chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Temperature of 102; A spontaneous report was received concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and temperature of 102 (pyrexia).   The patient's medical history was not reported. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #:unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient began to experience a headache and temperature of 102F.  No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/not reported.; Reporter's Comments: 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. Further information has been requested
Papular rash around injection site, noted 6 hours, post Prevnar vax, given on 2/14/01. On 2/16/00, this morning, noted to be over entire body.
The pt experienced a localized soft tissue reaction, redness, swelling, tenderness and some effusion to the left forearm and deltoid region.
have a very sore arm; This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION SITE PAIN (have a very sore arm) 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 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE PAIN (have a very sore arm). At the time of the report, VACCINATION SITE PAIN (have a very sore arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
ITCHINESS WITH BURNING SENSATION; WORSE RASH ON ARMS, LEGS, CHEST, NECK, BACK AND ALL OVER BODY; FEVER; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced fever. On 10-JUL-2021, the subject experienced worse rash on arms, legs, chest, neck, back and all over body. Treatment medications included: paracetamol. On 12-JUL-2021, the subject experienced itchiness with burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-JUL-2021, and had not recovered from worse rash on arms, legs, chest, neck, back and all over body, and itchiness with burning sensation. This report was non-serious.
Patient reported pain and redness to left arm starting about 9PM which progressed to swelling of the upper arm and the entire arm turning purple. Patient was seen in the ER on 7/10/13 at Medical Center for another problem, but it was noted at that time that she either had a reaction to the vaccines vs cellulitis of her left arm. Patient was given Cephalexin for 10 days and Benadryl.
Patient is a 57 y.o. male with no significant PMH who presented with chest pain and tightness, dizziness. He was found to have a pericardial hematoma with an aortic dissection that extended from the aortic root to the SMA. He was taken class A to the OR where it was repaired and was admitted to the CVICU with the following conditions: Active Hospital Problems   Diagnosis Date Noted POA ? Chest pain 12/24/2021 Yes ? Ascending aortic dissection 12/24/2021 Yes ? S/P aortic dissection repair 12/24/2021 No   Condition: Critically ill
(R) anterior thigh 10 1/2 x 13 cm increase warm erythema region.
swelling at site of injection, dizzy and heart palpitations within minutes high blood pressure tingling of arm and nausea call ems blood pressure went down within 10 minutes fill better and able to leave after 30 minutes was stable when ems arrived and did not  take pt to hospital pt rested and  left follow up with pt a few hours after at home and was feeling better
Sudden change in vision.  Loss of color for about 15 mins.   48 hours later vision change.  Vision appeared to be blurry and as if looking through a rectangle  with multicolored beams radiating around the edges
After I woke up at ~6:30a, I felt nauseated, so I walked 30' to ask my husband (working) to get our daughter ready for distance school. I felt no other symptoms and I fell unconscious when I was nearly back to the bed. I am still recovering from a "moderate/severe concussion" per ER notes and received 14 stitches on my scalp. I continue to have some memory issues, some problems with word selection which I did not have prior to this event.  During these 10 weeks it is significantly improved, I am concerned about getting the booster vaccine when needed however.
pt recvd vax; high fever, delirum, pain & local erythema to inject site;
One day after patient's 2nd covid-19 Pfizer vaccine, he experienced generalized urticaria lasting for approximately 3-4 weeks. I evaluated the patient 5 weeks after his 2nd dose, and the urticaria has since subsided. He never had a hive at site of vaccination, never had anaphylaxis, and never had any severe allergic manifestations, only itchy urticaria.
pain; fatigue; received a 3rd dose; This case was reported by a nurse via call center representative and described the occurrence of pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number PL3DE, expiry date 5th February 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th May 2020). Concurrent medical conditions included dementia.   On 11th September 2020, the patient received the 2nd dose of Shingrix. On 28th October 2020, the patient received the 3rd dose of Shingrix. In October 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 28th October 2020, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain, fatigue and extra dose administered were unknown.   It was unknown if the reporter considered the pain and fatigue to be related to Shingrix.  Additional deils were provided as follows: The batch number of Shingrix was updated from DL3DE to PL3DE as per sales data sheet. The reporter stated that, during evaluation of pain and fatigue, the patient received 3rd dose of Shingrix, which led to extra dose administered. No further details were provided.
L arm tingling / dizziness. Resolved with < 10 min time. BENADRYL 12.5 mg PO for Pt's emotional support.
Information has been received from an NP concerning a 15 month old white female who on 12/3/01 was vaccinated SC, in the right with the 1st dose of MMRII (lot 640962/1095L). The child had no noted adverse events following prior vaccinations. Concomitant therapy included azithromycin (Zithromax) for the treatment of an ear infection since 11/13/01. On 12/8/01, the child developed a severe "measles rash". The was described as being macular/papular and very red. It was also reported that some of the rash was raised and there was some "halos". In follow-up, the NP reported that the child had a left otitis media at the time of vaccination with no fever, which had been improving on therapy with amoxicillin trihydrate (+) clavulanate potassium (Augmentin). The child was seen on 12/12/01 for the rash and left otitis media and at that time had no fever. At the time of this report, the outcome of the rash was unknown. No further information is expected. The NP also reported that a 12 month old child developed a morbilliform rash, otitis media and a fever following vaccination with MMRII (lot 639514/0601L) (see WAES 0112USA02178).
