chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PASSED AWAY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-FEB-2022, the patient passed away from unknown cause of death. It was unknown if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220513819 - Covid-19 vaccine ad26.cov2.s -Passed away. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched.  It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it.  I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes.  The itching sensation continued off and on the next day but bumps weren't visible any longer.  The itchy eyes continued off and on for the next day as well.
sore injection site left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ACETAMINOPHEN for an unknown indication, LOPERAMIDE HYDROCHLORIDE (IMODIUM).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm) and HEADACHE (headache). On 26-Mar-2021, VACCINATION SITE PAIN (sore injection site left arm) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication included Gatorade, water. Treatment information included Tylenol and Aspirin.   This case was linked to MOD-2021-114526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Nonsignificant Follow up appended On 07-May-2021: Follow up received on 07-05-2021. included information of batch number for suspected product
mom called & stated pt had inc fever 9 days p/vax 16MAY96 w/a resultant convls;taken to hosp p/calling 911;t101.2 ax paramedics t104.7 R:
Initial medication error report received on 04 October 2013 from a medical assistant. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (route was intravenous, lot number and site of vaccination was not reported) on an unspecified date. Medical assistant gave the DTAP/IPV portion to the patient. List of documents held by sender none.
DAY 2- HEADACHES, CHILLS WEAKNESS DAY 3 - DIZZINESS
chills (approximately 4:30pm 3/13-3/14), fever (99.9 at 8pm 3/13, 100.6 at 8am 3/14, gone by 4:30pm 3/14), body aches (3/13-3/15), headache (mild, off & on 3/14-3/15), fatigue (3/14-3/15)...still achy & tired 7:30pm 3/15
10 mins p/receiving vax pt was found sitting on floor, alert but pale, state felt dizzy; mom stated pt had lost consciousness briefly but quickly regained it; vertigo ceased; pt sent home;
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (is under treatment for this illness.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  HCP stated they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days. Dates of administration were on 28Jan2022, 31Jan2022, 1Feb2022, 2fFeb2022 and 7Feb2022. All the patients had a clinical history of HIV, and all of them were under treatment for this illness. The  vials  where stored in the fridge for more than 30 days.
Face went numb for three hours. Throat became numb after two. Redness in face. Fast heart beat. Gullness in chest that is still current. Heart skips more than it ever did. Slight pain or sting in chest since I took the vaccine three weeks ago. Feels like I can't get a full breath. Forgetfulness.
Difficulty swallowing, felt like her lips were getting swollen, Tachycardic, Hive to neck and chin.  She also began shaking uncontrollably
Light headed, chills, body and joint aches, fatigue.  Lasted over 24 hours - fatigue lasted the longest. All over symptoms by 11/20 6am.
Received Pfizer first vaccination on April 21st and had diarrhea for a couple of days which I understand is an unusual side effect so I wanted to report it.  I received my second Pfizer vaccination on May 12th and also had mild diarrhea.  I am fine and over the counter medicine treated the symptom.  I just wanted to report the diarrhea with both shots. I also found that it was triggered when having dairy products.
pt recv vax 13NOV96 @ this office;seen in same office 19NOV96 for WIC appt;mentioned redness, pain @ inj site;RN examined site, reddened area size of quarter;red, hot, swollen;pt sent to PMD office immed; was seen;site drained by MD
p/vax pt had severe hot pains down lt arm & across top of breast, to neck to back;called MD;pt not seen;c/o temp during noc but didn't take temp had red raised hard area @ inj site;sore to touch;hand sl edema;
On Monday July 16, 2018 at 4:30pm, patient received a HIB-PRP-T (ACTHIB, HIBERIX) 0.5mL intramuscular vaccine to the left thigh. On Sat. July 21 he woke up screaming, and was not consoled easily. We took him in to see Dr that afternoon and he was diagnosed as "Fussy Child" since there were no outward symptoms. That evening he came down with a fever of 103F that persisted on and off for 3 days, while taking ibuprofen and TYLENOL. He had a follow up with MD on Mon. July 23 and was diagnosed with "Viral Illness". He started showing a mild limp on Tues. July 24th and it didn't resolve, so he was seen by MD on Fri. July 27, and he was diagnosed with Transient Synovitis. He recommended we give Ibuprofen and TYLENOL for the pain and come back if not resolved in 2-4 days. Patient's walking regressed to crawling so he was seen by MD on Tues. July 31. She ordered an xray and labs that day but based on results, continued with the diagnosis of Transient Synovitis. On Sat. Aug. 4 the fever returns so he was taken to Hospital. He was admitted and received an MRI on Sunday Aug. 5 that confirmed acute myelitis of the lumbar region and corresponding diskitis. Patient was released from the hospital on Wed. Aug. 8, and was treated at home with cephalexin 125mg susp 4 times daily for 6 weeks. During this time he saw MD and MD from Infectious Disease for the remaining treatments, receiving weekly lab checks to ensure he was improving. There was no known trauma that caused the myelitis. The problems began 5 days following the Hib vaccination.
