chrisvoncsefalvay/vaers-outcomes huggingface dataset:
?Covid arm?. Slight swelling and mottled rash. that I noticed about 3  or 4 days after the injection. Very little itching; moderate soreness.  It has lasted about a week and is still visible though very faint.
Daughter had breakout of huge hives all over with a temperature of 99F to 100F. Friday morning, 10/20/00 at 08:00, face, neck, back, legs, feet, between eyelash and eyebrow, stomach, private area and hands, etc. Dr on call, prescribed Benadryl. Daughter was finally clear of hives Sunday night or Monday morning. She had red blotches on back also; very uncomfortable and fussy, miserable and kicking legs.
This spontaneous report as received from a nurse refers to a 28 unspecified patients of unknown age and unknown gender. The 28 unspecified patients pertinent medical history was not reported. The 28 unspecified patients were received doses from an expired lot of M-M-R II (Dose/Frequency: 0.5ml) (lot # H011885, expiry date: 25-JUN-2014) subcutaneously between 01-JUL-2014 to 09-AUG-2014. No adverse effect was reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 11-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
he tested 21Feb2022 + positive home AG; he tested 21Feb2022 + positive home AG; then sx Sunday 20Feb2022 of mild congestion; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Feb2022, outcome "unknown" and all described as "he tested 21Feb2022 + positive home AG"; NASAL CONGESTION (non-serious) with onset 20Feb2022, outcome "unknown", described as "then sx Sunday 20Feb2022 of mild congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (21Feb2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasal congestion. Clinical information: It was unknown if the patient was tested for covid prior to vaccination and patient was tested Covid post vaccination. It was unknown if other vaccine were taken in four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Severe local rxn, swelling shoulder to elbow at 48 hrs, resolved 96 hrs (RA). Erythema multiforme rash at 6 days. Abdomen and legs.
swelling in eyes, throat-entire body & limbs, fever until 2 days p/med;hives over entire body-lasting 2wk;severe itching entire body-2wk;prescribed Pred, Hydroxyzine, Cephalexin x 10 days;
Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, DIARRHOEA (Diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
mild fever, chills. body aches, fatigue, joint soreness. started approx. 12-16 hrs after shot and continued another 24 -36 hrs.
Pt reported to HD on 05/04/05 that he had been itching all over his body. States he had a rash appear 3 days after injection of MMR and Td were given on 04/18/05. Stated rash lasted x 1 week and went away but began to itch. Pt states at time of reporting itching to RN that is was worse than ever. RN referred Pt to MD or to ER. Pt went to ER 05/04/05. Eval at ER. Doing better but still itching per follow up denied itching at injection site 05/05/05. Pt stated that ER MD was usure as to what the cause was. Possibly immunizations.
Present to doctor on 5/5/03 with 1.5 x 2 cm induration with 5 mm scab over it. MD's Tx was po Benadryl with neosporin ointment to area. Pediatric clinic notified us to fill VAERS sheet.
Information has been received from a physician concerning a female who was vaccinated IM with the first dose of GARDASIL (lot# not reported).  2 days post vaccination the patient experienced a localized rash at the injection site.  The patient sought unspecified medical attention.  Additional information has been requested.
Difficulty walking; Pneumonia, influenza, general malaise & fatigue, high fever, elevated WBC hands & feet numbness, stomach cramps.
felt so dizzy; spent 24 hours in bed; tongue did feel itchy and tingling, but that went away after a few minutes; tongue did feel itchy and tingling, but that went away after a few minutes; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE PRURITUS (tongue did feel itchy and tingling, but that went away after a few minutes), PARAESTHESIA ORAL (tongue did feel itchy and tingling, but that went away after a few minutes), DIZZINESS (felt so dizzy) and BED REST (spent 24 hours in bed) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced TONGUE PRURITUS (tongue did feel itchy and tingling, but that went away after a few minutes) and PARAESTHESIA ORAL (tongue did feel itchy and tingling, but that went away after a few minutes). On 22-Mar-2021, the patient experienced DIZZINESS (felt so dizzy) and BED REST (spent 24 hours in bed). The patient was treated with Bed rest for Dizziness. On 20-Mar-2021, TONGUE PRURITUS (tongue did feel itchy and tingling, but that went away after a few minutes) and PARAESTHESIA ORAL (tongue did feel itchy and tingling, but that went away after a few minutes) had resolved. On 23-Mar-2021, DIZZINESS (felt so dizzy) and BED REST (spent 24 hours in bed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment info was provided. No concomitant medications were given.
