chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe itching began on the same arm the shot was administered. Itching was localized to an area 2-3 inches below the location of the shot. About an hr later 3 - 4 quarter sized hives formed. At 6:30 PM hives widened and became one large hive when 2 tsp of Benadryl was taken and the itching subsided.
Low Blood Pressure 98 / 70; for two days, Oct 3d & 4th; Severe Dizziness; sleeplessness; severe "spike" headaches; muscle pains / aches; fatigue; and severe tremors.
RECEIVED COVID VACCINE BOOSTER ON 9/20/21. ON 9/21 AT 0900 PT WAS NOTED TO HAVE INCREASED LETHARGY, AND INCREASED NEED FOR ASSISTANCE EATING. AT 1100AM FACILITY WAS NOTIFIED THAT PT WAS TRANSFERRED TO HOSPITAL FOR EVALUATION.  09/28/21 THE DISCHARGE NOTES UPON RETURN TO FACILITY STATED THAT THE ALTERED MENTAL STATUS AND FEVER IN THE SETTING OF RECENT COVID BOOSTER VACCINE, HAD NO INTECTIOUS ETILOGY AND THUS WAS LIKELY DUE TO THE COVID BOOSTER. HE HAD RETURNED TO BASELINE MENTAL STATUS.
Patient was admitted as Inpatient on 2/1/2022 due to Acute ischemic right MCA stroke. Patient was intubated in the ER due to concern for airway management. Patient received tPA and was taken to IR. Patient was found to have extensive thrombus to ICA extending into the MCA and ACA, ACA partially reopened, unable to open MCA, potential vascular perforation during procedure. Patient was admitted to CCU post-operative intubated and sedated.
Narrative: Patient reported after receiving the 2nd Moderna dose experienced  symptoms of abdominal pain/ burning sensation, loose stools, and gas. Additionally reported leg swelling; no other information was documented in the EMR regarding duration of symptoms or interventions.
NO ADVERSE EVENT, PT WAS GIVEN 0.25ML INSTEAD OF 0.5ML PER GUIDELINE, WE GAVE ANOTHER 0.25 ML LATER THAT DAY
Instant headache on left side and down back of neck. Moved to right side also, after 18 minutes. Occurred right after vaccination. Patient drank juice and sat for 30 minutes. No changes, headache persisted.
Left arm with erythema, edematous, warm to touch from axilla level to 3/4/ or arm.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 11-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Patient describes tingling sensation and pain in arm/hand that has not resolved in 2 months following vaccination. She states the only thing that relieves it is lifting her arm above her head and moving fingers.
Pt recieved first covid shot during pregnancy at 34 weeks (pfizer 3/12/2021).  Pt noticed hand and wrist joint pain immediately following vaccine.   After second shot pt noticed continued symptoms, at which time she was 36 weeks pregnant (pfizer ER8733 4/2/2021).  Pt had rash noted after first vaccine and was diagnosed with PUPPS.  Following delivery of term infant on 5/3/21  of liveborn term infant, hand and wrist joint pain did not resolve.  Pt had f/u apt with internist 9/21 and workup that included x rays and nerve conduction studies, which were normal.  Pt felt symptoms were improving, but following booster (Pfizer FE3590 10/13/21 given at IMC memorial clinic), symptoms have worsened/returned.   Pt has daily wrist/thumb joint pain worst in R side.  Pt had ANA positive and "speckled" pattern with 1:80 titer noted.  Vit D was low at 27 and Tsh 3.78.  cbc and cmp were normal.
