chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My shot was at noon on March 5. That evening around 9 pm I started feeling very sore on my arm where the shot took place.  During the night and throughout the next day and night of March 6 I felt bad. I had a fever that ranged from 100.3 to 101.5. I had chills, a backache, headache, slight upset stomach, tiredness,  overall feeling of malaise, and a  sore arm at the shot site which became somewhat swollen and was red all around it. I really did not want to take Tylenol since I was concerned as to not knowing if it would interfere with antibody production.  After my first shot, I had to take Tylenol since my headache became unbearable. After this shot, it was not unbearable so I did not take any Tylenol.  When waking up at 8:00 am on March 7, I felt better. Only symptom that remained was redness and some soreness around shot area. That diminished each day for the next few days.
Within a few hours I started to feel flu-like symptoms. I had a very bad headache and extremely sore arm where the shot had been given and I started feeling very hot and feverish. My temp was 101 and so I went to bed and started treating it like a flu. It lasted about 36 hours and started gradually going away.
Facial/cheek muscle twitching/spasm  on same side of body that vaccine was given
Arm became very red and itchy and almost 3 weeks later the itchiness remains. Nausea occurred almost immediately after the shot and 30 minutes later a fainting feeling followed by vertigo that is still ongoing.
Moderna COVID-19 Vaccine EUA.   Thurs., Feb 25, my left arm became very sore a couple of hours after the injection. By next morning it was still very sore, including armpit and down to left side of my breast. Stayed that way until lunchtime on Saturday, Feb 27.  Then, on Friday, March 5, I woke up with a rash on the upper part of my left arm (but not wrapped around), very itchy, and still have it today, Monday, March 15.  No other side effects so far.  Second injection will be Thursday, Mar 25.
Pt reports fever 100.8 F, shivering under covers a few hours after receiving the flu vaccine 10/12/12. Fever spiked to 103.8 the next day. Linear vesicular rash in dermatome left leg on day 3 believed to be shingles per Dr diagnosis. Pt given Rx ZOVIRAX.
Fussiness and crying onset 9/12/14 early AM, blood in stool that AM. More lethargic 9/13/14, not tolerating feeds. Seen in Emergency Room 9/13/14 - 9/14/14 - diagnosed with right upper quadrant intussusception reduced with air enema. Symptoms of shock, disseminated intravascular coagulation, third spacing of fluid, difficulty ventilating and ultimate death on 9/15/14.
Adverse event: Complete AV block as of 10/1/2023 Complete AV block (HR of 36-40bpm) detected on Kardia ECG, following deteriorated health status with worsening dyspnea and overall weakness. After two days of observation, went to ER on 10/3/2023 and a PPM was placed on10/4/2023. Discharged from the hospital on 10/5/2023. Treatment: placement of PPM on 10/4/2023 Outcome: resolved
pt recv vax AM started to cry later afternoon;cried non stop for over 3hr;no one could console pt;
Patient was given influenza vaccine instead of desired Pfizer dose 1 despite showing customer the prefilled syringe and mentioning which shot was to be administered before it was injected
No, adverse event, no treatment needed. Parent falsified patient age on screening sheet. answer that child was 12. Health services reported today that child was under 12 at the time of first dose.
Shortly after receiving the shot, I had combination of headache/head pressure, which went away after about 2 hours. Somewhere in 36-48 hours later, I began having headaches (clearly aches, not pressure).  These were like my concussion headaches (but I hadn't had been experiencing such strong headaches for a while). These lasted about 2 weeks. Along with the headaches, I got lightheaded very easily. I also noticed my heart rate was lower than normal when I did light exercising (and maybe even at rest, too). I had been experiencing the headaches and lightheadedness when my concussion was worse; I figure some connection / recession brought about by the vaccine. Neurologist attributes the response to inflammation.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history, or concomitant medications were not reported. The nurse reported that on 15-MAY-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional niofmration has been requested.
hair loss on head and other parts of body; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153) via an unspecified route of administration, administered on the left arm on 13Apr2021 11:30 (at the age of 58-year-old) as dose 2, single for COVID-19 immunization. The patient had no medical history. The patient had other medications in two weeks (unspecified). The patient previously received first dose of Comirnaty (Lot number: EP6965) on 23Mar2021 11:30 AM at Left arm for COVID-19 immunisation. For the last few months experiencing extensive hair loss on head and other parts of body. Have seen doctors and had blood work done and there is no explanation, other than the vaccine. The event resulted to a Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of the events which included Finasteride, minoxidil. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included PCR Nasal Swab: Negative in Oct2021. Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Extreme dizziness and fatigue. Brain fog. Back aches. Headache. Cold sweats. Arm on injection site was very red and hot to touch.
