chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case report received from a health care professional on 14 OCT 2009. A female patient, born on 05 JUL 1960, was vaccinated with FLUVIRIN, batch no. 98445P1 i.m. into the deltoid on 14 OCT 2009. The reporter injected a single 0.5-ml dose of FLUVIRIN into the patient's deltoid, using a 1-inch-long needle. Shortly after injection, there was minor bleeding at the site, and the reporter felt a "knot" at the injection site. No treatment for the adverse events was provided. Addendum: We received on 16 OCT 2009 the following additional information. The reporter stated that the patient fainted immediately after vaccination. No change in assessment.
patient got 1 does of janssen then came and got 1 dose of Moderna. initially lied about status of COVID vaccination. Patient had no side effects/symptoms to report
Severe headache within 1 hour. Awoke next day with migraine, fever (101), all-over body aches, especially both shoulders, weakness. Slept on and off all day, tried to drink liquids but by 3pm started vomiting every time I sipped anything. Went to ER at 8PM on the advice of my doctor. After a CT scan of my head, xrays, Urine analysis, labs, and pain and nausea meds, I was discharged home. Currently on headache prescription that seems to help. I used to get migraines regularly, but not since menopause 10 years ago.
Information has been received from a 66 year old female patient who on 17-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included a dose of influenza virus vaccine (unspecified) at the same time, in the opposite arm.  The same day, the patient "passed out twice", and developed redness, pain, and swelling in arm, and pain after receiving Pneumovax 23.  The patient went to the emergency room but was not admitted to the hospital.  She stated that although she received the flu vaccine the same day it was administered in the other arm and there was no reaction in that arm.  An EKG was performed (results not provided).  The patient indicated the events were improving but that she was not yet recovered.  The patient stated she had a reaction approximately 10 years ago (approximately 1996) but received both the influenza virus vaccine (unspecified) and the Pneumovax 23 in the same arm.  The reaction then was "pain and swelling but not as severe".  No further information is available.
HPV VACCINE GIVEN ON 4/18/23; VACCINE EXPIRATION DATE 4/14/23
1. Big red splotch 2-3 inches in diameter at vaccination site  2. full body hives (not super itchy); size of a pen dot, slightly puss-filled. Started on abdomen and moved throughout to extremities over 7 days.  Treatment: Benadryl   Outcome: hives spread throughout the body to extremities over the course of a week and then disappeared.
Moderna vaccine vial was opened and punctured on 11/12/21. The vaccine the patient received was from this vial. Vaccine vial outside of recommended time frame.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted after administration of vaccine. patient was checked for responsiveness and flipped to the side. paramedics were called. patient regained conciousness upon tapping on shoulder. patient fell and hit the ground and had a few abrasions to the left head. paramedics arrived and patient was alert and oriented and declined ambulance. patient rested and left with cousin without any further issues.
Right ankle was swollen about three times normal size. I had pain with pressure. There was moderate bruising. It lasted about two weeks but never completely went away but it got a bit better. It swelled up more again on October 18th and it's been swollen ever since - pain with pressure and moderate bruising. They did recommend compression so I have used some compression and that helps some - just has not resolved it. When I got it checked out the second time, the primary care doctor said he would like to follow up again on 12/10/2021. That's to see if somehow that is a hairline fracture. But I have not had an injury.
A knot in the left forearm developed within the first few days and continued to grow very quickly. It was non-painful, but hard to the touch. Lump was on the top of the arm, close to the elbow.
Aches in neck, arms and legs; Aches in neck, arms and legs; Severe headache; Sneezing; Congestion; This is a spontaneous report from a non-contactable consumer (patient herself). A 55-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 19:00 (at the age of 55-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included obesity from an unknown date and unknown if ongoing. Concomitant medication(s) included magnesium citrate (MAGNESIUM CITRATE), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and multivitamin. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported whether the patient have allergies or not. On 03Mar2021 at 20:00, the patient experienced aches in neck, arms and legs, severe headache, sneezing and congestion. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
2-3 weeks ago started experiencing trembling in the hands which stopped only when she sat on them. Her children told her that her head was shaking too. Visited MD 4/8/04 who said it might be Parkinson's or her thyroid giving her problems. Again, not given any medication. Patient states this happened half-way through her vaccination series. Says she feels fine, otherwise.
Noted swelling and redness on eve of 12-18-12. Pt. was taken to ED where he was given an antibiotic for localized infection 9site) and BENADRYL.
