chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right after the vaccine, I started feeling a little bit of a headache - about 12:15. Got to work at 1:30-ish. 06:30pm  that night - Heavy feeling in arm and warmth in injection site; more pain and heaviness in my arm; headache, chills, fever, light headed - I continued to take two Tylenol - 500 mg. I slept the whole night and I continued with the arm pain and chills for two or three more days. My husband tested positive for COVID on January 29th. I called out Friday because I was exposed. I had no symptoms but I was checked on the 29th. I came back negative. Saturday morning  I had these symptoms: headache, dry throat , fever and body aches, and that same day I was tested for COVID on the 30th and I got the results on the 1st of February as positive. Those symptoms lasted two to three days. (I had doctor visit - telehealth on January 30th.)
Fever and general weakness for two days which resolved.  Burning pain in left calf muscle and decreased sensation in left foot, decreased sensation in left arm and left part of face.  I can still feel but it is not the same as the other side.  I am still having decreased sensation as I write this.
LETHARGIC; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 58 year old female. 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, and batch number: 1808973 expiry: 13-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced lethargic. On 30-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and low grade fever. This report was non-serious.
Shots given on 8-10-09.  Mom noticed redness down to elbow on left deltoid and swelling beginning in am, increasing swelling through out the day.
On October 17, 2017, a 4 year old male incorrectly received an intramuscular injection of MassBiologics' Td vaccine (Lot #A104B1) into his left upper vastus lateralis; the intended drug for this patient was KINRIX. The patient and his older sibling were being seen at the provider's office at the same time when the health professional wrongly injected this patient with the Td vaccine meant for the sibling. The patient received two other vaccines during the same visit, both were GlaxoSmithKline's flu vaccine (Lot #9M3F7), given intramuscularly into his right upper vastus lateralis and his left lower vastus lateralis. The patient did not experience any adverse reactions after Td administration. Sender's Comments: This medication error was assessed as non-serious. The Td vaccine was administered to the wrong patient that was under the prescribed age for the vaccine and administered via the incorrect route.
This spontaneous report as received from a medical assistant referred to a 3 months old female patient. The medical assistant who administers the vaccine reported the patient was inadvertently "administered her only dose of M-M-R II on 28-JUN-2012 subcutaneously when she was three months old". No adverse effect reported. The outcome of AE was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Narrative:  A78yo Bed-ridden male with PMH of Cerebral Infraction, Depression, Chronic Kidney Disease, Peripheral Arterial Occlusive Disease, Parkinson's Disease, Slurred Speech, DM II, GI hemorrhage, Aspiration Pneumonia, Dysphagia as a late effect of Cerebral Infraction, transition from Home Health Care to Hospice Received Pfizer Covid - 19 vaccine per protocol and policy without complication No ADE was reported System showed this patient passed away on April 1, 2021
Immediate side effects very mild (pain at injection site). Delayed side effects beginning 8 days post vaccine include much more significant pain at injection site, swelling, area is hot and itchy
felt sick for a 5-7 days after receiving each of the two injections; This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (On an unknown date received 1st dose of vaccine, refer case US2020AMR019016).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient felt sick for a 5 to 7 days after receiving injection. The reporter consented to follow up.
Chills, body aches, pins and needles, nausea, fatigue, fever, loss of appetite.
COVID arm. Red 2" diameter area around injection that appeared  11 days after injection. No pain, no itching, no worries. Simply a distinct red circular area around vaccine  injection point. No other side effects of any kind. Just reporting the red arm.
temp excursion/beyond use date excursion; temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) and EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Information has been received from a nurse concerning a 17 year old female who was vaccinated with Gardasil and passed out.  Subsequently the patient recovered.  No further information was provided.  Additional information has been requested.
patient and parent misrepresented age 2 times. Once upon registration then again when asked verbally if they were appropriate age
Initial report received on 24 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4 year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3397AB received on 29 July 2009, lot number CC3436AB received on 29 September 2009 and lot number C3545AA received on 30 November 2009 and 1 dose of TRIPEDIA; lot number C3545AA received on 15 November 2010 (routes and sites of administration not reported). On 02 February 2014, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced sleep disturbance without apnea. Laboratory testing included positive PCR on 14 February 2014. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 14 February 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 16 February 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Headache & NauseaVomiting Narrative:  Per supervisor report: "2nd Covid-19 vaccine administered on 3/30/2021. He states his symptoms are headache and nausea."  Other Relevant History:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6207), on 09Apr2021 as dose 2, single (Lot number: ER8733), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 29 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Generalized Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Patient has no known allergies. Concomitant medication(s) included: ISIBLOOM 0.15-0.03, start date: 01Jan2019; ESCITALOPRAM OXALATE 20mg, start date: 01Jan2021; ADDERALL XR 20 mg, start date: 01Jan2020, stop date: 19Jun2022; IPRATROPIUM 0.03% Nasal Spray 21mcg, start date: 01Jun2021 (Other medication in 2weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) positive, notes: I took an at-home antigen COVID test on 29Jun and it was positive; (24Jun2022) Negative, notes: I tested negative on a PCR on Day 5 (24Jun). Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included paxlovid from 20Jun2022 to 24Jun2022. Clinical course: It was reported as patient tested negative on a PCR on Day 5 (24Jun) of taking the Paxlovid series and all of her symptoms were gone, other than fatigue. On 28Jun, patient noticed that she was having a slightly stuffy nose and scratchy throat. (Notably, she did not have a stuffy nose during round 1 of symptoms.) she took an at-home antigen COVID test on 29Jun and it was positive. Overall, however, her symptoms were much less severe the second time around.