terrible time with her arm, swelling was so bad; pain in her arm; weakness; can't brush her teeth; very red; pain go to her hands and fingers; hot to touch; Feel like arthritis; extremely pain; Blood pressure was high 182; like a flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (terrible time with her arm, swelling was so bad), PAIN IN EXTREMITY (pain in her arm), ASTHENIA (weakness), LIMB DISCOMFORT (can't brush her teeth) and ERYTHEMA (very red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Complex regional pain syndrome and Blood pressure. Concomitant products included PARACETAMOL (TYLENOL), PREGABALIN (LYRICA) and METHADONE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (like a flu symptoms). On an unknown date, the patient experienced PERIPHERAL SWELLING (terrible time with her arm, swelling was so bad), PAIN IN EXTREMITY (pain in her arm), ASTHENIA (weakness), LIMB DISCOMFORT (can't brush her teeth), ERYTHEMA (very red), PAIN IN EXTREMITY (pain go to her hands and fingers), SKIN WARM (hot to touch), FEELING ABNORMAL (Feel like arthritis), PAIN (extremely pain) and HYPERTENSION (Blood pressure was high 182). At the time of the report, PERIPHERAL SWELLING (terrible time with her arm, swelling was so bad), PAIN IN EXTREMITY (pain in her arm), ASTHENIA (weakness), LIMB DISCOMFORT (can't brush her teeth), ERYTHEMA (very red), PAIN IN EXTREMITY (pain go to her hands and fingers), SKIN WARM (hot to touch), FEELING ABNORMAL (Feel like arthritis), INFLUENZA LIKE ILLNESS (like a flu symptoms), PAIN (extremely pain) and HYPERTENSION (Blood pressure was high 182) outcome was unknown.        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.   Concomitant medications reported were high blood pressure for drug use for unknown indication. Treatment medication were not provided.
Pt states she felt bad immediately after injection, did not report this to staff. Became groggy & febrile (101.0 F) once home. Also (B) kidneys, stomach & intestines hurt. Appetite decreased. (R) kidney & stomach pain decreased after 24 hrs. Also afebrile after 24 hrs, but developed pain at inj. site. Tx: fluids/TYLENOL prn for pain/warm soaks to arm.
Patients Right arm was swollen and red and warm to touch. She reported this 10/28/17 and received vaccine 10/23/2017. She picked up KEFLEX 500mg 2BIDx10d for treatment and from another physician. Diagnosed with cellulitis.
Wobbly gait and walking toward his right. This started 2 days, post vax. Also with fever of 101F to 105F.
pt recv vax; fever of 103 w/in hr p/ vax lasting 2 days; apap given; dec appetite; noticed sl enlargement of sub maxillary glands; no abnl crying;
I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheaded - Had a hard time waking to gurney due to dizzy. BP +180s Back burning pain traveling mid back to lower back, joint pain, general weakness, throat scratchy, itichess on legs + Think I was monitored for 2 1/2 hrs and sent home after Benadry + Tylenol given. I have continued to have extreme fatigue. general weakness, lightheaded, dizzy and burning back pain lasted 11 days. Today is 12th day and still have lightheaded, dizzy intermittent and general weakness, fatigue, "no energy."
Throat started closing; Blood pressure went to 185 over 125; A spontaneous report was received concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat started to close and blood pressure went to 185 over 125.  The patient's medical history included allergies to shellfish. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On the unknown date, approximately 18 minutes after receiving the vaccine, the patient's throat started to close and her blood pressure went to 185/125 mmHg. The patient had ice packs placed on her and she was hooked up to electrodes. Within 45 minutes, the patient's blood pressure went back down. No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, throat started to close and blood pressure went to 185 over 125, were considered resolved.; Reporter's Comments: This case concerns a senior, female patient, with a history of allergies to shellfish, who experienced a serious unexpected event of throat tightness and hypertensive crisis. The events occurred on 1 day (approximately 18 min) after first dose of mRNA-1273, lot # unknown. Treatment included ice pack. Very limited information regarding these events has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Patient's mother requested J&J vaccines for herself and her two sons. Date of birth was entered incorrectly at this patient's profile creation which made it appear to verifying pharmacist that he was over 18. When the mistake was caught and corrected, the vaccine had already passed the pharmacist verification step and was administered, despite not being indicated per the EUA. The error was discovered after administration. Pharmacist attempted to reach out to patient but voicemail was not returned. Thus it is not known if any adverse events occurred.
Admitted to hospital for positive COVID result 3/24/22 despite being fully vaccinated including booster.
tingling in mouth and lips, itchiness on neck, given Benadryl IM with improvement
Severe pain at injection site. Difficulty raising arm, pain felt for 10 hours, then pain resolved. No redness, no edema, no heat at injection site. Feet fine, otherwise last typhoid given O2.
Information has been received from a physician via a health science consultant referring to unspecified patients of unknown age and gender. There were no medical history and concurrent condition reported. The physician reported that he read in the following medical journals that there had been cases. The cases were reported as the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date not provided) on an unknown date, then developed zoster keratitis and uveitis. No concomitant medication reported. At the time of reporting, the outcome of adverse events was unknown. The causality between adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
On the evening of 11/14/22, I started feeling ill. I awoke in the middle of the night and was very hot and was pretty sure I had a fever, but I could not find the thermometer. The next day I awoke to my head full of congestion, took a home COVID-19 test that came back positive. I called my doctor and let them know that both my husband and I were positive, we were prescribed PAXLOVID. I have an autoimmune disease and it took 14 days for me to finally get rid of all the symptoms.