breast feeding; Redness generalized; Generalized hives; really bad rash all over the body; very itchy mostly on her legs and both arms, elbows and wrists; very mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Generalized hives), VACCINATION SITE PAIN (very mild arm soreness), RASH (really bad rash all over the body), PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists) and ERYTHEMA (Redness generalized) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 08) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (very mild arm soreness). On 14-Jan-2021, the patient experienced RASH (really bad rash all over the body) and PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists). On 15-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Generalized hives) and ERYTHEMA (Redness generalized). On an unknown date, the patient experienced BREAST FEEDING (breast feeding). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ALEGRA) at a dose of 180 mg and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (very mild arm soreness) had resolved. At the time of the report, VACCINATION SITE URTICARIA (Generalized hives), PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists), ERYTHEMA (Redness generalized) and BREAST FEEDING (breast feeding) outcome was unknown and RASH (really bad rash all over the body) had not resolved.            No concomitant medication was reported. event-6 week post partum.   This case was linked to MOD-2021-043776 (Parent-Child Link).   See case MOD-2021-043776 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2021: No specific follow-up information recorded. On 18-Jun-2021: follow up received on 18-jun-2021:second dose details, patient details,events were added
On 12/01/2022, late in the afternoon, I could tell I was starting to get sick. I was developing a sore throat and cough. It kind of got worse for a day or two. It started to get better by that following Sunday. However, Monday, I woke up feeling lousy, so I went to a local urgent care clinic where they prescribed azithromycin and montelukast sodium. I am not really feeling better yet, but I think I'll make it. They did not test me for anything at the urgent care clinic, but I did take an at home COVID-19 test on 12/04/2022 but it was negative.
pt recv vax 15FEB96 & began exp palpitations & a rapid heart rate;sx were worse later in the day, mild in the morning had persisted for 1 wk when was examined by MD;electrocardiogram @ that time showed sinus tachycardia 120 beats per min
25 minutes after patient got vaccinated. Patient states having itching throat, throat tightness, pt sitting talking in clear sentences while clearing throat. Paramedics arrived.  Pt has facial flushing, daughter states that is her baseline skin tone.  Pt has hypothyroid.   History of asthma, allergic to bees, preservative in fruits and vegetable, penicillin   Lungs sounds clear   Vital signs  100% o2sat HR 115  BP 192/121   Transportation , Fire department
slight upper lip swelling on 4th day after the injection. On the  5th day following, I had a lidocaine injection due to a dental procedure, and the lip swelling increased and spread to the lower lip. The lips were swollen, cracked, and oozing, and continue to this time (10th day following).
Breakthrough case after Covid vaccination. Dose #1 4/1/2021 Dose #2 4/29/2021. C/O muscle aches, runny nose, fatigue, and cough, onset 8/25/2021
This spontaneous report was received from a nurse and refers to an 8 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
She got her vaccine at 1:00 PM, she ate and drank enough.  The next day at 1:00 PM she was a theater and did not feel very well, and was going to the bathroom and halfway up the stairs she felt dizzy.  She then had an Aura, with her is a curious smell.  She got on top of the steps, when down an elevator and told them that she was going to have a seizure, which she was helped with two people. They helped her lie down, and they called an ambulance and she woke up in the hospital.  They kept her a few hours, gave her the Vimpat and was sleepy.  The next day she felt Okay.  This also happened with her 3rd shot as well.  24 hours after the vaccine she had a seizure.  She sat down with her friend after the 2nd one, he could not understand what she was saying, called the ambulance and then woke up about 4 hours later in the hospital. Hospital.    She has not had any other reactions, and does take her Vimpat which is seizure medicine.  She only had the reaction with the 2 boosters.
Vaccine received 3/28/14. On 3/31/14 developed SOB, palpitations, felt tired. Rested - but felt tired all day. Then: 4/02/14 developed symptoms once again (same) that lasted approximately 1 hour.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
His arm was a little sore for one day/left arm started hurting at the injection site; Right arm started hurting into the joint; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 (Lot number: EN6207) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (He had the first shot 19 Feb 2021 in his left arm. He had just a little soreness for one day. It was lot number EN6198.), administration date: 19Feb2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "His arm was a little sore for one day/left arm started hurting at the injection site"; VACCINATION SITE JOINT PAIN (non-serious), outcome "recovering", described as "Right arm started hurting into the joint".  Additional information: Patient did not require a visit to: Emergency Room/Physician Office. No prior vaccinations (within 4 weeks).  Follow-up attempts are completed. No further information is expected.
A report was received from a physician concerning a child patient of unknown gender. Medical history included PANS (pediatric acute neuropsychiatric disorder) during the 2009 H1N1 outbreak. The patient received nasal FLUMIST (intranasal) 18 months later and then relapsed after an unreported interval. At the time of reporting, the outcome of the event was unknown. The company physician assessed the event to be serious due to important medical event.
