chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received her first dose, She has since tested positive for Covid; received her first dose, She has since tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Unknown, NDC number: Unknown, Expiry date: Unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient tested positive for Covid. She states she received her first dose of the Pfizer Covid vaccine. She has since tested positive for Covid and wants to know when she can get the second dose of the vaccine. Patient stated tomorrow she was to have the second one, but she is sick now. She was talking about the COVID Vaccine. She is positive for COVID. She was asking when can she have second dose. There was a product problem complaint. The patient underwent lab work and procedures which showed Covid-19 was positive. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
heavy period bleeding lasting over 20 days; This spontaneous case was reported by an other and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy period bleeding lasting over 20 days) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy period bleeding lasting over 20 days) (seriousness criterion hospitalization). On 24-Apr-2021, HEAVY MENSTRUAL BLEEDING (heavy period bleeding lasting over 20 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Haemoglobin: 5 level at 5. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based in current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Left arm - red, swollen, warm to touch from deltoid to approx 1-2" above elbow. Band-aids were still in place. Instructed on comfort measures. Mother stated she was taking child on to clinic.
Patient complained of redness and a lump at the injection site. Patient stated his face swelled the morning after receiving vaccine, which he treated with Benadryl. Facial swelling resolved after one dose of Benadryl. No other complaints.
Rash is located on the legs and is described as red, flat, nondraining.  Treatments tried at home are Benadryl- 17.5 hours ago Antihistamine cream- 17.5 hours ago  HPI - Additional information: Felt well until 1 night ago. Sx began with red, swollen, nontender, non itchy area on right  lateral thigh that was hot to touch and rough on palpation.
After injection, pt had excessive bleeding immediately following along with a 4mm bump. After about 5 min, I noticed a red rash around the injection site. Pt was given 50mg of diphenhydramine.
right shoulder hurts; can't really use right arm and shoulder were very weak; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "my right shoulder hurts"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "can't really use right arm and shoulder are very weak".  Additional information: Patient's right shoulder hurts and had one shot and now can't really use right arm and shoulder were very weak and hurts at joint of shoulder especially.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Afternoon after receiving vaccine, he started with shaking, freezing, nausea and high blood pressure. Lasted 3 days. No local reaction.
Pt recvd MMR vax as a childp pt currently exhibited a lack of response to mumps; no further details were provided;
Information has been received from a physician assistant concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL (lot # and expiration date unspecified). On 24-MAR-2016, the patient received the second dose of GARDISIL (lot # and expiration date unspecified) and then received the third dose of GARDASIL (lot # and expiration date unspecified) on 18-MAY-2016 (Inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
THE PATIENTS UNDERARM SWELLED UP AND HER RIGHT ELBOW WENT NUMB.
Pain on Left  side, just below the 12th rib on the back part of body. Fever was 99.6 at 1:30pm 1/14/21. Feeling chills. Body aches. Arms felt sore.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24-years-old female patient who received an incomplete dose while she received 1 ml dose of vaccine IMOVAX RABIES (lot N1K303M, expiry date 28-Oct-2019) via unknown route in unknown administration site on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine on that day. It was a case of actual medication error due to vaccine underdose. It was reported that while the dose was being administered, some of the vaccine leaked out of the syringe near the needle, right around the seal. The syringe tip was pulled off. Vaccine was not available for return, as it had already been discarded. There were no signs of damage or tampering with the any of the items, or with the carton. This was also a case of syringe leak. It was not reported if the patient had any adverse event. Regulatory Authority number was updated as: 100003948. Status: in process. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. Follow-up information was received from a nurse on 13-Mar-2019. Regulatory Authority number was updated and changes made in the field and narrative accordingly. List of documents held by sender: none.
Employee received pfizer covid booster vaccine on 11/16 and soon after developed a sore back and headache originally. Employee notes that both of those symptoms occurred with 1st and 2nd doses of the covid vaccine. Then employee started to have bilateral hand and feet numbness and tingling. Employee reports that it occurs at various times throughout the day and has no certain duration or onset.
I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow  (injection was in left arm), and nausea.  Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night.  Symptoms continued until morning of March 20, 2021 and gradually lessened by evening.   Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache.  Ate a few saltine crackers to lessen nausea symptoms & drank ice water.  Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.
