chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose 08 Mar and second dose was on 04-may-2021; flu like symptoms; swelling in left armpit; sore injection site; red swollen sore injection site; red at injection site/the front part of arm has big red mark; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 08 Mar and second dose was on 04-may-2021), TENDERNESS (Tenderness), INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (swelling in left armpit) and VACCINATION SITE PAIN (sore injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 047A21A and 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 08 Mar and second dose was on 04-may-2021). In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). In 2021, the patient experienced TENDERNESS (Tenderness), SWELLING (swelling in left armpit), VACCINATION SITE PAIN (sore injection site), VACCINATION SITE SWELLING (red swollen sore injection site) and VACCINATION SITE ERYTHEMA (red at injection site/the front part of arm has big red mark). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 08 Mar and second dose was on 04-may-2021) had resolved. At the time of the report, TENDERNESS (Tenderness), SWELLING (swelling in left armpit), VACCINATION SITE PAIN (sore injection site), VACCINATION SITE SWELLING (red swollen sore injection site) and VACCINATION SITE ERYTHEMA (red at injection site/the front part of arm has big red mark) had not resolved and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reports experiencing tenderness and swelling in her left armpit, red swollen and sore injection site. The patient also mentioned that the front part of her arm has a big red mark, and after the second dose she experienced flu like symptoms. The symptoms are ongoing. No treatment information was provided.
Swollen lymph node above left collarbone (presumably on the same side as shot was administered).
In the middle of the night woke up with body aches. Pain in my knees which I never had for 1 week ago. Saw Dr. 01/19/2022  prescribed Naproxen which was taken for two weeks.
approx 24-36hr post vax exp rash on lower arms & legs;pt stated they were red raised bumps caused itching;no other sx devel;rash lasted approx 2 days;
This spontaneous report was received from a 80 year old female patient, reporting on herself. The patient's current conditions included osteoporosis and cholesterol. The patient did not had drug reactions and allergies. Concomitant medications included atorvastatin calcium, alendronate sodium(manufacturer unknown) and penicillin. On 29-NOV-2016, the patient was vaccinated with ZOSTAVAX dose reported as 1 vaccination and route of administration reported as "vaccination"(lot # and expiration date were not provided, for prophylaxis.  Other suspect therapies included PNEUMOVAX23. Administered at the same time(product use issue).The vaccines were given in different arms. On 01-DEC-2016 (also reported as 2 days), after getting the shingles vaccination the patient came down with shingles. She said that she had experienced a burning sensation tingling on the right thigh are that spread to the "crotch area hip and butt-ox cheek are. The patient sought medical attention and was given an unspecified treatment. At the time of this report the outcome of the event was not reported. The reporter did not assessed the relationship between the event and ZOSTAVAX and PNEUMOVAX23.  Additional information has been requested.
NO AE REPORTED, HOWEVER, VACCINE WAS GIVEN IM INSTEAD OF SQ
pt recvd vax & exp dime sized knot (inj site);lump dec over 1 month is now gone; seen by MD @ ER;tx warm compresses;swelling, redness & warmth (inj site);2wks post vax devel hives, swollen face & pox on hands & arms w/itching;
This spontaneous report as received from a registered nurse refers to an adolescent patient of unknown age. The patient was inadvertently vaccinated with a second dose of RECOMBIVAX HB (Lot # not reported) 7 days too early than recommended scheduled due date in series at an unspecified time. No adverse effect was reported. Additional information is not expected.
Severe chills for four hours then they broke, required two heating pads on high to warm up for four hours, severe pains in every joint and entire body, shortness of breath, stayed in bed and slept all day the next day October 22 because of exhaustion, could only walk to the bathroom and back to bed, then I felt much better on 10/23/21 and was back to normal on 10/24/21.
patient began to have left sided chest pain  which radiated to left arm.  stated sharp pain but also belt like pressure. does not have history of similar chest pain.  he also described dizziness and SOB, but additional questioning suggests this is his baseline.  12 lead showed  a fib.  patient denies history of similar.  patient given ASA and transported to ED for additional work-up for his chest pain
Swelling & redness on Rt arm at deltoid area. No fever. No respiratory distress. Area involved = 4cm x 4cm. Advised MOTRIN & Ice locally to area.
