chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Certified Medical Assistant concerning a 2 month old female infant who on 30-MAR-2010 was vaccinated orally with a dose of ROTATEQ. Concomitant therapy included a dose of PREVNAR, a dose of PEDIARIX and a dose of Hib (unspecified carrier). Within a minute of receive ROTATEQ the patient "threw up the medicine". The patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Heart palpitaions and weakness then after 5 days heart palpitations stopped and weakness continued with hot cold flushing. Numbness in toes started atarted about 4 days ago along with light sensitivity and headache and some nausea.
I had COVID-19 in November, diagnosed via PCR 11/11/20,  (no symptoms). Took a COVID antibody test 12/20/20, which was negative, so decided to get vaccinated at my place of work 12/30/20. A few days after the second dose, 1/19/21, I began feeling tired, nauseous after eating, with dark urine.  I reached out to my PCP, who ordered a liver panel. My AST was 1600 and my ALT was 800. They ruled out all other possible explanations (Hepatitis, HSV, autoimmune disorders, Wilson?s) and I took an ultrasound which was unremarkable. The diagnosis was transminitis. Since this happened so soon after my second dose, and I had had COVID, and since I work with a lot of Internal medicine doctors who thought I should report this, it was thought to be an autoimmune reaction to getting vaccinated so soon after having COVID and then the vaccine.
facial swelling. lower lip and left check swelling. Woke as result of swelling at 4am. took 2 oral benadryl and swelling appeared to stop growing. went back to sleep and woke at 7am with swelling still at same level. started to subside at 10am and by 5pm (the time of this submission) had almost fully subsided.
1 day p/vax pt devel inj site rxn of cellulitis.1 of 5 pt to exp rxn w/lot# 449578
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/11/2022 -- RECURRENCE OF SAME SYMPTOMS
A report was received from a healthcare professional on 10/24/2003 concerning 4 vaccinees of unspecified demography who experienced redness and wheals at the injection site with itching on the same day as receiving Fluvirin on 10/24/2003. On 10/24/2003 the vaccinees experienced redness and wheals at the injection site with itching.  The vaccinees recovered on 10/24/2003. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 11/17/2003: A follow up report was received indicating that a 35 year old female vaccinee experienced a large red wheal with redness, swelling and warmth within 20 minutes of receiving Fluvirin on 10/22/2003.  The vaccinee was treated with antihistamines.  The vaccinee recovered on 10/25/2003.
Overall body tremors, hypotonic, T 101, treated /w Tylenol liquid, Connected to a monitor in the ER. Slight swelling @ the inject site
patient received Menactra today and then later it was realized that she already received Menactra in Apr2018.; patient was to receive a meningococcal B vaccine, patient received Menactra today; Initial information received on 19-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who received 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (formulation: unknown, lot: U6015AA, expiry date: 06-Oct-2019, via unknown route in unknown administration site), on 19-Jun-2019 and she was already received Menactra in Apr-2018 and was supposed to receive Meningococcal B vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to extra dose administered and Wrong vaccine administered.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  List of document held by sender: none.
atrial flutter pain in right arm , pain kept going up arm but only if you touched it, got on xartorl ( blood thinner) . right forearm was really swollen , tingling and turned blue, went to hospital they did a ultrasound to check pressure in veins. if she had hand at 90 degree angel it wouldnt turn blue but if I drop it it would turn blue. next day ran more test. MRI on arm. taped vitamin c to spot where pain was in arm.  developed blood clot. told her to put heat on arm and take pain meds. felt better until she stopped blood thinner feb22, 2021. two days later had more blood clots on arms, veins were showing huge in breast and foot, pants got tighter. feb 27veins in  lower leg and neck started appearing more. feb28 my left hand was cold and the veins were showing more and u could see veins.  right back veins started appearing , got period but after 12 hours it stopped. march 3 veins started appearing again. march 4 right arm swelled and tingling in fingers and right right arm was so painful. Nerve pain. put back on blood thinner. march 4 in evening was put on new meds. I'm  still dealing with pain and different issues. march 9 had a Val moment but had tingling from butt to brain . next morning felt miserable, nauseous , throwing up and couldnt control it. 3/11 neck is swollen.  referring her to university because no doctor can figure out what it is.
the place were I got the shot hurt; This is a spontaneous report received from a contactable consumer (patient) from Pfizer-sponsored program Pfizer First Connect. A female patient of age 70 (units not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 at 16:00 at a single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date in Jan2021, the place were she got the shot hurt. Patient received Tylenol for the site pain. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Pt came to pharmacy on 10/21/15 reporting pain in left arm where flu shot was administered on 9/17/15.