The patients are not having any side effects that I am aware of.; temperature excursion/ the GARDASIL 9 was given to 3 different patients/ Temperature ABOVE 47degrees Farenheit (54.2F) for 0 hours 30 minutes/ Time frame ABOVE 47 degrees F (54.2F) for 0 hours 30 minutes; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-NOV-2020, the patient was vaccinated with incorrectly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # 1637648 with expiration date 19-JUN-2022 (route of administration and anatomical localization was not reported) for prophylaxis. Administered vaccine underwent temperature excursion of 54.2 Fahrenheit degrees for 30 minutes.  Digital data logger was involved. No previous excursions occurred.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA009546: US-009507513-2011USA009052:
Body Aches Mild-Moderate; Headache Mild-Moderate; Feeling Queasy; Pain Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches Mild-Moderate), HEADACHE (Headache Mild-Moderate), NAUSEA (Feeling Queasy) and INJECTION SITE PAIN (Pain Injection Site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body Aches Mild-Moderate), HEADACHE (Headache Mild-Moderate), NAUSEA (Feeling Queasy) and INJECTION SITE PAIN (Pain Injection Site). At the time of the report, PAIN (Body Aches Mild-Moderate), HEADACHE (Headache Mild-Moderate), NAUSEA (Feeling Queasy) and INJECTION SITE PAIN (Pain Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I suffer from vertigo pre covid and it got worse during early 2020" (unspecified if ongoing), notes: I suffer from vertigo pre covid and it got worse during early 2020. The patient's concomitant medications were not reported. Past drug history included: Meclizine for Vertigo, reaction(s): "no impact anymore it feels like", notes: Meclizine 25mg has had no impact anymore it feels like. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/lot number: Unknown), for COVID-19 Immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: patient reported that, had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there any links to case studies or general information about it. I suffer from vertigo pre covid and it got worse during early 2020. I noticed every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had. Meclizine 25mg has had no impact anymore it feels like, I had 5 shots already of  Follow-up attempts are completed. No further information is expected.
Dysphagia, neck pain/stiffness difficulty raising arm, headache, muscle spasm (cen cal) insomnia.
Patient began to get sick at stomach post imz and stood up to try and feel better. Patient then became lightheaded and informed us that something was wrong. she then sat down and I went to help her. I stayed with her and talked to her the whole time while she sat there. She never became unconscious to my knowledge and I kept her pulse the whole time. After a minute she started to regain her color and she received some water to help her cool off. After about 10 minutes she left the store and I escorted her to her vehicle and she stated she was doing good.
pt recv vax 12NOV96 & 9DEC96 pt devel an upper resp infect & a couple of lesions on neck;the lesions spread to back & torso;A school nurse confirmed chickenpox w/approx 30 lesions;
Itchy rash appearing on the neck. A couple of days after receiving the vaccine the rash started appearing daily. It continued to appear for 3 weeks until I went to see a specialist. The area on the neck became red, irritated, and itchy. The dermatologist prescribed an ointment to treat the rash.
4 month vaccines 6/16, Started with fussiness that evening, 6/17 with bouts of being inconsolable, Started with vomiting and diarrhea, Sunday and today more consolable, Decreased appetite. diarrhea, vomiting, red swollen legs and bloody stool.
Pt had orange size rash, no pain or itching. Pt had headache and lethargy when resolved overnight. Pt w/a f/u w/PCP.
No adverse side effects from vaccine administration error. This is an error only report for expired vaccine given. Moderna was contacted in efforts to conclude if the vaccines administered on  January 19th were efficacious or not. "The vaccine administered on January 19, 2022 from lot number 077C21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. "  No known sequela from the event.
Muscle inflammation, weakness, Fatigue, Hard to touch , swollen and painful lymph nodes, pain in the left arm, Axillary, limited mobility in the left arm
patient received expired IPOL/ NO AE; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 months old male patient who received expired dose of 0.5 mL IPV (VERO) [IPOL] (strength: standard, frequency: once, batch number: R1B251M, expiry date: 13-Mar-2021 via subcutaneous route in left arm) (expired product administered) on 30-Apr-2021 for prophylactic vaccination  The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (HIBERIX); INFLUENZA VACCINE (INFLUENZA VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic Vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good 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.
