chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 2 doses of vax on 7OCT91 & 17NOV92 & exp pain @ inject site; next day had pain, tenderness, & muscle weakness w/numbness & tingling in the inject arm; 30DEC91 tongue on lt side was numb; 31DEC91 woke w/lt sided facial paralysis;
Immediately nauseous. Forced out of the office with no waiting space to recover seated Immediately after shot. For several days felt weak and fatigued. Mild brain fog and lethargy beginning 12/30.
Area 5cmx3cm erythema immediately after MMR injection. Area 2 to 3cmx2cm, red, warm, and raised at 12:35 PM. 12.5mg Benadryl PO administered.
Information has been received from a physician concerning an 11 year old male with amoxicillin and CEFZIL allergies who on 21-JUN-2000 was vaccinated with a dose of VARIVAX (Merck), SC and on 03-AUG-2007 with the second dose. There was no concomitant medication. On 16-JUL-2010 the patient broke out in chickenpox. He presented to the office with no fever. He had macules, papules, and vesicles in various stages. The patient was given ZYRTEC, and had not recovered at time of reporting. Additional information has been requested.
patient received an expired dose of Daptacel, no AE; 3 years old patient received an expired dose of Daptacel (4th dose in series) , no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old female patient who received a 0.5 mL dose (4th in series) of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5281AA, expiry date: 05-Oct-2019), via intramuscular route in the right thigh on 11-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Raised red, irritated area that is hot to the touch and muscle seems firm. Minor pain in area and shoulder joint. Rash spreads from shoulder to just above elbow, and mid inner bicep to mid outer tricep. Taking ibuprofen and applying ice packs to alleviate pain and discomfort.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: watery eyes itchy throat-Mild
Left deltoid, 1.5cm wheal at injection site. No itching or pain. No fever or warmth at area of injection.
A trained employee and a employee in training were administering the vaccines to this patient. The employee in training injected all the ones in the left thigh listed above. The MMR was administered correctly, but the Hep A and HiB were not. One of these IM injections was administered in an area of the leg lateral to the cleansed region, and the other was administered at a 45 degree angle. Patient's parents were concerned when an erythematous area appeared 24 hours after injections in left leg. Uncertain which vaccine was administered in site of erythema noted by parents. Parents took infant to physician for evaluation today and monitoring was recommended.
vertigo; runny nose; headache; joint pain; extreme fatigue; Initial information was received on 14-Jan-2021 regarding an unsolicited valid serious case received from a other health professional in United States.  This case involved a 42 year old female patient who experienced vertigo, runny nose (rhinorrhoea), headache, joint pain (arthralgia) and extreme fatigue  (fatigue), while she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced vertigo, runny nose (rhinorrhoea), headache, joint pain (arthralgia) and extreme fatigue  (fatigue), unknown latency following the administration of INFLUENZA VACCINE.   Seriousness criteria for all event was assessed as medically significant as per reporter.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as not resolved for all the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an 42 year old female patient who experienced vertigo, runny nose, headache, joint pain and extreme fatigue after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Moreover, concomitant medications, patient's medical condition at time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Hives (allergic reaction) only one left; Very itchy skin; Headache / Pain in temples / Head hurts so bad; Fatigue / feeling very tired; Felt that something internally move in her chest that woke her up from her sleep; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt that something internally move in her chest that woke her up from her sleep), URTICARIA (Hives (allergic reaction) only one left), PRURITUS (Very itchy skin), HEADACHE (Headache / Pain in temples / Head hurts so bad) and FATIGUE (Fatigue / feeling very tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Felt that something internally move in her chest that woke her up from her sleep). On an unknown date, the patient experienced URTICARIA (Hives (allergic reaction) only one left), PRURITUS (Very itchy skin), HEADACHE (Headache / Pain in temples / Head hurts so bad) and FATIGUE (Fatigue / feeling very tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt that something internally move in her chest that woke her up from her sleep) outcome was unknown and URTICARIA (Hives (allergic reaction) only one left), PRURITUS (Very itchy skin), HEADACHE (Headache / Pain in temples / Head hurts so bad) and FATIGUE (Fatigue / feeling very tired) had not resolved.            Patient stated that she otherwise does not take medications, does not smoke and drink alcohol, or take drugs.