Right arm became swollen from injection site down to wrist 1 day after injection was given in right arm.
Warm Injection Site; Arm Hurts; Pain around her waist (Muscle pain); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm Injection Site), PAIN IN EXTREMITY (Arm Hurts) and MYALGIA (Pain around her waist (Muscle pain)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warm Injection Site), PAIN IN EXTREMITY (Arm Hurts) and MYALGIA (Pain around her waist (Muscle pain)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Warm Injection Site), PAIN IN EXTREMITY (Arm Hurts) and MYALGIA (Pain around her waist (Muscle pain)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Difficulty breathing/she has had other people tell her that they have had the same type of symptoms; Cough/she has had other people tell her that they have had the same type of symptoms; This is a spontaneous report from a contactable consume or other non-health care professional. Report 2 of 2. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date patient had Difficulty breathing/she has had other people tell her that they have had the same type of symptoms and Cough/she has had other people tell her that they have had the same type of symptoms. It was reported that, when the patient got the Pfizer vaccine, she had a cough that lasted a long time and she had difficulty breathing. The woman said her cough lasted a month. Outcome of the event difficulty breathing was unknown, and outcome of the event cough was recovered on unspecified date.
Presented to PCP, reports getting her first Pfizer Covid vaccine in April, patient reports 24 hours after getting some shortness of breath, throat closing that patient reports has continued since having that vaccine.  Patient currently taking DayQuil/NyQuil to help with her symptoms.  Patient denies any severe symptoms. Referred to ENT and allergy for evaluation and recommendations regarding second Covid vaccine.
This case was reported by a consumer and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 17th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were recovered/resolved. It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: At the reporting time, the patient was in very good health. The age at vaccination was not reported but could be 75 years or 76 years. The patient experienced extremely painful reaction. Pain was so bad in the patient's right arm. The patient could not move or use it for two days and it was hard to sleep due to the pain. The patient was uneasy about going through such excruciating pain again. The patient was asking if it was necessary to have the 2nd dose or it was possible she would still get some protection from just one dose.
Low grade fever, severe arthralgias (no arthritis), Dizziness, fatigue, headache, treated symptomatically.
Narrative: Patient is a 73 year old MALE who received the 1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to the vaccination.-------------------------------------------------------------------------SYMPTOMS: Fever No if yes temp: n/a Fatigue Yes Myalgia No Arthralgia No Rash/Hives No SOB no Bell's Palsy No Injection Site Reaction No Other No If yes describe: felt tired x2 days
104 fever, nausea, BP 160/98, heart rate 98, Oxygen 90, blood sugar 258
Patient complained tightness of her throat.  No difficulty breathing no edema noted, no rash or redness.
PM of 11/02/2001 lethargy, couldn't stay awake to nurse more than 1 minute at a time. Lasted through 11/03/3001 saw MD 11/03/2001 nursed well in office.
Pfizer-BioNTech COVID-19 Vaccine EUA  Side Effects:  Injection site pain, tiredness, headaches, joint pain, feeling unwell, swollen lymph nodes, rough-feeling throat lasting just over 24 hours
some mild pain at the injection site; This is a spontaneous report from contactable nurses (one is patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some mild pain at the injection site on 15Jan2021 shortly after injection. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Pain on left side of neck still persists, feels like swollen lymph node,  sore and sensitive to touch, there is a small mass in pain area. I've reached out to my PCP to have it examined.
Pain in left arm, fatigue, headache, muscle aches starting at about 4 hours after the vaccine was administered and lasting for about 36 hours. Chills and mild fever starting about 12 hours after the vaccine was administered and lasting about 8 hours.
Afflication Site Reaction: Skin Erythema; swelling - Information has been received from a physician concerning a 11 year old white female who on 23 Mar 2000 was vaccinated with the first dose of varicella virus vaccine live (lot 632041/1399J) in the right deltoid, concomitant medication included the sixth dose of diptheria toxoid (+) tetanus toxoid (adult) in the left deltoid and tetracycline.  On the same day, the patient developed a local reaction with redness and swelling after only a partial dose was given.  During the vaccination the syrings came away from the needle and part of the vaccine squirted out and was sprayed into the eye of another person (waes 000323901) the patient sought unspecified medical attention.  No further information is expected.
Bell's Palsy left side, eye and mouth droop.  Eye, ear and face pain.  Doctor prescribed Prednisone and Valtrex.  Systems are still present along with pain and discomfort.
