chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse on 30 January 2015. A 54-year-old male patient had received a dose of TETANUS TOXOID (Tetanus Vaccine), (batch number unknown, dose and dose in series was not reported) intramuscularly in right deltoid on 29 January 2015. The patient had a medical history of migraine headaches, asthma and concomitant medications were not reported. On 30 January 2015; one day after vaccination, the patient experienced headache, red eyes and diffuse body aches. Oral flu swab was negative and patient was treated with Tamiflu. At the time of this report outcome of events were unknown. The parent required ER/doctor visit. Documents held by sender: none. Follow-up information received from a nurse on 16 March 2015: The patient had received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) corresponding to batch number U4939AA. On an unspecified date, the patient had recovered from the events.
Beginning 9/19/22, fever, back pain, severe headache, vomiting/nausea in the morning of 9/19, body aches, fatigue, cough, sore throat, nasal congestion.
Patient reports sore arm day after receiving the vaccine. 3 days after receiving the vaccine patient reports having several symptoms of COVID virus attributed to vaccine; myalgia, low grade fever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Dec2022 to 23Dec2022.  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.
fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED BRONCHIAL SECRETION (fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight) and INSOMNIA (can't sleep) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCREASED BRONCHIAL SECRETION (fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight) and INSOMNIA (can't sleep). At the time of the report, INCREASED BRONCHIAL SECRETION (fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight) and INSOMNIA (can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment history was not reported.; Sender's Comments: This case concerns a patient of unknown age, sex and history who experienced the unlisted events of Increased bronchial secretions and Insomnia after the first dose of Moderna COVID-19 vaccine. No re-challenge is noted. The benefit-risk relationship of Moderna COVID -19 vaccine is not affected by this report.
Noticed that I would start sweating profusely after even light exercise. Only 10 minutes into a 'family' workout session with my children I was sweating so much that I had puddles of water at my feet. My children and instructor were noticeably concerned for me. I reported this condition to my local care provider multiple times and they have done nothing for me. I am still suffering form this condition. It does not seem as extreme as it used to be, but I may have just become accustomed to it. Of note, I am normally in excellent health, I am 5'8" and weigh approximately 135 pounds. I exercise 3-4 times per week (lighting weights, cardio) with my local gym. I am also a Level 1 Instructor. I know how my body reacts to strenuous exercise and this is not normal/acceptable. I'd also like to note that I did not exercise for two weeks after my second dose of the COVID vaccine due to a temporary assignment where I had limited access to an exercise facility.
On or about 12/29/2021 I began to have severe shortness of breath. I scheduled an appointment with my internist on 1/6/2022 who scheduled me for an EKG on 1/7 after hearing a murmur during my visit. The EKG confirmed the atrial fibrillation and I was referred to cardiologist Dr. who confirmed the diagnosis and began treatment with Eliquis.
The first two shots I got sick, like the flu; I was pretty sick.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (The first two shots I got sick, like the flu) and ILLNESS (I was pretty sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (The first two shots I got sick, like the flu) and ILLNESS (I was pretty sick). At the time of the report, INFLUENZA LIKE ILLNESS (The first two shots I got sick, like the flu) and ILLNESS (I was pretty sick) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. The patient reported to refer to her own side effects after doses 1 and 2.  The patient was afraid to go get the booster, but she went anyway. The patient reported that she received the booster the day before yesterday of reporting, they gave her half the dose. She did not get sick and did not felt anything.   This case was linked to MOD-2021-027948 (Patient Link).
Patient called 1 week after receiving injection, started experiencing pain and tingling in left arm, lower back and left hip and leg. Received steroid Rx from physician and symptoms are still persisting at this time.
I had SCAD occur to me. Sudden Coronary Artery Dissection (Heart Attack).
