chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy, room spinning, evolved to very tired/weak.  Unable to eat.  Had extensive movement to liquid.  Stayed in bed with eyes closed til 2PM when started feeling less dizzy.
59 yr female with history of 2021/Feb stroke (right sided weakness) and Open Heart surg, felt light headed 15 minutes post vaccination. She had taken clonazapam prior to coming to site. Rested, given apple juice, no changes in Vital signs, ambulated without assistance with Spouse to departure.
PATIENT STATED SHE HAD EXPERIENCED NUMBNESS IN THE ARM. SHE HAD TRIED HEATING PAD, EPSOM SALT, PAIN KILLER BUT THE NUMBNESS HAS NOT GONE AWAY. SHE STATED THE NUMBNESS HAS NOT GOTTEN ANY BETTER SINCE 9/14/22 (AS OF 9/19/22). IT IS WARM TO THE TOUCH.
Headache, body aches, fatigue, low grade fever, loss of appetite and nausea
ITCHY, RED, RAISED AREA AT INJECTION SITE ABOUT A WEEK OUT.  ABOUT 4CMX 3CM.
Muscle aches, fever, chills, vomiting, diarrhea, headache, fatigue
Pt developed a flushed feeling along with lightheadedness. She notes that it feels similar to prior episodes of vertigo. Symptoms came on almost immediately after vaccination. BP 120/80, HR 73, SP02 98%. She ate a snack and felt slightly better and elected to go home with her husband driving. She declined EMS services and ER evaluation,
Muscle aches, red face, chills, night sweat, headache, fever from 7:00 3/23 to 12:00 pm 3/25.   Symptoms stopped as suddenly as they appeared.
Headaches, Nausea, Vertigo next morning and persistent   Approximately 10 times since 2/24/22.   Never before have I experienced any of these symptoms for any reason.
High fever, redness and swelling at injection site, dark red spotted rash all over enitre body
female patient received by error Engerix-B pediatric formulation; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 54-year-old female patient who received HBV (Engerix B pediatric) (batch number DD707) for prophylaxis.   On 27-SEP-2023, the patient received the 1st dose of Engerix B pediatric. On 27-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: female patient received by error Engerix-B pediatric formulation) and accidental underdose (Verbatim: Underdose). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK receipt date 1 November 2023: Clinic Administrator reported that an adult patient received by error Engerix-B pediatric formulation as a First dose and then an Engerix-B second adult dose on 31Oct 2023.  The patient did not received Engerix-B third dose yet. The reporter consented to follow up via email The adult patient received by error Engerix-B pediatric formulation which led to adult use of a child product and accidental underdose.
Pain, swelling, erythema, ice Benadryl, Ibuprofen
pt recv vax & 2hrs p/vax pt exp an asthma attack;pt had diff w/food that hadn't before;very sensitive to other things,& sensitivity inc as time went on;also exp a yeast hypersensitivity;
Itching starting one week later. Morbilliform, papular red starting next day, on leg and arm, especially arm where vaccine adminstered. Pt is afebrile of clammy. Normal vital signs.
(L) arm pain from shoulder to hand, aggravated by ROM of wrist and fingers - no skin irritation, nodules or warmth at site of injection. Pt reports pain 8/10.
Left arm pain and swelling for 3 days. Started to have shortness of breath, mild wheezing for few mins then subsides. The shortness of breath and mild wheezing occurring few mins once or twice a day occurred 3-5 times since getting the Pfizer vaccine.
