chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dermatographia; This spontaneous case was reported by a patient and describes the occurrence of MECHANICAL URTICARIA (dermatographia) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis.     The patient did not report any medical history or condition. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 1, batch no- EN5318) on 29-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 2, batch no-GV6201) on 21-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 3, batch no-3D1308A) on 31-Aug-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 4, batch no-FK9896) on 13-Feb-2022, PFIZER BIONTECH COVID-19 VACCINE (dose 5, batch no-GH9702) on 08-Sep-2022, PFIZER BIONTECH COVID-19 VACCINE (dose 6, batch no-GJ3670) on 12-May-2023, INFLUENZA VACCINE in September 2023 and RSV in September 2023. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and RSV.    On 16-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced MECHANICAL URTICARIA (dermatographia). The patient was treated with PREDNISONE at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (dermatographia) was resolving.            No concomitant medication was reported. The dosage text was reported as unknown. The patient had been having symptoms for 3 weeks and a solid 2 weeks of the symptoms.
Pt was vaccinated with a 1st and 2nd dose of MMR in 1996 and on 7/15/99, respectively. On 7/22/99, the pt presented to a physician with a "rash break out on entire body. The pt's cheeks were red, there was a yellow discharge from the eyes and a fever of 103F on the night of 7/22/99 and 99.1F on the morning of 7/23/99." The physician stated that it is her strong opinion that this is a case of measles. Follow-up from the physician, indicated that the pt developed an erythematous rash that started on his face and extended down to his trunk, arms and legs. The pt was sensitive to light and very irritable with a pruritic rash. The pt was treated with Benadryl. Yellow mattering present in both eyes. Oral cavity with small 1-2mm white spots on the inner aspect of his lower lip. Neck with mild cervical lymphadenopathy. Clear nasal discharge noted. On an unspecified date, the pt recovered. No further information is available.
No adverse reaction.  Reporting because there was a deviation from the recommended age group. Patient is 10 years old, turns 11 years old next week, but was administered Moderna SpikeVax 12 years plus.
This spontaneous report as received from a medical assistant refers to a 22 year old male patient. No information about medical history, drug reactions and allergies was specified. On 01-OCT-2014 the patient was vaccinated with temperature excursion supported GARDASIL injection (lot # J015378, expiry date: 09-APR-2016, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. The patient did not seek medical attention. There was no product complaint. The outcome is unknown. This is one of the seven reports received from the same reporter (MARRS # 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005585, 1410USA005586 and 1410USA005587). Additional information has been requested.
pt recv vax;edema & soreness of arm began 25jul;was given motrin;cont to inc throughout the day;edema included shoulder to mid lower arm area;PC to HD;no fever;advised to cont motrin w/apap,cold compresses;dec ROM & inc warmth on 26jul;
Almost immediate swelling, fever, headache for 2 days. Indurated wheal of about 2 inches, flare of about 4-5 inches - lasted about 1 1/2 wks.
First day, stiff neck. Second day area below injection extremely sensitive to touch and also itchy; fatigue. Third day fever of 101.5. Thereafter for a week, arm painful and itchy.
Fever of 100.1F for 2 days. Painful red circle at injection site and muscle ache.
pt recv & devel petechiae over the upper chest, entire abd,  on trunk & under both arms;pt reported a h/a & blood (small amount) in stool since 6/6/98;6/12/98 WBC count 2..4 w/ 34% segmented neutrophils, 3% reactive lymphocytes & 25% mono
Case number PHEH2015US006239 is an initial spontaneous report from a nurse received on 30 Mar 2015. This report refers to a 18 year old female patient. She had her normal menstrual period on 18 Feb 2015. She was vaccinated with BEXSERO (batch number: 146101) intramuscularly on 24 Feb 2015. On the same date, after vaccination she experienced sore arm. On 30 Mar 2015, the nurse reported that the patient was currently pregnant and possibly 6 weeks pregnant (not confirmed). The patient did not believe that she was pregnant at the time of vaccination. The patient did not receive the second dose of BEXSERO at the time of reporting. The outcome, seriousness and causality of the event sore arm was not reported. This case was identified with a wrong pregnancy outcome during checks: This prospective pregnancy case was ongoing.