Severe itching that started at injection site to my whole body. Pain, swelling, redness, and lump at injection site also. Noticed a big red circle on opposite arm (left) that was very itchy. The itching started maybe an hour or so when I took bandaid off after injection to present, just not as bad. Took Benedryl per pharmacist and spoke with triage nurse at doctor's office. Also been in contact w/ Dr. via portal. Advised to call office the next am if needed (too late to be seen) and/or go to ER if throat closes or sob. Dr. Sent script for Hydroxyzine for the itching. As of today, 10/23, feeling much better. Some itching but very mild. Lump on arm going down as well as redness and swelling. Left arm appears to have improved also.
Injection site because firm, red, and hot to touch. Circular 5? diameter. Quite painful to touch.
On ~10/18 patient began to show signs of being short of breath when doing any activity.  She also felt dizzy and light headed.  She has had melena over the last few days.  Her O2 saturation was low at PCP appointment 10/25 and she was sent to ER.  She has been found to have auto immune hemolytic anemia.
Some of the fluids squirted out and the individual did not receive the full dose of the vaccine; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the fluids squirted out and the individual did not receive the full dose of the vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the pharmacist administered the Moderna COVID-19 vaccine to her coworker and during vaccine administration, some of the fluids squirted out and the individual did not received the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, some of the fluids squirted out and the individual did not receive the full dose of the vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered.
Was diagnosed with COVID-19 infection in 3/2021.  Recovered without issues.  Did not require hospitalization.  Received 2nd Pfizer vaccine on 6/11 and developed nausea, vomiting, and hematochezia on 6/13.  Presented to ED with CT abdomen showing pancolitis felt infectious versus inflammatory.  She was started on IV abx and supportive care with clinical improvement.  Evaluated by GI and further evaluation deferred given clinical improvement.  Required 4 day hospitalization and discharged safely on 6/19.
I already had a case of the shingles on July 10-2009. They finally cleared all out about November, but the pains were very bad. I got some nutritional I.V.'s and built up my Immune. In March I had another light attack of shingles. One day my Dr approached me and told me to get the vaccine for the shingles. Soon Aug 11-2010 I did. A month later I got the hives and I have been suffering with that ever since. I do have allergies. I did not know if you have allergies, do not get the vaccine. My Dr knew that I had allergies. How do I get cleared from the hives. I am going to an allergist. I can't seem to get better. I have been taking ALLEGRA. I have the hives all over my body, it has really ruined my life. If you know of any information to help me, please let me know.
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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PRASCOLEND, start date: 12Jul2023; BREO ELLIPTA, start date: 12Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 08Aug2023 to 14Aug2023. The patient had no known allergies.  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.
Narrative: SORENESS MUCH IMPROVED WITH APPLYING WARM COMPRESSES AND TAKING TWO TYLENOL Symptoms: & SORENESS AT INJECTION SITE Treatment:  ACETAMINOPHEN 325 MG BID
3 short-lived (<15 mins each) seizures all associated with fever within 4 hr of admin. of Hib #9, DTaP #4, PCV #4, Hep A #1 12/3/07-records received for DOS 10-31-11/1/07-DC DX: Fever. Complex febrile seizure. Adverse vaccine related event. Hospitalized for observation. Presented in ED with third seizure in past 24 hours. Fever began night before. Generalized tonic clonic seizure the third one lasting 4 minutes. Normalized his mentation between seizures. Temp 39.8. In hopsital nor futher seizures or fever.
Patient felt lightheaded and faint after the vaccination. He believed he did not loose consciousness but was not sure. He was lightheaded and sweaty. He said he was "seeing stars." He sat upright for a few minutes. He wanted paramedics to come just in case. He progressively felt better as he waited for them. He walked out with them on his own to the emergency vehicle. Unknown if he went to the hospital.
The next morning by at least 10am the opposite arm (the right sore arm) I had severe pain in my vein and a knot. I didn't have a fever but again that's the only thing I've done in a long time. Severe pain in my forearm and when you felt the area there was a knot, I was able to massage it. It was alarming because it was very painful and I was advised to see a doctor, so 36 hours into this I called a doctor, and no one could see me and encouraged me to go to the emergency room; that it sounded like a blood clot. I went to ED July 23rd and from massaging myself I got a bruise and the ED felt I hurt myself but did do an ultrasound and it was normal. Now I have pain; has moved to above my elbow and lump is there in my forearm.