High fever of 103 for 1 1/2 days very irritable, lethargic for 4 days.
who's the only one that got real sick/he bounced back; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient in his 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "who's the only one that got real sick is [Patient Name]" (unspecified if ongoing), notes: Before vaccine available for young, healthy guys, whole family got sick. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "who's the only one that got real sick/he bounced back".  Additional information: The other patient experienced unexpected therapeutic benefit from COVID vaccine. Well last year right before the vaccine became available for the young, healthy guys the whole family got sick, the babies, his daughter, his wife, and himself. And who was only one that got real sick. But after six months, he decided let try something else, cause we had no treatment. He got the vaccine and in two more months he bounced back. So he was fired and quit his old job, told his boss to go to a different place.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
didn't feel well; the vaccine was out of stock; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (Refer linked case US2020156565 for 1st dose.).   On 3rd August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell and product supply issue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix because the vaccine was out of stock which led to product supply issue and patient didn't feel well for 24 hours, after the 24 hours period, she felt fine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156568:same reporter US-GLAXOSMITHKLINE-US2020156565:same patient
I had severe chest pain, shortness of breath, shooting neck pain, headache, nausea, and I could not move any of my extremities.
right breast cyst had lumpectomy; This spontaneous case was reported by a non-health professional and describes the occurrence of BREAST CYST (right breast cyst had lumpectomy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Lumpectomy on 24-Mar-2021. Concurrent medical conditions included Hypertension (High blood pressure) and Thyroid disorder.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CYST (right breast cyst had lumpectomy). At the time of the report, BREAST CYST (right breast cyst had lumpectomy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Mammogram: cyst in right breast (Positive) cyst in right breast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes high blood pressure and thyroid.  No treatment medication was provided.
Friday Night 11/4/2022: extreme body aches - head to toe - different than previous 3 shots - considered emergent urgent care but stayed home. Saturday 11/5/2022: body aches, fevers, arm pain all day noticed red spot developing on arm below injection site and bruising at injection site. Sunday 11/6/2022: body aches, fevers, arm pain continued, and red site continued to grow, swell and became hard and hot and painful.  Monday 11/7/2022: tried to go to work and was continuing to have all of the above symptoms including developing shooting pain in my arm (red site was continuing to get larger and was still hot, hard and tender). Was encouraged by employee health (I work at a hospital - where I got the vaccine) to go to urgent care. Urgent care advised continued NSAID and Tylenol use and cold compress on arm and monitoring for signs that would require emergency room visit. Tuesday: symptoms continued; fever worsened otherwise other symptoms were the same. Did not go to work. Was contacted to follow up on my responses and advised to fill out a VAERS form. Wednesday: symptoms seem to be mildly improving. Arm is less red - some areas are bruised, and it is still tender. Body is still painful mostly in shoulders, armpits, and neck. Still feverish. Did not work today.
arm hurt; headache,like rubberband around head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and HEADACHE (headache,like rubberband around head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache. Concomitant products included LISINOPRIL, TRIAMTERENE, ACETYLSALICYLIC ACID (ASPIRIN 81), CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and VITAMIN D3 for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (headache,like rubberband around head). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) and HEADACHE (headache,like rubberband around head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Negative) Negative CAT Scan.         Action taken with mRNA-1273 in response to the events was not Applicable. No treatment medications provided by the reporter.
Hard to breathe, pounding heart & fast heart rate.  Bad headache, shaky.  Felt like throat was closing, dizzy.  Resolved after po BENADRYL.
received a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   Previously administered products included Shingrix (received full series 2 years ago).   On 12th May 2021, the patient received the 3rd dose of Shingrix. On 12th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Pharmacist reported a patient who received a third dose of Shingrix on the same day as reported, which led to extra dose administered.  The patient had received the full series 2 years ago and they were not aware of that. The reporter consented to follow up.
Non-immunocompromised patient presented for booster dose. Primary series was Pfizer, given 6/5/2021 and 6/26/2021. Given CDC criteria, patient should have received his booster dose a minimum of 6 months after second dose. Patient received his booster dose 24 days earlier than the minimum required time period. Patient monitored for 30 minutes, no immediate side effects noted. Patient provided facility contact information for questions, instructed to seek emergent care if needed.