Patient fainted at th end of her office visit. Patient was here for her 18 yr PE.  She received Hep A #1 and MCV #2.  Also had point of care lipid test done via finger prick. Procedure and shots were at the end of her visit.  She proceeded to get up without symptoms and head to the bathroom with the MA to give a urine sample.  While in the bathroom patient described feeling unwell and came out of the bathroom and satdown in the waiting room to which our receptionist noted something seemed wrong.  She opened her window and inquired if the patient was OK to which the patient said she felt like she was going to faint.  This nurse was within the reception area when the receptionist noted this response and asked me to respond.  I came out to the waiting room to find her starting to slump forward and then to the side of her chair, fainting. This nurse ran to the patient catching her preventing her from falling to the floor.  Another MA and nurse responded.  We immediately brought her to the floor and raised her legs.   She immediately became alert again and started talking with us. Patient's mother was called into the office.  The patient was given juice boxes x 2 and a pack of crackers.  She admitted to not eating anything this morning prior to her office visit.    After remaining in supine position for approx 10 minutes she tolerated a change to sitting then standing.  After she reported feeling better she was offered to be escorted to her car with her mom. They declined an escort and were discharged.
1 day after vaccination I developed nausea, light headed feelings and felt like the room was spinning. I am now on day  4 after the vaccine and I still feel tired and nauseous.
patient called claiming that after the initial injection the reaction from the vaccine caused the area to look red and feel warm to the touch. she stated that the area around the injection site is improving but the area has now moved to another location where it is red and tender. My thoughts that I said were a potential bacterial/cellulitis infection. I recommended going into urgent care and getting the area looked at due to the description the patient gave.  The patient stated they would probably go into urgent care tomorrow from my suggestion.
She verbalize she develop headache, nausea, dizziness.  She was evaluated onsite by Rescue and released home feeling better at 10:25 am.
He was weak and complaining of not feeling well. At first, he had a low-grade fever and then went up to 101. Then, he had a sore throat, coughing, and congestion. He tested positive for Flu on 12/10/2022. I gave him Tylenol and a cough medication. I contacted his doctor, and she prescribed Tamiflu. His symptoms lasted for about a week.
left arm at the injection sight developed a huge (between golf & tennis ball) itchy bump that was painful to touch; Arm is still a bit tender; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to dogs, pollen, mould, guinea pigs and dust. Concomitant medication included isotretinoin (CLARAVIS) 40mg; from an unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On Saturday, 20Mar2021, the patient developed a huge itchy bump (between golf & tennis ball) on the left arm at the injection sight, that was painful to touch. The arm was still a bit tender and the bump had reduced in size. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site lump and pain in arm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recieved two Hep B vaccines during hospital stay. Date and times are listed under # 10 and 11.
Resident received Moderna booster vaccine at a on-site clinic at 3:42pm on 12/1/2021. No sign of adverse reactions after vaccination. Resident was rounded on and living in the 2am hour on 12/2/2021 per chart. Vitals were fine. When rounded on in the 4am hour on 12/2/2021, patient was found deceased. Nursing home staff has yet to identify anything leading to cause of death.
Patient  With Lower back pain 5-10 minutes after her vaccination, 911 was called, They checked the patient, vitals were all normal. Patient was transferred  to the  MCN.
report side effects; insomnia for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia for 3 weeks) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy, Asthma and Allergy to antibiotic.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced INSOMNIA (insomnia for 3 weeks) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION COMPLICATION (report side effects). At the time of the report, INSOMNIA (insomnia for 3 weeks) had not resolved and VACCINATION COMPLICATION (report side effects) outcome was unknown.            No concomitant medication were reported.  MD had prescribed medication but did not worked. So she had taken self medication with over the counter medications to help him asleep.  Company comment- This case concerns a 37-year-old, female patient with previous relevant medical history of Food allergy, Asthma and Allergy to antibiotic, who experienced the unexpected events of Insomnia and Vaccination complication. The event Insomnia occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable since the events occurred after the first dose. The reporter assessed the events as possible.  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow Up information was received on 16-Sep-2021 and contains new event added.; Sender's Comments: This case concerns a 37-year-old, female patient with previous relevant medical history of Food allergy, Asthma and Allergy to antibiotic, who experienced the unexpected events of Insomnia and Vaccination complication. The event Insomnia occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable since the events occurred after the first dose. The reporter assessed the events as possible.  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
At site of Comvax, pt developed redness, induration and warmth measuring 23mm x 12mm.
Narrative: 95-year-old male received Pfizer COVID vaccination #3 on 12/2/2021. He received Moderna vaccines #1 and #2 in the spring of 2021. On 12/5/2021 he presented to the ED with falls, increased sleeping, and weakness with dizziness. Noted patient did have a fall fall 1 month prior. ED provider felt these symptoms were secondary to Covid vaccination and possibly mild dehydration. No medications were prescribd for the patient; however, he did receive 1000mL of 0.9% normal saline at a rate of 250mL/hour.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. In May 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. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The age at vaccination was not reported. The patient experienced a sore arm for 3 days but no other reactions. The patient still intended to receive the 2nd dose. The reporter denied for follow up. This case has been linked with case US2018GSK160167, reported by same reporter.
