chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized weakness, palpitations and syncope on 02/06/17. Presented to the ED with same. Admitted to rule out cardiac etiology and started on Clindamycin for cellulitis of left upper extremity.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PATIENT SAYS SHE HAS BEEN EXPERIENCING SORENESS IN RIGHT ARM THAT HAS NOT GONE AWAY SINCE RECIEVING VACCINE
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 09-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient stopped by the pharmacy today (12-7-17) to report on-going arm pain after receiving her seasonal flu shot. She stated that her arm was "very sore" at the site of injection, and that she had "shooting pains" that ran down her arm into her fingers as well. Based on the information she provided, it was implied the symptoms evolved into the shooting arm pain (not sure of the time frame) but the injection site soreness was from time of vaccination (as explained and expected) through today. I immediately suggested a visit to her physician for an examination of the affected arm, as it had been 3 weeks since her vaccination. I also explained that the vaccination does go into the muscle tissue and there is no way of knowing if a vessel or nerve will be hit during vaccination. I again suggested a visit to her physician to ensure there was not something else going on, and informed her I would document the reaction in her profile as well as submit a VAERS report of the incident.
Extreme fatigue late into day 2, day 3 severe nausea, brain fog and muscle aches.
Information has been received from a nurse practitioner concerning a 20 year old female who on 31-AUG-2007 was vaccinated with a second dose of GARDASIL. One or two days after vaccination, the patient experienced peeling feet. Medical attention was sought. The patient's peeling feet persisted. No product quality complaint was involved. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever,  swollen axillary lymph nodes Narrative:  fatigue, body aches
This spontaneous report was received from a registered nurse via medical assistant and refers to a 14-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 29-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
Dull pain and ache in arm receiving  second moderna vaccination going on over 1 year.  Received booster shot of moderna in October 2021 in other arm with no adverse effect
On Friday, November 12, 2021 client came to ECC vaccination POD for a Covid-19 Pfizer booster dose. Client received her first dose of Astrazeneca on July, 2021. During assessment questions, client denied any allergic reaction to previous vaccines and no chronic medical history. Astrazeneca is an approved vaccine. Submitted medical consult via text to Vaccine Operations Lead who confirmed for client to receive Pfizer booster dose with 30 minute observation. Client received her Covid-19 Pfizer (LOT #: FF8839) at approximately 12:16 PM in her left arm. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 12:35 AM.
Parent reported that their baby had a fever for about a week; This non-serious spontaneous safety report, with reference number 02250753, was received by a partner on 20-SEP-2022 and forwarded on 21-Sep-2022, from a Health Professional via employee.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Parent reported that their baby had a fever for about a week".  No further information is expected.
Approx 5 minutes after receiving the vaccine, the patient became pale and sleepy. she did not lose consciousness. 6:10 pm  BP 80/60, P 72. She rested with her parents and about 10 minutes later she was feeling better, more alert and less sleepy. 6:20 pm BP 80/60, P 72. No change in vitals but she felt better and her color improved. Mother stated she hadn't eaten recently and this has happened in the past when she doesn't eat. It also happens when she has blood drawn. 6:25 patient fully recovered, was fully alert and oriented and left with parents. She was advised to follow up with doctor.
I developed soreness on my clavicle and had lumps starting 02/22/2021 which worsened over time into larger and more numerous lumps (assumed it was a chain of lymph nodes). When I noticed it was persistent and more swollen/sore, I went to my doctor (03/06/2021)  and was diagnosed with Chronic Fatigue Syndrome and Acute Lymphadenitis. An ultrasound was ordered and done the next week and an x-ray was done (which was negative) on the second visit (unsure of date). I did not have to follow up more after that.
-Neck swelled - patchy bump under chin - gave 2 Benadryl she called her primary care MD.
Side effects started at the 6 hour mark. numbness (with "pins and needles" sensation) in both arms up to elbows, fever of 103.7F, vertigo, dizziness, difficulty breathing, chest heaviness, elevated blood pressure 130/90, elevated pulse. Severe chills and a sensation of skin being on fire. I treated with benadryl, tylenol, and ibuprophen. Day 2 fever continued at 101.0, mental fog, dizziness, severe headache, fatigue, severe hot flashes and intemittent numbness in bilateral fingertips. I treated with tylenol. I also started menstrating 2 weeks early exactly 24 hours after injection. Day 3 I had diarrhea and headaches, fatigue, hot flashes.
Initial report was received from health professional on 06 October 2011. A 25-year-old female patient had received a FLUZONE intramuscular injection in left deltoid, lot number UH454AA on 19 September 2011. On the same day, shortly after the injection the patient experienced numbness, stiffness and pain at the left deltoid. Her symptoms worsened during the night; however her symptoms has not improved or worsened since the injection was given. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
No adverse reaction noted/reported.  Patient was given Tdap; was to get Dtap.