Pt exp sx similar to pts who were dx w/fibromyalgia; details of these sx @ time of the report were unk; No further details were provided;
Pt is reporting to ER from home with CO FTT on 2/3. COVID positive upon admission 2/3, pt AOx4, on room air, no acute CR distress, Troponin elevated at 0.09. On 2/4 Pt is aox4,BSC, HL ,Chronic afib on heart monitor, Heparin IV discontinued, Troponin =0.09, on Lovenox and Remdesivir requested. 2/7 Patient A&Ox4 with no complaints of pain and no signs of respiratory distress. 2/8 awake and alert, in no acute distress, some forgetfulness noted. PT discharged  to SAR 2/9 with IV discontinued, and monitor discontinued.  Pt was A & O x4, cooperative and pleasant.
Child was nervous gave TDAP and MCV4 and she was doing ok said shots weren't as bad as she thought then gave HPV4 in Lt. Deltoid, she c/o dizziness, looked to be holding breath. Advised to breath. Then lip curved up, eyes crossed and upper body began shaking, laid her down and she came to called PCP and advised to go to ED. During shaking applied cool compress and elevated legs. BP 118/72 P75.
Chills, fever, HA, dizziness on 12/25/20 - Tested positive for COVID on 12/27/20.  Returned to work on 1/11/2021.  Treated by physician with azithromycin and steroids.
Patient received MMR vaccine on 7/1/2010. She began running a fever (104.7) on July 11th and started to develop spots (hives). She saw the doctor on July 1th, which she was diagnosed with hives at that time (they were severe). Also, on July 4th patient complained of an upset stomach and had diarrhea.
FEVER; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102, 100.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and nausea. This report was non-serious.
Since the monovalent and the bivalent vial look alike. The monovalent was taken from the fridge and administered to the patient
Narrative:  62yo male patient died at outside agency hospital from Carcinomas of liver on 9/30/2021 in acute inpatient care at hospital. Pt present to hospital on 9/27/21. Pt had received vaccines on 3/11/21 & 4/9/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
pt recvd 2nd dose of vax 7MAR94 &  c/o dizzy, pulsating ache in head, fever;
Pt recvd 3 doses of Engerix-B 18FEB91, 18MAR91 & 18AUG91 & 10OCT91 reporter indicated pt gave blood & was found to be positive for anti-HBC
arm is still swollen lumpy; Arm bothers when she exercises; Arm giving off heat; very red arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is still swollen lumpy), PAIN IN EXTREMITY (Arm bothers when she exercises), FEELING HOT (Arm giving off heat) and ERYTHEMA (very red arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical medical condition nor concomitant medication was reported.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is still swollen lumpy), PAIN IN EXTREMITY (Arm bothers when she exercises), FEELING HOT (Arm giving off heat) and ERYTHEMA (very red arm). At the time of the report, PERIPHERAL SWELLING (arm is still swollen lumpy), PAIN IN EXTREMITY (Arm bothers when she exercises), FEELING HOT (Arm giving off heat) and ERYTHEMA (very red arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
I do not know if there was any adverse event that occurred. Instead of giving the vaccination subcutaneously, it was administered through the intramuscular route instead.
Patient stated her arms were very itchy. Mild redness and scratch marks noted on inside both forearms.
Woke up with low grade fever, joint & muscle pain, headache, mild nausea.
patient was accidentally given just Dtp and Polio part not HIB part, no AE; Initial information received on 04-Aug-2020 regarding an unsolicited valid non-serious case received from a physician .  This case involves a four month old female patient who was accidentally given DTap-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine not HIB part (product preparation issue).  Medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 03-Jun-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6613AA and expiry date: no reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique.  New staff member did not realize that the portions needed to be administered together once mixed. Caller wanted to know if it was valid because it said not to give alone.   At the time of report 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 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.
Mild case of chicken pox.  Between 8- 10 small, blistery spots on nose, face belly and thigh.  Two scabbed over, others went away in a day or so.
Information has been received from a physician referring to a 43 year old male patient. Concurrent conditions and medical history of the patient were not reported. On 02-OCT-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose, route unspecified). Other suspect and concomitant therapies were not reported. On 04-OCT-2015 the patient experienced a small reddened area and a skin rash "that looked like cellulitis" localizing at the injection site. On 05-OCT-2015, the patient was seen in an unspecified emergency department where he presented with a larger reddened area at the injection site, a fever, mild cough, malaise, generalized weakness, and a possible urinary tract infection. The primary reporter confirmed that the patient was not admitted to the hospital, and was treated in the emergency department with an unspecified dose, and type of antibiotic. The outcome of the events was not recovered. Additional information is not expected as the physician was not consented to be contacted.
I had a little bit of sore arm for two days after receiving the vaccine. Test positive for COVID-19 07/02/2022. I tested with the COVID-19 home test. Symptoms where: coughing, fatigue and I felt like I had a fever but never did. I had a telehealth visit with a COVID-19 center and they prescribed PAXLOVID. After the second day of taking it, I started to feel better. It tasted like metal. I have been symptom free for three days.
