chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fifteen minutes post vaccination client developed tingling in her arm after a dose of Pfizer Covid-19 vaccine. No other symptoms of allergy developed. Injection was given on her left arm. BP 128/91, p 85. Client was evaluated by on-site EMT. Client left clinic after symptoms subsided and was advised to seek medical care if symptoms return or if new symptoms emerge.
Pt recvd 1st dose of Hep B vax & following vax devel flu-like sx, nausea, & itching; w/in 24 hrs pt sx resolved;
This initial spontaneous case was received on 26-Sep-2017, from other health professional, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not provided. On 26-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 01144621A, expiry date: 30-Jun-2018). On the same day, immediately after the injection the patient experienced nausea and passing out (as reported). The patient was also very tired and heard herself talking and recognized the change of voice. No treatment was taken for the events. The patient recovered from the events after 3 to 5 minutes (as reported), on the same day. The reporter considered the report as non-serious. Follow-up received from the reporter on 16-Oct-2017: The start date of the vaccination and event onset date were updated. Narrative amended accordingly. Follow-up received from the reporter on 08-Nov-2017: Added route of administration and anatomical location. The narrative was amended accordingly.
Patient passed out . No fall injury occurred and patient recovered from the episode immediately. Removed from vehicle to EMS  to get vitals. Patient has had syncope episodes or nausea in the past after receiving a shot. Patient then returned to vehicle and was monitored by EMS for an additional 30mins.
Metal taste in mouth within 30 minutes of injection., similar to injection 1.   I otherwise felt fine and had a normal day of moderate physical activity.     I awoke in the middle of the night with chills and body aches and a strong feeling of anxiety.   I was able to fall back asleep and woke up as normal a few hours later.  I had a very strong head ache centered behind my sinuses,  body aches in my pelvis and legs, and hot flashes mixed with chills.  Aches were manageable with Tylenol.  As the day progressed those continued and I was very fatigued.   I went to bed earlier than normal and after a full night's sleep symptoms subsided.
After receiving vaccines, 24 hrs later, the child developed unconsolable crying episodes for hours at a time for three days. No specific treatment, besides Tylenol and reassurance, given.
Child had preschool PE - was given 5th DTaP and 4th IPV. Left clinic-returned about 1/2 hour later with swelling of lips, eyes and face-no swelling at injection site-to ER.
still in the store started feeling dizzy and nausea. couple hours later everything got really bad. Nausea got worse, pain all over like the flu. Been so exhausted difficulty to move. Had a low grade fever but not today.
Fever; sinus pressure and pain so bad it caused upper jaw pain; visibly swollen and painful underarm lymph node on side of injection
lethargy; body pain/aches/pain; malaise; fever; This spontaneous case was reported by a pharmacist and describes the occurrence of LETHARGY (lethargy) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Cardiovascular disorder.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 10-Oct-2023, the patient experienced LETHARGY (lethargy) (seriousness criterion life threatening), PAIN (body pain/aches/pain), MALAISE (malaise) and PYREXIA (fever). At the time of the report, LETHARGY (lethargy), PAIN (body pain/aches/pain), MALAISE (malaise) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided. Company comment This spontaneous case concerns a 60-year-old female patient with medical history of Arthritis and Cardiovascular disorder, who experienced the unexpected, serious (life-threatening), event of lethargy on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) and had not resolved at the time of the last observation. It was reported that patient experienced fever, lethargy, aches, pain, body pain, malaise. No further clinical information was provided for review. The medical history of Arthritis and Cardiovascular disorder could have certain complications and be a confounder for lethargy. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.
Itching, hives, sore throat - treated with 50 mg diphenhydramine
it hurt a lot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case is self-reported by the patient. The age at vaccination was not reported. The patient received Shingles vaccine and it hurted a lot.
fever of 101 degrees/chills x 3 hours difficulty breathing/coughing x 1 hour paleness/weakness x 12 hours
Severe tinnitus in right ear. I have no history of this. It occurred three days after my second Pfizer shot.