I had headache, body ache, and very tired for 24 hours.  Then I was tested positive for COVID-19 on Nov 18th.  I had sore throat, stuff nose, and very tired.  I developed a fever of 102.  I had body ache, chills, and SOB. I had a headache and I was coughing.  I had sinus pressure.
Extreme chills and body aches in the beginning.  This started about 4pm. Mild discomfort at the injection site (totally normal). I took some DayQuil at 4pm and at 10pm to help relieve some symptoms. I woke up in the middle of the night (about 2am)- broke out in a cold sweat. I took some ibuprofen for the body aches. When I woke up at 5am, the chills and body aches were gone. The pain at the injection site was also gone.
I did not have a reaction to the vaccine. On 01/13/2023 I started feeling sick. I had a tickle in the throat and stuffy nose. The next day, I thought it was a cold and didn't think anything about it. I tested positive for COVID-19 on 01/15/2023. I talked to my doctor in the online portal. I got a prescription for PAXLOVID. I tolerated the medication but had a metal taste in my mouth. I had no appetite and very tired. I was able to do most of my work as normal.
little lump where I received my shot; arm is very sore; pain; swelling; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site lump, pain in arm, pain and swelling. On an unknown date, the outcome of the injection site lump, pain in arm, pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, pain in arm, pain and swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she received Shingrix vaccine yesterday from the date of reporting and his/her arm was very sore and a little lump where the patient received the shot. The patient asked could he/she apply a heating pad or ice pack to reduce pain and swelling.
hands had mild swelling; intermittent tingling in the thumb and forefinger; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: fr8730) via an unspecified route of administration in the left arm on 27Mar2021 at 16:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as allergies to penicillin allergy, possible shellfish allergy. No concomitant medication was reported. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration in the left arm on 06Mar2021 at 16:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On an unknown date in Apr2021, the patient experienced approximately 2 weeks after the 2nd shot hands had mild swelling and intermittent tingling in the thumb and forefinger that continues to be an ongoing problem, the patient had not seen a doctor yet but planning to make an appointment in next few days. No therapeutic measures were taken as a result of the adverse events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hands had mild swelling, intermittent tingling in the thumb, intermittent tingling in the forefinger was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
After the booster shot, patient felt extremely tired, difficulty with breathing, shortness of breath, swollen legs and increasing waistline. He could not lie flat in bed at night when he slept. He had to sit-up all night in order to be able to breathe during sleeping hours. The situation lasted for a few weeks until he had a seizure and passed-out on Dec 27, 2021. He was sent to emergency room and diagnosed for heart failure due to clotting in his pulmonary arteries. He stayed in ICU for 6 days on a ventilator. He was released from hospital on Jan 12, 2022 after staying there for 16 days.
Bell's palsy is reported in a pt who recvd flu vax & 5 wks flu shot, pt devel Bell's Palsy; As of 28FEB92 pt is much imporved w/minimal residual weakness; MD does not believe event assoc w/vax;
Cardiopulmonary arrest; shock 56-year-old female with a past medical history significant for ESRD in the setting of diabetes and hypertension, chronic diastolic heart failure, and other medical problems, who received hemodialysis treatments on a Monday, Wednesday, Friday regimen at dialysis facility, followed by Doctor. The patient became hypotensive and bradycardic during a routine outpatient dialysis session on 11/05/2021, and had struggled with this for several weeks according to outpatient dialysis nursing staff. In the past, she has responded to IV fluid bolus when her blood pressure gets low although on this occasion she was persistently hypotensive receiving 2-3 L of IV fluid prior to discontinuation of her treatment and arrival of EMS. The patient was arrested en route to the ED and was redirected to Hospital, where she was intubated, received one dose of ketamine, and started on Levophed, per report. Upon arrival, she was found to have systolic blood pressures in the 120 to 130 range on Levophed at >20 mcg's per minute. This was subsequently down titrated and she was on 2-6 mcg per minute with an SBP in the 130-150 range. Unfortunately she was found to be unresponsive with no spontaneous movement noted since her arrival, with no sedation administered since leaving the emergency department in Hospital.
This study case was received from the investigator in a trial on 24 May 2013. A 21-year-old male subject was found to have other acute pericarditis 11 days after receiving the following vaccines on 23 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number route and site of administration not reported). ECG was not available. Treatments were not reported. The subject had no past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
(L) upper arm 50mm x 40mm light pink color & induration. (+) tender (+) itching.
"Moderna COVID-19  Vaccine  1230 am 03/18/21 headache fever of 101 chills and body aches.  /todays date is 03/20/2021 and same symptoms continue. I am taking ibuprofen and tylenol for symptoms.