Headache  going on 6 weeks and no sign it ceasing, lethargic/no energy, libido and sexual function gone, joint and muscle weakness, thyroiditis, difficulty swallowing,
Dizziness, Headache, Myalgia, loose stool Narrative:  flu like symptoms causing employee to  miss one day of work
Patient received vaccine and was fine then transitioned to another chair, after a couple of minutes he passed out in the chair, his wife was able to shake him and he came back after a minute. The patient stated that he usually passes out after all vaccines due to a severe fear of needles. After he came to it he stated he felt fine. We provided the patient with water and an ice pack to place on the back of this neck. He stayed at pharmacy for additional 15 minutes and when he left he felt fine and his wife was going to be with him for the rest of the day.
2 days after DTaP shot, site of injection became red, itchy. No fever, pain, limp, shortness of breath, PE 14.5 x 11 cm red, hot, flat non-indurated. Not tender area left anterior thigh. Lung clear.
Patient reported redness, swelling, inflammation and pain around injection site. She stated this also happened with her first Varivax injection as well. She had been given an antibiotic for cellulitus after her first Varivax injection because the correlation with the injection site reaction was not made at that time by another provider.
developed two watery like blisters in the palm of Right hand; This is a spontaneous report from a contactable consumer(patient). A 66-years-old non pregnant female patient received bnt162b2 (COVID 19, Formulation: solution for injection), dose 2 via an unspecified route of administration in Arm Right on 22Feb2021 at 15:45 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine received bnt162b2 (COVID 19, Lot number= EL9264), dose 1 via an unspecified route of administration in Arm Right on 29Jan2021 at 11:45 AM, hypertension from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; hctz taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. There was no COVID prior vaccination and no COVID tested post vaccination. On 23Feb2021 at 17:00, The patient experienced developed two watery like blisters in the palm of right hand. The event was considered as non-serious. The outcome of the event was reported as Not recovered.  No follow up attempts are needed. No further information is expected.
Adverse event was lower heart rate at around 61 at rest. Normal at rest rate is approximately 75. Normal rate while walking is around 110.  Previously had 200 rate lasting 60 minutes in November. Adverse event was 4/1/21 and 4/2/21. Slight swooning feeling, uncomfortable feeling, difficulty finding pulse.
Patient admitted with COVID-19 breakthrough case. Sent for possible dehydration, N/V. Complaining of dry throat. No SOB. On Room air.
Pfizer-BioNTech COVID-19 Vaccine EUA: admitted for pneumonia and COVID-19 infection. Received antibiotics and steroids and discharged to home medically stable.
Noticed blood in urin 3 days after injection. Kept seeing color in varying degrees for about 12 hours after first discovery.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (rHA) lot # M025607, expiration date 18-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Celsius for 8 hours and 26 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA002146.
Information has been received from a pharmacist concerning her 21 year old daughter with polycystic ovarian syndrome and no known allergies who in March 2009, was vaccinated with the third dose of GARDASIL (lot number not reported). Concomitant therapy included DESOGEN. It was reported that the patient has started having severe food allergy reactions to foods that in the past she could eat with no problem after the vaccination in March of 2009. These food reactions started as rash reactions, but have become anaphylactic reactions in recent episodes. The pharmacist stated that her daughter has been in the emergency room three times in the past month. EPIPEN and oxygen were used. The patient was not admitted. At the time of the report, the patient had not recovered. The rash and anaphylactic reactions were considered to be disabling, life threatening and other medical events by the reporter. Follow-up information has been received from a registered nurse at whose office the patient received her doses of GARDASIL. On 10-SEP-2007 the patient was vaccinated with the first dose of GARDASIL (lot number unspecified) on 16-NOV-2007 the patient was vaccinated with the Second dose of GARDASIL (lot number 655154/1210U), on 08-MAY-2009 (previously reported as in March 2009) the patient was vaccinated with the third dose of GARDASIL (lot number 661953/1130X). The patient did not receive any concomitant vaccinations when GARDASIL doses was administered. The patient was taking birth control pills LOESTRIN 24. The R.N. stated that the patient had not seen in the office since 08-MAY-2009. Additional information has been requested.
Pt devel fever to 103 same day as vax; 48 hrs later presented w/blue color, t102.9, shaking extremities, awake, not seizing, poor perfusion of extremities; pt tx APAP; fluid bolus, sepsis w/u, IV ATB;
Shingles, stiff sore neck, swollen lips, a sore inside his mouth.
Confirmed Breakthrough Case  COVID-19 (Moderna) 1  04/01/2021 Moderna 047A21A   COVID-19 (Moderna) 2  04/29/2021 Moderna 048B21A   COVID-19 (Moderna) 3 8 10/29/2021 Moderna 005C21A   COVID-19 (Moderna) 4  06/24/2022 Moderna 037A22B
Developed Shingles 1-2 weeks after 2nd dose. Began with painful sciata-like symptoms on right side of body. Approx 1 week later developed relatively minor rash sites on right thigh and buttock. Cleared up after 2-3 weeks. Was not seen. Self-diagnosed. Only made connection to vax administration after seeing an article citing Shingles as a rare side effect to the Moderna vaccine.
