chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd flu vax & w/in 48 pt devel soreness @ the inject site;
Information has been received from a medical assistant concerning a 73 year old female patient who on 03-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, intramuscularly and developed cellulitis of the whole arm, warm, sore to touch, and pink. The nurse reported this patient was seen in the office on 05-NOV-2008 and was given CLARITIN and ALEVE for pain, as needed. The nurse stated that they haven't heard back from the patient so they are assuming she recovered. A lot check has been requested by the medical assistant's office. A standard lot check investigation was performed. All in-process quality checks for the lot number 662100/0745X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. Follow-up information has been received in the form of medical records on 15-Dec-2008, which indicated that the 73 year old female patient had a CODEINE allergy. On 03-NOV-2008, the patient was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, on the right arm intramuscularly. On 05-NOV-2008 the patient developed a local allergic reaction including pain and swelling on the arm through the elbow. She also experience warm and sore to touch, pink, skin firmness, distal N/V/M intact. CLARITIN twice a day and ALEVE as needed were indicated. On an unknown date in 2008 the patient had recovered. Additional information is not expected.
My underarm area and area near my breast became very sore (It hurt to put my arm down) and it appeared swollen and felt lumpy.  The lumps seem to have disappeared and it's no longer sore or swollen.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). Concomitant therapies were not reported. The pharmacist reported that she heard from the patient when he came in for a flu shot that he came down with shingles on an unspecified date even after vaccination with ZOSTAVAX. The pharmacist did not have the patient's information since he was not her regular patient but he came in just for flu shot. The outcome of the event was reported as recovered on an unspecified date. The causality between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
After approximately 3-4 weeks after my second dose of Pfizer, I began having signs of Vertigo. I was wondering why I was having Vertigo, since I have never had this before. The symptoms  are several times per day and last 1-2 minutes.
I got both the flu shot and pneumonia vaccine at the same time.  I ran a fever of 101, and ached so bad I was unable to lift my arms.  Pulse which is normally 75 was 110 for about 12 hours
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Brain tumor" (unspecified if ongoing); "poor balance" (unspecified if ongoing), notes: poor balance. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "recovered" (07May2022) and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (26Apr2022) Negative; (04May2022) Positive; (07May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient tested positive for COVID 19Apr2022. Started Paxlovid 21Apr2022. Tested negative 26Apr2022 & symptoms gone. On 29Apr2022 flew back home. On 03May2022 symptoms returned & on 04May2022 tested positive again. On 04May2022 started second course of Paxlovid (lot: 641513). On 07May2022 symptoms gone and tested negative. On 09May2022, treatment with Paxlovid was stopped. Adverse event is that COVID returned after taking Poxlovtd. No known allergies. Other medication in 2 weeks product included Atorvastatin.  No follow-up attempts are needed. No further information is expected.
pt recv vax 28JUN96 & 17OCT96 pt removed beard d/t alopecia barbae;15OCT97 pt discovered onset of alopecia areata;10SEP98 alopecia areata covered 90% of scalp;no tx;
patient is observed for 60 min after administration with LVN, RN and MD. patient reports itching, feeling "flushed", and dizziness. Patient then given famotidine 20mg po and tylenol 650mg PO. Patient loses consciousness and code MET is called. patient is then transported to ER via gurney.
July 2nd, had a headache, fever, chills, aches, sore joints, and my stomach felt awful...  I took 2 Ibuprofen every 4 hours.  July 3rd, felt great, even worked in the yard.  July 4th, felt awful again, did very little, but not as bad as July 2nd....  Ibuprofen helped
No acute complaints upon hospital admission this morning. She was recently diagnosed with COVID-19 on December 19, 2021 after undergoing routine pre-procedure testing.
Patient was seen in clinic for covid booster. my co-worker look at it and said he and his sister that are coming in was okay. so i give him the 0.2 dose of the covid booster and tell Dad to wait for 15 min after that we notice at check out that the kid was 1 week early. Clinic employee went over to talk to dad.
Had MMR on 12/6/04. Came in at health department 12/8/04, relating history of "shaky, jerky,tightness of neck affecting ability to talk" Episode about 15-20 minutes after leaving immunization clinic. Went to doctor and was given "Atarax". No other unusual episode after that. Looking good during today's visit 12/8/04.
The following day or two I had an increase in my Tachycardia and 7 days after I noticed an inflammation on my arm.