it (cyst) became infected; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) at single dose (at the age of 76 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated that on Feb2021, everything has been just fine not even the sore arm, but couple of days ago the patient had a cyst and that's why she visited her dermatologist for and the couple of days ago it (cyst) became infected. So, he prescribed an antibiotic Clindamycin 300 mg.  The patient just wondered if that was alright to take, as she did not want to mess up the effectiveness of the vaccine.  The outcome of the event was unknown.  The patient stated, "so, this was like a, maybe a pre-existing condition I don't think it has to do anything with the vaccine but I don't know that you know. I just want to know if I can take the medication and not having affect my vaccine."  Information on the lot/ batch number has been requested.; Sender's Comments: The reported cyst was most likely a pre-existing condition, and unlikely causally related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The patient was 76-year-old, and there were probably other factors induced it (the cyst) became infected.
Left arm rash and intense  itching at site of injection began 2/13/21 7 days after the injection. Somewhat painful and aching arm. Size of area with redness approximately 2 by 2 inches.   Symptoms began to resolve after 30 hours.
Migraine, heart palpitations, 5 days of diarrhea so far, lack of appetite, bouts of extreme fatigue, and anxiety (I?m don?t have anxiety so this is very unusual).
flu-like symptoms; stomachache; body ache; headache; chills; left arm of injection ache; chest like bandore; left arm of injection warm; left arm of injection barely can move it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHEST DISCOMFORT (chest like bandore) and ABDOMINAL PAIN UPPER (stomachache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), CHEST DISCOMFORT (chest like bandore) and VACCINATION SITE PAIN (left arm of injection ache). On 10-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL PAIN UPPER (stomachache), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHEST DISCOMFORT (chest like bandore), ABDOMINAL PAIN UPPER (stomachache), VACCINATION SITE PAIN (left arm of injection ache), MYALGIA (body ache), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was reported.
Persistent herpes outbreak in genital region. Sores will start to heal, then a new outbreak will start. Prescribed Valtrex and Acyclovir, neither of which helped. Supplements such as lysine and vitamin D also ineffective.
Monday morning I woke up with tightness in my chest, slightly to the left (where my heart is). It continued  for several hours and I also experienced shortness of breath. It did go away during the day. That night, when I went to bed, it came back. It hurt more as a took a deep breath and when I was lying down. The next morning, it persisted and I still experienced shortness of breath. I did call the center and MD (I do not have a primary physician because I'm in good health overall). It went away by the next day and has not returned.  I also had an earlier and extremely heavy period that month after vaccination and more swelling/joint pain in my right knee, which I had surgery on 11 months prior.
Patient felt itchy. BP 118/62; temp 97.9; BPM 62 and oxygen 99% at 3:45 pm. Final update patient BP 112/78; temp 97.7; BPM 65 and oxygen 99%. Patient reported feeling fine was cleared by nurse. Patient directed to go to urgent care if any side effects later on.
Mom called 10-29-10 to report fever after FLUMIST. Child saw MD 10-29-10 for con't fever. Child placed on Amoxicillin. I spoke with mom 11-01-10 - child still running T greater than or equal to 101.
Trouble walking/ could hardly walk; thighs and arms will swell up looks like bug bites; If I have to rate from 1-10, the pain is 10; Pain was all the way from her hip to leg; severe pain in right leg, it is not just achy, but it is real pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain in right leg, it is not just achy, but it is real pain), GAIT DISTURBANCE (Trouble walking/ could hardly walk), PERIPHERAL SWELLING (thighs and arms will swell up looks like bug bites), PAIN IN EXTREMITY (If I have to rate from 1-10, the pain is 10) and PAIN (Pain was all the way from her hip to leg) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-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 19-Apr-2021, the patient experienced PAIN (severe pain in right leg, it is not just achy, but it is real pain) and PAIN (Pain was all the way from her hip to leg). On an unknown date, the patient experienced GAIT DISTURBANCE (Trouble walking/ could hardly walk), PERIPHERAL SWELLING (thighs and arms will swell up looks like bug bites) and PAIN IN EXTREMITY (If I have to rate from 1-10, the pain is 10). At the time of the report, PAIN (severe pain in right leg, it is not just achy, but it is real pain), GAIT DISTURBANCE (Trouble walking/ could hardly walk), PAIN IN EXTREMITY (If I have to rate from 1-10, the pain is 10) and PAIN (Pain was all the way from her hip to leg) outcome was unknown and PERIPHERAL SWELLING (thighs and arms will swell up looks like bug bites) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Additional information was received on 20 Apr 2021.Additional information on vaccine and event were added. There is DOB discrepancy in the SD. On 03-Aug-2021: TCR received. Event added.