Information has been received from a health professional concerning an 8 year old male at approximately 12 moths of age, who on 02-OCT-2001 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (lot # 657408/0517U) and on 19-Dec-2007 was vaccinated subcutaneously with a second dose of VARIVAX (Merck) (lot # 659358/1568U).  On 02-APR-2009 the patient called the office to complain of red, itchy rash and was seen in the office on the same day.  The patient had pink papules on chest, neck, arms and legs and one clear vesicle on trunk.  Nothing had ever been crushed over yet.  The patient was diagnosed with chicken pox.  At the time of reporting, the outcome was not reported.  No further information is available.
6 hours post high dose flu shot, pt had fever of 102.5 degrees F that lasted 12 hours. TYLENOL 650 mg and MOTRIN 400 mg did not help.
This spontaneous prospective pregnancy report was received from a physician assistant and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L043213, expiration date: 28-AUG-2017 (exact dose, dose number, anatomical location and route of administration were not provided). The reporter, stated, that the patient received a dose of GARDASIL 9 inadvertently while being pregnant at the time of administration. There were no adverse effects reported. The last menstrual period (LMP) and estimated date of delivery (EDD), date of conception and trimester of exposure were unknown. The pregnancy outcome was pending. Additional information has been requested.
@ 72hr post vax erythema @ site 13x6cm, induration/nodule 6x4cm;mild tenderness lt anterior thigh;nodule gone 18 days post vax;recipient is MD;onset 48hr post vax lasting 24hr;mild myalgia, arthralgia, fatigue;
This spontaneous report was received from a physician concerning 65 year old male patient with heart disease and drug reaction/allergy to LIPITOR. On 26-FEB-2014, patient started therapy with ZOSTAVAX, 19400 PFU, (Lot: J011830) to prevent shingles. (Dose and frequency not provided). Concomitant therapies reported as AMBIEN, aspirin, CRESTOR, LEXAPRO, isosorbide mononitrate, lisinopril (manufacturer unknown), NIFEDICAL, NORCO, PLAVIX and XANAX. On 28-FEB-2014, patient experienced chills and persistent fever since he received ZOSTAVAX. Patient sought medical attention through an office visit. Patient received treatment with TAMIFLU. Lab diagnostic test were not performed. At the time of the report, the outcome of the events was reported as not recovered. The causal relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
Information has been received from a medical assistant and a physician concerning an 11 year old 7 month old female who on 14-JAN-1998 was vaccinated with a dose of Varivax. On 24-DEC-2006, the patient developed a fever and more than 250 lesions which was described by the physician as a "full blown" case of chickenpox. The patient was seen by a physician and the examination revealed many lesions that were all in stages including teardrops to crusts. The child was fully alert and in no distress. The patient had lesions in her mouth and scalp, which her lungs were clear and there was no cough. There was mild itching and used diphenhydramine hydrochloride (BENADRYL) and oatmeal baths. The physician also reported, "child appears well and doesn't seem to be having any complications of chickenpox, but seems to be a vaccine failure". At the time of the report, the had not recovered. No product quality complaint was involved. It was reported that the patient's sister was also previously vaccinated with a dose of Varivax and developed chickenpox (WAES# 0701USA01186). Additional information was received on 13-FEB-2007 and indicated that the patient recovered completely. It was also noted that the patient did not have any pre-existing allergies, birth defects or medical conditions and no diagnostic or laboratory tests were performed. No further information is expected.
Patient was administered a 2nd booster dose of 0.25 ml. Patient had received a 0.25 ml dose in Nov 2021
tiredness; fever of 101; had the runs; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old male patient received BNT162B2, (COMIRNATY, solution for injection, lot# EN6206) via an unspecified route of administration, administered on left arm on 09Mar2021 as 1ST dose, single dose for covid-19 immunization. The patient medical history including but not limited to these conditions:  diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine ab-normalities (including diabetes) and obesity, COVID virus in October 2020. The concomitant medications were not reported. Symptoms came on right at the same time, he had second Pfizer Covid vaccine at 10:40 in the morning and by 17:00 in the evening had the reactions. The patient experienced headache on 09Mar2021 15:00, on 10 Mar 2021 woke up about 8:30 and he had all the symptoms start right after that. Tiredness on 10Mar2021, fever of 101 on 10Mar2021, had the runs on 10Mar2021. Outcome of headache tiredness, fever (fever of 101) and had the runs recovered on 11Mar2021.  No follow-up attempts are needed. No further information is expected.
