chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Between the first one and the second one I got Covid; Between the first one and the second one I got Covid; This is a spontaneous report from a contactable consumer (Patient) and follow-up received on 20Feb2021 from same reporter via Pfizer-sponsored program was processed together with initial information. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 03Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to reschedule second vaccine because between the first one and the second one patient got Covid and patient haven't get 10 days of Covid yet and patient can't get the negative for  test can patient reschedule vaccine through you or no because not then patient have to call somebody else and hold for another 25-30 minutes." Patient received her first dose 3Feb2021, 9 days ago, she contracted COVID-19, she is due to her 2nd dose on the 23rd. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on Between the first one and the second one I got Covid. Patient have been on hold and have been on phone for now 45 minutes, she trying to work. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
No adverse event noted. Improperly stored vaccine given to patient. Patient called back to receive repeated dose per  interim clinical considerations.
The patient started falling over, our staff caught him so he did not fall out of the chair. His eyes were rolling back,  he was shaking and his throat was making abnormal movements. His mother rushed over and bear-hugged him, and its like he came back to reality and was okay. We got him a cold pack, water, fruit snacks, a mat to lay on and a fan and the patient walked out okay. His reaction was directly after the shot and lasted about 5-10 seconds. Patient walked out of the facility fine and had his mother with him.
Within minutes after vaccine administration, parents called from that she was not breathing, her eyes closed and her color changed (pale). Upon assessment she had independent respiratory effort, oxygen saturation was 100%, heart rate 1:30 to 140, eyes closed, pale, no twitching noted. A code was called, she was evaluated, blow by oxygen provided and transferred to emergency Department and then admitted for observation. Diagnosis of BRUE.
This case meets vaccine breakthrough criteria. KNOWN EXPOSURE TO COVID+ PERSON.  SXS INCLUDE COUGH AND RUNNY NOSE
pt vax 3 times w/ hepta B. after each dose pt ex dyspepsia, abdo cramps, diarrhea. sx remitted spontaneously on each occasion.
Exceptionally lethargic; Very tired; Patient received secnd dose as 0.3 ml; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Exceptionally lethargic), FATIGUE (Very tired) and ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concurrent condition included (start date- 1995) high cholesterol (Meds have reduced.  Slightly high). Patient not been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Blood pressure high (Meds have reduced BP but still on high side) since 1990, Gout (Improvement-Taking Allpurinol, 300mg No symptoms) since 1998, Hay fever (Allergy injections result in very minor symptoms) since 1950 and Anxiety (Reduced level of anxiety) since 2008. Concomitant products included AMLODIPINE BESYLATE from 1990 to an unknown date and IRBESARTAN from 2000 to an unknown date for Blood pressure high, ALLOPURINOL from 1998 to an unknown date for Gout, ESCITALOPRAM from 2008 to an unknown date for Tension.   On 04-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 01-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 milliliter. On 01-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml). On 02-Apr-2021 at 8:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Very tired). On 01-May-2022 at 9:00 AM, the patient experienced LETHARGY (Exceptionally lethargic). On 03-Apr-2021, FATIGUE (Very tired) had resolved. On 02-May-2022, LETHARGY (Exceptionally lethargic) had resolved. At the time of the report, ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml) outcome was unknown.            On an unknown date in 2016, the patient concomitantly received allergy injections every three week for extract.  On 03Feb2021 and 24Mar2021, one month prior to Moderna COVID-19 vaccine, the patient received allergy injections on both arms.   Treatment medication were not reported.   This case was linked to MOD-2022-557731, MOD-2022-560592, MOD-2022-557731 (Patient Link).
Patient hospitalized on 4/23/21 and 5/19/21. These visits are within 6 weeks of receiving COVID vaccination. Diagnoses were mass of pancreas and pancreatic adenocarcinoma, respectively.