I initially my upper right arm was extremely sore.  I also  had a 3 inch red, raised, hot rash.  It lasted for approximately 10 days.  It also was and continues to be very itchy, even though it is 19 days later.  The symptom that I am most worried about though is pain that exists approximately halfway down the lateral side of my right upper arm.  This is where the deltoid muscle's tendon is.  I believe that the pharmacist, who gave me my injection did so too far down on my arm, thus causing this pain.  I have an image of my arm when it had the rash and you can clearly see that the epicenter of this rash, where she injected me is not in the meaty part of the deltoid.  This pain is becoming increasingly worse as time goes on.  I have images I can share with you if you want to see them.
Developed hives 3-4 days after receiving Menactra & Adacel. Hives started on arm when received Menactra
Heart palpitations in the night; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: PALPITATIONS (non-serious), outcome "unknown", described as "Heart palpitations in the night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Neurocardiogenic syncope, history of femoral hernia repair, MVP, bursitis RT shoulder, history pinched nerve in neck, Femoral hernia repair, bursitis right shoulder, Pinched nerve in neck, Allergies to medications and foods include Sulfa, squid and octopus. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE), ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10). On 29Mar2021 07:00, the patient experienced had a partial day of feeling unbalanced, felt dizzy a couple of times; i didnt fall but walked with arm around husband and his around me for a while and lightheaded. It was reported that night of vaccine on a walk, felt dizzy a couple of times. In a way I havent felt before. I didnt fall but walked with arm around husband and his around me for a while. A week after shot, had a partial day of feeling unbalanced, lightheaded. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of all events were unknown. No follow-up attempts are needed. No further information is expected.
pt recv vax; 30apr96 pt vaccinated w/ varicella vax; pt exp rash w/ 20-30 lesions w/ thin walled watery blister on upper back,neck,behind ears and both armpits and low low grade fever;  no further details provided;
No additional AE reported; administered expired dose of M-M-R II.; This spontaneous report was received from a medical director referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.   On 04-FEB-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength and route were not provided; lot# was R030806 and expiration date was not provided but upon internal validation as 24-OCT-2020) for prophylaxis (expired product administered). No additional adverse event (AE) reported.  This is one of two reports received from same reporter.; Sender's Comments:  US-009507513-2102USA003583:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Ischemic Stroke" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID-19 Treatment; (19Jul2022) Negative, notes: Tested negative 3 days after finished paxlovid; (23Jul2022) Positive, notes: Test positive 7 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not receive any medications within two weeks. Anti viral details: Product COVID 19 Treatment, brand Paxlovid, Treatment start date 12Jul2022, Treatment stop date 16Jul2022. Adverse event: Rebound Covid after taking paxlovid. Tested negative 3 days after finished paxlovid. Test positive 7 days later.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
There was swelling at the top of the shoulder/it was a different kind of swelling; Ended up getting COVID arm about 8 days later/there was a red bulls eye rash; Had a stinging sensation at the skin level, when the vaccine was being administered; The liquid that was going in felt very cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS, SWELLING, VACCINATION SITE RASH and VACCINATION SITE PAIN in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE COLDNESS and VACCINATION SITE PAIN. On 16-Mar-2021, the patient experienced SWELLING and VACCINATION SITE RASH. On 20-Mar-2021, SWELLING and VACCINATION SITE RASH had resolved. At the time of the report, VACCINATION SITE COLDNESS and VACCINATION SITE PAIN outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Approached by vaccination staff reporting that a patient who had just received the Moderna COVID-19 vaccination was not feeling well at approximately 1:45 pm.  Upon assessment, patient complained of itching all over her body, chest/throat tightness and difficulty swallowing.  Called nurse to the scene to assess vital signs and patient continued to complain of above symptoms.  Administered (1) epinephrine pen (0.3 mg) to patient's right thigh at 1:50 pm as 9-1-1 was called per protocol.  EMS arrived and provided emergency care.  Patient was transported to local ER at 2:00 pm.
Side effect; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (Side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    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 ADVERSE EVENT (Side effect). At the time of the report, ADVERSE EVENT (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication of the patient was not provided. Concomitant medication of the patient was not provided.
On 03/15/2021 1st dose of Moderna vaccine was administered to patient and was observed for 20 minutes. Patient said she was feeling fine with no reactions and was given permission to leave. Patient returned to office 5 minutes later and stated that her throat started  itching and had mild shortness of breath. Patient was immediately checked by PCP and was administered 50mg of Benadryl IM. Patient responded very well to Benadryl and symptoms started to clear up right away. Patient was monitored for 25 minutes before being released from doctor's office.. I followed up with patient this morning (03/16/2021) and per patient, all symptoms had cleared and was doing very well.
(L) deltoid 110 x 110mm (L)upper arm red, swollen & hot to touch.