chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A huge red bump on the site of jab tender and sore to touch size increase 3x from the date of the jab
13 year old male received a pediatric dose of Pfizer COVID vaccine for his second dose in the series.
Slight arm pain and headache the day after first dose. Similar symptoms the day after second dose. Highly fatigued the second and third days after the second dose. The fourth day after the second dose (9/7/21), I had numbness down my left arm and on the left side of my face which I thought were signs of a stroke. I went to the ER and they determined there was evidence on the CT scan that indicated I had a TIA. I was in the hospital overnight and released the following day as the numbness had mostly subsided. The medical team prescribed Plavix for 21 days which I began taking on 9/10/21. I had another episode on the morning of 9/11/21 where my whole left side went numb. I returned to the ER via ambulance.  A second CT and MRI results showed that I had a second TIA.
Swollen and painful lymph nodes - left axilla . Painful bruising - site of injection .
Pt had a temperature of 98.0 at the time of administration(10:58am).  The patient contacted the pharmacy around 5:00PM stating that he did not "feel well" and took his temperature, which was 99.5.   Pt also complains of arm discomfort(w/o swelling) at site of injection and mild stomach discomfort.
My glands throughout my body are sore and then I break out in an itchy red rash in all the places I sweat. Under my arms, under my breast, crease in my stomach, creases of my genitals and in between my upper legs.
On Thursday I was given my first Gardasil shot in my left arm. I remember my nurse putting a band aid on my arm and instantly my vision was becoming bright and I felt nauseous.  My nurse told me to stay seated. At this point I passed out, I woke up what felt like instantly to a bunch of people saying my name, I was told I was unconscious for 7+ minutes. There were 5 or 6 nurses holding me up in my chair,  2 doctors, and EMT in the room. I was told I had a seizure and I had an oxygen mask on. I had urinated on myself while I was unconscious. I was soaked in sweat, freezing cold & trembling. My blood pressure had dropped significantly.  2 EMT carried me to the stretcher because I could barely feel my legs.  When I arrived to the ER I felt almost normal, I could talk again and I had quit trembling. It is day two and my body is instantly rejecting any food I eat- I have thrown up 2 times the day of the occurrence and have diarrhea . I am extremely bloated and have severe stomach aches that give me the cold sweats. I have a follow up appointment with my primary doctor on Monday.
Developed flu 5 days of shot. Developed shingles 2-3 weeks of shot.
Patient has had intermittent pain in the left deltoid on and off since vaccination. No rash or swelling.  For certain movements, he has continued pain.
Information was received from a licensed practical nurse regarding a female patient, age unknown, who received an expired dose of M-M-R II on 08-APR-2014, 0.5 ml subcutaneously (lot #0426AE, expiration date 27-FEB-2014). No symptoms reported. Additional information has been requested.
The described waking up  around 9pm after going to be early the day after he received the vaccine.  He said that his hands burned and itched. He took Benadryl and the symptoms eased after about an hour. He reports he had a similar experience after being exposed to rubella many years ago. At that time the symptoms spread to his whole body.
Covid19 breakthrough.  1st Vaccine 03/03/2021.  73 y/o initially seen in ED 1/6/2022 for c/o SOB, had + covid test at PCP office 6 days prior.  Pt left AMA, not satisfied with service and wanting Ativan.  Pt returned 1/7/2022 to ED again with c/o of fever, cough and worsening SOB.  Pt on 4L NC and CTA chest with nodular and ground glass infiltrates at bilat lung bases.  Started on IV steroids/IV Abx, nebulizers and Remdesivir.
Itchy, erythemic rash covering body, excluding palms of hands and soles of feet.  Swollen face.  Fever 101.1 degrees orally.  Malaise.  Treated with Methylprednisolone 4mg starting 7/2/08.
Pt, approximately after 20 minutes post first dose vaccine, developed dizziness, nausea, and sub-sternal 8/10 chest pain.  Pt airway patent, breathing, tachpemic and non-labored.  Pulse strong and tachycardic with adequate perfusion.  Pt pale, warm, dry skin.  Pt transported by emergency services to Hospital.