10/30: 2pm - Sinus congestion, headache, runny nose, body ache; 6pm - same as 2pm with fever. 10/31: 7am - sinus congestion, runny nose, cough, headache, body ache; 9am - same as 7am with nausea. Treated on 10/30 at 10pm with Acetaminophen (650mg), Chlorpheniramine maleate 4mg, Dextromethorphan HBr 20mg, Phenylephrine HCl 10mg. Treated on 10/31 at 8am and every 4 hours with Acetaminophen (650mg), Dextromethorphan HBr 20mg, Phenylephrine HCl 10mg.
Called patient's legal guardian, to inform her that the COVID vaccine had been given to patient 5 days before her 15th birthday. Left 2 messages, the legal guardian did not return the phone call. Patient had been asked 2 identifiers (name and date of birth) before vaccine by tech assistance and she thought patient was old enough to have the vaccine. My role was to ask the COVID questions before administrating the vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), on 09Feb2021 as dose 2, single (Lot number: EN9581), on 29Aug2021 as dose 3 (booster), single (Lot number: EW0185) and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetic" (unspecified if ongoing), notes: other medical history: type 1 diabetic. Concomitant medication(s) included: INSULIN; VANCOMYCIN; ELIQUIS; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: After testing positive 13Jul2022; (22Jul2022) Negative, notes: tested negative on 22Jul2022; (27Jul2022) Positive, notes: Testing positive again on 27Jul2022. Therapeutic measures were taken as a result of covid-19. Clinical course included Adverse event: Anti-viral details: product=COVID 19 Treatment. Treatment start date was 13Jul2022, Treatment stop date was 18Jul2022.  If treatment ae: No, known allergies: no, other medical history: type 1 diabetic, after testing positive 13Jul2022 on and taking 5 days of Paxlovid tested negative on 22Jul2022. Tested positive again on 27Jul2022  No follow-up attempts are possible. No further information is expected.
Left thigh 8cm x 7cm red, indurated no fluctuance. Same leg as DTaP.
June 28, 2022 Tuesday - Stuffy nose. Some congestion. Negative Covid home test. Expected it was normal allergies. June 29. Same stuffiness. June 30 Thursday - Coughing lots. Got cough syrup prescription. July 1 Friday - Kenalog shot for allergies. Dr says heart murmur. Bad cough. Friday night. Very bad dry hacking cough & severe sore throat that night. July 2 Saturday. Cough & throat better. Tired. Tested positive on home test. Went to urgent care. Saw provider who suggested referral for monoclonal antibody treatment. July 3 Sunday. Slept til after 12 p.m. Cough & throat like yesterday. Still tired and have stuffy head. Coughing up phlegm. Legs ache below knees. Chest ache. Headache. Feel weak. In bed most of Sat. & Sun. No fever 97.7. July 4. Less cough and throat not as sore. Coughs produce phlegm. Stuffy nose &  head. Slight headache. Muscles at backs of legs ache when I get up. In bedroom. Now joined by lady who tested positive 6/3. July 5. Had lots of coughing @ 5 a.m. Regular cough syrup worked. Cough gone after that. Lots of phlegm and head & chest congestion goop coming loose throughout the day. Hacking and snorting up goop. Headache returned in afternoon. No fever 97.7 again. Periodic pain in left side at mid rib cage level. June 6. Had Covid monoclonal antibody infusion this morning of bebtelovimab at Facility. I have been at a plateau. Not getting better. No side effects that I could Identify. Seemed to tolerate ok. Feeling tired. July 7. I seemed to have a bit more energy today and lady says I'm not coughing as much. Still have a mild headache as the day goes on. A little less congestion today. July 8 - 13 Low energy, loss of appetite, mild headache continue. July 14. Finally started feeling much better. Not all gone but much better.
Deep Vein Thrombosis in left calf.  Pain in leg.  Treating with Eliquis for three months.  Still in treatment but no more pain.
my stomach is upset; my stomach is/bubbly; my stomach is/growling; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2021, the patient received Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced upset stomach, gas in stomach and abdominal noises. On an unknown date, the outcome of the upset stomach, gas in stomach and abdominal noises were unknown.   It was unknown if the reporter considered the upset stomach, gas in stomach and abdominal noises to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix shot on Saturday before the day of reporting and his/her stomach was upset, bubbly and growling. The patient asked could this be a side effect of shot. The follow-up would not possible as no contact details were available
Given vaccines around 3 pm at 4 pm presented to office with severe hives- lip/eye swelling- persistent cough no wheeze no stridor- give Epinephrine 1 :1000 0.16 ml Sa x l Benadryl 15 mg/5ml 1 1/2 tsp. orally- 45 mins later for improvement given Orapred 15 mg/5 ml 1 tsp. orally -sent to ER for monitoring.