This case was reported by a other health professional via call center representative and described the occurrence of injection site wheal in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site wheal, influenza-like symptoms and injection site swelling. On an unknown date, the outcome of the injection site wheal, influenza-like symptoms and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, influenza-like symptoms and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu-like symptoms and had an injection site welt the size of a baseball. The purpose of the healthcare professional's call was not to report the adverse events, she mentioned these, as an information, the reporter was asked if she wanted to report any case specifically and she declined, said the patient had flu like symptoms and larger swelling around the site. This case has been linked with case US2018158133, reported by the same reporter.
Pt had redness and swelling at site of injection, it was also warm to the touch. The spot grew over 2 days before she came in to about 2 inches in diameter. She took BENADRYL, Ibuprofen and applied ice; it went down but she stated she had a 101 degree fever and it still burned. We sent her to a clinic on day 3.
Missed second dose; A spontaneous report was received from a pharmacist, concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine and missed second dose(product dose omission issue).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 24 Jan 2021, prior to the onset of events, the patient received her first of the two planned vaccine doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, patient had to go out of state due to medical emergency due to which she missed the second dose. It was reported that it has been past 42 days since the first dose.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, missed second dose, was considered to be resolved on an unspecified date.; Reporter's Comments: This report refers to a case of Product dose omission issue, for mRNA-1273, lot # unknown, with no associated AEs.
Within a few hours got very, very weak later body aches, overall weakness, fever chills basically couldn't even move.
11AM on 24OCT96 vax given approx 12PM on 24OCT96 returned to staff givening vax c/o lightheadedness & feeling itchy;stated has allergies & can tell when skin is going to break out; no c/o SOB or diff breathing;BP 130/84;skin warm & dry;
Information has been received from a 57 year old female registered nurse regarding herself. She has a history of a diltiazem hydrochloride (Cardizem) allergy, coronary artery disease, hypertension and high cholesterol. On 02/25/2003 at 11:00 AM she was assisting with a vaccination with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #643954/0878M) and the vaccine squirted out of the syringe and the needle into her left eye and face. There was mild burning and slight redness noted. Concomitant therapy included vaccination on 02/11/2003 in the left deltoid (inoculation with 15 sticks) with a third dose of small pox vaccine (Dryvax) (batch #...0077). The measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) vaccine was manually flushed from the eye and face with water. She was referred to a workman's compensation physician and the eye was flushed with 500 cc of sterile water and she was released the same day. No further problems have been noted and she was recovered from these events on 02/25/2003. No further info is expected.
The pt experienced swelling, redness, warmth over right deltoid, malaise, chills, low grade fever and not associated URI.
grandma reported that pt began shaking p/arriving home on afternoon 5MAR97;also grandma noted cyanosis of pt fingers & mouth;advised to seek med attention immed;t104.8, p200, purple coloration, stiffness poss indicating sz;inc hydration;
patient had a third dose of the Moderna vaccine by mistake. he received his first dose at another clinic - unknown to us - in January of 2021. Pt then received a 2nd dose at our clinic on 5/27/2021 and then another dose today 6/24/2021 - we thought this was his 2nd dose but when we went to enter his vaccine in the state vaccine registry saw that he had already had two doses.
DVT and PE; DVT and PE; This is a spontaneous report from a contactable Physician. This Physician reported that a 54-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No.unknown) at single dose for COVID-19 immunisation on unknown date. Relevant medical history included Migraines, CAD, CKD III, morbid obesity, and allergy to sulfa. Relevant concomitant drugs included escitalopram oxalate (LEXAPRO), levothyroxine sodium (SYNTHROID), topiramate (TOPAMAX), metoprolol succinate (TOPROL-XL). No other vaccine was admitted in four weeks. The patient experienced DVT (deep vein thrombosis) and PE (pulmonary embolism) on 19May2021. Doctor or other healthcare professional office/clinic was visited. Emergency room/department or urgent care required. The patient was hospitalized for 2 days. Treatment therapy included anticoagulation. The outcome of events was resolving. The events were reported as serious (hospitalization and life-threatening). The patient did not have COVID tested post vaccination.  Information on the lot/batch number has been requested; Sender's Comments: The reported deep vein thrombosis and pulmonary embolism are considered unrelated to BNT162B2 vaccine. No details on the administration date of vaccine were provided. The presence of morbid obesity and chronic kidney disease (CKD) are considered possible contributory factors for the events.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Admit for heart block and asymptomatic bradycardia to 40 bpm, found to have acute myocardial injury concenring for NSTEMI vs myocarditis; suspected immune checkpoint inhibitor myocarditis/myositis w/ complete heart block. 1 of 3 patients with similar presentation within 1 month (2 received 2nd dose Moderna, 1 received Janssen)
Soon after receiving my second dose on April 9, 2021, I got a headache.  This is a severe headache that I have not had relief from. On Apr 16, I went to the ER.  After 5 hours, and not being seen, I left.  A few days later, I saw my PCP and was prescribed Butalbital-apap-caff, which did not offer my any relief.  Eventually I was referred to the neurology clinic. There they prescribed amitiptyline and ordered an MRI. On Jun 22, I finally got the MRI, which was unremarkable.  PT was ordered, which was useless and caused more pain to my neck.  Headaches presist. In Sept, I was prescribed Medrol dosepack. Again this did nothing to help the headache.  Currently awaiting follow-up w/ Dr
Facial edema (angioedema), mild, urticaria of arm, legs, pruritus.