Swelling, hard, raised, warm area of injection 48 hours post injection. Red area still growing approximately 48 hours post injection.
non-serious COVID but no symptoms; non-serious COVID but no symptoms; Chills; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4253927-00.  A 28 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab rzaa (SKYRIZI), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", ASYMPTOMATIC COVID-19 (medically significant), outcome "recovered" and all described as "non-serious COVID but no symptoms"; CHILLS (non-serious), outcome "recovered", described as "Chills". The action taken for risankizumab rzaa was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 vaccine trial. Other relevant history: No known allergies. The reporter's causality for the event(s) of Covid but no symptoms and chills with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of Covid but no symptoms and chills with Moderna Covid-19 vaccine was no Not Related.  The lot number for bnt162b2 was not provided and will be requested during follow up.
He received the last COVID Moderna vaccine on 04/26/2022.  He was very healthy, active individual with no signs of illness found dead at home.  His cause of death is surmised to be a thromboembolic event due to coagulopathy.  He has no known history of coagulopathy, nor any known in his family.  Of note, his family is characterized by longevity.   The coagulopathy is suspect to be secondary to the COVID vaccines.
anaphylactic reaction; swollen face; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Fluarix (received Fluarix in 2018 and did not develop adverse events).   In November 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and facial swelling. On an unknown date, the outcome of the anaphylactic reaction and facial swelling were recovered/resolved.   It was unknown if the reporter considered the anaphylactic reaction and facial swelling to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 62 or 63 years. The patient developed an anaphylactic reaction with swollen face. The vaccines batch number or expiration date was not recorded. The reporter consented to follow-up.
A week after vaccination my upper arm near the vaccination site began to itch and feel a bit warm and swollen. This has been going on for 2 days.
Extreme headache, overall listlissness, numbness in appendages, slight fever, neck and shoulder pain, swelling at injection site, pain at injection site, heaviness in arm of injection site.
Eye swelling 10 minutes after injection, patient reported throat swelling 20 minutes after injection. EMS called.
Hard lump appeared instantaneously after administering vaccination, swelling as well. Several hours later redness appeared, tingling, more swelling, fever, which lasted for several days. * Still experiencing.
Full-body rash (redness patches all over)and hives (including on face, arms, legs, back, stomach, thighs) with itching started on Wednesday after second dose on Monday, after fever/fatigue settled down (which had started on Monday and stopped by Wednesday).  No symptoms like this after first dose (expect fever headache, fatigue for 2 days which also happened after second dose).  Treatment - Taking prednisone 40 mg a day for 5 days,  Altarax once a day for 5 days.
Patient developed headache on day 5 following vaccination.  This was followed by malaise, and fever to 100.9 degrees F on day 13.  She was placed on medical leave of absence and improved with medication, bedrest and fluids.  All symptoms resolved by 15 days post vaccination.
Patient developed runny nose, nasal congestion, fever with Temp>100 for few day and body aches a day after receiving vaccination - Treated with supportive care for possible COVID infection, especially after known COVID + exposure at work 4 days after receiving the vaccination
Flu shot around 3:30 pm 10/14/15. Around 7pm patient noticed swelling in left elbow. By morning 10/15/15, patient reports redness, swelling, and pain to the touch in left elbow.
Hives behind both knees.  Noticed after dinner, and the sight became extremely itchy.  Hives may have developed earlier, but the itchiness became overwhelming after drinking beer.  Placed ice packs to subside the itchiness.
sever chest pain , heart palpitations/ irregular  heart beat for 4 months after shot, burning sensations in throat, left arm pain to the finger tips , light headed
One week after receiving the shot, my left arm started to itch, and there was a bump on the injection site. I?m not sure if my arm was red and bumpy because of my scratching, or if I had a rash. It continued for two more days and is better today.
4/2/21 Hives began a week after 1st vaccine 4/19/21 Prescribed Levocetirizine and hydrOXYzine hydrochloride  4/23/21 2nd dose of Moderna 5/4/21 Prescribed Hydrocortisone cream. 5/4/21 extremely swollen upper lip, went to urgent care on 5/5/21, received steroid injection  5/9/21 lower lip swollen upon waking up, urgent care again, received steroid injection and  predisone. Throughout this entire time, I have broken out in hives all over my body and still dealing  with that to this day.