Hot injection site; sore arm; swollen  lip; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 08Jan2021 07:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient's historic vaccine included Other Pfizer vaccine on 18Dec2020. The patient experienced hot injection site, sore arm, swollen lip, nausea on 09Jan2021 15:00. Therapeutic measures were taken as a result of events included Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. Information on Lot/ Batch number has been requested.
ADMINISTERED EXPIRED PRODUCT; This spontaneous report received from a health care professional 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: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-APR-2021, the subject experienced administered expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired product was not reported. This report was non-serious.
Started about 35 minutes after shot with ringing in both ears. At first with low muffled ringing and then after a couple of hours increased to severely loud ringing to screeching sounds.(also with slight headache) As the time went on this continued to get louder and louder in tone. I started having palpitations and a lot of anxiety all related to the constant sounds. Later the same nite started with neck pain, continued headache, left clavicle and left shoulder pains , and  to general aches. After midnight same symptoms with the addition of chills and  fever(only 99.8-100.5).didn?t  Last but abt 6 hrs.  The ringing is still continues today. Constant only goes away briefly but always returns.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 96 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Moderate pain and swelling in the injection site; Moderate pain and swelling in the injection site; moderate headache; chills; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration on 20Jan2021 at 14:00 at single dose on left arm for COVID-19 immunisation. Medical history and concomitant medications were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies: None. The patient experienced moderate pain and swelling in the injection site started abought 5 hours after receiving the vaccine and experienced moderate headache and chills as well, on 20Jan2021 at 21:00. No treatment was received for the events. Outcome of the events was resolving.
Flu shot on 9-26-16 sometime between 2:30 and 3:30. About 4:30 I started to feel cold and developed a headache. By 6:00 was still feeling cold although wrapped in a blanket. By 6:30 was feeling muscle aches, headache and couldn't get warm. Then started a violent shaking so that I could hardly stand or walk. Wrapped up in several heavy blankets, then began a very high fever, extremely bad headache, coughing and felt like I had the flu. Had a high fever through half the night but then it broke and I slept well.
start feeling pain on the arm two months after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (start feeling pain on the arm two months after 2nd shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (start feeling pain on the arm two months after 2nd shot). At the time of the report, MYALGIA (start feeling pain on the arm two months after 2nd shot) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
I have experienced the common side effects i.e. body aches, fatigue and headaches but on a more severe scale.  My symptomps have surpassed the 48 hour period.  I am still experiencing random muscle aches, which I would describe as moderately uncomfortable.    Headache which goes way with IBP or Tylenol.  On 5/3 and 5/4 I just began to take two doses throughout the day instead of three.  I am still experiencing moderate to severe fatigue.  I am slowly recovering, a little less tired since Saturday 4/30, but am still exhausted.  I have sought no treatments.
Patient given adult dose of Pfizer vaccine instead of age 5-11 years dose at Walgreens pharmacy.  No signs, symptoms present at the time of this report. Please contact parent, at patient contact phone number provided for additional details.
20 minutes after receiving shots the patient noticed that his neck started to itch, pounding sound in his ears, eyes started to twitch and became mildly swollen, and hands and fingers itched.  Patient returned to clinic and was roomed within 20 minutes of symptoms onset.  Patient reclined, itching subsided substantially, but became dizzy.  2 tsp of Benadryl was given, patient rested, then went home just feeling tired.
1/18/05: Pale, 01/19/05: Rash, 01/20/05: Seemed dizzy and week., 01/21/05: Balanced seemed off, mother witnessed no seizure or increase in temperature.