Dorsum of left thigh there is an area of 1 1/2 in. in diameter erythema.  Warm to touch.
Pt found asystolic at approximately 2 AM in his crib on 11/29/2001. COD as per autopsy report --SIDS/sr
The following morning after the influenza vaccine, the patient awoke with widespread rash to trunk, extremities and neck that was pruritic. Rash was maculopapular and widespread. Patient was instructed to take BENADRYL and that likely it was not an allergic reaction but an immune reaction to the virus. She was informed she could receive the flu vaccine again in the future. No other history of immunization reactions to the patient who was 35 weeks pregnant and had received flu vaccines in the past. No other known exposures to suggest causing the rash.
Patient had an appt schedule through MyChart for COVID booster. The vaccine was ordered by the Medical Assistant and the screener questions were completed per protocol. The Medical Assistant then drew up the medication and scanned into the chart. Medical Assistant verbalized they did not didn't look closely at the last given date of his 2nd COVID vaccine. The chart was opened in the room to document and patient identifiers were completed. The COVID booster was given to patient 3 months early and the patient was then notified after injection that is was given 3 month in advance. Patient stated they were aware. Patient then informed the medical assistant that due to his diagnosis of cancer that his Oncologist wanted him to have it sooner. The medical assistant then spoke with with Dr. in regards to the vaccine given early. Dr. completed a chart review on the patient. Dr. then stated that he will be fine due to his current health issues even with receiving the vaccine too soon. Leadership was also notified of the error and patient was monitored for 15 minutes post vaccination with no adverse reactions to the vaccine.
flu like symptoms; sinus headache; injection site arm aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (injection site arm aches) and NAUSEA (nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included GABAPENTIN, BACLOFEN, PANTOPRAZOLE, ESCITALOPRAM, RIVAROXABAN, VITAMIN D3, ASCORBIC ACID (VIT C) and CALCIUM for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (injection site arm aches) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (injection site arm aches) and NAUSEA (nausea) outcome was unknown.            Patient received the Moderna Covid-19 vaccine in her right arm shoulder deltoid muscle
60 year old male with hx asthma presents for evaluation of increased shortness of breath and wheezing, inspiratory and expiratory which over the past week has worsened, he reports he ran out of his inhalers a week ago. In the ED he was hypoxic on room air, sats 88% initially and improved after nebs and IV solumedrol given up to 96% on 50%VM. His wheezing has inproved and on exam he has much improved air exchange. He denies fever or chills or sore throat or congestion. He is vaccinated x 2 with moderna and is negative rapid sars covid in ED
Mild swelling and pain Left hand and bilateral feet. no rash. c/o cough and earache given Z-pk.  Follow-up information received January 15, 2010. Dr did not administer injection. As noted pt. received at POD given by Dept of Health.  Patient received H1N1 at POD given by Dept of Health. Came to our office with adverse reaction.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 9:56 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient Race is Black
Lump at site, initially (no pain).  Reaction began 3 days after injection.  Beginning with redness and hardness about 2 inches in diameter, redness and hardness spread to about 4 inches in diameter.  I applied hydrocortisone and icepack, with Benadryl . Started taking NSAIDS for pain relief with no relief.  Swelling and hardness  is now extending to under my arm and spreading to armpit.  I have tingling in my fingers and pain in my forearm.  My arm feels heavy and too weak to hold anything without severe pain.  Pain level is a dull constant pain - 4/10, with movement, a sharp pain - 7/10.
Received Pneumovax 23 0.5mL, IM right arm.  No complaints of pain.  Observed redness and swelling right arm below the injection site.  Did not use ice to area as recommended.
Patient states arm extremely sore next day and now 2 days later. No redness, warmth to touch, streaking from injection site. Sore from shoulder to elbow.  Encouraged to reach out to PCP and inform them of this- seek immediate medical attention if necessary.
Pain red rash and hard knot at injection site, Migraine, Chills, Nausea, Entire body and back are painful, To tired to get out of bed. Stiff neck on left side where the injection was.