Student c/o "bad headache" approximately 5 minutes after receiving H1N1 Nasal spray. (Escorted to Health Room to lay down, ice pack applied to forehead. Headache "3" out of 5 scale. Apned pulse 92. Returned to class after 15 minutes).
Pt, after being observed for 15 min per protocol for receiving flu shot for 1st time, went back to workplace situation and smoked a cigarette.  After smoking, c/o dizziness, light-headedness, racing heartbeat, and faint.  VS BP 160/100, P 96.  Given water to drink.  No itching or breathing problems noted.  Pt remained with RN x40 minutes with no worsening of symptoms.  VS after 40 minuted, BP 156/92, P 80.  Pt taken home by his supervisor.
nasal congestion. chest congestion.  chest discomfort.  Has been persistent to today 1/29/21.
Acute diffuse urticaria starting one day after administration of Covid-19 vaccine, (Moderna), mRNA, LNP-s, intramuscular pf injection (0.5 mL dose) and persisting for ~3 weeks at time of evaluation
4/6/11 - Tdap given. 4/11/11 - to our office with complaints - swollen arm at site plus swollen glands (L) neck. 4/15/11 - symptoms were gone.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: mild redness and singular hive/bump appeared on left arm 1 - 1 and 1/2 weeks after injection, 3 inches away from injection site. Arm felt bruised, sensitive and had a bump that is stillon the arm. bump appears like a big bite
Red rash that feels hot to touch with slight itching at the vaccination site in about a 6 inch area
It was reported, "A mother reported that her 2 month old son received Rota Shield, Hep-B, IPV and DTP on 6/27/1999. The infant developed diarrhea and a low-grade fever on 6/27/99. The infant developed diarrhea and a low-grade fever again on 7/17/99."
Crusty and itchy: topical skin reaction site of flu shot. Resolved with hypopigmented round area 12 mm diameter site injection. Not itching. Not sore.
NauseaVomiting lips swollen, extremely itchy in face, very hot to  touch in face and arm, fatigue Narrative:  Other Relevant History:
Vertigo; large red and warm spot on left arm; large red and warm spot on left arm; sore arm; felt run down; Headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (felt run down) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt run down), HEADACHE (Headache) and PYREXIA (fever). On 03-Mar-2021, the patient experienced VERTIGO (Vertigo). On 19-Feb-2021, FEELING ABNORMAL (felt run down), HEADACHE (Headache) and PYREXIA (fever) had resolved. On 23-Feb-2021, VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VERTIGO (Vertigo) had not resolved.            No concomitant medications were provided.  Treatment for the events included Meclizine and Amoxicillin/Clavulanic Acid 500/125mg (twice a day for 7 days).
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 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 16Jan2023 to 17Jan2023).  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.
7/13/08 Reports "sore head" on 7/15/08. Taken by ambulance for "facial twisting" remained hospitalized 7/15 - 7/18. Biopsy taken - results pending and treated for shingles per client.8/11/08-records received for DOS 7/17-7/18/08-Seen for C/O right scalp discomfort beginning 1-2 days prior, neuritic in quality and sam distribution as previous bout of herpes zoster several years ago. Received vaccine 7 days prior to admission. DC DX: Altered level of consciousness, resolved. Scalp lesions with neuritic pain.
Pt was to receive H1N1 and seasonal vaccinations. Documentation indicates pt. was given seasonal injectable and seasonal mist. Pt brought back 12/22/09 and given H1N1 inj
Patient with injection at 1245.  At 1250 Patient felt shaky, nausea, he experienced some gagging.  He indicated he didn't feel right, he felt a "wave" come over him, feeling lightheaded, and felt a "panic attack coming on."  He specifically asked to be seen at the emergency room.  Patient never lost consciousness.  Vital signs taken:  BP 146/86, P 109, RR 24, SPO2 97%.  911 was called by RN.  Cool towel to back of neck, encouraged slow deep breaths, verbal reassurance provided.  Wife was called per his request.  Paramedics were present by 1255 and took over care.