ROT ATEQ being given outside the recommended schedule; ROT ATEQ cannot be given after 3 months of age; No adverse event; This spontaneous report as received from a nurse and refers to a 4-month-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with his first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration, product administered to patient of inappropriate age). No adverse event was reported.
pallor generally, perioral cyanosis, extremities, peripherally purplish, intermittent breathing, whimpering & fine tremors of all 4 limbs lasting about 5-7 mins; instructed by MD to bring to ER immed;
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old male patient who experienced high lead level. The patient received the second dose of PREVNAR 7 on 11-May-2010, and the first dose of PREVNAR 13 on 14-Jun-2010 (34 days). Additional suspect medication included PREVNAR, PROQUAD, PENTACEL, Hepatitis A and Hepatitis B Vaccine. The patient experienced high lead level on an unknown date. The outcome is unknown. No additional information was available at the time of this report.
Smallpox vaccine received 3/28/2003. On 3/31/2003, pt reports slept all day. Woke up at 10pm with fever 101. Called in sick on Monday c/o headache and neck pain. Headache continued Tuesday with fever 101. Continued malaise, wanting to sleep. C/o axillary pain at left side. To employee health. Reports continued headache, neck pain and stiffness. Transferred to ER. Reports negative spinal tap. Kept for observation. IV Rocephin given. Discharged home.
The patient received the Janssen Covid-19 vaccine after already receiving the Moderna COVID-19 Vaccine series.   The patient never disclosed that he already received  Moderna. No adverse events or side effects have been reported.  The patient is aware to monitor and report any changes.
This literature marketed report from author (physician) refers to a 12 year old male patient with stage IIA Hodgkin disease. On an unknown date, the patient developed vesicular lesions on his trunk and left shoulder. He had been diagnosed with Hodgkin disease 3 months before the current episode. As for all new cancer patients, a history was obtained, which revealed that the patient was vaccinated with a single dose of VARIVAX (Merck) at age 1 and confirmed a positive varicella zoster virus (VZV)-IgG antibody titer of >0.90 on an unknown date, before administering chemotherapy or any blood products. Within 3 months, the patient had completed 4 cycles of chemotherapy, as well as radiation therapy. The patient's father, who was the sole caregiver, had contracted varicella 9 days before the patient's rash was evident. The father had no history of varicella of vaccination. The father was given a prescription for oral acyclovir after diagnosis. When the father's varicella diagnosis was reported to the patient's physician, the patient was given a single infusion of intravenous (IV) immunoglobulin (400 mg/kg), owing to the close exposure to a family member. Nevertheless on an unknown date, the patient presented with varicella 4 days later. Considering that VZV was transmissible for 2 days before the onset of rash, the incubation period between father and son was at least 11 days. The patient was admitted to the hospital and was given IV acyclovir (45 mg/kg/day). His lesions quickly crusted and he was discharged on oral acyclovir after completing a 5-day course of IV acyclovir. On day 8, however, the patient developed new vesicles on his trunk, and subsequently was readmitted and restarted on IV acyclovir. He was discharged with a prescription for oral valacyclovir (1000-mg tablet every 8 hours) for 1 month. On an unknown date, the event varicella was resolved. His symptoms resolved without a recurrence of varicella. A VZV-specific polymerase chain reaction amplification test performed on a peripheral blood sample obtained on day 8 was positive for open reading frame (ORF) 62 sequences resembling those found in wild-type VZV DNA and negative for those found in vaccine VZV DNA. The author assessed the event as related to VARIVAX (Merck). The author concluded that protection after varicella vaccination especially after a single varicella vaccination is not life long. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # L033343, expiration date 13-SEP-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 24, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same reporter. Additional information has been requested.
Patient came into pharmacy on 10/22/18 with a red upper arm, a small amount of edema, and reporting itching. Patient also reported swollen lymph node under the arm (in arm pit) of arm that received injection. Pharmacist advised BENADRYL. Patient reports that she has taken BENADRYL for past 2 days with no relief. Pharmacist advised patient to call or visit MD due to swollen lymph node being abnormal. Patient said she was going by the doctor's office that day. Pharmacist called MD ahead of time to make him aware of patient's situation.
This spontaneous report as received from a physician via company representative refers to a 87 year old female patient. Her medical history included shingles in 1997. On 17-APR-2012 the patient was vaccinated with ZOSTAVAX (lot number not provided). On 27-MAY-2012 the patient experienced shingles. The outcome of shingles was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
A 23-year-old female patient, who no pre-existing medical conditions and no illness at the time of vaccination, had received a first dose, intramuscular injection of Adacel, lot number C2690AA, on 09 May 2007. At an unspecified amount of time post-vaccination, the patient experienced severe left neck pain and stiffness. She did not experience fever or headache. Other medications were "not available." The patient recovered from the event. Additional medically relevant information was not provided. The reporter in this case is the same as in cases 2007-02489, 2007-02495, 2007-02497, 2007-02498, and 2007-02499.