Information has been received from a physician's assistant concerning a 26 yr old white male student with no known allergies and a history of asthma as a child who on 27Aug04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 644981/1235M). Concomitant therapy included guaifenesin (Bidex) and albuterol). On approx 28Aug04, within a day or two post vaccination, the pt developed reddened bumps on chest, some with vesicles that were fading at the time of this report. The pt also felt bad and had no fever. Unspecified medical attention was sought. No treatment was required. It was reported that the pt was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  in the past (no specific details could be provided). On 25May04, the pt had a negative titer to mumps. Additional information was received from RN who reported that on 31Aug04, the pt notified the office that during the weekend prior to 31Aug04, he had red bumps from the chest upward. Some of the bumps had vesicles, and some areas were fading. The pt was referred to a physician. The pt subsequently reported that the physician's diagnosis was a coincidental rash that had nothing to do with the vaccine. The pt subsequently recovered from the rash. The nurse also reported that on 23Aug04, the pt had finished therapy with methyl prednisolone (Medrol Dosepak), clarithromycin (Biaxin), and montelukast sodium. No additional information is expected.
a rash, it is like blisters; a rash, it is like blisters; This is a spontaneous report received from a contactable consumer reported for self. This female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 as single dose for covid-19 immunisation. Medical history was none. This week the patient noticed a rash, it is like blisters in Apr2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Diarrhea and trouble sleeping x 24 hours after imm. at 2 mo. No fever. 9-25-2017. 11-13-17 Parents agreed to 4 mo. imms.
vax on 11/3. on 11/6, spiked temp to 104.5, down to 101 same day.  11/7 am temp down to 99.seen on 11/7, normal pe, no focus for any infection
Case previously recorded as MA2009-4034. Initial case report received from a physician via MedCom on 05 NOV 2009. A 34 year-old female patient was vaccinated during pregnancy with 0.5mL of S-OIV FLUVIRIN (batch no. 100738) i.m. on 03 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007596.
excursion where the temperature rose to 49.6F for 12 minutes for IPOL with no reported adverse event; the patient received IPOL post excursion with no reported adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 9 months old female patient and reporter reported excursion where the temperature rose to 49.6 f for 12 minutes for poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] with no reported adverse event and the patient received ipol post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; HIB vaccine conj (tet tox) (ACTHIB) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) for Prophylactic vaccination.  On 04-May-2023, the patient received a dose of 0.5 ml  of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (lot V1A022M, expiry date- 17-FEB-2024) via intramuscular route in the right deltoid for Prophylactic vaccination (Immunisation).  Caller reported, excursion where the temperature rose to 49.6f for 12 minutes for poliomyelitis vaccine (inactivated) IPV (VERO) with no reported adverse event (product storage error) (unknown latency) and the patient received ipol on 04-May-2023 post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, there was an excursion where the temperature rose to 49.6F for 12 minutes. IPOL multidose vaccine was opened and deemed not viable by manufacturer. No adverse reactions were noted.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.; Sender's Comments:  US-SA-2023SA146876: SanofiPVPortal20230524000365: SanofiPVPortal20230524000379:
Narrative: COVID infection following COVID vaccine serious 01/08, Pfizer, dose #1 01/29 Pfizer, dose #2 08/08 pt cc: fever, rhinorrhea, dyspnea exposure: GOLFING PARTNER 08/09 -- 0902 pt symptoms continue 08/16 COVID swab, result: detected 08/16 CXR impression: CHF versus hazy infiltrates most prominent in the LEFT lower lung. Correlate with clinical scenario. Follow-up recommended. 08/16 pt admit to ED, admit to medicine Cc: SOB dx: ACUTE HYPOIX RESPIRATOR FAILURE 2/2 COVID PNEUMONIA LOS: 14 days 08/16 Troponin I result: <0.016 08/16 PROCALCITONIN result <0.11 08/16 ESR result: 26 08/16 BNP Result: 672 08/16 ABG: I-[H 7.42, iPCO2 28.3, i-PO2 62, i-HCO3 18.2 08/16 DDIMER results: 0.97 08/21 ESR result: 24 08/21 Fibrinogen result: 308 08/21 DDIMER result: 30.29 08/23 PT result: 47.1 08/23 INR Result: 4.21 08/23 DDIMER result: 17.82 08/23 FIBRINOGEN result: 245 08/23 ESR Result: 16 08/24 PT result: 38.1 08/24 INR Result: 3.40 08/24 DDIMER Result: 15.52 08/25 PT Result: 25.2 08/25 DIIMER result: 7.59 08/26 PT Result 24.0 08/26 INR Result 2.14 08/26 DDIMER result 14.096
pt recv vax 28OCT94 & 1 to 2 wk later NOV94 devel fever, arthralgia & polyarticular arthritis of feet, knees, elbows & hands; tx Iodine & unspecified anti-inflammatory med;
Zostavax vaccine given SC was mistakenly diluted by nurse with Gardisil vaccine instead of sterile diluent.Given 7/18/2007 at about 2 pm. Patient notified. Has had no problems resulting from this.
