chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client  presented to the clinic today for his booster dose of Pfizer (lot FJ8757) received at 1230 to his RD. At 1236, observation LPN  noted the client stand and transfer himself to the cot. She alerted this writer ( RN PHSS) and we both responded.  He reported that he felt lightheaded and was presenting with diaphoresis and slight pallor. No LOC was noted, his responses were appropriate and his speech was clear. He denied alterations to his vision or hearing and reported that he?s had similar reactions to this before.  His VS at 1238 were: BP 118/80 laying, HR 70, and SPO2 96% RA. Juice was provided at 1241 and he consumed it without difficulty. He stated that he felt ?better already? after laying down and consuming juice. Water was also provided at 1246. Pallor and diaphoresis were visibly resolved. VS at 1250: BP 116/70 Laying, HR 71, and SPO2 98% RA. He was educated on vasovagal responses and what to expect/when to seek medical care was provided, client verbalized understanding.  At 1252, the client sat without difficulty and reported that he feels ?totally normal? except for a sensation that his heart was pounding. Pulse was bounding at his radial pulse point, but it was also steady and 72 BPM. BP was 120/60 sitting. He stood a moment later at 1254 and his vitals were taken. BP was 124/60, HR was 74.  The client sat at the edge of the cot for a while and drank more water. He reported that he felt normal, except for the sensation that his heart was beating more strongly than usual, but he wanted to wait under observation for a while since he?d be driving home and wanted to make sure he?d be safe. He was encouraged to wait as long as he needed and to exercise extreme caution when he leaves, including to pull over immediately if he feels lightheaded or like driving was unsafe. The client?s BP standing was 128/82, HR was 74, and SPO2 was 98% on RA at 1302. He reported that the heart pounding sensation had improved and he was able to walk around the observation area without any difficulty. He indicated that he was back to baseline and he exited the facility at 1304.
On 6/6/00, the pt received his 1st dose of Lymerix. Nine days later, on 6/15/00, the pt presented with right-sided Bell's palsy. The most recent information, received on 6/15/00, reports the outcome of the event as unresolved.
Patient reported large, dark bruise from injection site down to elbow. Bruise noticed Friday 11/6, roughtly. Got worse then today (11/9) gotten a little better.
Left arm hurt for 2 days; Bump at injection site; Itching at injection site; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurt for 2 days), VACCINATION SITE MASS (Bump at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ACETYLSALICYLIC ACID (DISPRIN), METOPROLOL and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm hurt for 2 days), VACCINATION SITE MASS (Bump at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). On 20-Jan-2021, PAIN IN EXTREMITY (Left arm hurt for 2 days) had resolved. On 28-Jan-2021, VACCINATION SITE MASS (Bump at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) had resolved. On 29-Jan-2021, VACCINATION SITE ERYTHEMA (Red at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Email-id updated and Email Document Attached
Swelling; Redness; A spontaneous report  was received from a nurse concerning a female patient of an unknown age who received Moderna's (mRNA-1273) COVID-19 Vaccine and experienced swelling and redness.    The patient's medical history was not provided. No concomitant medications were provided.   On 22 Dec 2020, approximately ten days prior to the onset of the events swelling and redness, the patient received their dose of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced a continued weird side effect of swelling and redness. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events swelling and redness was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
This spontaneous report as received from a health care professional and refers to a patient of unknown age and gender. Information on patient's concurrent conditions, medical history and drug reactions was not reported. On 14-AUG-2015, the patient received the first dose of GARDASIL 9, injection (concentration, dose, anatomical location not reported) which had a lot # reported as K006117 with expiration date on 14-JAN-2017. On 16-OCT-2015, the patient received the second dose of GARDASIL 9 and on 22-DEC-2015, the patient received the third dose respectively (inappropriate schedule of drug administration). At the reporting time, no adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Night after vaccine, experience dizziness and Vertigo that worsened until patient had to report to ED.  Remains dizzy to this time.  Never had this effect before vaccine.
Pt vaccinated with DTP/OPV developed rt arm red & 2+ edema, decreased ROM Tylenol with Cod, Atarcia cool compresses.
Within a few minutes I felt like my throat was getting tight, constricted, and maybe even the description would be inflamed. I was still able to breathe okay and swallow with only some restriction so I didnt say anything.  I felt a little foggy and shaky as well for about another 2 hours and then was fine.