Chills, hands and feet freezing while remaining part of body with tingling and hot like a painful sunburn , usually late evening , no energy, horrible headache with inability to concentrate.   Brainfog frequently.
INTRANASAL DOSE OF H1N1 GIVEN AT SCHOOL 11-16-09 WAS GIVEN 1ST DOSE OF INACTIVE H1N1 IN OUR OFFICE 11-10-09
Anaphylaxis  (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine. Because patient has a history of anaphylaxis, she was able to treat it by giving herself epinephrine, oral antihistamines, and nebulizer treatment with levalbuterol every few hours for the next 3 days. She recovered and did not report this until  5/12/21.
08/30/2021 10/08/2021 dx with covid 01/04/2022
pt recv vax JUL95 & in FEB96 pt exp muscle weakness in rt arm;pt was seen by neurologist;exam was unremarkable;no further details were provided;
This spontaneous report was received from a pharmacist via a company representative referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot No. not provided) and a dose of PNEUMOVAX 23 (Lot No. M018766; expiration date: unspecified) in separate arms (Start date, and dose were not provided). The pharmacist reported that on an unknown date after the patient received both vaccines developed injection site swelling at the ZOSTAVAX injection site. At the time of reporting, the outcome of injection site swelling was unknown. There was no product quality complaint involved. Additional information has been requested.
Patient experienced "hot poker" feeling on top of her head, on her leg, and 1 or 2 other places.  Lasted about 2 hours.  Developed red spot over place on leg where had this sensation.  Injection site became fiery red, itchy and swollen the next day.  Also had flu like symptoms.  Took antihistamine and applied hydocortisone cream with relief.
I had fever, chills, achy bones, headache. The next time I got my lab work done. My kidney level was only working at 4% when it usually is working at 26%. My thyroid quit working totally. My medicine quit working also. My kidney started spilling out protein and uric acid, blood, and sugar. I got more depressed and more anxiety. I also was fatigued as well.
child suddenly got pale & non responsive for several minutes;called 911 when arrived pt was OK;
Patients right arm, which is whare PNEUMOVAX 23 was adminstered, swelledm turned red and was painful. Pt also had difficulty moving this arm.
Numb tongue More flushed than normal skin Allegra administered 0836, vitals obtained. BP 138/86, SPO2 96%, P 55. At 0856 patient complained of increased numbness of tongue, vitals signs BP 153/83, SPO2 100%, P 71. Patient remained in no acute distress, no angioedema noted, patient remains without respiratory distress. Patient advised to report to closest Emergency Room.  Patient agreed, patient accompanied by wife.
Narrative: She developed a non-pruritic rash a/w headache and fatigue after the first vaccination. The rash was described as more pink than erythematous and was localized to the anterior portion of her deltoid/axillary area of the vaccination arm (left) It started 2 days after vaccination and lasted for about 2-3 days prior to spontaneously resolving. It was described as indurated and unknown if warm to touch. There were no other reported common adverse effects other than HA and fatigue (which also resolved w/o intervention), including peeling/sloughing.
Acute ischemic CVA involving left cerebellum, brainstem, thalamus, and left posterior circulation eventually leading to multiorgan failure and death
LOSS OF APPETITE; HOARSENESS OF VOICE; COUGH; HEADACHE; SLEEPINESS; TIREDNESS, FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sleepiness. On 12-MAR-2021, the subject experienced tiredness, fatigue. On 14-MAR-2021, the subject experienced loss of appetite. On 14-MAR-2021, the subject experienced hoarseness of voice. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, loss of appetite, cough, and headache on 15-MAR-2021, and was recovering from tiredness, fatigue, and hoarseness of voice. This report was non-serious.