Approximately 18 hrs after receiving my second dose of Shingrix, I became dizzy and fainted. When I awoke, I had a horrible headache and began vomiting. I was also unable to move my body for about 18 hrs due to extreme muscular and joint pain. I vomited several times throughout the day. My GI distress and headache continued the following day (Day 2 after immunization) in the form of diarrhea. During this entire time, I developed a rash all over my torso and arms. The rash slowly began to disappear after Day 2. Tylenol was ineffective so I switched to ibuprofen which helped alleviate the headache. I was unable to eat but drank electrolyte drinks until I recovered. I am better now, but I will not get this vaccine again.
FLUZONE HIGH DOSE was administered accidentally with no reported adverse event; Initial information received  on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 4 years old female patient to whom influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]was administered accidentally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) , MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  On 09-Sep-2022, the patient administered 0.7ml once (1x) dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ901AC and Expiration Date :30-Jun-2023) via intramuscular route in the left thigh for immunization accidentally with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). The physician prescribed FLUZONE QUAD for the patient. However, another nurse in the practice accidentally "grabbed the wrong dose" and administered the FLUZONE HIGH DOSE instead. The patient was retained in the office for 20 minutes following the administration with no noted issues.  Action taken : not applicable.  Outcome : Unknown.   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 the 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.
he woke up on 9/11/19 with bad stomach pains and diarrhea  9/12/19 came home from school with 101 fever  middle of the night woke up burning up, crying, yelling, thrashing, screaming and trembling.  He was delirious and having hallucinations.   This continued 9/13/19  and 9/14/19
1146 patient c/o feeling nauseated. Gave patient trash can while another nurse obtaining w/c. Patient began harshly coughing and heaving and then began vomiting thick white to clear liquid. Assisted into w/c x 2 and transported to private observation area while patient vomiting in trash can.  1147 Patient states it hit her suddenly. States she initially felt lightheaded and then severely nauseated. States she immediately had a taste of metal in her mouth post injection. States she thinks it was the taste that nauseated her. BP 156/104 HR 96; O2 98%. States she took her BP meds, can't remember name of them. Took water and  rinsed out mouth, then drank some water. States that is all she needed was to get that taste out of her mouth. Offered cookies, declined.  1159 BP 128/89; HR 92; O2 98% on room air. States she is no longer lightheaded or nauseated.  1200. Had patient stand. Denies dizziness. Patient states her husband is in car and is driving. Patient declined transport to personal vehicle per w/c. Ambulated without difficulty to awaiting car. Instructed to continue to monitor BP and seek medical attention if symptoms return. Patient agreed.
patient experienced numbing and tingling in her left arm (same arm she received the vaccine) after receiving the pfizer covid shot. she went home and the numbing and tingling went away but now she feels like her muscles around the injection site is tight.
pt became unresponsive immed p/vax;BP 90/60, P64, R16;pt became alert slowly p/1 1/2min then became lightheaded & diaphoretic;911 called et responded, no tx given to pt;
Pt reported to clinic 2 days after vaccine with hoarseness and wheezing starting 7 pm on 2/7/18.  Pt had not had asthma exacerbation in 10 years, albuterol nebulizer treatment given and wheezing and hoarseness cleared no other Sx of anaphylaxis present. Set home on step up asthma care. Started Fluticasone inhaled steroid, Albuterol MDI prn, ZYRTEC 10 mg daily, Ranitidine 150 mg bid, SINGULAIR 10 mg qd. (Did not start on oral steroids due to vaccines administration).
3 hours after vaccine i got a blotchy rash on face, chest, and back with a feeling of a sunburn. One day after I experienced sob and asthma exacerbation. I still have rash 7 days later.
"We are not sure if a patient got an increased dose (Instead of a booster, they got a 0.50 mL dose)"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE ("We are not sure if a patient got an increased dose (Instead of a booster, they got a 0.50 mL dose)") 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE ("We are not sure if a patient got an increased dose (Instead of a booster, they got a 0.50 mL dose)"). At the time of the report, ACCIDENTAL OVERDOSE ("We are not sure if a patient got an increased dose (Instead of a booster, they got a 0.50 mL dose)") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. Treatment information was not provided.