chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mom states child had severe rash p/vax over body;pt taken to hosp;mom told per MD that hep b caused rxn;
Administration flu vaccine first, then HPV4 in other deltoid. Within seconds, client complained of pain from the HPV, Then she grew pale and said she didn't feel well. Began to move client to lie on exam table and she fainted, revived immediately with smelling salts, lying on exam table awake x 15 min then up and feeling okay.
Client attended a POD held at the School, where the Moderna COVID-19 vaccines were being administered to group. She received the vaccine without event and after she left, it was noted that she is 16 years old and does not meet the minimum age requirement of 18 years for the Moderna vaccine. Client?s father was immediately contacted when the error was realized and informed about it. CDC has been contacted regarding the incident and we are awaiting their response. 1/16/2021 CDC responded by saying that there was no harm in giving the vaccine, but when she turns 18 her next dose would be counted as Dose 2.
~ 45 minutes after receiving the injection in left upper arm, the patient c/o a scratchy throat, dyspnea, increased oral secretions and 'no feeling well'. A blotchy rash was noted on his right anterior abd. His lungs were clear and his speech was clear.  50 mg diphenhydramine was injected in his right deltoid and a prescription for a tapering dose prednisone was walked to our in facility pharmacy. He was given his initial 30mg dose of prednisone.  The patient began to improve quickly, with the blotchiness disappearing and the oral secretions returning to normal.  He was then discharged with instructions to notify us immediately (off-hours phone number provided) if any problems should arise.  The patient and his family will be traveling out of country and a prescription for an epi pen was sent to their pharmacy.
Started to have left leg pain on Friday night  9 April 2021 into Saturday 10 April 2021. Woke up Saturday night, tried to massage the leg pain to include a back massage.  Took a Tylenol 8hour muscle ache and pain which worked. It took the pain away. So far no returned left leg pain.
all over body itchy starting small red spots on back site of inject red lump 1 1/2 around, tender; taking APAP, DPH & putting heat/ice on site;
Information has been received from an other health professional concerning a 19 year old female student with no known drug allergies who on 20-OCT-2006 was vaccinated IM with a first 0.5ml dose of Gardasil.  On 15-DEC-2006  in the morning, the patient received a second dose of 0.5 ml IM Gardasil (lot # 653650/0702F, also reported as lot # 653978/0955F) and a second dose of Vaqta (lot # 655090/0651F). Concomitant therapy included hormonal contraceptives (unspecified). On 26-DEC-2006 the patient tested positive for HPV on PAP testing with atypical cells. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved.     Additional information has been requested..
Patient reports low grade fever, slight headache, body aches, stomach pain, and soreness at injection site. Patient states was very lethargic and slept for most of the day. Soreness at site lasted 4 days, but other symptoms resolved in about 8 hours after onset. Patient says when symptoms resolved he felt back to normal with no lasting effects.
This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with the first, second and the third dose of 0.5 ml VAQTA (Lot# unspecified) on 23-JUL-2009, 22-AUG-2009 and 01-FEB-2010. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unspecified if the patient had sought medical attention. This is one of the reports from the same source. Additional information has been requested.
Upper Respiratory Infection, Bronchitis, temp of 100.6, severe cough and congestion, sore throat and fluid behind both ear drums.
Warmth, pain and induration at injection site on day 1. Day 2, day 1 symptoms plus fever, chills, body aches, headache, runny nose, congestion, neuropathic pain, fatigue and malaise. These are present symptoms.