The expected soreness in my arm developed throughout the afternoon of the morning (Friday) I had the shot along with a fever. I had fever and chills all night - my teeth chattered all night. The fever continued throughout Saturday and my nose was congested. My chest felt tight. Of most concern my neck was so stiff Saturday and Sunday that I could not move it or turn it in the slightest. The pain radiated down through the shoulders but no further. The overwhelming fatigue I had felt when I had Covid in late March-early April was back. I could not stand long without having to sit down and walking around made me feel breathless. I stayed in bed all weekend. The fever broke Sunday night and by Monday morning I could move my neck,  but it was very tender and I did not have my normal range of motion. My congestion turned into a runny nose on Monday which cleared on Tuesday. By Tuesday my energy level was close to normal and I had full range of neck motion, although still tender. I never had a headache at any point over those four days.
Chronic horrible Insomnia is my adverse affect. Two weeks after my second dose (Moderna) I woke up prematurely  at 5:30am  -- and that continued every morning  for the next 3 months no matter what time I went to sleep. Up at 5:30am with an alertness that was very strange. Could not fall back to sleep. It was weird and not great but I could still cull together 6 or 7 hours asleep even waking up that early.   Then 3 months later -- vivid dreams began to occur and jolt me awake. With an accelerated heart rate. Every single night. Sometimes two or three times a night -- where it proved very hard to get back to sleep. It would take an hour and a half of reading to fall back to sleep.. My resting heart rate  is very low, in the 40s or low 50s but once I was jolted  out of the dream -- it'd be up to 100 or 110.   I couldn?t be sure it was the vaccine ? I had not found corroborating accounts online -- but it being two weeks after the second dose had me thinking it could be. Then I found my corroboration with the Booster. I chose Pfizer this time ? and after the first night ? my insomnia symptoms were intensified to the degree I?m now on beta blockers and Tranzodone. The intensified symptoms continue to this day and I fear to have to take the next booster -- because my insomnia will just get worse.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history was not reported. In approximately January 2017 (reported as a couple of days ago), the patient was vaccinated with an expired dose of VAQTA (lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. Additional information is not expected as no contact details were provided.
Approx 14 hours after vaccination with 3rd dose (booster; primary vaccination series also Pfizer/BioNTech) developed a cold sore (HSV-1 recurrence) at left side and corner of upper lip (vermillion border extending to oral commissure). It consisted of erythematous pa pulse and a few vesicles.  It was associated with burning, numbness and tingling at the site of the rash/outbreak. Blistex medicated lip ointment was applied. This report has been made at the time of the event so no information is available at this time regarding the course of the event and or time to recovery.  There have been no new exposures other than vaccine. No recent HSV1 outbreaks in over 5 years.
Developed aortic heart valve murmur.  No symptoms.  Detected at annual checkup.  No previous murmur despite no change in other health conditions.
pt recv vax in AM, pt states 1hr later itching of face & @ the inj site; seen in clinic @ 2PM c/o itching face, knees & @ the inj site;
A report was received from a health care professional on 12/3/03 concerning a 50 year old female vaccinee who inadvertently received Fluvirin SC on 10/23/03. On 10/23/03, a female vaccinee inadvertently received Fluvirin SC. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
No adverse effects; improperly stored vaccine administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 30-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot # S015460 an expiry date 20-MAY-2021 verified to be valid) (strength, dose and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the vaccine was properly stored. The suspect vaccine was stored in a temperature from 6 Fahrenheit (F) to 14 F (average temperature: 7.4 F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Red swollen area, 4" x 3", warm to the touch at the injection site. Headache - relieved by ibuprofen. Symptoms persist to current date although greatly improved - a "pea-sized" area and although headache persists ibuprofen not needed.
Patient got the shot, bleed a little and after seeing blood patient fainted. On investigation it was found that patient did not eat anything since morning. Patient was fine after having some water and candy after 3-4 minutes.
On 5/14/99, received Anthrax #3, Rabies #3, YF, MMR. At the site of Anthrax vaccine, LLR >12cm, itching, soreness X 4 weeks, flu-like, fever >102F X 3 days, arthralgias X 4 weeks. History of 2 syncopal attacks with shots due to pain. History of chest tightness/flu-like with Influenza vaccine in the past (+) responded to Motrin.
no effects until 4/22/2021 in PM noticed hive-like rash near injection site with very painful neck/throat pain on left side of body. Rash is super itchy so I thought it was hives or an effect of a bug/spider bite and thought I must've slept funny the night before. No other real side effects except maybe a little tired.