Quadracel was given out of age indication/no AE; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional(office staff).  This case involves a patient (unknown demographics) who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] out of age indication (lot number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination(product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to Inappropriate age at vaccine administration.  At the time of report 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 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.  There will be no information available on batch number for this case.
This case was reported by a nurse vial call center representative and described the occurrence of inappropriate age at vaccine administration in a unk patient who received ROTARIX (batch number A41CB403A, expiry date 3rd September 2015). On an unknown date, the patient received ROTARIX. On an unknown time after receiving ROTARIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: A 9 month old was administered ROTARIX. RN did not want to give any further information.
Fever, CoughWheeze, Chills, Fatigue Narrative:  Employee states missed a day of work due to symptoms.
Has new onset generalized fasciulations, migraine headaches and arthralgias since AVA # 5 (States the 1st 2 doses were given in 1991). Is on neurotin which has helped fasciulations to the point that he can now sleep. In on amitriptylene which have diminished migraine headaches to 2/week. Condition has caused abrupt change in lifestyle loss of flight status and ability to exercise. Symptom: Fatigue, Malaise, <60 Days Symptom: Abnormal sleep patterns, NOS Symptom: Headache, Migraine Symptom: Joint Pain, multiple joints Symptom: Tinnitus Symptom: Fasciculation Symptom: Dizziness Symptom; Depression Symptom: Memory loss, short term Has gone to develop autonomic neuropathy with involvement of the bladder, GI tract and CNS. 11/8/07-records received-received Anthrax vaccine #2 and simultaneously prescribed Ciprofloxacin for severe loose stools, while deployed. Resulting impairments and disability are temporally associated with his receipt of anthrax #2 and ciprofloxacin. His physical, mental and emotional impairment profoundly and significantly affect his personal, professional, social and economic status. He has constant pain and dizziness associated with medications for pain. Cognitive testing revealed cognitive functioning with normal limits. His performance tests of muscle strength and fine motor functioning fall in mildly impaired range. DX: cognitive disorder NOS, major depressive disorder, single episode in remission, migraine headaches, chronic fatigue syndrome, joint pain, myofascial pain/fibromyalgia. Tinnitus, nausea, burning sensation in mouth, insomnia NEC, blurred vision, vertigo central origin, lower back pain, TMJ syndrome, bilateral. Fasciculations, muslce spasms, tingling in extremities, dysuria, urinary frequency, osteoporosis, kyphosis, hyperlipdemia, constipation. These signs and symptoms have progressively worsened leading to serious and significant impact on the quality of life with probable permanent disability. Per 60 day follow up: Remains seriously ill & gradually worsening. Has autonomic neuropathy involving multiple body systems. Is 100% disabled.
Stomach became upset roughly 3 hours after the vaccine was administered along with fatigue. The following day I was fine but then had repeats of the symptoms over the weekend and even still today (Monday after the vaccine.)
When i woke up at 6:30 a.m i felt dizzy, light headed and weak. When i went to brush my teeth i felt that i was going to faint and so i sat down. After sitting for 5 minutes in the bathroom i went back to my bedroom to lay down to sleep again. Once i woke up at around 8.a.m i had joint pain  and a strong headache and lower back pain. This entire day i bedridden. The next day i felt great, i had no symptoms.
Lost balance and fell three times. Upon final stumble, while lying on the ground, her right arm and leg stiffened straight out and her left side began convulsing (this lasted for about 10 seconds). I picked her up and noticed her eyes moving somewhat fast from side-to-side (this lasted for about 20 seconds). She DID NOT have a high temperature and she was back to her normal playful self immediately following this adverse event. Took her back to Clinic and we were told to wait and watch if it happened again. Setup appointment with a Neurologist.
Patient felt dizzy and vision went black while checking out from appointment with parent.  Patient was lowered to the ground with feet elevated. Patient was given juice and crackers.