Rash on the injection site about the size of a tennis balls; Itchiness; hotness/sensitive pain-touch; Redness; Head rush; Low blood pressure; Heart palpitations; Chills; Body aches; Night sweats; Extreme are soreness and arm pain; Flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Body aches), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Extreme are soreness and arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 12-Jan-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Extreme are soreness and arm pain). On 13-Jan-2021, the patient experienced PALPITATIONS (Heart palpitations). On 15-Jan-2021, the patient experienced DIZZINESS (Head rush) and BLOOD PRESSURE DECREASED (Low blood pressure). On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site about the size of a tennis balls), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (hotness/sensitive pain-touch) and VACCINATION SITE ERYTHEMA (Redness). On 14-Jan-2021, PALPITATIONS (Heart palpitations) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Body aches), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Extreme are soreness and arm pain), VACCINATION SITE RASH (Rash on the injection site about the size of a tennis balls), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (hotness/sensitive pain-touch), DIZZINESS (Head rush) and BLOOD PRESSURE DECREASED (Low blood pressure) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included Benadryl-one and Motrin- 2. No concomitant medications were provided by reporter.; Sender'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.
Pain Similar to flu, then a week later developed spinning sensation in high I could not get my head up an inch without vomiting, finally  after consultation with DOCTOR I was told it was  likely VESTIBULAR NEURITIS and also concurrently I developed Acute sinusitis.
Pt reported that she had shaking, 103 degrees temperature, and diarrhea 2 hrs after she received the vaccine and that she went to the hospital afterwards. She dropped by the pharmacy, appearing to be fully recovered, to report her symptoms on 10/17/12.
Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose). On 05-Nov-2021, ACCIDENTAL UNDERDOSE (Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  It was reported that, the patient wanted additional dose.
Whole body numbness and tingling , muscle twitches, sensation to temperature, severe back spasms and pain in hips and legs
admit with cardiorenal syndrome, tachypnea, volume overload, acute HF, COVID - on admit. Uses 4.5 L O2 at home. 3L O2 in ED. Able to wean to 2L O2. Pt had 6 beat run V tach on 1/9.  pt having involuntary jerking movements. baseline creatinine 1.1, creatinine 2.6 (1/11). worsening renal failure, low grade temp. COVID + on 1/12.  O2 @ 4L.  Pt refuses to accept COVID diagnosis. Zinc given, no other COVID treatment noted. Pt discharged to rehab.
This patient came for his COVID vaccine today.  Post vaccine while in the waiting area, patient became pale and diaphoretic.  Pt then became unresponsive, laid him to the ground and elevated his legs, pt quickly become responsive with any further intervention.  Continued to monitor the patient who left with his wife 30 minutes later with no complaints or deficits.
Trembling and shivering while trying to fall asleep, tingling on only the side of my body that got the vaccine, feeling hot and cold, was sick for the rest of the year
This spontaneous report as received from a healthcare worker who reported that GARDASIL (lot # was unknown) was exposed to 31F for 84 hours over the past two months, which could not be supported. She stated that she was unsure whether any of these doses were administered to patients. No adverse effects reported. Additional information has been requested.
Sore shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and the only side effect were experienced was sore shoulder for few days. Additional Supportive Information: This case had been linked with US2022AMR146747 by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR146747:Same reporter / master case
Patient had a large pulmonary embolism 3 weeks after receiving the vaccine.  Unclear if vaccination was the cause, but giving the timing we are reporting it.  The health care proxy also noted some palpable masses on distal L extremity, unclear if related to vaccine or what these are.