This case was reported by a nurse via call center representative and described the occurrence of headache recurrent in a 17-year-old male patient who received HPV 16-18 (Human papilloma type 16 + 18 vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Human papilloma type 16 + 18 vaccine. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine, the patient experienced headache recurrent and drug use in unapproved population. On an unknown date, the outcome of the headache recurrent and drug use in unapproved population were unknown. It was unknown if the reporter considered the headache recurrent to be related to Human papilloma type 16 + 18 vaccine. Additional details were provided as follows: This case was reported by the patient's mother who herself was a nurse. The age at vaccination was not reported. The male patient received unspecified Human Papillomaviru Virus (HPV) vaccine, which led to drug use in unapproved population. In 2015, the patient experienced recurring headaches. The reporter did not take the patient back for the second one for 2 years. This case has been linked to the US2018GSK204638, reported for the different dose of the same patient.
~ 30 minutes after the injection I developed in my lower left throat a painful hard lump.
Pt received Pfizer pediatric dose instead of J&J vaccine. PCP will notify patient and request that they come in for correct dose.
Day #1  Intense itching, swelling and redness within 3 hours after injection Day #4  Swollen tongue, itching, difficulty swallowing, coughing, wheezing. Called 911 and transported to Hospital. Received Prednisone 20mg for 5 days, Famotidine 20mg Day #9  Tele-visit with Dr. Received Azithromycin 250mg for coughing. continued Azithromycin Day #10 Symptoms returned. Swollen tongue, difficulty swallowing, breathing difficulty, left arm is swollen, red and itching at injection site. continued Azithromycin Day #11 Woke up with same symptoms in addition to nausea. continued Azithromycin
Case previously recorded as MA2009-5098. We received the following information via the Vaccine info call center, from a healthcare professional on the 19 NOV 2009. This 1-year-old female patient was vaccinated with 0.5ml S-OIV FLUVIRIN (batch number 102041P1) intramuscularly into the thigh on 17 NOV 2009. No adverse events were reported. Vaccine info call center reference no. NA09-008532.
Patient developed cough and feeling like her throat was getting tight. Lung sounds were clear with good aeration.  Patient was not in respiratory distress but getting anxious. Initially, she was given Benadryl 25 mg po with no change after 20 minutes. She was then given Depo-Medrol 40 mg IM. Thirty minutes later she was asymptomatic.
Pt c/o itching at noon and developed 1/2 dollar-sized hives over arms,back, knees. Lips appeared raw. No swelling of airway or difficulty breathing. Pt's Mom called a local pharmacist who instructed mother give Benadryl 2 tabs for next 3-4 days. Mother gave child 4 doses; hives resolved by 11/15/09 except on knees;resolved today. Mom instructed to report reaction to MD-done. Child to be seen at school by Nurse Practitioner for general eval school based clinic.
Information has been received from a nurse practitioner concerning a male patient who on 01-FEB-2007 was vaccinated with SC with a dose of Zostavax. About a week later, on approximately 08-FEB-2007, the patient experienced a painful rash near the left side and underarm. Unspecified medical attention was sought. The patient was treated with famciclovir (FAMVIR) 500 mg and over the counter analgesics. A product quality complaint was not involved.  Additional information has been requested.
Ever since I received the COVID-19 vaccine my heart has been beating very hard intermittently. At my annual physical my doctor conducted an EKG and found an arrhythmia. I was referred to a specialist and have been to the cardiologist twice. I wore a 24 hour heart monitor for two weeks and have gotten a transthoracic echocardiogram. Prior to receiving the vaccine I have never had this condition or any related heart issues.
lower back pain; Consistent lower back pain/ muscle pain in her lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) and MYALGIA (Consistent lower back pain/ muscle pain in her lower back) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure (Patient was born with a genetic disease called Turborosis Seizure complex, she is physically and mentally disabled.). Concomitant products included LAMOTRIGINE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back pain) and MYALGIA (Consistent lower back pain/ muscle pain in her lower back). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain) and MYALGIA (Consistent lower back pain/ muscle pain in her lower back) outcome was unknown.            After 1st dose patient experienced a mild soreness in the arm, but after 2nd dose of vaccine patient experienced consistent muscle pain in her lower back and it was so painful that she had to take medications every 5 to 6 hours. Patient had gone to the ER and urgent care and they couldn't pinpoint what is going on.