Rash (red and puritic) on right side of neck/chest Immediately took Benadryl Rash resolved within 8 hours
Information has been received from a consumer concerning her friend's child who was vaccinated with MMR II.  After the vaccination the patient was diagnosed with autism.  The reporter would not provide further information.  Upon internal review, the patient's autism was considered to be an other important medical event.
cough sometimes feels like a "gerd cough"; Prolonged Cough/Dry Cough; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), since 01May2020. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER: UNKNOWN, ), for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset 2021, outcome "unknown", described as "Prolonged Cough/Dry Cough"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "cough sometimes feels like a "gerd cough"". The action taken for tofacitinib citrate was unknown. Therapeutic measures were not taken as a result of cough, gastrooesophageal reflux disease.  Additional information: Patient reports adverse event of prolonged cough. Symptoms include: dry cough since Oct2021/Nov2021. Patient unsure if it was due to COVID booster that he got. Patient had spoken with his doctor and has an appointment later this week. 3 months ago patient was on z-pack from the cough as he had yellow mucus as an additional symptom from the cough. Patient stated cough sometimes feels like a "gerd cough". Patient had not tried any OTC meds for relief.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
had administered an expired MENACTRA with no reported adverse event; Initial information received on 22-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11-year-old male patient who had administered an expired menactra with no reported adverse event while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) and HPV vaccine VLP RL1 9V (Yeast) (Gardasil 9) both for Prophylactic vaccination.  On 21-Apr-2022, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine lot U6921AA, expiry date: 17-Apr-2022 with unknown formulation, strength via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed non-serious had administered an expired menactra with no reported adverse event (expired product administered) (latency same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.  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 the guidelines. 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.
Swollen and Induration first noted on 7/17/04 given on right deltoid IM. Reaction was documented by Dr.
Presented with SOB; Acute on chronic respiratory failure --Multi-factorial i.e possible healthcare acquired pneumonia in addition to  COVID Positive and advanced COPD; Rec'd IV steroids, Singulair, vitamin C, Pepcid, zinc sulfate, Remdesiver; tocilizumab, merrem, vanc; Supplemental O2 via CPAP/BIPAP/HFO2; pt failed to improve and decided on hospice
Patient complained of nausea after receiving GARDASIL vaccine. She complained of blurry vision, back aches, tingling sensation in body and throat pain. Patient given oxygen via face mask. Patient vital signs stable alert and no loss of consciousness patient monitored on exam table and alert and oriented, blood pressure, HR and oxygen stable and sent for EKG.
pt had exam a/immun & had a sl URI, & was cranky & was crying inconsolably; 3 dasy later mom brought pt back ot MD because of little swelling & redness @ the inject site & the pt exp periods of inconsolable crying;
mom called ofc late Tuesday evening & reported redness around the site of inj;advised to bring pt in to let MD assess it;MD noted a reddish flare 3 inches in diameter on thigh;pt c/o being hot & it was sl swollen;
1) Caught Covid 19 just about 9 days after receiving first dose of vaccine 2) Was treated for Superficial Vein Thrombosis that was first manifested on August 31, 2021. No previous history of blood clots.
Patient presented to the ED and subsequently hospitalized on 2/18/2021 with fever. Again she presented to the ED and subsequently hospitalized on 2/24/2021 with hypoxia. These visits were within 6 weeks of receiving COVID vaccination.
My menstrual cycle became irregular for the first time ever in my life. It has remained irregular ever since the second does, with some shorter cycles and some longer cycles.
IM given in left arm 3rd dose. Moderna COVID-19 vaccine Lot 045C21A given was removed from freezer on 10/6/2021 at 11:45 am. Given on 11/5/2021, out of range. Patient contacted that evening.  Moderna manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/17/2021 and let him know that Moderna let us know the vaccine was viable, no additional booster vaccine is required.
stomach upset, body aches, possibly small fever (temperature not taken but patient reports feeling warm) x 24 hours post vaccine
14 YOM pt accompanied by father with c/o localized pruritic vesicular rash on back x 1 day. Pt reports rash started 1 hr after influenza vaccine was given. Pt denies any other symptoms. Pt will be treated with acyclovir PO for possible shingles and triamcinolone topical cream. Pt to f/u with his PCP upon return and ER recommendations given. Pt and parent verbalized understanding.
worsened ability to think; Lightheadedness; blood pressure fluctuating between 150/90 to 224/147; electrical shocking; pain; muscle spasm; new non migraine headaches; This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache. On an unknown date, the outcome of the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache were not recovered/not resolved.   It was unknown if the reporter considered the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache to be related to Shingrix.     Additional Information: Additional Information: GSK receipt date: 16-SEP-2022 Reporters comment: This case was reported by a consumer. The patient receive shingrix vaccine and experienced Lightheadedness, blood pressure fluctuating between 150/90 to 224/147, worsened ability to think, electrical shocking, pain, muscle spasm, new non migraine headaches. The patient reported that he/she was on day three of severe reaction and it did not match extremely limited list of symptoms. The patient wish he/she had the shingles back. The follow up information received on same day and updated the patient initial and contact details