Patient Complained of brain fog - trouble thinking. also some pressure in sinus area?  says its getting better but persisting - i reccomenede she contact her dr when she told us this upon getting seconf Moderna shot.
This case involves a 78 years old male patient whom administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was left in the box (product storage error). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2021, the patient received a dose of suspect ADACEL (0.5 ml, total, lot U7187AA expiration date: 28-SEP-2023) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to incorrect product storage (same day latency). It was reported "Caller would like to know how ADACEL is suppose to look before you shake it. Caller stated that he notice a cloudy white appearance. Caller stated that the ADACEL was brought out of the fridge and he noticed a white, cloudy, clumped particulate at the bottom of the vial prior to shaking it. The caller had never seen the medication sediment. The solution became a homogenous liquid after it was shaken. The remaining supply of ADACEL all looked similar with the same white, cloudy, clumped particulate. Caller would like to know whether these ADACEL vials are suitable for use?" No adverse event 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 the 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.
Patient said she had a FLUZONE on October 14th.  Patient said she had normal achiness for the first day or two following the injection. She has had many years of flu shots and has never experienced a problem with them. After initial achiness of this past dose on 10/14, she began experiencing increasing pain. She has difficulty sleeping; putting clothing on the site; and moving her arm. She denies redness; swelling; warmth; and fever. I advised her to contact her primary care physician and to call us with the outcome.
"covid arm" - A rash developed at the injection site one week after the shot. Redness, inflammation, itchiness, mild discomfort
Narrative: COVID infections following completion of COVID vaccine series 02/24/21 COVID vaccine dose #1 03/17/21 COVID vaccine dose #2 07/28/21 Pt presents to ED reporting body aches, sore throat, fever, chills, burning sensation while voiding, constipation x4 days; CXR mild pulmonary edema, increased opacities over right lung base; troponin negative; admitted to SDU; COVID POSITIVE 07/29/21 Pt reports feeling better; being treated for acute hypoxic respiratory failure - remdesivir, dexamethasone, zinc, ascorbic acid, vitamin 07/30/21 Pt had temp 101 in the AM; mobile 07/31/21 Pt reports feeling much better than yesterday, walking in room; had low BP last night w/o CP or SOB 08/01/21 Pt discharged home with rx for ascorbic acid, cholecalciferol, dexamethasone, zinc 08/04/21 Pt reports productive cough, mild muscle pain and sore throat, resolved chills and diarrhea 08/06/21 Per wife, pt is feeling better overall and is afebrile 08/08/21 Pt meets CDC guidelines for end of isolation
Fever of 101, chills, body aches and headaches.  Fever and chills lasted about 8 hours and the aches for about 16.
p/vax pt feverish & achy, swelling & lump on rt arm, heat radiating from arm applied hot & cold doing better but not yet recovered;
Onset of congestion, sneezing, runny nose, body aches, loss of energy/concentration, headache, post nasal drip, occasional cough
Pt left arm - subcutaneous area began swelling after the injection and continued to increase in diameter over past 2-3 days. No 15cmx15cm slightly raised, warm and tender
Vaccine (Pfizer Covid 19) was given to the patient who is 15 years and 5 months (under 16). The vaccine was given by a national guard. Nurse called and talked to his mom the next day, and she said she thought the vaccine got approval from 12 years old and up. There was no adverse reactions.
PNEUMOVAX 8/17/09 developed high fever that night with shaking chills vomiting the next day right arm was also very red and sore left arm fine. Fever lasted 4 days Low grade on 8/20/09.