Patient received her second Moderna Covid-19 vaccine 2/24/21.  The following morning her left arm (injection site) was swollen.  As the day progressed a red, raised rash developed on both arms and her chest.  No treatment was sought at that time.  One week later, on 3/4/2021, patient presented to emergency room in Hospital, due to severe uncontrollable itching on the rash areas. Patient reports that she was prescribed a Medrol Dosepak and an 'anti-itch pill' at the emergency department and received a shot. The therapy caused the itching and rash to subside.  She also reports the rash occurring t the incision sight of a previous c-section delivery. Patient presented back to the pharmacy that administered the vaccine on 3/18/21 and reported the above reaction for the first time.  While the above mentioned therapy helped, now that the therapy is complete the rash and itching is returning with severe itching  again. Patient was advised to seek further medical attention from her PCP>
allergic reaction of hives/Hives on bilateral arms; This is a spontaneous report from contactable consumer. A 39-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8733), via intramuscular, administered in left arm (as reported Injected in left arm in the muscle) on 31Mar2021 08:25 (at the age of 39-year-old) as dose 1, single for covid-19 immunisation at clinic. The patient took paracetamol (TYLENOL; Lot Number: SLA051; Expiration Date: Jun2024) at 500 mg, via an unspecified route of administration from 31Mar2021 to an unspecified date, for an unspecified indication. Medical history included patient had severe food allergies diagnosed first in 1986: allergic to oranges, milk, mild reaction to eggs, compromised immune system, respiratory illness: Asthma, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes), anal cancer (previously) and obesity. The patient's family medical history included mother had lung cancer. The patient's concomitant medications were not reported. Patient took 2 of Tylenol about half an hour after getting the shot. Patient was not administered with any other additional vaccines on same date of the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No adverse events after prior vaccinations were reported. Caller stated she received the first dose of the Pfizer COVID vaccine this morning and she had an allergic reaction of hives/ hives on bilateral arms which occurred around 4pm today (on 31Mar2021 16:00). Caller would like to know if she should go to her doctor's office or if she can treat them on her own. There was no prescriber. No ER or physician's office required, and she can ride it out at home. Patient has Benadryl if she needs it. Patient wanted to be sure that taking the Benadryl and Tylenol should be all right for this type of response. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient is over 220 lb and a 5/8 inch needle was used so vaccine was given subcutaneously. Se thinks that it was administered subcutaneously instead of IM; Wrong sized needle was used to give vaccine; experienced swollen arms after getting the 2nd dose; This is a spontaneous report from a contactable nurse (patient). This 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), subcutaneous at single dose in the left arm on 10Jan2021 07:15 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 (first dose) for Covid-19 immunisation.   It was reported that wrong sized needle was used to give vaccine in 10Jan2021 10:00. The patient is over 220 lb and a 5/8 inch needle was used so vaccine was given subcutaneously. She received the 2nd dose with 1 inch 5/8 size needle which she believes that is inappropriate to use since her weight is 240lbs. She experienced swollen arms after getting the 2nd dose and she thinks that it was administered subcutaneously instead of IM. Asking for recommendations on what to do next if she needs to have another dose or not. The outcome of the events was unknown.    Information on the lot/batch number has been requested.  Follow-up (11Jan2021): New information received from a contactable nurse (patient) includes: Events details, and new event (swollen arms)
Lump appeared in the neck.  same side as the injection Lump was visible when she woke up in the morning.  lump was ~1-2cm in size The lump gradually reduced each day.   Took ~1 week to resolve
Redness/rash at injection site and about a 3 inch radius below it. Some pain when touching it.
I have only been getting more sick since the vaccine. I had body aches those went away the soreness in my arm went away but then when they went away my chest started to burn I started hacking up thick brown gray stuff growing up and having abdominal pain from time to time I just need to know if the vaccine can cause flare-ups and people with an autoimmune disease or disorder.
Sore arm, diarrhea and gastrointestinal discomfort, headache, extreme fatigue, body aches
Red wheel, hot area about 4 cm around injection site. The reaction lasted for 2 days.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted in chair shortly after receving vaccine. She came to within a minute, but body became very rigid and she began to seize throughout her whole body. This lasted less than 30 seconds and she was very pale and lightheaded. Patient decsribed feeling extremely nauseous with chills, slowed breathing and lightheadedness. Moved patient to a new area to elevate feet, stated feeling better but was extremely nauseous and unaware that she had fainted or seized. 911 called per parents request
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 017C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received added Race and Ethnicity information. On 03-Sep-2021: Follow-up received include no new information. On 03-Sep-2021: Follow-up received include no new information.