12 noon, begin running fever (100), both arms weak, burning sensation, flu like symptoms. At 9 PM had chills. On 2/28/04, left arm broke out in rash; called MD and was told to take Benadryl. Left arm red and hot to touch and weak. Tylenol for pain. Saw MD on 3/1/04. 3/2/04 left arm still somewhat red.
Started feeling short of breath and dizzy on 3/27/21 (the day following vaccination). Symptoms continued into Monday 3/29/21.  Was seen by urgent care on 3/29/21 due to shortness of breath, dizziness, and cough (congestion in lungs).   EKG (normal), O2 Sats (normal), and COVID testing (normal) all done at my appt.
mild swelling, erythema and pain in area of injection; mild swelling, erythema and pain in area of injection; mild swelling, erythema and pain in area of injection; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 24Oct2019 at single dose for immunization. Medical history included rheumatoid arthritis (RA) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced mild swelling, erythema and pain in area of injection on 26Oct2019 at 03:37. She denied any fever or systemic signs. She took Ibuprofen as needed for treatment. The outcome of the events was resolved on 01Nov2019 at 09:00.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
p/vax pt became reddened, blotchy w/in 15-20";
Swollen lymph nodes under left arm within armpit and also in groin area. Both significant and painful. The armpit one went away after two days. The groin one remains. Also noticing changes to menstrual cycle flow and it started earlier than normal this month.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22. When error discovered facility contacted for course of action. At direction of the, patient outreached regarding occurrence to offer re-vaccination of dose. No adverse side effects or event as result of dose.
Patient had swelling redness at site of injection of ZOSTAVAX. Called me on 10/6 and told me what it looked like and I told her to take some Benadryl or use the Benadryl cream to see if that would help.  She came by the pharmacy on sunday 10/7 to show me. It had a red circle at injection site about the size of nickel and a lighter pink circle around that about the size of a tennis ball. It was warm to the touch. Asked her if she had used anything yet and she hadn't. Told her to do Tylenol and Benadryl cream.
During the day, child had slight fever & poor appetite, that evening had a seizure /w staring, fell backward /w some jerking, lasted 10 min.  Vax time 3:00pm, Onset 3 days later @ 7:00pm.
7:45am April 13th, 2021 at hospital  I was very excited to finally get the vaccine ...I was given the Pfizer shot in my upper left arm and felt small pain a the site of injection ...In 5 minutes I felt nauseated, very dizzy and weak to the point of falling off the chair ...they gave me two cups of orange juice and a few fig bars in the hopes that I was just having low blood sugar ...I was offered a hospital bed to lay down ...I experienced numbness in my left arm and in both hands ...also across the lower part of my face ...I was at the hospital for over an hour an was unable to return to work ...  A few days later I began experiencing high pitch ringing in both ears that has gotten worse to the point of being so loud I can't hear a person talking to me on the phone ...noises around me are extremely painful to my inner ear ...this high pitch sound wont go away and keeps me up all night ...I have been to the hospital several times to see ENT doctors and I have tried many medications to help me sleep with this 24/7 tortuous ringing sound ...I can keep myself busy all day trying to ignore it yet at night it haunts me like a demon ...please contact me with any help you know of to reduce this sound in my ears ...I am extremely desperate for sleep ...