3-25-21 @ 2:30PM PT STATES SHE HAD 'HIVES AND RASH TO CHEST, ARMS AND LEGS  THAT STARTED ON 3-14-21' NO SOB, NO DYSPNEA. STATED SHE' WENT TO HOME TOWN URGENT CARE AND MISSED WORK AND WAS UNABLE TO GIVE PLASM'. PT VERY ANGRY AND STATES IT IS 'COSTING HER MONEY!'. AS OF TODAY THE HIVES ARE GONE AND SHE STILL HAS SOME REDNESS AND RASH TO BOTH ARMS AND CHEST.
General symptoms: Chills, fever, joint pains, muscle pains, fatigue Narrative:
Requested for vaccine to be given w/out pertussis component. DT vial taken from fridge, drawn and administered w/out noticing vaccine expired. No harm to patient. They will return for updated vaccine.
Poison ivy like rash started on Hands and arms 2-3 weeks following administration of vaccine treated with cortisone 1% ointment. Arms and hands healed and rash moved to lower back with severe itching and blistering. Biopsy done 2/8 diagnosis is Grover's disease.  04/11/07-records received. DX early cellulitis. questionable vaccine fever.  Per annual follow up report: Product should be labeled: Risk of systemic herpes zoster reaction. Follow-up: During recovery carpal tunnel syndrome developed in the dominant hand (right), may or may not be related? Otherwise patient is fully recovered. Cortisone injections into the tunnel have reduced numbness slightly.
This case was reported by a consumer via out of hour services and described the occurrence of myalgia in a elderly female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 2nd dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, shivering and headache. On 16th September 2018, the patient experienced fatigue. On an unknown date, the outcome of the myalgia, shivering, fatigue and headache were recovered/resolved. It was unknown if the reporter considered the myalgia, shivering, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient via After Hours Voicemail (AHVM). The age at vaccination was not reported. 2 days after receiving SHINGRIX, the patient experienced fatigue. The patient reported that she contacted her pharmacist. Limited information was provided.
Pt received Influenza vaccination on 9/30/08 (pt unable to remember site). The pt states that at that time her lupus sx were stable (intermittent joint pain; no hx of viral illness or GI sx). She states that about 2 days later she noted a severe right-sided headache (10/10) and severe pain behind her right eye. She states that she was diagnosed with a 6th cranial nerve palsy with inward turning of her right eye. She was evaluated by Ophthalmology and per the pt had a normal brain MRI. Her headache resolved after 2 days (of note her BP med dosage was increased) and her ocular sx resolved after 3 weeks (without tx per the pt). The pt received her next Influenza vaccination on 08/27/09. Again at that time her lupus sx were stable (intermittent joint pain) and she had no sx of a viral illness (ENT or GI). The following day the pt noted arm pain (at the injection site; no erythema, induration or swelling). Within 3 days the pt noted that the joints in her hands were swollen, stiff and painful (5/10). The next day she noted "knots" on her elbows and shoulders which were also painful and stiff. The pt was having difficulty with ADLs. Within the next 2 days she noted bilateral knee and ankle pain, stiffness and joint swelling. She was having difficulty getting out of bed and ambulating. The pt was evaluated by her Rheumatologist approx. 8 weeks after her vaccination. She was started on prednisone with improvement of her pain and decrease in the swelling and stiffness. After 4 weeks the prednisone was discontinued and she was started on PLAQUENIL. The pt states that all of her sx have returned to baseline (intermittent joint pain worse in am and cold weather) except for her right foot and right leg which she states are frequently painful (4/10) and increases to a 9/10 with activity that requires ambulation of longer than 30 minutes.