PT WAS GIVEN VACCINE WITHOT ABEING DILUTED  PT HAD NO SIDE AFFECT AT TIME OF VACCINE
no adverse event; Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother) and NO ADVERSE EVENT (no adverse event) in an elderly female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Sep-2022, received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 12-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient has received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of eachother).    The concomitant medication was not reported by reporter. The patient had received 2, 0.5mL doses of the Moderna covid-19 vaccine bivalent today within 30 minutes of each other. Patient was being held for observation currently. This patient was over 65 and had not yet experienced any symptoms. The treatment medication was not reported by reporter.
The mother states in 2 hours after receiving Rotavirus vaccine patient was lethargic & having vomiting & diarrhea. Treatment: IV fluids at ER 09-26-11.
Two siblings came in together for a well child visit with the same provider and they were given each other vaccinations. A 4 year old female was given a dose of hep A pediatric dose when she was suppose to receive the MMR, Varicella and KINRIX. Her brother, a 11 year old male received the MMR, Varicella and the KINRIX when he was supposed to only get the Hep A vaccination. Supervisor was notified as well as CDC and the mother of the two patients regarding the incident.
Pain on arm for about 6 days/tiredness, nausea, weakness, dizziness, sweating, fast heart beat, noise like pin head moving. Resulting on missed wages for 4 days.
Starting 3 hours after the vaccine - deep body aches and arm soreness that progressed over the night to include vomiting, chills, sweats, 102F fever, headache, and inability to walk without feeling prodrome for syncope (vision went black, ringing in ears, lightheaded).  Most of the more severe symptoms resolved after 36 hours with  the exception of muscle aches, headache, and exhaustion which slowly improved but took until day 4 to fully resolve.
7 days after vaccine I had a pretty intense, unprovoked anxiety attack. I was not under any stress, have never had anything like this occur, was not doing anything strenuous and all of a sudden had what I thought might even be a stroke or heart attack. I walked back to the house and took BP and it was 172/75 and pulse rate was only 64...but I was sweating, faint feeling, blurred vision, completely exhausted and it felt like my heart was pounding...but it wasn?t.??  I took BP multiple times but it was fine.  Just a really strange anxiety attack I guess that lasted a few hours.  I wasn?t worried about it and was t going to report it but have had 3 other people who unsolicited told me about their anxiety attack between 5 -7 days after shots. Two were phizer and one was Modena. Figured I would report it in case it helped someone else to not panic if they had an event like this.  It was quite scary and I don?t get worried about things like that!
Child developed a brief seizure, 10-15 seconds (upward rolling of eyeballs with tonic/clonic contractions of extremities) immediately after receiving Hepatitis A and Td vaccines. He did not require oxygen inhalation; BP 81/43, HR 58/min. He was pale and clammy. He recovered after 10 minutes.
2hrs post vax pt became very pale & listless, had tremors of upper & lower extremities, hands seemed blue; Pt listless for several hrs; no apparent ill-effect the next day;
Bruise from shoulder to elbow. Growing. (extending) No swelling. Minimal pain.
Patient returned after Typhoid pills with nasal "sores" then returned again with rash on arms.
Patients other contacted school nurse the morning after shot. Child had "fever 101 deg and body aches". "Lasted into next day". Mother took patient to PCP doctor, no treatment.
A spontaneous, non-serious event of administration of FLUMIST to a pregnant women was received from a nurse concerning an adult female patient. The patient was eight months pregnant. On 09-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to report when the pregnancy has ended and report if the patient experiences any adverse events during the pregnancy.
Increased resting heart rate within an hour of the vaccination. Abdomen pain that started the next day less than 24 hours.
Swollen lymph node in left arm that is growing in size each day; A spontaneous report was received from a pharmacist concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen lymph node in left arm pit that's growing in size each day/lymphadenopathy.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date in 2021, prior to the onset of the events the patient received their unknown dose of two planned doses of mRNA-1273 (lot batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date in 2021, the pharmacist reported that a patient whom she administered the vaccine experienced the event swollen lymph node in left arm that is growing in size each day. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event swollen lymph node in left arm pit that is growing in size each day was not resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122691:dose 1
10.18.2022 PATIENT HAD SYNCOPE AND HYPOTENSION WHEN MOVING FROM CHAIR TO SHOWER AND WENT UNRESPONSIVE. PATIENT WAS TRANSPORTED TO THE ER AND WAS TRATED FOR ACUTE KIDNEY INJURY AND SYNCOPE.
Patient called me at the above time and date to say that his left arm has been sore (the same arm in which he was administered an inactivated flu vaccine). We are attempting to contact his primary physician in the meantime.
A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant Medications were reported No treatment medications were reported
This spontaneous report as received from a registered nurse refers to a patient with unknown age and gender. On an unknown date the patient received a dose of improperly stored ZOSTAVAX (1 dose). No adverse effects reported. It was not specified if the patient sought for medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.