Headache for 4 days and still going on; Soreness; Nausea; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for 4 days and still going on), PAIN (Soreness), NAUSEA (Nausea) and PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (Headache for 4 days and still going on), PAIN (Soreness), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache for 4 days and still going on), PAIN (Soreness), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol, Motrin.   Reporter did not allow further contact
04-22-2021 Woke up with severe chills at 3am; got extra covers and returned to sleep. Fever started around 7am and continued to high of around 102F at 2pm Muscle and joint aches; extreme fatigue Didn't eat Fever broke around 7pm; had chicken broth Slept for around 22 hours. 04-23-2021 Nominal fever 7am and for the day Off and on sweats Able to get up and about  04-24-2021 Recovered
Reaction reported by patient - A-fib after the COVID booster which required cardioversion. Reports similar experience of A-fib after a flu shot in 2019.
For the next few days after I received the second dose of the vaccine, I experienced muscle and body aces, fatigue, and a low grade fever. About 3 days after getting the vaccine I woke up at about 2 AM on the 18th with severe chest pain, the other side effects had subsided at this point. I ended up going to the ER after about a half hour of the pain not going away. They ran a Troponin blood test and foinf my levels to be high. They also tested me for Covid which came back positive. They ended up doing an ultrasound of my heart, using a catheter to take a look at my arteries, a chest xray, a CT scan, and an EKG. The final diagnosis was myocarditis of the heart. I had to stay in the hospital for a few days while my heart stabilized. I was given orders to only participate in light exercise and to take it easy for now. I have a follow up visit with the cardiologist in about a week frok now. It was also found out through testing that I may have Wolf Parkinson's white syndrome.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUN-2016, the patient was vaccinated with one dose of improperly stored VARIVAX lot # L029472, expiration date 06-AUG-2017 (exact dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
12 days p/vax devel mult discrete maculopapular lesions on back, chest, arms, face, neck, itching;
Left deltoid with 4 x 4 inch erythema, swollen, patch over vaccine injection area.
The adverse event occurred on 3/3/22 at 7AM. The symptoms included sharp pain to the upper arm near injection site and traveled to the mid forearm. Other symptoms experienced includes severe swelling, tight skin, warm to the touch, numbness in fingers, tingling in fingers, pain near elbow, and discomfort. Swelling started at 7:00AM and continued to swell until 8PM.
She received the vaccine on the morning of 12/29/20.  She came to work on 11-7  that evening.  At approximately 1:30 am on 12/30/20, she began feeling anxious, with palpitations.  She was taken to the ER in house and noted to be in SVT with HR of 178, T100.1 and hypotensive.  She received 2 doses of Adenosine and fluids.
damage done to my body from the Covid 19 Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious), outcome "unknown", described as "damage done to my body from the Covid 19 Pfizer vaccine".  Additional information: The patient asked who do to report damage done to the patient's body from the Covid 19 Pfizer vaccine.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This is a spontaneous report from a non-contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (BNT162B2; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included ongoing psoriasis, ongoing restless legs syndrome, uterine leiomyoma from an unknown date and unknown if ongoing , cyst from an unknown date and unknown if ongoing , primary progressive multiple sclerosis from an unknown date, ongoing ear infection , ongoing glucose tolerance impaired , ongoing fibromyalgia. Concomitant medication(s) included ocrelizumab (OCREVUS), clonazepam (KLONOPIN), apremilast (OTEZLA), metformin (METFORMIN) and duloxetine (DULOXETINE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had a big lump the size of a lemon at the injection site which led to vaccination site reaction and vaccination site warmth. She described the lump as hard and hot. The clinical outcome of the events was recovering. No further information was reported. Information about batch/ lot number has been requested.
About 10 minutes after receiving vaccine, pt complained of arm numbness going down her arm and up into her neck. she was experiencing no other symptoms and no discomfort. We observed pt another 20 minutes with no improvement or worsening of sx. Shot administer by intern, we did pull pt back into counseling room to look at site of injection, shot site looked good about 2 inches below bony process. Pt was counseled to seek medical attention if symptoms continued or progressed
Red bumps on arms-legs.  24-48 hours after injection.  Small/itched.  On right wrist there was 50 cent size "patch".  Complained of joint pains, hips and knees.