Was given the Pfizer Biopntech COVID 19 EUA, 1st dose. A few minutes after the shot I started feeling very very dizzy, and a strong pain down my legs. Could not hold myself up.  The EMTs there gave me a wheel chair and took vitals.  I felt very weak all the time, like I was going to collapse. and  I was breathing heavily. Good news is that my vitals stayed within normal range., and nothing more severe happened (my doctor had said to bring my Epipen, just in case). After about a half hour, I was getting weaker, and the dizziness had not subsided, so they called an ambulance and transported me to the Hospital.  The  dizziness started to subside after another hour or so.  They dismissed me after I was able to walk  and was not in danger of falling.
At 1:30 2nd day after the first shot I experienced an ocular migraine - seeing zig zag lines in my right eye. I never get head aches of any kind or have ever had eyesight issues. It was very sudden.  Have not gone to a doctor yet. I?m waiting to see if it gets better on its own
HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB  WAS TOLD TO TAKE BENADRYL 50MGS STAT AND IF WORSENS WILL GO TO  ER
expired product was given; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves male patient of unknown age who received an expired dose of Expired product administered] QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] 0.5 ml via intramuscular route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired product administered.  Description: Nurse noticed expired product was given. Was dated June 2019. Stated product was pulled out of box for the 2019-2020 season. Other doses stated 2020 expiration and this dose was 2019. The nurse re-immunized the patient with a non-expired dose.  At the time of report, no adverse event was reported.  Information on the batch number was requested.  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.
Patient received 2 mon. vaccines on Feb 8, 2022 and Feb. 24 2022. NO Adverse event/No treatment needed
fever, red/swollen/painful injection site got tetanus booster on 4/16/19 and developed fever the next day; had continued fevers for the following few days and a red/swollen/painful injection site; continues to take ibuprofen and tylenol to keep pain and fever down.
pt recv vax 12AUG98 & pt presented to office 25AUG98 w/ c/o sensation of warm/pain behind calves/legs & occasionally posterior neck;exam unremarkable;
administered to patients after excursion occured; This spontaneous report was received from a nursing assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 07-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # T002846, expiration date 23-JAN-2022 (exact dose, strength, route of administration and anatomical location were not reported) for prophylaxis. the data logger registered, that the vaccine was stored at the temperature of -10.2 degree Celsius (C) for 1 hour and 53 minutes. There was no previous temperature excursion.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000132: US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014697: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2009USA000112:
Pt states she was fune until 12/29/07 when she developed a headache and flu-like symptoms and nausea.  She states there was a quarter sized lump, then on 12/30/07 it was worse--silver dollar sized.  By 1/1/08, she states that the lump was the size of a baseball.  Symptoms are resolving now, lump is quarter sized.  Pt is taking benadryl and ibuprofen and states she starts itching when she is not on the benadryl.
Patient felt very cold on the inside, teeth chattering. Patient went to bed and her muscles were contracting and relaxing on and off. When she would lie on her left side her right arm moved involuntarily and when she rolled over and lied on her right side her left arm would move involuntarily. Her hands felt like they were burning. The episode lasted about an hour. She took an ADVIL and went to bed. She awoke fine and symptom free the following morning.
day p/vax pt arm became very red, painful, swollen, warm, pt had low grade fever, nausea, headache. use ice pack, hydrocortisone cream, tylenol.
less than 24 hours after getting shot #1 i felt as if i was coming down with a cold, very congested, stuffy nose, slight sore throat probably from drainage. injection site pain which is normal, but i just felt under the weather. it cleared up within 48 hours of time of injection.
Left arm redness, edema, tenderness beginning morning after flu shot. Admitted to hospital on 11/8/03 for 48 hours for cellulitis IV therapy.
1st dose of Shingrix on 02Feb2018 / 2nd dose on 11Sep2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2SP, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd February 2018).   On 11th September 2021, the patient received the 2nd dose of Shingrix. On 11th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. No symptoms reported.
11/21/22 presents to EC ED for "fever, chills". PMHx of "breast cancer s/p bilateral mastectomy"