chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client was found unresponsive by wife on Saturday morning April 3, 2021 the morning after receiving his second dose of the COVID-19 Moderna vaccine. Wife reports patient seemed fine Friday night after receiving vaccine, he did not eat dinner, but took his medications and watched programs on TV. Wife went to wake him Saturday morning and patient was awake but unable to communicate, move, or respond.  Wife called 911 where he was taken to ambulance via hospital.  Hospital patient is currently at has not told family if they believe it is related to the vaccine.  All tests have come back negative including testing for CVA.  Wife also reports after first dose on March 5th, the next day he could not wiggle toes.  She did
The patient is 14 years old and received Pfizer 5-11 dose according to consent form.  Parents have not return phone calls at this time.
Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 13:00 (Lot number: EN6198) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea", start date: 2002 (unspecified if ongoing); "migraines", start date: 1985 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Had a sore arm". The event "had a sore arm" was evaluated at the physician office visit and emergency room visit. No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of pregnant female was inadvertently given H1N1 was received from a registered nurse concerning a 27-year-old female. Neither relevant medical history nor obstetrical history have been reported. On 05-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was considered resolved.
I don't know if my medical issues are a result of the vaccines, I'm just reporting so that this information can be noted.  #1. At the end of November I started to have fatigue in my arms and hands went into spasms if I used them very much.  An ultrasound of arms showed 100% blockage in axillary arteries in both arms with some blood still flowing through collateral arteries. After an angiogram this blockage was determined to be caused by inflammation.  Cardiologist and Rheumatologist believe it's caused by an autoimmune, but it hasn't been confirmed which one.  #2. In February 2023 I was also diagnosed with hyperthyroidism caused by Graves Disease, which is also an autoimmune.  I did have the shots administered in both arms.
About 4 hrs after shot I had a severe pain in arm. I was unable to raise arm for almost 24 hrs. Tenderness in arm for almost a week.
TC from client 8/26/10, states within 24 hours of shot she had rash, itchy at site, lasting (1) week. Then hip & leg pain with excruciating pain onset 8-21-10 (Sat). Saw DR 8/23 and 8/24. Received hydrocortisone shot & pain RX medication. DX low back pain. On 8/25, rash onset. Client saw Dr. today 8-26-10 with DX shingles related to vaccine.
Vomiting; body aches; fatigue aroumd 3:00 AM; Chills around 2:00 AM; Nausea around 2:00 AM; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 28-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318, Expiration date: Unknown), via an unspecified route of administration, in Left Arm on 12Feb2021 at 12:00 as Dose 2, single for Covid-19 immunisation. Patient received first dose of bnt162b2 (Solution for injection, Lot number: EL1283, Expiration date was unknown), via an unspecified route of administration in Left Arm on an unspecified date as dose 1, single for Covid-19 immunisation. The patient medical history was not reported. The patient received concomitant medications within 2 weeks included Tri-Lo-Sprintec. Patient was not diagnosed covid prior vaccination. Patient did not receive any other vaccine within 4 weeks. Patient had not been tested for COVID-19, after the vaccination. On 12Feb2021 at 02:00, the patient experienced chills and nausea while around 3:00AM, she had vomiting, body aches and fatigue. Patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Started 1 week after injection, itchy arm, redness with hives in redness all local to site of injection, hard edema with redness still present, hives decreases as long as stop scratching. Has been from 10 am continuing now not itching as much since taking benadryl but still hard red edema
Upon administering the injection, there was an immediate swelling on the site of injection. Patient waited by the pharmacy for 15 minutes after. He said he didnt have stiffness of the arm or pain at the site of the injection. He said this is the first time he had gotten the high dose flu vaccine and that he has always gotten the regular flu vaccine in the past. He has not had similar reactions to other vaccinations in the past. There is a picture of the swollen part of right deltoid on his cell phone. He will ice the area (ice wrapped in a towel). He will take ibuprofen as needed.
tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient's wife). A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, weeks after the first dose, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The reporter classified the event as non-serious. The outcome of the events was unknown.  Information regarding Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021178604 same reporter/vaccine/AE, different patients
This spontaneous report was received from a physician and refers to a patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ dose 1, lot # R002516, expiry date 13-SEP-2018, oral for prophylaxis. On an unknown date, the patient received dose 2, of the same vaccine. It was reported that the vaccines were stored at temperature 9 - 25 degrees Celsius for 12.5 hours. Temperature excursion was detected by digital data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter (MARRS# 1812USA006405, 1812USA005223). Sender's Comments: US-009507513-1812USA006405: US-009507513-1812USA005223.