COVID Breakthrough  Pfizer Dose 1 2/24/21 EN6198 Pfizer Dose 2 3/17/21 Lot:unknown  CV+ 9/4/21  9/21/21 The patient presents with difficulty breathing and Patient is a 77-year-old female who was seen and diagnosed with COVID on 9/4.  Chest x-ray was unremarkable at that time, patient discharged home with prescription for Levaquin secondary to UTI, presenting today with progressive shortness of breath.  Patient was hypoxic on arrival here today.  She complains of shortness of breath, cough, fever, weakness, fatigue.  Patient denies any abdominal pain, no dysuria.  Patient does states she felt like she was better until last night to this morning she experienced this worsening..  The onset was 1  days ago. The course/duration of symptoms is constant and worsening. Degree at onset mild.  Degree at present moderate.  The Exacerbating factors is none.  The Relieving factors is none.  Risk factors consist of COVID.  Prior episodes: none.  Therapy today: none.  Associated symptoms: fever and chills.  Patient is a 77-year-old female who was diagnosed with COVID on 09/04 is presenting today with worsening shortness of breath.  It is unclear, but does seem that patient did have some improvement, and now interval worsening.  Her prior x-ray on 09/04 was no acute disease.  Today the patient is hypoxic to 85%, requiring around 5 L of oxygen. She is tachycardic, febrile with bilateral crackles.  X-ray with interstitial changes, which actually was read as potential edema.  I actually suspect this infectious event probably a viral pneumonia from COVID.  There may be a secondary bacterial infection, therefore Levaquin was ordered.  Patient developed a rash following, this was listed as an allergy.  She had received no other medications besides this at this time.  She was treated with Benadryl and Pepcid.  Discussed patient with hospitalist, who did accept admission, requested I also add vancomycin and Decadron.  Will scan the patient for PE, but she does have CKD and therefore cannot tolerate a contrast scan.  We will order V/Q scan.  Patient is stable on oxygen as above.  V/Q scan resulted with high probability for PE.  Patient to be started on heparin. Hospitalist updated, added on BNP and troponin for signs of secondary heart strain.  Patient updated on findings.  Considered to be stable for floor..
Patient tested for COVID on 4/27/21 via PCR and results positive. Symptoms include: body aches, headaches, dizziness, loss of taste and smell, cough, runny nose
6 days after injection of MMR fever 102 started, followed on day 7 of a rash originating on face neck and ears, day 8 on rash spread to rest of body.  Only place that is not covered in rash is her eyelids.  Rash on day 12 changed from a hive looking rash on face to more of a typical measles appearance of small red spots, and is slowly following down her body on day 13.  Fever is absent on day 13, larangytis has developed.  This is all of the symptoms up until now.  She still has rash and fussy and uncomfortable.  MD quoted that this is the worst sever raction to a MMR that has been seen by her and to treat it as if she has measles.
This spontaneous report was received from a nurse refers to unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with 2 doses of MMR II (dose, route and lot # unspecified). No concomitant medications were reported. The nurse reported that she received an e-mail from one of her colleagues from student health center describing that the students had received during childhood one or two doses of immunization with MMR II vaccine. Two doses were thought to provide adequate immunity; however, in several recent mumps outbreaks, many of those who became ill had already been immunized with 2 doses of MMR II. The outcome of both the events was unknown. Causality assessment was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Very swollen, redness, sore, fever in arm, hot to touch in arm and around the site where injection was given, bump in arm (very large).
5:30PM Monday after shot was fine, no reaction - Tuesday morning was fine no reaction, Tueday nite Left bicep red, warm, hard, sore 6:30 PM. Went to local ER, diagnosed with cellulitis at injection site. Put on antibiotic to LC monitor, call health dept. Call doctor. Health dept. didn't seem too concerned when called made aware situation.