6 hours after MENACTRA onset congestion, cough, sore throat, - observe
Adverse event: Pt received first dose Pfizer COVID-19 vaccine on 4/13  at approximately noon. She states later that evening, approximately 6pm, she noticed her right eyebrow and corner of mouth "looked funny", as they did not raise in symmetry with the left side of her face. She denied any other noticeable deficits in the head/neck, upper and lower extremities.    Treatment: none  Outcome: patient reached out to our facility and asked whether or not she should get the second dose. I described the risk / benefit ratio of not receiving the second dose. Pt states she would research the topic further on her own before making a decision. I advised the patient may report the incident to V-safe as well.
swelling at injection site about the size of the palm of the hand per patient estimate, warm to the touch.
Pt came in on 5/18/01, complaining of stomachache, low-grade fever, crying, rubs head, not himself, decreased appetite, dry heaves last night. On Augmentin for right otitis media, rash on trunk on 5/21/01.
Headache, nausea, diarrhea, nerve-like pain, muscle pain. Took Advil and otc anti-diarrheal. Continues to have nerve pain, headache, and muscle pain. Today she obtained a red hot rash to injection site.
Erythema, warmth within few minutes of injection. 8cm x 7cm erythema. Took BENADRYL 50mg-observed. Erythema decreased 2.5cm x 5cm. No systemic effects. Continue BENADRYL x 24 hrs.
ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced TINNITUS (ringing in ears). At the time of the report, TINNITUS (ringing in ears) outcome was unknown. Not Provided          No concomitant was provided. Patient treatment information was not provided.
Patient presented for Hepatitis B vaccine. Adult dosage administered (1.0ML) as opposed Adolescent dosing (0.5ML).
Symptoms  began in February 2022 and continued periodically until diagnosis of Cerebral Amyloid Angeopathy  by Dr.
Ringing in ears, fever, chills, fatigue, dizziness, blood in urine, headache, body aches for first month following vaccination. Then a series of chronic symptoms that have persisted for two years and are getting progressively worse, ulcerative colitis, chest pain, extreme fatigue, wheezing, shortness of breath, uncontrollable eye twitching, headaches, body aches, heart flutters, pale skin, extreme hair loss, sweating, lack of ability to stand for long periods of time, faintness, nausea, diarrhea, dry cough, inability to lay flat (can?t breathe), tingling hands and feet, c diff.
Chills, slight fever, headache, general fatigue, nauseousness, body aches
Moderna COVID?19 Vaccine EUA  For the first vaccine, I was not expecting much of a reaction. I have all the symptoms: soreness of injection site, headache, body/muscle ache, nausea, fatigue. I had COVID-19 in March 2020, but was only confirmed through antibody test. My antibodies now measure low. Also I am talking a dietary supplement MCT ( medium chain triglycerides). I wondered if either would exacerbate the symptoms.
Rash on both arms and legs with minor blisters started the day after injection, blister is gone now, but rash is still visible as of today, but it has gotten a lot better with time. Patient also got itchy on the rash; she had soreness on injection site, bodyaches, fatigue lasted for 2 days.
Patient's dad fill in and signed the vaccine form with DOB wrong.  His daughter is 12 years old and she is qualified for the vaccine.  We get trouble of billing with insurance and we called insurance, they have her Dob is correct and that means she is only 11 years old.  We called the Dad and he said he was mistaken her Dob with family member and he also thought the vaccine is approved for toddlers now.  We informed she cant have 2nd dose of Vaccine until she is 12,.  She is doing fine after the vaccine.
Pain, swelling, and pressure on right side of abdomen, sometimes on left as well. Started occurring about a week after vaccination with second dose.
Headache, NauseaVomiting, c/o fatigue,injection site sore. Told to follow up with primary care physician if no improvement.
