referred to dermatologist. According to the patient's mother the rash looks like "blotches over the back like a sun burn. There is no itch and it is not raised." The patient was noted to be recovering. Additional information has been requested.
half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm with no adverse event; leaked on the patient's arm with no adverse event; Initial information was received on 25-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 23 years old female patient who experienced half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm and leaked on the patient's arm with no adverse event after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient received a 0.5 ml, once dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT8155LA, expiration date: 30-Jun-2024, strength: standard) via Left arm in unknown administration site for Immunization.  On 25-Oct-2023, half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm with no adverse event (accidental exposure to product) and leaked on the patient's arm with no adverse event (exposure via skin contact) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Reportedly, none of the vaccine was administered to the patient. Caller is requesting for the replacement of the affected FLUZONE QIV pre-filled syringe, she mentions that they have a contract with Vaxcare and they were instructed to reach out to the manufacturer for replacement.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC 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.
Itchiness; Bumpiness; Hot; Tenderness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness), SKIN MASS (Bumpiness), FEELING HOT (Hot) and TENDERNESS (Tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced ERYTHEMA (Redness) and TENDERNESS (Tenderness). On 10-Mar-2021, the patient experienced PRURITUS (Itchiness), SKIN MASS (Bumpiness) and FEELING HOT (Hot). On 16-Mar-2021, SKIN MASS (Bumpiness) had resolved. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itchiness), FEELING HOT (Hot) and TENDERNESS (Tenderness) 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.   Treatment included Antihistamine. Concomitant medications were not provided.   This case was linked to MOD-2021-046099 (Patient Link).
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's medical history and current conditions were not reported. On 11-SEP-2014 the patient was vaccinated with GARDASIL (lot # K006117 and expiry date 14-JAN-2017), 0.5 ml, intramuscular in the left arm. Other co-suspects were not reported. Concomitant therapies included ABILIFY and WELLBUTRIN. Approximately on OCT-2014 (reported as, in the first week of October) the patient experienced unspecified joint pain after she received her first dose of GARDASIL. The patient consulted her pediatrician, who was unspecified by the nurse. Unspecified laboratory blood tests were ordered by the pediatrician, and the results were within normal limits. The patient has been referred to an unspecified rheumatologist for further evaluation. The unspecified joint pain has persisted since the onset of the symptoms. Cancer was not reported. The outcome of joint pain was reported as not recovered/not resolved. Causality was unspecified by the reporter. Additional information has been requested.
Noticed bilateral parotid gland swelling, fussiness, fever up to 101.5. Later noticed testicular tenderness.
This spontaneous report as received from a 66 year old female registered nurse refers to herself. On 09-MAY-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). On an unknown date in August 2012 the patient was diagnosed with a lump in her breast during her yearly mammogram. Her mammogram the previous year had demonstrated no signs of any abnormality. After her diagnosis of breast cancer, she received radiation and chemotherapy treatments in "September and November of 2012". The patient stated that the breast condition was currently in remission. The outcome of the event was reported as recovered. The reporter considered breast cancer to be not related to ZOSTAVAX. Upon internal review, breast cancer was considered as medically significant. Additional information has been requested.
Red bumps under eyes then swelling, 2 days after vaccines. Vomited once - 3 days after.
Information has been received from a physician concerning an 8 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 27-JUN-2007 the patient experienced rash at the injection site (patient's thigh). The rash was originally the size of a quarter but eventually spread to the whole thigh. Medical attention was sought. The patient was given benadryl which did not help then steroids (manufacturer unspecified) then the rash went away in couple of days. The patient was recovered. No product quality complaint was involved. Additional information has been requested.
Patient presented with palor to face and lips while waiting in recovery. Jacket was removed with sleeves pulled up. A&O times 3. Patient was placed on floor for safety and air. V/S obtained BP 110/70, HR 93, O2 98% room air. Patient was given cold water with gatorade to drink. Patient finished drink and stated he felt better after 10 mins. Mother and father at child side. No acute distress noted. Extended monitoring done in recovery. Patient ambulated from facility with parents without any difficulty noted.
pt recv vax 5NOV97 & the next morning pt exp hives on upper eyelid & both feet;7NOV97 pt was examined by a MD & found to have a rash on thorax that pt was stated was urticarial wheal prior to office visit;
2hrs p/vax pt has SOB & diff breathing, had tingling & swelling of mouth & lips;took Alupent & DPH;also exp hives & ha/
Mother reported headache as reported by patient approximately 10 minutes after receiving vaccination. Patient alert and talkative. He had not eaten or had any liquids recently. Mother advised to give patient water and planned to retrieve a snack for him from the snack machine. Patient has a history of headaches in similar location and mother reported he tends to be very nervous with vaccines. Patient advised to monitor, may take pain reliever PRN and notify provider of any worsening or new symptoms. Mother in agreement.
HIV; heart condition; Chronic obstructive pulmonary disease (COPD); Chronic obstructive pulmonary disease (COPD)/heart condition; visually impaired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HIV INFECTION (medically significant), outcome "unknown", described as "HIV"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "Chronic obstructive pulmonary disease (COPD)"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "Chronic obstructive pulmonary disease (COPD)/heart condition"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "visually impaired". Clinical details as follows: The patient had a heart condition and I have HIV. I'm visually impaired, I received my primary vaccination series and a booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). He asks: "Do you have any information on the effectiveness of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) booster dose 4 months after vaccination?" The patient mentioned that he has a heart condition and Chronic obstructive pulmonary disease (COPD) now. And he already had his first and second dose of the vaccine also he already had his Booster Shot. He is asking the effectiveness of the booster shot after 4 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt has redness, swelling, and induration greater than 100mm (approx. 6-8 inches in diameter).  Pt also had redness and pain develop at a previous surgery site 3 days after the vaccine
DPT and IPV given in lower mid Lt thigh where bled after injection VARIVAX then swelled and became red / Lt posterior arm was in injected 3x / keep pulling away - reddened.
Approximately 5 minutes after receiving the second dose of COVID-19 vaccine individual reported feeling short of breath and felt like she was losing her vision.  1 mg Epinephrine IM administered along with 6cc of Benadryl.  911 called.  Approximately 5 minutes after the Epinephrine injection the individual stated she was feeling better.  Individual was able to walk, unassisted, to the ambulance cot.  Individual transported to ER in stable condition.  Stated SOB has subsided.  Individual also took 2 puffs of her rescue inhaler.
Menstrual spotting/bleeding day after receiving first vaccine dose, spotting still currently lasting following week. Spotting started 1.5 weeks before next period
Headache,  joint pain, fatigue, muscle fatigue and weakness, exhaustion, difficulty word finding Treated with vitamins and steroids  Ongoing
It is not a big deal, but I feel it is strange. I have regular periods, every 35 days followed by 45 days, then alternate. My period was altered by this vaccine. Period happened 2 days after the shot.  The exact same pattern happened after the first dose of Moderns vaccine administered on 5/2. I have never had period shorter than 30 days in my life. I suspect there must be a hormone change induced by the mRNA vaccine. It could be easily ignored by most women recipients due to 28 days interval. But, could it cause any potential consequence to teenagers? That's why I want to bring this issue to attention.