Pt recv vax on 2/8/99; immediately post vax pt exp hives, edema/warm of right shoulder, right arm; tx=Tavist & warm compresses
At first I had a headache right after I got the second dose. It was an extreme headache. I started walking to my car and started to feel like I was getting a cold and then I was very tired. The second day I had a headache which wouldn't go away with any medication. I also had chest pain and swollen lymph nodes under my arms. I started feeling sharp, needle like pains going from my arm to my breast which wasn't constant but just randomly happened. So after still feeling like that for a few days, my doctor advised me to go to ER. I went there and explained what I was feeling. I got some tests and now have an appointment with the cardiologist.
Pt had fevers, sores in her mouth, crankiness, not eating, drinking only water, swelling in her throat and it happened almost immediately.
moderna covid 19 vaccine eua developed red rash around site  11 days after infection and a few red spots on face and torso
Moderna COVID-19 Vaccine EUA  Localized rash noted to torso (bra line to belly button).  Rash not raised, no hives, no itching.  No oral or topical medications used.  Rash self resolved in 24hrs from when first noted.
A serious spontaneous report of tear in his thigh muscle and bacterial infection has been received from a non-health professional concerning a nine-year-old male, subsequent to FLUMIST. The patient received FLUMIST last season and had no adverse events. Concomitant medications were not reported. The patient received FLUMIST on 15-Nov-2010. The patient started getting a fever and leg cramps on Thursday 18-Nov-2010. The patient's leg cramps were really leg pain. The pain became more severe, he continued to have fever and on 23-Nov-2010, the subject was taken to the hospital urgent care. He was diagnosed with a "tear in his thigh muscle" and had a bacterial infection. He was admitted that day and was treated with intravenous antibiotics. He was discharged on 26-Nov-2010. A home health nurse visited the patient at home and administered IV antibiotics. His fever resolved and the leg pain resolved. The hospital physicians reported that the events were not related to FLUMIST. The outcome of tear in his thigh muscle and bacterial infection was resolved. Additional information was received on 04-Jan-2011 and incorporated in the narrative: adverse events changed to 'tear in his thigh muscle' and 'bacterial infection', outcome of the events and medical history. case has been upgraded to be a 15-Day case due to hospitalization and unlabeled events.
11/19/21 woke up and was running a low grade fever, pain at injection site and felt a softball size lump under left axilla.   throughout the day fever increased to 102.8 F.  Also experiencing numbness down to left hand into fingers.  Experiencing chest pain radiating to left shoulder  and breast as well.    She took Motrin and Tylenol - did help fever and did not help the pain.  Came to the  on 11/22/21 to see physician.  Physical exam completed.  Did see blisters in throat and did a strep test today.  Still a lot of pain in the axilla area, but much better than it was.
Fever up to 103.9, Headache, fatigue, tachycardia (125) in office.
Patient called stating that she had gotten her first dose of Pfizer Covid-19 vaccine on 10/07/21. She noticed redness, itchiness, and swelling at the injection site, and It was also warm to the touch the following day 10/08/21 . Patient informed that there was no rash anywhere on the body, and there was no difficulty breathing.
Pt's left arm below area where vaccine administered in LD was red, warm, swollen and painful. Pt states onset of symptoms shortly after vaccine given.
From initial info received on 7/1/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 43 year old female pt received a dose of TD ADS ADULT, lot U186AA, IM, in the left deltoid and a dose of Typhim VI, lot X0521, IM, in the right deltoid on 6/23/04. That same day, she also received a dose of Gamma Globulin, lot ISG158, IM, in the right deltoid. One day after receiving the products, on 6/24/04, the pt experienced small rash. She was given a Medrol pack on 6/25/04. The pt was evaluated by a physician on 6/30/04. At that time, the rash had improved, but began to resurface as the Medrol was decreased. The pt was schedule for a re-evaluation the following week. Her recovery status was reported as unknown. The lot number provided for TD ADS ADULT, does not match the mfr.
overwhelmingly uncontrollable chills started 5 hours after the shot.  vomiting.  103 fever; could barely walk due to astonishing muscle weakness.  Today, 8 days after the shot, there is a great deal of pain from my elbow, through the site where the needle was administered up to my neck.  The arm socket is throbbing with pain.