Patient stated she had a lot of side effects; she felt dizzy and had blurry vision.  Patient also stated "...moderna vaccine is not safe for me to get second dose."
were more than 6 months apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th September 2018, Batch number- EH9z7 and expiration date- 8th March 2021, intramuscularly on an unknown arm), Flu vaccine (received a dose on 24th September 2018) and Prevenar (received a dose on 24th September 2018).   On 5th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 5th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by the retails pharmacist. The patient received the 2nd dose of Shingrix on an unknown arm, later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case is one of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002784:same reporter US-GLAXOSMITHKLINE-US2022002782:same reporter
Patient was administered a Moderna covid vaccine with the published expiry date 10/15/2021.  She was monitored 15min after the injection and no complications were noted.
pt recv vax;devel rubella;f/u indicated exp pruritic rash & sl fever for 24 hrs;to ER;test eval showed rubella antibody; twin patient;
redness, swelling around injections sites (both legs), face was red and splotchy.  Patient placed on pulse oximeter (100%), no difficulty breathing, no vomiting.   Patient was given 12.5mg Benadryl in response and patient was monitored for 45 minutes following adverse event and Benadryl administration.  Patient improved, only small spot of redness on left check after assessment before family left the clinic. Family felt comfortable leaving and were given return precautions and advised to call clinic if any questions or concerns.
Soreness, redness, bump the size of a golf ball. Soreness and redness lasted 5 days then redness subsided, bump went down. After 8 days, the site started itching and I  still have a slight discoloration where the injection was. It was very uncomfortable  for 10 days. My pharmacist  told me to report it. I am okay now. Not sure I want the second one.
Client had what mother described as a seizure following vaccination.  Mother denies previous seizure activity.
Worsening DOE (as detailed on pg 1). She will undergo chest xray, ambulatory o2 testing in office, consideration of steroids, antibiotics, and hospital admission.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received vaccine and passed out. Father reported after event that patient has passed out from needles and previous vaccines and did not notify the pharmacist prior to administration. Patient recovered quickly and remained in store for 20 minutes post event with no reported issues. Father denied need to call 911 and patient was responsive within 5-10 seconds.
Client reported a headache.  When she went to stand she said "she had an unusual feeling in her head.  Blood pressure 140/88. Reports normally runs 130 's , stated it was in the 140's this am before coming.
Shot Tdap given 1/16/07. Shot site infected. Seen and treated 1/19/07 as add on patient.
Moderna covid  19 vaccine:    Shot give on Friday, Saturday night during sleeping heart beats up over 115 per min.  The beats continued to be over 90 per min thru Sunday night.   Monday morning felt tired, but heart rate back to normal66-67 beats per min.  Rapid beats were experienced for at least 24 hours.     I am not complaining.  Doing this only to help !!!!!!
Complained of pain & discomfort to left deltoid muscle greater than 1 month post Tdap vaccination. 10/13/2010: Was seen in Employee Health by Dr. 10/14/2010: MRI was done. Referred to Orthopedic Center for consult and treatment. 10/22/2010: Dr. diagnosed employee: rotator cuff tendinits of left shoulder, probably underlying exacerbated by the injection with subsequent shoulder pain and limited function. 11/01/2010: Employee was treated with Depo-Medrol injections. Recommended Physical therapy. Still ongoing treatment.
Patient received Moderna for first C OVID Vaccine Dose.  In alignment with CDC guidance on unauthorized age group, Moderna was administered as second vaccine. Per Table. Interim recommendations for COVID-19 vaccine administration errors and dviations. Type: age; Unauthorized age group; If age 16 to 17 years and a vaccine other than Pfizer was inadvertantly administered:  if moderna vaccine administered as the first dose, may administer Moderna vaccine as second dose (as off label use).  Because Moderna is NOT authorized in this age group
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a non-Health Care Professional. This case was linked with 2018SA226678, 2018SA226689 and 2018SA226688. This case involves a 17 years old female patient who was administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA on 13-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Aug-2018, the patient received a 0.5 ml (single dose) second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA, exp: 09-OCT-2019, in the right deltoid. It was a case of actual medication error due to incorrect product storage and extra dose administered. It was not reported whether the patient experienced any adverse events after vaccination. 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 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.
On 08/19/2021 I woke up with the lymph node swollen  and painful in my right armpit, the following day I woke up with the left one in the same condition. I called my doctor on 08/19/2021-on 08/20/2021 she called in Prednisone for the swollen lymph nodes.