Pt cant find the lot number on the card, the pharmacy did not write it down. 12/18/2022 I went on a cruise and my lower was hurting on my right side. I had shoulder pain as well. I thought it was the way I was carrying my backpack which was heavy and strained myself. The pain got worse. I saw the Nurse Practitioner in Jan23 and she suggested doing the MRI and the results showed that I had two kidney stones one lodged in the kidney and that need to be taken out. I went to a surgical center - locally to get it out. I had to do it twice as they could not fully get it out and I have another appointment on 4/25/23 to see the urologist.
low fetal heart tones; Fetal exposure during pregnancy; This prospective pregnancy case was reported by a nurse and described the occurrence of fetal heartbeat absent in a patient exposed to Men B NVS (Bexsero) (batch number ABXA14AB, expiry date 30th March 2021) in utero. The mother received the product for prophylaxis.   Co-suspect product exposures included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe, Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020), ceftriaxone (batch number JR6214, expiry date 28th February 2022) and azithromycin.   The parent's medical history included Had medical history of attention deficite hyperactivity disorder in 2011 and obesity in 2017.   On 11th February 2020, the 18-year-old mother received Bexsero .5 ml, Bexsero Pre-Filled Syringe Device and FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 20th February 2020, the mother started ceftriaxone (intramuscular) 250 mg at an unknown frequency and azithromycin (oral) 1 g at an unknown frequency. The mother's last menstrual period was on 16th October 2019 and estimated date of delivery was 22nd July 2020. The patient was exposed to Bexsero at week 15 of gestation. The action taken with ceftriaxone was unknown. The action taken with azithromycin was unknown. The patient was diagnosed with fetal heartbeat absent and fetal exposure during pregnancy. On an unknown date, the outcome of the fetal heartbeat absent and fetal exposure during pregnancy were unknown.   It was unknown if the reporter considered the fetal heartbeat absent to be related to Bexsero, Bexsero Pre-Filled Syringe Device and FluLaval Tetra 2019-2020 season.     See case US2020AMR026586 for details regarding the mother case. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's parent received Bexsero, Flulav tetra 2019-2020 season), ceftriaxone and azithromycin during pregnancy which led to fetal exposure during pregnancy. The patient's parent visited emergency room due to decreased fetal heart tones.
Information has been received from a Nurse concerning a 15 year old female with shellfish allergy and drug hypersensitivity to albuterol who on 09-OCT-2007 was vaccinated with the first dose of Gardasil.  On 29-JAN-2008 the patient was vaccinated intramuscularly with 0.5 mL of her second dose of Gardasil (lot # 659653/1448U).  Concomitant therapy included Typhoid vaccine (unspecified) which the patient was given by injection one hour after she received her second dose of Gardasil.  On 30-JAN-2008 the patient experienced abdominal cramps, went to the ER and was discharged.  Subsequently, the patient recovered from the abdominal cramps.  No product complaint was involved.  Additional information has been requested. 02/12/2010 The nurse reported that the patient's nausea started at approximately noon on 29-JAN-2008. It was also reported that the patient developed abdominal pain at 5pm. Diarrhea with abdominal pain in the lower right quandrant lasted from 5 to 10 pm. Morphine was give in the ER at 10pm. The patient remaine din the ER until 2 am on 30-JAN-2008 with no further diarrhea. The patient was discharged to home, weak with more dizziness which lasted for 24 hours. On 31-JAN-2008, the patient was "back to normal". It was reported that the patient called the doctor's office and a call was "put in to Allergist to see if related-"no". There was no illness at the time of vaccination. Follow-up information included mention of an unspecified adverse event patient's sister had following a 0.5 cc dose of DPT. No further information is expected.
Priorix admin IM instead of SQ; This non-serious case was reported by a nurse via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a male patient who received MMR (Priorix) for prophylaxis.   In AUG-2023, the patient received Priorix (intramuscular). In AUG-2023, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix admin IM instead of SQ).The outcome of the subcutaneous injection formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2023 This report was submitted via the online direct entry reporting system.  The reporter stated that Priorix administered intramuscular instead of SQ, which led to subcutaneous injection formulation administered by other route. The reporter consent to contact was not given.
Pt. was here on 4/10/18 for a 4 yr WCC. On 4/11/18 came back to the office with swelling and redness on (L) side area where vaccines were given.
Sore arm for a day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 11:15 (Batch/Lot Number: EL3247) (at the age of 43 years) as dose 2, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EL3247) (at the age of 43 years) for covid-19 immunisation. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination. There were no known allergies. The patient experienced sore arm for a day on 11Feb2021 with outcome of recovered with no treatment.   No follow-up attempts are possible. No further information is expected.
Adolescent patient vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent patient vaccinated) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent patient vaccinated). On 30-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent patient vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not reported.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 018B21A) with no associated AEs.
Initial report received from a health care professional on 15 November 2011. This reporter also reported another adverse event, which was captured in case number 2010-02044. A male patient (age not reported) received the fourth injection of DTaP, manufacturer and lot number not reported, on 06 October 2006. Two months later, he developed pneumonia which was believed to be an adverse reaction to the vaccine by the patient's mother. The outcome was not reported. Documents held by sender: None.