Day #1 following vaccinations fingers of both hands became + 1 swollen and points of bending on hands itched as well as both forearms.  Day # 2 no reactions.  Day #3 lips swollen which decreased and stayed non swollen after ice to area.
Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours after vaccine received, lasted 24 hours
Patient presented to ED with lower extremity weakness and pain, severe pins and needles sensation. No DVT seen on ultrasound so sent home with prednisone. Patient returned to the ED two days later with 8/10 pain that has spread to his spine/lower back, feet numbness and cramps, and calf pain. Patient was unable to raise his legs off the bed or curl his toes.
Initial and follow up information has been received through the Merck pregnancy registry from a licensed practical nurse concerning an 18 year old female who was vaccinated with GARDASIL. The patient became pregnant after receiving all 3 doses of GARDASIL (dates not specified). The patient's last menstrual period (LMP) was 24-DEC-2007. The estimated date of delivery was 29-SEP-2008. The patient sought medical attention. Follow up information indicated that in February, at 6 or 7 weeks gestation, the patient's pregnancy was aborted. No further was provided. Upon internal review, abortion at "weeks from LMP 6 or 7" was considered to be serious as an other important medical event. This is one several reports from the same source. Additional information has been requested.
For 2 days after the 2nd shot, eyes were extremely sensitive to light and vision was extremely blurry.  Had to work in a dark office to even see the computer screen.  Day 3 blurriness subsided but not totally gone.  Still have some blurriness but think it may be due to dosage change on Chlorthaladone in late Dec. Both shots really seemed to target my eyes since I was having issues there any way
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Five minutes after receiving the dose, patient reported feeling dizzy, light-headed, with an itchy throat, cough, swollen red face, abdominal pain. The RN administered 50 mg. Benadryl PO at 1900. VS as follows:  At 1900: BP 112/80  P 80  R 20 At 1910: BP 144/100  P100  R 20       At 1915: BP 120/80   P75   R 18. The RN monitored symptoms. at 1915 symptoms resolved. On 9/21/2022, RN spoke with  the patient. She had swollen eyes, no difficulty breathing or throat constriction. Plans to discuss with her PCP at her physical. She has the hotline number if needed for further questions.
Patient presented with mildly erythematous macular blanching rash on trunk. Three lesions, vesicles, on erythematous base consistent with Varicella per physician exam.
Next day I got  rash, redness, and swollen lyph nodes on left arm, hot to touch and itchy on injection site. I also had aches and pains which little by little started to get worse and turned into spasms in my right side of my back, shoulder blade and elbows swollen and hurting. The my right started to hurt and continued elbow pain. To find out there is now inflamation in my blodd.
administered an Expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5z3x9, expiry date 3rd July 2022) for prophylaxis.   On 12th July 2022, the patient received Boostrix. On 12th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The reporter works at Department of Health. The healthcare professional reported a patient was administered an expired Boostrix (expiry date: 3rd July 2022) dose. The reporter was unable to provide any patient or additional details.  The reporter denied to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
This spontaneous report as received from a pharmacist refers to a 83 year old male patient with hypertension, cardiac murmur, arthritis and dementia alzheimer's type. On 26-OCT-2016 the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On 10-JUL-2017, 8 months 15 days after onset of therapy the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovering/resolving.; Sender's Comments: US-009507513-1708USA002305:
Severe skin pain on torso and lower back; diagnosed with shingles six days later after symptoms got worse and visit to physician became necessary.
PCP suspects shingles.....reports rash as vesicular cluster of eruptions on left mid axillary line and near the epigastrium on the left in a dermatomal fashion, onset 4/4/21 ( approximately three days post second series given 4/1/21)
Patient was brought to the ED after receiving the Moderna vaccine for difficulty breathing. Per RN progress note: "Pt arrived via wheelchair from auditorium, pt had received her first COVID vaccine left deltoid, approx. 10 minutes later pt appeared to have an anaphylactic reaction, pt arrives wheezing and tachypneic, labored breathing with accessory muscle use." The patient was placed on supp oxygen and received epinephrine 0.5mg IM x1, Benadryl 50mg IV x1, hydrocortisone 200mg IV x1, lorazepam 1mg IV x1. Pt discharged after 6 hour observation with Rx's for EpiPen, prednison, Benadryl, and famotidine.
1. Swollen lymph node in left armpirt (side of injection) 2. Fatigue 3. Chills