Patient states 1 week after vaccination on 12/7/2006 left arm starting itching at vaccination site. Long "golf ball size knot" appeared and area was very red and arm was not to touch. No breathing problems. Patient works for an MD who checked her arm and gave her Benadryl.
At 1332, she called into the office to let us know that she was not feeling well after her vaccine. 1331 2 RN's got to her vehicle to assess her. She stated she was feeling "not right", complained of her left arm hurting, a headache, and right ear pressure. Vital signs at 1339 showed a BP of 138/76 done by manual cuff, a pulse was taken radially and was 78 bpm, with a regular rate and rhythm by palpation, respirations were 26 breaths per minute, and her O2 saturation was 99%. 1342 she had episodes of emesis out the side of her vehicle multiple times. 1344 EMS was called. 1347 50mg of IM Benadryl was administered into her right deltoid. EMS arrived at 1349 and care was transferred over at that time. Her husband took her car keys and was driving separate to Emergency Department.
No adverse event, reporting for monitoring purposes since patient received vaccine while pregnant and this was not known prior to vaccine being given.
Pt got a DTaP #4 shot on 5/14/03 in right thigh IM. Reaction started the morning of 5/16/03 with a 17.5 x 9.5cm diffuse pink, warm swollen area. Was given Benadryl for symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9810), on 04Mar2021 as dose 2, single (Lot number: EN6202), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3182) and on 14Mar2022 as dose 4 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imuran, reaction(s): "Known allergies: Allergic to Imuran". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid (COVID 19 treatment) from 08Dec2022 to 13Dec2022.
In weeks subsequent to vax, manifested inc back pain & pain in peripheral joints including toes on rt foot, rt sternoclavicular joint & both knees;pt is now taking pred & sulfasalazine to dec inflammation
Received the first dose of the Pediatric Pfizer formulation for ages 5-11 years COVID-19 Vaccine on 12/14/21 in the morning.  Grandma (guardian) reports that the following day, 12/15/21, he was picked up from school and his entire bottom lower lip was swollen. She does report that he may have a nut allergy but, he did not eat nuts and did not have any facial injury known/reported. The only new thing he had introduced was the COVID-19 vaccine the following day. He did recover from the lip swelling and did not have a rash, hives or trouble breathing.  Patient came into the doctor's office anticipating their 2nd COVID-19 vaccine on 1/4/22. Discussed with pediatrician and determined it was best for patient to be evaluated by allergist before receiving 2nd COVID-19 vaccine. A referral to the allergist was made 1/4/22. Has pending allergist appt. for 1/5/22.
big hematoma in the injection site; vaccine may not have been properly administered because it looked like it spilled outside the needle; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE HAEMATOMA (non-serious), outcome "unknown", described as "big hematoma in the injection site"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "vaccine may not have been properly administered because it looked like it spilled outside the needle".  Additional information: It was reported that, the patient received the dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, but was not sure that all the vaccine was administered. The vaccine might not had been properly administered because it looked like it spilled outside the needle.   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.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in September 2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). Since that, the patient had been administered three doses of GARDASIL 9 (strength, dose, frequency, route of administration, lot # and expiration date were not reported). The last doses was administered on 16-AUG-2016. No adverse effect was reported. Additional information has been requested.
Pt recvd vax on 24JUL92 & approx 4-5 hrs later, devel flu-like synd characterized by pharyngitis, h/a, sweating, arthralgia, myalgia, fatigue; felt flush but had no fever;
48 hrs p/vax pt had 7 cm warm, hard, reddened area @ site of inj
10 minutes post vaccination, patient began feeling a warm sensation under her left cheek and the tip of her tongue became itchy. No other signs or symptoms reported or noted. She was offered Benadryl but she stated her symptoms were waning and not worsening.  She denies any history of allergies except having hay fever as a child. She denies any PMHX and she is not currently on any prescribed or OTC meds. Her vitals were stable and after 10 mins into observation, her symptoms began to wane. Patient was monitored for 45 mins and was stable prior to leaving the vaccination POD. She was educated on what signs and symptoms to monitor. She was advised to follow up with her PCP and or allergist for further evaluation. Patient was informed her 2 nd dose if cleared by her PCP would have to be in an observation facility with a higher level of care. Patient understood and agreed with the above. Patient does not want to evaluated by local ER facility.
about 20min p/vax pt was @ work & started feeling weird body weakness & body warmth;pt noticed rash about arms stomach, back & legs;had severe itching;supervisor took pt to ER where given epi & DPH;
1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--very sleepy; bad balance--small steps and holding wall/furniture; lips swollen; slow cognition
This spontaneous report was received from a licensed practical nurse concerning a 4 months old patient of unknown gender. On 29-JUL-1992 the patient was vaccinated with dose 1 RECOMBIVAX HB (lot number, expiry date, dose and route unspecified), on 22-DEC-1992 the patient was vaccinated with dose 2 RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) and on 09-FEB-1993 the patient was vaccinated with dose 3 RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effect was observed or reported. Additional information has been requested.