Local swelling, continuing to spread deltoid to elbow - lateral and medial, erythema, pain  8/26/08 Reviewed hospital medical records of 7/29-8/3/2008. FINAL DX: mild pancreatitis; cholelithiasis s/p lap chole. Records reveal patient experienced crampy abdominal pain, diarrhea, nausea x 2 days, 1 episode of emesis.  In ER had fever & shaking chills.  Had laproscopic cholecyctectomy done.  Progressed & d/c to home. .
low-grade fever; headache; body ache; dizzy; weak; queasy; chills; shaky; fatigue/tired another 24 hours/Third day still tired.; mild brain fog; higher fever 101.5+/couldn't get fever below 100.; This is a spontaneous report from a contactable other health care professional. A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration in right arm on 25Jan2021 11:30 as second dose, single for COVID-19 immunization. The patient previously received first dose on 04Jan2021 11:00, (lot number: EL0142) via an unspecified route of administration in right arm as first dose, single for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included metoprolol 100 mg, vitamin D [COLECALCIFEROL], beclometasone dipropionate (QVAR) 80 ug. No known allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 (nasal swab, rapid test) post vaccination on 21Jan2021 test result was pending. On 25Jan2021 24:00, the patient experienced mild brain fog at 3pm; fatigue at 7pm; 11pm low-grade fever, headache, body aches; 4 am higher fever 101.5+, headache, body ache, dizzy, weak, queasy, chills, fatigue. Started ibuprofen and took every 4 hours and could not get fever below 100. Fever broke early hours the next day, but still was queasy, shaky, dizzy, achy and tired another 24 hours. Third day still tired. The patient received treatment for the events as OTC non-steroidal anti-inflammatory drugs. The events were non serious. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007634 same patient/drug, different vaccine dose/event
Pt vaccinated with DTP/OPV developed abscess at injection site requiring drainage. Culture results: Staph aureus.
Difficulty breathing; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 11Feb2021 at 13:30 (Lot Number: El9265) at the age of 65-year-old as single dose for COVID-19 immunization. Medical history included sickle cell disease and diabetic. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. On 12Feb2021 at 04:00 PM, the patient experienced difficulty breathing and fast heartbeat. No treatment was received for events. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of rash on arm, nausea (nauseous) and fatigue (extremely tired) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011D21A) for COVID-19 immunization. No medical history reported. On Jun 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 8, 2021, patient experienced rash on arm, nausea (nauseous) and fatigue (extremely tired). Patient treated with ibuprofen at an unspecified dose and frequency (to alleviate the symptoms experienced). At the time of the report, rash on arm, nausea (nauseous) and fatigue (extremely tired) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications provided.
No additional AE information provided; Office manager calling to report an AE. Caller states that PROQUAD LOT T030944 exp. 3/9/2022 was administered to a patient today, 6/16/2022. Caller confirms that the product was stored appropriately and did not have any temperature excursions.  HPC t; This spontaneous report was received from an administrator and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 16-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 ml, lot number T030944 was found to be valid, expiration date: 09-MAR-2022 (strength, route of administration and vaccination site were not reported) for prophylaxis (expired product administered). The reporter confirmed that the product was stored appropriately and did not have any temperature excursions. No additional adverse events were reported.
Information was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX (lot# M037014 with expiration date 22-NOV-2017; concentration, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at more than minus 15 Celsius degree (C) but less than minus 10 C for 1 hour 38 minutes. The data logger was involved. There was no previous temperature excursion. No product quality complaint was involved. Lot number M037014 has been verified to be a valid lot number for zoster vaccine live. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005922: US-009507513-1702USA012153.
mom reports that pt began a persistent high pitched cry 3hr p/vax lasting approx 4hr;pt was taken to ER -MD informed mom pt was probably allergic to the vax;
3/18 Initially aches and chills. 3/20-29 Progressed on to more severe pain in muscles, joints, tendons and ligaments. 3/30-4/3 pain became debilitating, difficult to get out of bed without  using arms to move legs, sitting and rising from a sitting position required extensive use of arms. 4/4-4-26 pain gradually diminished but was not eliminated. Remaining pain is mainly in shoulders, hamstrings, buttocks and hips. 4/23- some breathing difficultly started, only when taking deep breaths. Appt with PCP tomorrow to diagnose and for potential EKG.
Full body aches, night chills, sore throat, high fever. Chills only lasted over night. Broke 101 fever and body aches after the 12 hour mark of onset (36 hours after vaccine). Sore throat lingers after 48 hours.
2hrs after the injection the pt developed a headache, itching, and a swollen eye. Pt took aleve with some relief. Pt is now back to normal.