Mouth ulcers and oral thrush developed within a week after taking the second booster by Pfizer.
Parents concerned about fussiness, general malaise lasting 5 days after vaccine and requested reporting. Infant returned to normal.
CHEST COLD; FEELING SICK; FEVER; PRESSURE IN CHEST; COUGHING ON AND OFF; DIZZINESS; NOT FEELING GREAT; SORE ARM; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23/JUN/2021) dose was not reported,1 total administered administered on 03-MAY-2021, 17:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, after 30 to 50 minutes of vaccination, the patient started feeling not sober, dizzy, not feeling great and sore arm. On 04-MAY-2021, (Tuesday), the patient woke up feeling really sick, feeling feverish then felt better during the afternoon (around 5 pm). The patient felt like he had a chest cold, he was clearing his throat more often, feels a kind of pressure in his chest (but no shortness of breath) and was coughing on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, feeling sick, and fever on 04-MAY-2021, had not recovered from cough, and pressure in chest, and the outcome of sore arm, chest cold and feeling bad was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210509097 (same reporter).; Sender's Comments: V0;20210509350-covid-19 vaccine ad26.cov2.s-Chest Cold. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Approximately 1 week after vaccination client stated developed a slightly itchy, warm,  red rash below the COVID vaccination site.  Person showed a picture of the rash on her phone and stated rash was still present. Rash area was red, maculopapular, and spread around 75% of the upper arm just below the vaccination site and approximately 2 inches wide.  Client did not seek medical attention for the rash or any other symptoms.
Swelling of face is under left eye more close to the nose; now it is going up to my eyes; 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 female patient received bnt162b2 (BNT162B2), administered in hand left (Lot number: Unknown) at the age of 52 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: Verbatim: Crohn''s. Concomitant medication(s) included: PENTASA taken for crohn's disease. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer: Unspecified), for COVID-19 Immunization; Bnt162b2 (Dose: 2nd, Manufacturer: Unspecified, second dose was Mar2020), administration date: Mar2020, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "Swelling of face is under left eye more close to the nose"; EYE SWELLING (non-serious), outcome "unknown", described as "now it is going up to my eyes". Therapeutic measures were taken as a result of swelling face, eye swelling.  Additional information: Consumer stated, Yes, yesterday I did booster vaccine Pfizer. It was like around 1PM and today 6PM I starts my swelling of face is under left eye more close to the nose now it is going up to my eyes. Yesterday I received booster because before I did 2 vaccine. Consumer stated, Its, this wasI do not know exactly like 1 meter 65 centimeter and then I have weight that was approximately 65, oh no 60kg, 56kg, no 56 kg. Yeah I think so they gave it me on my Vaccination card it's supposed to be there, it was for Pfizer, it was like FJ6369. Consumer stated, Yes, I was taking Pentasa. I have a Crohn's (Captured as provided). I was taking 15 tablets. Consumer stated, No, It was like my second dose was March 2020. It is over a year ago. I was 51(years) that time. No, I did not do any vaccine prior to 4 weeks. I just took Benadryl. I thought might be it would stop the reaction. I took one tablet of Benadryl.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient immediately became dizzy right after injection.  Waited 12 minutes to walk to observation area. By 1020 symptoms were gone.  Reports she gets dizzy with needles.  1000 blood pressure 117/92 Pulse 103 o2 98%  1030 blood pressure 113/88 Pulse 84 o2 99%  Dismissed at 1035 - no complaints dizziness is gone
Chills, body aches, headache, and fever started approximately 12 hours after vaccine booster dose. A rash appeared on my chest, armpits, neck, and face approximately 24 hours after the does. Rash continued to spread for another 24 hours and was most intense 48 hours after the dose. Rash did not itch, but felt like a bad sunburn. Visible face swelling along jaw line 48 hours after does. Rash has mostly receded today in all areas except face, which still feels like a bad sunburn and has started peeling.