Information has been received from a healthcare worker concerning unknown number of patients, who, on unspecified dates, may have received VARIVAX (Merck) (dose, route and lot # not reported) exposed to unknown temperatures for 2 months, which subsequently were found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports from the same source.. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
dizziness; nausea; headache; This is a spontaneous report from a contactable female Nurse (patient). A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN5318) via an unspecified route of administration on 06Feb2021 11:45 as dose 1, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure had this for years, ongoing high cholesterol, ongoing allergies had for at least 20 years, perennial allergy from an unknown date and unknown if ongoing she has perineal allergies. also, she has an allergy to penicillins and erythromycin with penicillin being an anaphylaxis reaction. Caller has no NDC, Lot, or Expiry for any of the products which caused these reactions, this was a long time ago, cancer from an unknown date and unknown if ongoing, swine flu from an unknown date and unknown if ongoing AE(s) following prior vaccinations: In the 1970's with the swine flu, she was given the vaccine and right after she felt like she was going to pass out. EMS gave her oxygen, and she was fine. No NDC, Lot, manufacturer, or expiry. Concomitant medications included lisinopril (LISINOPRIL) 40 mg taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. No prior Vaccinations within 4 weeks. On 06Feb2021, less than 48 hours ago the patient experienced after she had the first shot, she has had a headache and mild nausea for 2 days. On 08Feb2021, this morning she has been very dizzy and so she was wondering if this was normal; she didn't see it on the side effect list, but I am not having weakness or anything really bad and asked if this dizziness could be from the COVID-19 vaccine. When she eats, she feels sick to her stomach, in regard to the nausea. She gets a flu shot every year and has never had a problem. The clinical outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
THE LADY THAT GAVE ME THE INJECTION TOLD ME THAT THE SHOT WOULD BE PAINFUL GOING INTO MY SHOULDER/ARM, BUT SHE DID NOT SAY HOW LONG THE PAIN WOULD PERSIST. AFTER SIX MONTHS I AM STILL EXPERIENCING PAIN FROM THE SAME LOCATION. IT BOTHERS ME SOME DURING THE DAY AND NIGHT. I HAVE HAD TO INHIBIT OR STOP SOME OF MY REGULAR ROUTINES OR JUST ENDURE THE AGGRAVATION THAT EXIST. IT AWAKENS ME AT NIGHT AND I TRY TO FIND A POSITION WITH LESS DISCOMFORT. I JUST WANT TO GET RID OF THIS AGGRAVATION  SO I CAN GET BACK TO BEING MYSELF.  MAYBE MORE RESEARCH SHOULD HAVE BEEN  DONE BEFORE THIS DRUG WAS APPROVED OR AM I IN THE PART OF YOUR STUDY THAT DOES NOT MATTER; IF SO THEN SHAME ON YOU.
1st, i got sore throat, about 6 hours later,  I got my 1st UTI in my life after the 2nd dose.  Saw the doctor,  got antibiotics.  Then, for the next 3 weeks,  I got chest pain ( I can feel my heart tight even when I sat, walking made heart more pain  for  a week.  The 2nd week  only had heart pain when walking,  the 3rd week had heart pain if running), also  severe headaches.  I  wanted to call my doctor,  but  close to  July 4th week,  so I didn't call.  Also I don't know if doctor can do anything to make it better.
About 2 1/2 hours after the flu shot, I felt severe pain in my left shoulder (right shoulder too but left). My left arm was painful and useless for the next 7 days. My doctor said the needle may have scraped my muscle because there was black and blue mark 1 inch wide. The vaccine maybe fighting off something.
This spontaneous report was received from a physician assistant via field representative refers to a 16 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. The patient was not pregnant. On an unknown date in 2015, the patient was vaccinated with first dose of GARDASIL via intramuscular route. On an unknown date, the patient experienced high fevers which occurred 12 hours after receipt of GARDASIL and was subsequently hospitalized for three days. The patient declined getting second and third/final dose of GARDASIL due to the event. The outcome of the event was reported as recovered. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Right underarm (Armpit) swollen.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 02Apr2021 at 12:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included HIV infection, high cholesterol and known allergy to shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 03Apr2021 at 12:00, the patient experienced right underarm (armpit) swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right underarm (armpit) swollen was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
In morning on Feb 26th, blood pressure 105, at 1pm standing up dizzy ,almost passing out. following two days slight headache and slight nausea .noticed slight swelling of eyelids
complained of heated, burning feeling in arm of injection right after vaccination. Noticed rash on arm in area of injection that spread to neck, behind ears and face. Injection given in Left arm and rash is on left side. Took Benadryl 25mg for itching and helped symptoms, but still feeling sick.