This spontaneous case reported by a nurse, describes the occurrence of pain (ache) and pyrexia (fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025B21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 30, 2021, patient experienced pain (ache) and pyrexia (fever). On Apr 6, 2021, pain (ache) and pyrexia (fever) resolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication use or treatment information. Most recent follow-up information incorporated: On Jun 16, 2021: Attachment.
mom noticed pea size redness @ inj site last noc;this day inc size to quarter;mom reports redness & feels warm to touch;per MD localized rxn;cool compresses & APAP;
pt recv vax 13SEP96 & devel classic chicken pox vesicles/lesions on trunk, back, & legs;
Two weeks after getting the second shot my son developed extremely, all over his body hives. Tried several doctors which started with his primary, dermatologist and allergists/immunology. Tried several medications including oral and topical steroids and treatments with Zyrtec. We are almost approaching one year after the 2nd shot and my son still is getting the hives. I need to know if there is a facility handling these cases of vaccine induced hives. I need a doctor who can handle this. My allergist just told me that 95% of people get hives for no reason but I see many cases where people are getting this reaction after a second dose. We need a treatment that will work to get rid of these outbreak of hives.
Patient received Janssen vaccine while Age 17. Janssen vaccination is only approved for age >18. Age was realized immediately after immunization. No adverse reactions reported.
Patient was given Moderna bivalent booster too soon.  Last monovalent booster on records with public health was administered on 08/10/2022.  Patient wad administered bivalent booster on 09/27/22.  Patient was notified of error and is doing well.  Patient denies having any adverse reactions.  Patient advised to return to clinic if he begins to feel unwell or to call911 or go to the nearest hospital if he experiences any adverse effects or any signs of a severe allergic reaction.
Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup neg. Was advised that chest pain may be muscular pain from vaccine. Chest pain resolved. Continues to have fatigue, headache.
Swelling at injection stie, warmth and redness. Noticed induration on left thigh 5.5cm x 5.5 cm, redness 5.5x7.5cm : anterior aspect of left thigh.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 05-NOV-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N025428 with expiration date on 19-JUN-2020 (strength, anatomical location or route of administration were not provided), for prophylaxis. The storage temperature of the vaccine was reported as 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36 to 46°F for 10 hours and 25 minutes; and 32 up to 35 °F for 3 hours and 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. Data logger was involved.
First dose: just some pain; First dose: fatigue; This is a spontaneous report from a contactable nurse (the patient herself). A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6199, Exp 30Jun2021) intramuscular in left arm on 04Mar2021 12:50 (at the age of 39-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes flu shot in Feb2021 (exact date unspecified). Other relevant medical history was not reported. Concomitant medications included vitamins (unspecified) taken for years. The patient experienced some fatigue from 04Mar2021 and just some pain on an unspecified date. It was further specified that she experienced fatigue the same day/night she got the first vaccine. She was just really, really exhausted and mentioned she just had some pain. She confirmed she recovered completely from the fatigue and pain. No seriousness was reported for the events. The events resolved on an unspecified date and both were considered related to the vaccine.  No follow-up attempts are needed. No further information is expected.
Numbness in both legs. Goes away when I take Bayer aspirin and comes back the next day. Mostly left leg. Or whole left side. Feels like pins and needles
Pt had redness, swelling at inj. site starting 1 day post inj. also had rash on stomach & back 1 day post inj.
neurological hearing loss; deaf in one ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 2 (booster), single (Lot number: SK9895) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DEAFNESS (medically significant) with onset 03Apr2022, outcome "unknown", described as "deaf in one ear"; DEAFNESS NEUROSENSORY (medically significant) with onset 03Apr2022, outcome "unknown", described as "neurological hearing loss".  Clinical information: The patient had no history of any side effects with this Vaccine until now. Patient stated he wanted to report a side effect and then maybe get some guidance on what to do next? He was having neurological hearing loss after his 2nd Booster (Clarified and confirmed as Pfizer Covid-19 Vaccine). He did not have this issue before and from doing research, he thought this was somewhat of a rare side effect that had happened to him need to get medical attention immediately if he wanted it reversed. He was deaf in one ear. Site of vaccination was pharmacy.   Follow-up attempts are completed. No further information is expected.