About a month and a half after my vaccine my hip started hurting. It was hurting so bad I went to the ER and got an internal ultrasound. They said I had a substance in my uterus, but they said everything looked healthy and let me go. Less then a week later I was having an extremely heavy period (that was five days early and I am very regular.)  I was having to sit on a towel because I was bleeding through everything. One day I had a workout class and when I got home I used the restroom and noticed my menstrual cup was overflowing and there was about a golf ball sized blood clot. During the night I passed 20+ golf ball sized blood clots. The next day I called my OBGYN who got me in at 930 am thankfully. I got there and got a negative pregnancy test so I was allowed to get prescribed some medicine.  Before I left my dr wanted to take a blood sample to be extra cautious but I have lost so much blood when she tried to take blood I passed out. Within the next 2 days after the medicine I was done bleeding and now my period is regular.
Patient passed out about 5 minutes after receiving flu shot. We helped her to a chair - she was pale & sweating for a few mins. She sat there about 20 mins. Paramedics came to check her out but she said she was fine & declined.
Information has been received from a physician and a consumer concerning the 25(also reported as 26) year old female consumer with irritable bowel syndrome who on 18-JUN-2008 was vaccinated intramuscularly with GARDASIL vaccine (yeast). The physician reported that the consumer felt "sick" all night after receiving the dose of GARDASIL vaccine (yeast). There was no concomitant medication. The consumer reported that the same night after receiving the GARDASIL vaccine (yeast), she experienced diarrhea, nausea and "I even threw up a little". The reporter also noted that she was feeling anxious and scared. The consumer sought medical attention with a call to the physician. The consumer reported that she was "feeling a little better but not fully myself." No further information was available. Additional information has been requested.
I was fine the day of the injection. The next day I was so weak I couldn?t transfer and didn?t eat or drink or go to the bathroom. I fell asleep for hours, and although I?m usually a light sleeper, my 6?3? friend couldn?t rouse me by jostling me or yelling at me. He spent his time making sure I was breathing. The next day I was a little weak but I could transfer; I felt fine. I didn?t go to the doctor for it, but I?m afraid to get a third shot from Pfizer. I?ll use Moderna instead.
Received 3rd Hep-B vaccine-had 15 minute observation period & noted face, neck, & both upper arms to be red/blotchy in appearance & warm to the touch. Employee c/o "feeling hot". Denied any lightheadedness, itching, nausea. VS's: 128/86, 60, 18. Employee observed for additional 30 minutes from start of reaction with face, neck, & arms no longer blotchy/red/warm. Observed 10 more minutes, employee no longer warm feeling, states "feeling normal", & denies any other problems. Allowed to leave facility.
Patient had noticed some mild bruising 1 month ago and had recently received Janssen vaccine on 5/21/2021. She developed severe bruising to the site of injection on left arm. Later she developed more bruising on abdomen, wrist and arms. She presented to the hospital with right flank pain with kidney stone and found to be severely thrombocytopenic of which likely was ITP. Received IVIG and steriods with improvement in her platelet response. Thankfully no bleeding.  Patient has been in hospital for 4 days and still hospitalized at the time of this report.
Vomiting; Aches; slight fever; tired; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in arm left on 21Feb2021 at 16:30 (04:30 PM) (at the age of 47-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included birth control, COVID-19 (COVID prior vaccination: Yes). The patient had no known allergies. The patient concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) taken for birth control, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. The patient was diagnosed with COVID-19 prior vaccination. Patient had not COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in arm left on 31Jan2021 at 16:00 (04:00 PM) (at the age of 47-year-old) as dose 1, single for COVID-19 immunization. On 22Feb2021 at 11:30 AM, the patient experienced vomiting, aches, slight fever, tired. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.