Got the shot years ago, had shingles now/ suspected vaccination failure; Shingles; Frightening; Pain; Miserable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot years ago, had shingles now/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), feeling anxious (Verbatim: Frightening), pain (Verbatim: Pain) and feeling miserable (Verbatim: Miserable). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the feeling anxious, pain and feeling miserable were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, feeling anxious, pain and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, feeling anxious, pain and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that she received Shingles vaccine when it was offered several years ago still experienced shingles. The patient stated that if she had to pick one word to describe the having shingles and it would be frightening. The patient did not known shingles can happen to her and the pain was miserable. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
I GOT MY VACCINE ON 03/20/2021 AND ON 03/25/2021, I FELT THAT I AM REALY TIRED AND HAVE PAIN IN ALL OF MY BODY BUT ON 03/27/2021, I FELT THAT I CAN'T BREATH WELL SO I MONITORED MY OXYGEN SATURATION AND IT WAS 93. I TRACKED IT THE WHOLE DAY AND IT WAS GOING UP AND DOWN AND ONE OF THE READINGS WAS 84. I THOUGHT MY OXIMETER WASN'T WORKING, SO I MONITORED FOR MY HUSBAND AND MY SON AND THIER OXYGEN SATURATION WAS ALWAYS OVER 98. I WENT TO THE URGENT CARE AND THEY CHECKED MY OXYGEN AND IT WAS 96 BUT I TOLD THE PROVIDER THAT MY OXYGEN WAS FLACUATING UP AND DOWN, BUT I FORGOT TO TELL HER THAT I GOT MY VACCINE A WEEK BEFORE. SHE ADVISED ME TO KEEP MONITORING MY OXYGEN FOR MORE DAYS. THE OXYGEN SATURATION WAS LESS  THAN 93 FOR 2 MORE DAYS, THEN IT WENT UP. I REALLY DON'T KNOW IF THIS WAS BECAUSE OF THE VACCINE OR BECAUSE OF ANOTHER FACTOR.
No additional AE/PQC; Adult patient was inadvertently administered a pediatric dose of VAQTA; Adult patient was inadvertently administered a pediatric dose of VAQTA/Expiration date 06-FEB-2022; This spontaneous report was received from a certified medical assistant concerning a 38-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 27-MAY-2022, the patient was inadvertently vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml, lot # U013476, for prophylaxis (Lot No. U013476 has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated, expiration date reported as 06-FEB-2023, but upon internal validation established as 06-FEB-2022) (dose number, route of administration and anatomical location were not provided) (Incorrect dose administered) (Expired product administered). No additional adverse events were reported (No adverse event).
tested positive for COVID- 19 despite having received his second Pfizer vaccine dose; tested positive for COVID- 19 despite having received his second Pfizer vaccine dose; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Jan2021 (Batch/Lot number was not reported) at the age of 74-years-old in the right arm, and second dose, on 26Jan2021 (Batch/Lot number was not reported) at the age of 74-years-old in the arm; both via an unspecified route of administration at single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks. The reporter stated that her father tested positive for COVID today (02Mar2021) (also reported as 01Mar2021; pending clarification) despite having received his second Pfizer vaccine dose on 25Jan2021 (also reported as 26Jan2021, pending clarification). No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/polymerase chain reaction (PCR) with positive result on 01Mar2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
pain in arms and legs; Headache; Bitter taste in the mouth; Fatigue; Fever; Bone pain; Chills; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), BONE PAIN (Bone pain), CHILLS (Chills), MYALGIA (Muscle Pain) and PAIN IN EXTREMITY (pain in arms and legs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID-19 on September). Concomitant products included IRBESARTAN for Blood pressure.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever), BONE PAIN (Bone pain), CHILLS (Chills), MYALGIA (Muscle Pain), HEADACHE (Headache), DYSGEUSIA (Bitter taste in the mouth) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arms and legs). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), BONE PAIN (Bone pain), CHILLS (Chills), MYALGIA (Muscle Pain), PAIN IN EXTREMITY (pain in arms and legs), HEADACHE (Headache), DYSGEUSIA (Bitter taste in the mouth) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: had COVID-19 on September.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On Saturday around 11 am I just started itching badly in my ears and neck.  I took Benadryl and it helped for a few hours.  I had to take more around 4PM.  I went out to get more Benadryl, When I got home, I took off the clothes I was wearing and put on some other clothes and put on clothes that were washed in a different detergent. I am unsure if it is the different detergent that I have used or the vaccine. That evening I took Claritin D. I went to an urgent care Atarax 25mg I take 4 times per day and a prednisone pack to take.  I also went to the ER this morning due to not getting any better.  Also, on Sunday I did rewash everything to make sure it is not the detergent.  I am suffering from acid reflux due to steroid.  I have never had a reaction to detergent, it seems so severe.