Systemic Reaction to FLUARIX. Rash, redness, minor difficulty breathing, increase b/p. Treated with epi, benadryl, solumedrol, iv fluids. Monitored for 2 hours. Patient stabilized.
High fever spiked for a few days - up to 104 degrees F alternated acetaminophen and ibuprofen. Behavior- 5-6 days of "fussy", irritable behavior.
Patient present to clinic with swelling on the left upper thigh area measuring 13cm x 5 cm. Area was tender and warm to the touch. Mom states that she noticed swelling on the evening of 10/11/19.  Patient was evaluated in clinic and prescribed cephALEXin 250 mg/5 mL oral suspension with instruction to take 4 mL 3 times a day by oral route as directed for 10 days.   Patient was instructed to call office with phone follow-up to let staff know hoe she's doing.
On 7/19 the patient was administered a full, diluted multi-dose vial of the Pfizer COVID-19 vaccine, instead of the single .3mL dose. The patient was notified when this was discovered on 7/23 and the patient reported no adverse events or reactions.
Have shooting sharp pains in arm and leg both left. Happens intermittently since I got 1st shot
ON JAN. 22.2021, I WAS INJECTED WITH THE MODERNA VACCINE.  THE NEXT 2 DAYS, MY RIGHT ARM WAS VERY SORE,  AND HAD SOME REDNESS 1" by 4".   THE REDNESS WENT AWAY.  BUT ON SATURDAY, JAN. 30, 2021, I AWOKE WITH  A RED RASH ON SAME ARM SIZE WAS 3" by 4" and  THE RASH TENDED TO ITCH A LOT.  I SPOKE WITH DRS OFFICE, THEY RECOMMENDED TAKING  BENADRYL, WHICH I HAVE DONE.  ALSO, WAS NOTIFIED BY OFFICE PER DR NOT TO  TAKE SECOND MODERNA SHOT. TODAY, FEB 2, 2021, I AWOKE, THE RASH SEEMS TO BE MUCH BETTER WITH NO ITCHING.
Urticaria on back and back of his arms bilaterally with red, round erythematous rash. Has two red round rash spots on R finger that were blistered that are same as rash on back.
Child c/o cough.. mother brought child to car - before leaving child c/o itching all over and turned bright red. Brought back into office c/o cough sweating, body wide itching flushed. Gave 2 1/2 tsp BENADRYL PO and observed. Gave ORAPRED 15 mg/5ml 3 tsp PO x 1 in office. @ approx 5:30 p. Observed. Itching improved w/ BENADRYL. Observed till approx. 6pm-6:15 pm. Advised to continue BENADRYL q6 hours prn and ORAPRED 1 1/2 tsp BID x 4 days. Will f/u in am. Advised any signs of severe Rx should go to ER. F/U am 6/11/09 pt was doing much better. No rash no redness advised to continued meds. F/U prn.
9/17/98 1st vax. 11/19 2nd vax. Malaise cont until Xmas 98'. Checked for titer which was positive so discontinued series.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Asthma, Vitamin D deficiency and Allergy to antibiotic (Allergic to ciprofloxacin). On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The HCP stated that patient took second booster dose on 06-Apr-2022 and no side effect experienced. HCP explained vaccine was expired 2 days ago. No treatment details were reported.
Vaccine administered on 3/12/11. Patient called on 3/14/11 to complain of swelling at site of injection. Told patient we'll check with manufacturer to see if this is normal or not. Called patient back but no answer so left msg to call us back. Next day patient called back to say it got worse & painful. Per manufacturer pt be directed to MD for treatment. Pt will go see MD.
UPPER ARM PAIN DEVELOPED IN THE MID-AFTERNOON, A FEW HOURS AFTER THE INJECTION, GOT WORSE OVER THE NEXT SEVERAL HOURS AND IS NOW STABLE/UNCHANGING. PATIENT STATES PAIN IS AT SITE OF INJECTION AND IS CURRENTLY LIMITING RANGE OF MOTION.
