chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out with hives. Itching started 2 days after shot and (1st shot) hives at 9 days and (2nd shot) at 4 days.
Thursday 10.5 ? fairly normal day with a moderate site pain/ some throbbing ? took Iburpofen before bed that evening. Friday 10.6 ? didn't notice anything until afternoon when the site and my upper arm began to ache ? took ibuprofen before bed. Saturday 10.7 ? woke up with a circular swelling which started about 2 fingers below the injection site and was 12.2 centimeters across ? heat and redness present ? feeling of paresthesia in the fingers of that hand ? aching in lower arm. Went to my physician to have it looked at. She suggested light icing and Ibuprofen which I did that day. Sunday 10.8 ? swelling/ heat  mostly gone by end of day ? did not take Ibuprofen that day. Monday 10/9 ? still some general swelling in that arm but no pain/ no paresthesia in my hand.
Zero symptoms until February 01, 2021, am. Warm red blotch anterior and distal to injection site. That night the injection site became reddened. No pain, itching or swelling.
5 Minutes after injection, Difficulty hearing, nausea, Dizziness, weakness, difficulty swallowing, breathing, fast heartbeat. Acute symptoms subsided within 15 minutes. Over next six weeks experienced intermittent low blood sugar events chest pains. Was seen at Hospital ED on July, 6 2021 for chest pain, shortness of breath, tachycardia, pounding heart.
Left hand very stiff and left arm had golf ball on injection site followed by extreme sore thigh muscles (both legs) and lower back pain, knee pain, 101 fever, bone chills, diarrhea, major headache where I thought my eyes and my teeth on upper jaw were going to pop out.  Tylenol every 4-6 hours.  Didn't help.  Symptoms Start:  4/30/21 at 6am and finished  4/2/21 at 10am (approx).
Significant swelling at injection site, and in the opposite arm. Redness and hardness from the elbow to the shoulder of the arm that had the injection. 2 days after injection vision became blurry. 3 days after injection eyes were not focusing and my wife could see that both eyes were not looking in the same direction. 5 days after injection the eye blurriness stopped, although I had eye fatigue for a couple weeks. Severe fatigue and nausea from the day after injection was almost constant for 1 month. On August 12, one week after injection I had a fever of 100.5, and fatigue, and nausea. Doctor was called, and I was seen and tests were run. I was given an antibiotic for my sypmtoms (cough, nasal drainage, fever). After 3 days the fever subsided, and the fatigue and nausea persisted for about 3-5 weeks from the time of injection. About once a month, a rash appears on or around injection site of both arms since the injection of DTap acel. Severe fatigue still occurs for several weeks, followed by 1-2 weeks of more "normal" energy levels. Then, fatigue again continues with a slight rash on arms. This pattern has continued from the 2nd dose of DTaP on August 5, 2015 until present (January 2016).
Extremely lethargic / sleepy for the following 24 hours, some mild upper respiratory signs, high pitched crying the night of December 9th. Fever >102 F December 9th. She was seen by her pediatrician and the ER both said completely opposite things: her Dr said she had bronchiolitis and redness in her ears, the ER doctors said they saw neither. She was not treated for anything. She continues to have difficulty sleeping overnight (as opposed to sleeping for long stretches and putting herself to bed before December 8th) and now will cry for hours before falling asleep which she has never done, not even as a newborn. She has never been colicky or sick before. During her vaccines at 2 months she developed hard swellings that lasted right up until a week prior to her next vaccines December 8th.
01/19/23 presents to ED for "fever, cough". PMHx of "Mild intermittent asthma, benign premature adrenarche"
Initial misuse report received from a healthcare professional on 07 November 2013. This is an invalid case as individual patient identifiers are missing. It was reported that out of the PENTACEL only the DTAP/IPV was given and the ACTHIB was not given. No adverse event was reported. List of documents held by sender: none.
I had my vaccination on 04/19/2022. My health had started to decline rapidly to include tremors. I started to seek medical attention in 09/2022. I had a physical and I brought my health concerns to my physician. I do speculate that I may have had COVID-19 in 2020 prior to lockdown. I became unwell and ended up sleeping for 7 weeks. I had extreme fatigue during this time and would only wake to use bathroom and eat. The doctor put an order in for a neurologist. I am working with the physician but I have run into road blocks. I have some testing scheduled. No one seems to be listening to be in regard to being it related to the vaccination. My tremors on the left side of my body with a slight shutter developing in the body. All my vaccinations have been on the left side. There are good days and really bad days in regard to my fatigue. If I physical exert myself the tremors increase in occurrence. I have been ruled out as having Parkinson's.
Patient received second dose of Monkeypox vaccine at 1000. Patient vaccinated intradermally,  sitting down. Post vaccination, patient experienced a syncopal episode which resolved after 5 seconds. Bilateral lower extremities elevated, ice packs applied, water and protein bar provided as patient stated they did not eat breakfast. Patient safety maintained. 3 sets of vitals taken, all within normal baseline. Patient observation time extended an additional 15 minutes. Post observation period, patient stated complete resolution of symptoms and left facility safely.
Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot# M000760 with expiration date 06-JAN-2018, lot# M006722 with expiration date 08-FEB-2018, strength, dose and route were not expected). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the highest temperature of -11.4 Celsius degree for cumulative 4 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261; Expiration date was not reported) on 30Jan2021 (15:00) at a isngle dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma and allergies to non-steroidal anti-inflammatory drugs (NSAIDS). Concomitant medications included unspecified medications. The patient previously took omalizumab (XOLAIR), and had drug allergy. The patient was not pregnant at the time of vaccination. On 30Jan2021 (17:00), the patient had diarrhea. The patient did not receive any treatment for the reported event. The outcome of the event, diarrhea, was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
pt recv vax;began to exp pain in inject arm;inject site characterized by erythema & warmth;
BOTH SHOULDER WAS IN PAIN; HEADACHE; FEVER; EXHAUSTION; BODY ACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 042821A, and batch number: 042821A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced exhaustion. On 07-APR-2021, the subject experienced both shoulder was in pain. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and exhaustion on 07-APR-2021, was recovering from body ache, and had not recovered from both shoulder was in pain, and headache. This report was non-serious.
Full body rash and itching started 06-15-2021 (day after vaccination)
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2009, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
At 20:00, gave Tylenol; no fever. At 04:30, temperature 101.9F; child shaking-chilling. At 04:30, temperature to 103.4F and Motrin given. At 05:00, called MD. At 05:10, Tylenol given. At 05:30, temperature was 104.7F and tepid bath given. At 06:00, took to ER and temperature was 101.4F, then 100.8F. Fever coming down; went home. At 08:00, temperature 100.8F. At 13:00, temperature was 100.9F and at 14:00, temperature was 101.1F.
Day 1, 2, 3: injection site pain Day 2-5: Skin itching, scalp hives, wrist hives Day 5: vulva hives, enlarged cervical lymph node (left side)
felt very fatigued; heart was erratic; a lot of pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart was erratic), INJECTION SITE PAIN (a lot of pain at the injection site) and FATIGUE (felt very fatigued) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021.    On 20-Jul-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021 at 7:30 PM, the patient experienced INJECTION SITE PAIN (a lot of pain at the injection site). On 21-Jul-2021, the patient experienced CARDIAC DISORDER (heart was erratic). On 21-Jul-2021 at 10:00 AM, the patient experienced FATIGUE (felt very fatigued). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jul-2021 at an unspecified dose and frequency. On 22-Jul-2021, CARDIAC DISORDER (heart was erratic), INJECTION SITE PAIN (a lot of pain at the injection site) and FATIGUE (felt very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Heart rate: 50-55 beats per minute (Low) his normal is around 70 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 91 years old female patient who was vaccinated with 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AC, expiry date- 30-Jun-2019, via intramuscular in unknown site on 20-Oct-2018 and 07-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was reported that Caller wanting to know any potential side effects, because of this, and asking if this be considered equivalent to her receiving a FLUZONE HIGH-DOSE injection. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
She had normal reactions after the first 2 shots; The first dose her arm hurt a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had normal reactions after the first 2 shots) and PAIN IN EXTREMITY (The first dose her arm hurt a lot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION COMPLICATION (She had normal reactions after the first 2 shots) and PAIN IN EXTREMITY (The first dose her arm hurt a lot). On 07-Apr-2021, VACCINATION COMPLICATION (She had normal reactions after the first 2 shots) and PAIN IN EXTREMITY (The first dose her arm hurt a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. No treatment information was reported.    This case was linked to MOD-2021-406084, MOD-2021-406085 (Patient Link).
First started off with a cold feeling around injection site. Around 11:30 at night I felt muscle aches in my calves. 30 minutes later my legs were having severe muscle aches and joint pain in my ankles. I was having cold chills and aches the whole night along with sweating. On 1/20/2021 (the next day) the muscle aches, chills, and joint pain continued through the whole day. I was nauseous at times and did not have an appetite. Around 5 o clock I felt some relief with my leg pain but it started again around 9 o clock. I continued switching Tylenol extra strength and ibuprofen. I went to bed on 1/20 at midnight with little leg pain but major neck and back aches. I did not have cold chills through the night or sweating. Today (1/21/2021) leg pain is near gone, but joint pain is still there in my left ankle and knee. My legs feel heavy and strange and is causing me to walk slowly because I feel like my legs are very fatigued and off balance. I have had neck and back aches all day. I have not had chills today
Pain in arm, heavy chills, headache, tiredness, loss of appetite, bitter salty chemical taste in mouth, no fever
pt recvd vax & was hospitalized w/poss dx of pneumonia; addtl info recvd 13OCT95 revealed that the pt's admission dx of pneumonia was confirmed & pt recvd IV ATB;
received a late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 513HB, expiry date 20-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received first dose on 13th December 2021).   On 04-APR-2023, the patient received the 2nd dose of Shingrix. On 04-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received a late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 4-Apr-2023 The medical assistant provided information about vaccine, patient and consented to receive follow-up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Information has been received from a nurse for the Pregnancy Registry for GARDASIL concerning a 22 year old female who on 31-JUL-2008 was vaccinated with the first dose of GARDASIL (lot# 0250X) I.M. in a deltoid.  The patient's pregnancy was terminated on 30-AUG-2008 or 31-AUG-2008.  The patient's LMP was 23-JUL-2008 and EDD 29-APR-2009. No adverse symptoms.  The lab test performed was urine pregnancy.  Upon internal review, the patient's pregnancy was terminated was considered an other important medical event.  Additional information has been requested.