Patient received injection SQ in left arm on 3/25. Injection site was a little itchy and tender but no redness.  On 3/26, injection site had a large, firm, red area about an inch in size. No pain, a little itch. On 3/27, the area was much larger. Firm red center about 1 inch in size, with fainter red circle extending 6 inches in diameter. Area is slightly swollen, firm and warm to touch. No pain but discomfort because skin "feels tight" and is itchy. No signs of blister, rash, streaking of redness, or discharge. Pt reports rest of arm feels fine and works fine. No rash elsewhere. No fever. No other symptoms or complaints. Patient told to manage with compresses, oral and topical Benadryl. Call if worsens, fever develops, blistering, red streaks on arm. Checked on patient 3/29, arm seems to be improving. Red area is still warm and firm to touch but is smaller than yesterday. More itchy, though.
He had the vaccination on 08/22/2022. I noticed that afternoon hives inside both wrists, elbows and knees. I gave him a full dose of ZYRTEC. On 08/23/2022, he was fine in the morning. But by that evening he couldn't stop scratching his foot and going to sleep. He had hives all over his extremities. We gave him more ZYRTEC. In the morning I called the nurse line 08/24/2022. We took him to the ER. Barely visible hive on left cheek. Gave steroid to drink. I picked up children's BENADRYL on the way home. 08/25/2022 patient had hives all over his body. The progression of the hives seem to be working through his body. He is home from daycare today. We are treating with BENADRYL and ZYRTEC. We don't know a plan going forward with the 3rd vaccination.
Patient called office next day states that she has been sweating every 30 minutes after receiving TDap and hurting under her armpit. Also states that the injection site was red, swollen, and warm to touch. Patient also states that she has taken Ibuprofen and Tylenol for pain. Patient was informed to go to the ER if any signs or symptoms of an allergic reaction occurs. Phone call to patient to inform her to go to her PCP or the ER.  9/5/19 Patient states that she was still not feeling well from receiving the injection. inquired if she went to urgent care, PCP or ER as instructed on 9.4.19, to be evaluated. Patient states that there was nothing wrong with the injection site but that her body is in pain and wants this reported to the FDA. Phone number was provided to the patient per her request. Also on 9/5/19 patient reports ti the ER and reports she had body aches, joint pain, and had red bumps to her forearms. States that she feels generally weak and fatigue, "not myself" and that she took 2 doses of 50mg of Benedryl and rash has resolved.  Per ER: "suspect immune reaction to recent immunization. no signs/symptoms of anaphylaxis. UA negative for infection as this was a concern because patient felt like it was her kidneys were hurting. Decadron give possibility of allergic rash itching."
04/13/2023, I was feeling like I had the stomach flu. I was really dizzy, and I thought I was getting bronchitis and I went to the doctor. I was doing really well for a few years. I think my health is declining. It is reacting to the treatment that I take. I am chronic immunocompromised. I saw my doctor 4/19/2023. He just listened to my chest and said I do not have fluid in my lungs. I do not have pneumonia. He prescribed albuterol and said to call him in a few days or if I am feeling any worse.
Headache onset an hour after vaccine received that turned into severe migraine by day 2. As of today I am still experiencing severe migraine that has stopped me from working. Joint aches, and pain that aren?t remedied by OTC pain medication. Low grade temp since day of vaccine.
Approx 3 hrs p/immun pt devel t104 R & started to scream; The unconsolable screaming lasted for 3 1/2 hrs; pt was taken to ER & observed x 4 hrs;
Patient received vaccine on 3/31.  Developed significant headache the evening of 4/12.  Called hospital telephone nurse advisor, and was directed to come to the ER for further evaluation.  The patient was not admitted.  No evidence/concern of thrombotic event.  Patient does have a history of migraines.