Information not available.  Patient died at home. Covid 19 listed as a cause of death on certificate.
Approximately 5 minutes after receiving vaccines, walking out of office and had syncopal episode lasting only a few seconds with brief jerking movements.  Rested in office for approx 30 min and given some water and apple juice.
sudden onset of chills-uncontrollable shivering even w/coat on-no fever;parent called-pt sent home
Large lump measuring 3"x3". Injection site is red and raised with heavy itching.
Shortly after Moderna vaccine pt started reporting lightheadedness, flushing and feeling hot. Put on gurney for comfort, ice pack applied to forehead, VS taken x3, all WNL. Declined Benadryl at this time but stated she'd take a dose when she got home. Ate a snack from her purse and drank some ice water. Note entered in record including all VS. Monitored x30 minutes in observation area. Within 15-20 minutes stated she was feeling much better. She continued to have hot feeling with headache and myalgias for the next 2-3 days. She took Tylenol 2 days after vaccine.  She had dizziness for much of the first 2 days. no describes episode of vertigo with hot sensation and fatigue.  These come intermittently and last 5-15 minutes. She is now on day 5 since vaccine. She has no rash, no itching or difficulty breathing. She will be getting 2nd vaccine
Missed second dose (11 weeks since first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (11 weeks since first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (11 weeks since first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose (11 weeks since first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient couldn't take second dose of vaccine due to Bypass surgery. No concomitant medications and treatment information were reported.
Information has been received from a registered nurse via field employee referring to an 11 year old female patient. The patient was not pregnant. Information about concurrent condition and medical history was not provided. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (lot number, expiration date and dose number were unknown, 0.5 ml, intramuscular). Other suspect therapies included VAQTA (lot number, dose and route were unknown). Concomitant therapies included Tdap and MENACTRA. On 04-JUN-2015, the patient experienced syncope. The patient sought medical attention via office visit. The outcome of syncope was unknown. The causality between the event and suspect therapies was unspecified. Additional information has been requested.
Initially muscle ache fatigue c/o (L) deltoid armpit pain & decreased ROM shoulder with (+) LAD. Confluent, round erythema, swollen, tender to palpation 7 1/2 x 6 1/2 cm (L) deltoid: Tx ice, KEFLEX with (+) response.
Localized redness and swelling of left upper arm after 2 dose of hep B vaccine. Skin warm to touch. Vaccine administered 09/22/04 with gradual increase in redness and edema over 48 hrs. Seen in local ER.
Osteoporosis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), 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; unknown manufacturer), for Covid-19 immunization. The following information was reported: OSTEOPOROSIS (non-serious), outcome "unknown".  Additional information: Reporter mentioned that, she received the booster of the Pfizer-BioNTech Covid 19 Vaccine monovalent and she had some bad reactions due to this vaccine (no date regarding when she received it was provided and no adverse events were specified). She was concerned that she might have allergic reactions if she receive the bivalent and wanted to know what are the reported adverse events and if deaths have been reported for the Pfizer-BioNTech Covid 19 vaccine bivalent. She mentioned that, she has osteoporosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, nausea, tired for two days; Nausea for a total of a week
Two-dose varicella vaccine recipient diagnose with varicella. Reported about 50 lesions all over the body, fever >100 degrees F. Lesions in all stages, including vesicles. Also had strep throat. No antivirals prescribed. Lasted 10 days before scabbing. Appeared in crops. History of asthma. No history of varicella.
Patient complained of mild itching within 5 minutes of receiving vaccine. After 15 minutes, the itching had resolved. Approximately 2 hours later, the patient called and complained of a rash all over. The patient was instructed to go to the ED where he was treated with IV Benadryl, Pepcid and Solumedrol for hives.
Systemic: Seizure-Mild, Additional Details: Patient had a seizure a few minutes after receiving the vaccine. The patient was sitting down when seizure occur and was place on the ground in a safe position. Parent denied an ambulance or calling 911. Once patient recovered, temperature and blood pressure where checked and normal. Patient and parent left about 30 mins after incident and were recommended to see the provider.
pt recvd vax 28OCT92 stated arm felt sore & like a boil; 30OCT92 woke up w/nose & eye area "beat red" & broke out on other parts of body; p/being in water broke w/welts; seen by MD given DPH;