Saw pt on 8/5/05. She is a 17 yr old right handed white female with h/o GBX x 2 after tetanus as child. Urgent visit for symptoms after receiving meningitis vaccine.  She was accompanied by both parents. Mother described 2 adverse reactions to tetanus vaccination. First adverse reaction occurred in Fall 1990 when pt was 2 yrs old. Mother states she was getting vaccinations at the normal schedule. 2 weeks after her shots, mother states pt stopped walking and lost the reflexes in her lower extremities. She was hospitalized for over a week and was eventually treated with IVIg after an extensive eval. The IVIG helped to reverse her symptoms and she started to walk again. Hosp 10dd. The second occurrence was in 1993 when she was 5 yrs old. She was starting elementary school and got her immunizations updated. She again stopped walking one week after her vaccination and was diagnosed with a second episode of Guillain Barre syndrome. She was given IVIG again earlier in her course, and resumed walking shortly after. She was out of the hospital within 5-7 days per mother. Both episodes: symptoms after 2 weeks, legs wouldn't work, walking like a drunk. Did not need ventilator. 17dd ago 07/19/05 received immunization against meningitis. Tues (3 dd ago): toes and tongue numb; lump in throat. Numb back of thighs, buttocks. Unable to run, falling. Difficulty walking. Now numb/tingling up to buttocks; also fingertips, toes, tongue. No double vision. Feels like big lump in throat; swallowing not quite normal. Developed Guillain Barre Syndrome after immunization. Recovered after IVIG.
Per hospital event report "Pt given TDAP vaccine per order. Vaccine given in L deltoid, no problems documented at time of injection. Pt called 2/14/22 to report: She feels she has had a reaction to it. Had chills and pain in the shoulder. She is bruised and until yesterday was unable to move her left shoulder higher than 45 degrees. Has a difficult time dressing due to the pain in the shoulder joint. The shot was given very high on the shoulder. Has not used any ice or tylenol. Her shoulder does not look swollen to her. Dr suggested seeing PT in office to evaluate, pt scheduled with NP for 2/15. Pt was encouraged to use OTC for pain, heat and ice at injection site. Called again 2/25/22 to report intense L shoulder pain. Dr suggested Ibuprofen, pt requested appointment. Brought in on 3/1/22 to see Dr documentation: 3 weeks ago she had her tetanus shot. She shows pictures of where the shot was with her associated bruise and is high on the deltoid muscle just below the acromion process on the left side. Since having the shot she has had pain in her left shoulder that has been debilitating and severely limiting her left arm movement. She says that she is not been able to raise her arm above her shoulder and has severe pain with putting on a seatbelt, putting on clothing and cannot lie on that side. She has never had pain like this before. The pain seems to be on top of the bone and not in the joint. She is very frustrated about the limitations in her movement and the pain. She has been taking Advil twice a day and does not take it any more than that because she only eats a couple times a day. There is a dull ache in the pain all the time. She did not have any rash, swelling with the shot. Left shoulder she has significant decreased range of motion on initial evaluation and is not able to abduct the shoulder greater than 45 degrees, flex shoulder greater than 70 degrees or externally rotate shoulder greater than 45 degrees. Passively she is able to go through almost complete range of motion all these movements. Dr L performed manipulation (OMM) on shoulder, documented after manipulation completed she was able to raise arm above her head before becoming painful actually rotate fully and able to flex joint to greater than 90 degrees. Pt called on 3/10/22 to update PCP that left arm/shoulder still painful. Will be going to PT."
Site: Pain at Injection Site-Medium, Additional Details: Pain in upper arm when putting pressure on arm while sleeping.  Also pain when lifting arm.  If resting arm, no pain.
Headache, fever, bodyaches, sick to stomach, blurry vision Took 600mg advil
No additional AE reported; VARIVAX expired was administered; This spontaneous report was received from a medical assistant and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T032319, expiration date: 22-SEP-2022, administered subcutaneously for prophylaxis (strength, dose, anatomical site were  not provided) (expired product administered).
Severe shaking spell with decreased responsiveness. No loss of consciousness.   Given 6 month immunizations earlier that day at noon, including DTAP #3, HIB #3, PCV #3, Hep B #2.  Episode occurred same evening, went to ER, had fever.