Initial information regarding an unsolicited valid non-serious case received on 08-Oct-2018 from a consumer. This case involves an unknown age female patient who experienced upper arm redness and swelling hand size, while she received vaccine FLUBLOK QIV. The patients past medical history included Food allergy. The patients past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1807 via unknown route in unknown administration site. The patient developed a non-serious upper arm redness and swelling hand size (vaccination site inflammation) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was upper arm redness and swelling hand size. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for the event. List of documents held by sender: none.
Within 5 minutes of vaccination, client stated she felt funny in the head and her left hand became swollen and red.
Hep A vaccine #2 was given only one month after #1 instead of 6-12 months later. No adverse events.
Fatigue set in about 11 hours after I was given the shot on Sunday, but it was bedtime so I didn't think much of it. At 1:15 am, I woke to violent shaking all over, and all-over achiness but no fever. I took one 500 mg Tylenol, and slept fitfully, I felt like I was aware that I was extremely uncomfortable, and I was either too cold or too hot. My temperature fluctuated from normal to about 100.8, on and off all the next day. It was an extreme effort and it was difficult to even shift my body position in bed, and my arm that was vaccinated could barely move and it hurt tremendously. My head ached, and my lower back ached the most, aside from my arm. I slept nearly all day yesterday (Monday), and I was very weak, with hardly any appetite. It took all effort to get out of bed to use the bathroom. I took a Tylenol 500 mg pill every 5-6 hours and those first couple hours felt the most pain relief. I counted down the time to get past 5 hours to take another one. Around 7 pm, after sleeping all day, I got out of bed to sit upright on the couch to relieve my back pain, and that helped. Symptoms started easing up later last night. I slept more than 9 hours again and today am feeling weak but no body aches or headache, only my arm is sore but not as bad as it was yesterday. I am less fatigued today but moving slowly, and my appetite is slowly returning. I have avoided taking more Tylenol since bedtime last night and feel like the worst is behind me. I hope.
2 hours post vaccination, she developed lower back pain, followed shortly with a persistant cough, within the next hour both eyes swelled shut with matter developing in the eyes. The back pain grew more intense with hives following and a fever of 99.1 degrees. Several hours after the vaccination, she complained of constricted breathing both in the lungs and tightness around the throat. Also noted was hoarseness in the voice. She went to a local medical clinic where a Physician's Assistant declared that she developed an allergic reaction to the (protein)in the flu vaccination and he prescribed Zyrtec for the symptoms. Complete resolutions of the symptoms with treatment occured after 48 hours.
Pain to the touch.  Hot, red, swollen lump about the size of a half dollar around injection site.  Typical soreness in muscle, but red lump is quite painful.
Narrative: Patient received the Janssen vaccine on 4/10/2021. On 4/16/2021, he  developed mildly red, itchy rash that started on forearms that then spread to  abdomen, thighs, calves, and feet. Patient applied calamine lotion which relieved  rash, no oral medications. No generalized symptoms, no SOB/DOE, wheezing,  abdominal pain, N/V/D/C, fever/chills, myalgias, arthralgias, etc. No other new  exposures. Patient reports no prior hx of allergic reactions. By 4/19/2021, the rash:  had resolved with only has minor itching around ankles b/l which was improving.
Information has been received from a physician's assistant, via a company representative, concerning a patient (age and gender not specified), who on an unspecified date was vaccinated with a dose of Gardasil (lot # not specified), and fainted. No further information was available. This is one of two reports received from the same source (WAES#0710USA00040). Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: fg3527) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression and anxiety" (unspecified if ongoing); "depression and anxiety" (unspecified if ongoing); "mild bradycardia" (unspecified if ongoing), notes: mild bradycardia. Concomitant medication(s) included: LEXAPRO.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive; (May2022) Negative, notes: nearly negative for a few days; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Other medication in 2 weeks was reported as yes. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes. If treatment AE was reported as no. No known allergies reported.  No follow-up attempts are possible. No further information is expected.
Hidradenitis suppurativa flare up bumps after covid second shot; Hidradenitis suppurativa flare up bumps after covid second shot; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up bumps after covid second shot) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up bumps after covid second shot) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up bumps after covid second shot) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up bumps after covid second shot). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up bumps after covid second shot) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up bumps after covid second shot) was resolving.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
large local rxn vs cellulitis 11x9cm;warm, raised, deep red inj site of DTAP;
This spontaneous report was received from a medical assistant/ clinical supervisor and  refers to a 17 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-MAR-2017, the patient was vaccinated with an expired dose of VAQTA 25 U/ 0.5 ml, lot # L032749, expiration date 04-NOV-2016 (dose, route of administration was not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.     Additional information has been requested.