Patient was given BOOSTRIX to rt deltoid first; GARDASIL Rt deltoid 2nd, and MENACTRA left deltoid third. After injection of MENACTRA patient experienced syncopal episode with tonic clonic movements; patient transported to ER after 30 min of symptoms by squad.
patient noticed on his smart watch that his heart rate during the night had gone up to about 120 and it is normally 60.  He called and I told him to go to urgent care clinic.  Doctor had clinic said it was vaccine and related and may last about two weeks.
Patient was supposed to get the bivalent vaccine and was administered the monovalent vaccine. No adverse events took place. Patient is recommended to get vaccinated with the bivalent vaccine in 2 months time.
Information has been received from an 75 year old female consumer reporting herself with drug reaction to tetanus shot and "nastain" and allergies (unspecified), who on 15-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and site not reported). On 21-MAR-2011, the patient experienced sharp nerve pain along her leg. The consumer believed it may be due to the ZOSTAVAX (Merck). It was given a steroid shot for the adverse event. Lab diagnostics studies were not performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
pt recvd vax;given apap every 4 hrs through noc;turned red & splotchy over entire body;slumped over in chair eyes open & fixed;unresponsive;eyes rolled back;choking, vomited;pt v shaking all over approx 1min;had sz;to hosp;lethargic 20min;
Arm was swollen and red and extremely sore for several days. Since I have had the flu shot I still get pain in the shot area and it hurts when I move my arm certain ways like to sleep on it, to put my coat on or do a jumping jack. It also is weaker.
Employee had onset of chills nausea on 12/17/20, headache, body aches, fatigue, dizziness on 12/18/20 symptoms relieved by Tylenol. Treatment dugs:
PATIENT RECEIVED HER 2ND COVID VACCINE IN HER LEFT UPPER ARM ON 01/27/21 AND LATER THAT NIGHT HER LEFT ARM WAS RED, SWOLLEN, AND TENDER TO TOUCH. DAY 2 THERE WAS A LARGE RED CIRCLE AROUND THE INJECTION SITE. ON FRIDAY DAY 3 SHE HAD A HARD RAISED AREA THAT FELT ROUGH. ON DAY 4 PATIENT NOTED SHE HAD BLISTERS AT THE INJECTION SITE. PATIENT THEN WENT TO SEE HER PCP AND WAS TOLD TO TAKE BENADRYL AND TO MONITOR THE SITE. AREA IS NOW SCABBED AND DRY.
got COVID-19 and was hospitalized; sleeping more frequently; not hungry; tired, sleeping more frequently; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (got COVID-19 and was hospitalized), SOMNOLENCE (sleeping more frequently), DECREASED APPETITE (not hungry) and FATIGUE (tired, sleeping more frequently) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced COVID-19 (got COVID-19 and was hospitalized) (seriousness criterion hospitalization). On 22-Mar-2021, the patient experienced SOMNOLENCE (sleeping more frequently), DECREASED APPETITE (not hungry) and FATIGUE (tired, sleeping more frequently). The patient was hospitalized on sometime in March 2021 due to COVID-19. At the time of the report, COVID-19 (got COVID-19 and was hospitalized), SOMNOLENCE (sleeping more frequently), DECREASED APPETITE (not hungry) and FATIGUE (tired, sleeping more frequently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medicine.  Treatment information was not provided.  Based on biological implausibility the event of COVID-19 infection causality are assessed as not applicable in relation to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Based on biological implausibility the event of COVID-19 infection causality are assessed as not applicable in relation to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient was hospitalized for 7 days due to Covid-19.   For mRNA-1273 (Moderna COVID-19 Vaccine) the reporter did not provide any causality assessments.  Treatment information was not provided.  On 22-Mar-2021, the patient experienced SOMNOLENCE (sleeping more frequently), DECREASED APPETITE (not hungry) and FATIGUE (tired). The patient was hospitalized on sometime in March 2021 due to COVID-19. At the time of the report, COVID-19 (got COVID-19 and was hospitalized), SOMNOLENCE (sleeping more frequently), DECREASED APPETITE (not hungry) and FATIGUE (tired) outcome was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: New serious event of Covid-19 was added and case was upgraded to serious.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection causality are assessed as not applicable in relation to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On Friday 12-07-2018 at 3pm flu-like symptoms, headache, fever, chills, body aches. On Sunday 12-09-2018 at 1:00pm swollen arm at injection site, cellulitis from elbow to forearm then moved above elbow, redness from shoulder to mid forearm circling around arm all on left arm.