At 4:00 AM the morning following his vaccinations, patient drank an 8 oz. formula bottle as usual, but immediately projectile vomited it up. This was his first time to vomit in his life. We stopped formula. At 7:30 he vomited again, this time a bright yellow bile type vomit. We began giving PEDIALYTE as the pediatric nurse at his clinic recommended over the phone. He continued to vomit at 9:20 AM, 10:30 AM, and 5:30 PM. Around 8 PM, after having no wet diapers since 9:00 AM, I took him to the ER at Hospital to be treated for dehydration upon the suggestion of his pediatric nurse. He was given an IV for fluids and ZOFRAN for nausea. His vomiting continued into the next day, but on a smaller scale. The following 7 days he was lethargic, had a low appetite, was not smiling as usual, and was pale. On 10/14/18 we visited his pediatrician for a follow-up and after vomiting that morning. She examined him and said his stomach exam was clear. He has not been the same since his vaccinations: he still has a low appetite, he is still vomiting about once a day, he is not smiling as usual, and he is still fussy and seems not to feel well. No one in the house has gotten a stomach bug, which leads me to think this is not a virus, but a reaction to his vaccines since it began just hours after.
Patient was seen in ED last night and came to report reaction. Pt developed urticaria & received a MEDROL DOSE PACK. Pt. reports feeling better today.
1) Fever up to 101.9 degrees for about 24 hours starting at 10:00 PM on evening of 1/26 (acetaminophen 1 g every 4 hours did not affect the fever) 2) Severe headache, severe muscle and joint pain for approximately 36 hours starting at 10:00 PM on evening of 1/26 3) Arm swelling beyond what would be considered normal (pictures available) with erythema  I was unable to go to work on 1/27 and 1/28.  More unusual adverse events: 1) Approximately 24 hours after receiving the shot, my Restylane Lyft fillers (tear troughs and cheekbones) became  swollen and painful. The visible swelling lasted only about a day, but as of this report, the area is still tender. 2) I experienced bleeding gums when I brushed my teeth the morning and evening of the day after the vaccine and once more (less blood present) on the morning of 1/28.  There was no more visible blood when I brushed my teeth on the evening of 1/28.
Pt experienced fever, chills, altered state of consciousness described as "being so out of it, I was past left field" short term memory loss. Lasted roughly 8 hours. No treatment.
Case number PHEH2016US025960 is an initial spontaneous report received from consumer on 06 Oct 2016. This report refers to 60-year-old female patient. Past medical history included herpes infection and breast cancer with lymphedema. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number and expiry date not reported) at a dose of 0.5 ml intramuscular on 27 Sep 2016. The three days after vaccination, on 29 Sep 2016, the patient experienced body aches all the way to her ankles, profuse sweating, lightheadedness, weakness, fatigue and lymphedema exacerbation (not in the injected arm). When symptoms started, patient began to take herpes medication (unspecified) to help with symptoms. It was reported that, no past reactions to flu vaccines. The outcome of events was reported as unknown. The seriousness and causality of events was not reported.
Diffuse nerve pain, zaps of pain throughout random areas of the body affecting sleep and daily functioning. Lasted 72 hours. Also experienced the expected fatigue, muscle pain, injection site soreness, and headache. These lasted 48 hours.
About 14 hours after receiving my second dose of the Pfizer COVID vaccination, I developed sharp, shooting chest pains and a pounding, racing heart. This occurred at night and lasted for what I recall as a few hours. Eventually I fell asleep and awoke the next day with it being resolved.  Since I no longer had these symptoms, I didn't seek out medical care.
(swelling of cheeks, eyes, throat and neck) Narrative:  A 68 yo male was reported with a historical ADR of Angioedema after receiving Covid vaccine The reporting attending physician note included patient developed swelling of cheeks, eyes, throat and neck within four hours of receiving the vaccine and was advised not to take the second shot. Other documentation from patient's Tel call included refusal to go to the ER and patient's description of reaction as experiencing chills when he got home, went to sleep and when he woke up found his face slightly swollen, involving his eyes, cheeks and glands under his neck with no lip, tongue or throat swelling. PMH - Heart Murmur, OA, Cocaine abuse, Sleep Walking, Migraine, Depression, Crohn's Disease, Rectal Bleeding, HTN, Chronic Hepatitis, Anxiety, OSA
5/15/12 6:00 PM, Tightness in chest and rash on trunk & extremities. 5/16/12 7:30 AM, TX with Solucortef 100mg IV, Diphenhydramine 50mg IV, Prednisone PO, & Diphenhydramine PO.
Flu symptoms headache, stomach pain, nausea, exhaustion, body aches, chills, mild fever, mild throat congestion  Started late on day 6 after vaccine, lasted until early day 9
Allergic reaction on body. Pt came on 4 21 17 to mention she had allergic reaction. No treatment or hospitalization.