chills; swelling; headache; dizziness; soreness; still fuggy, can have a clear head, little dizzy; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), SWELLING (swelling), HEADACHE (headache) and DIZZINESS (dizziness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Jan-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHILLS (chills), SWELLING (swelling), HEADACHE (headache), DIZZINESS (dizziness), MYALGIA (soreness) and DIZZINESS (still fuggy, can have a clear head, little dizzy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 27-Jan-2021, PYREXIA (fever) outcome was unknown. At the time of the report, CHILLS (chills), SWELLING (swelling), HEADACHE (headache), DIZZINESS (dizziness), MYALGIA (soreness) and DIZZINESS (still fuggy, can have a clear head, little dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was taken.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
This spontaneous report was received from a health professional referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 16-JAN-2015, the patient was vaccinated with the first dose of VAQTA (Lot#, expiration date, dose and route of administration were not reported). On 26-JUN-2015, the patient was vaccinated with a second dose of VAQTA (Lot#, expiration date, dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Approximately a week after receiving 2nd and 3rd dose of vaccine I lost my voice; it starts with very rough voice; it goes into literally like unable to speak; My vocal cords feel like easy to get tired; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 10:00 (Lot number: FF8841) at the age of 47 years as dose 3 (booster), single and administered in arm left, administration date 19Mar2021 12:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "i am alergic to some food" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 26Feb2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: APHONIA (non-serious) with onset 2021, outcome "recovering", described as "Approximately a week after receiving 2nd and 3rd dose of vaccine I lost my voice"; DYSPHONIA (non-serious) with onset 2021, outcome "recovering", described as "it starts with very rough voice"; SPEECH DISORDER (non-serious) with onset 2021, outcome "recovering", described as "it goes into literally like unable to speak"; VOCAL CORD DISORDER (non-serious) with onset 2021, outcome "recovering", described as "My vocal cords feel like easy to get tired". Therapeutic measures were not taken as a result of aphonia, dysphonia, speech disorder, vocal cord disorder.  Additional information: facility type vaccine was Clinic. The patient took no other vaccine in four weeks, had no covid prior vaccination, had not covid tested post vaccination, he took no other medications in two weeks. The patient stated that approximately a week after receiving 2nd and 3rd dose of vaccine she lost her voice, it started with very rough voice, it went into literally like unable to speak. Her vocal cords felt like easy to get tired and after 2nd dose it lasted at least 1.5 months. No honey or vocal cords medicine helps it, but eventually it vanished on its own (events onset date: 2021). She got a booster, and it was happening again (events onset date for dose 3: 25Oct2021, event start time: 08:00 AM) and it was why she was only now realizing that it was related to COVID 19 vaccine last time. she must underline, never had a problem with losing voice or anything like that never.   No follow-up attempts are possible. No further information is expected.
Initial report was received on 09 November 2012 from a consumer, who is also the patient's parent. A four month old male patient received an injection of IPOL (lot number reported as 944240, but to be confirmed) on an unspecified date. The patient's medical history and concomitant medications were not reported. After vaccination, "for 1 hour the patient was sleepy, didn't move limbs when flicked, limp then recovered". Laboratory tests were not reported. Details of treatment were not reported. The patient had also received an injection of HIB, manufacturer unknown, approximately a few weeks prior to IPOL vaccination on an unspecified date. Details of vaccination were not reported. The reporter declined to provide further details. The patient's outcome was reported as recovered. Documents held by sender: None.
(R) arm, deltoid was red 12 x 13 cm, mild tender and warm, no D/C. Ice and clindamycin.
Allergic reaction with bright redness and swelling of face, tingling, itching and swelling of tongue, mouth, gums, tingling, heat and itching in hands and fingers, feet,insoles, between toes, in crook of arms, behind knees, itchy eyes, ears, scalp,  increased itching throughout body
Nauseous, diarrhea, chills, aches, headaches, sinus, could not turn off my brain.  Awake till 3 am.
Initial report received from a health care professional on 17 September 2013. A female patient (date of birth not reported) had received FLUZONE INTRADERMAL (lot number, site and date of administration not reported) and an unspecified amount of time later, "broke out in a rash all over her body and the doctor had to give her a shot of BENADRYL." The patient's arm swelled up "about the size half of a dollar bill and is extremely red and itches." No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 16:00 (Lot number: 3R038D) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Blood clotting", start date: 2016 (ongoing), notes: 2016 and then 22Mar2021(Blood clots in chest), 27Apr2021 test found hereditary clotting condition. Concomitant medication(s) included: AMLODIPINE BESYLATE taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing); JANTOVEN taken for thrombosis, start date: 27Apr2021 (ongoing). Vaccination history included: Bnt162b2 (Dose 1,Time: 14:00,Left arm, Intramuscular, Batch/Lot number: EN6203,Exp date: Jun2021), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose 2, Time: 14:00, Right arm, Intramuscular, Batch/Lot number: EN6203,Exp date: Jun2021), administration date: 18Mar2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "Sore arm and back", "Sore arm and back". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild sore arm".  Additional information: Patient reported no Prior vaccinations. All 3 doses caused mild sore arm and 2nd dose aggravated back possible blood clot diagnosed week later and month later determined as genetic condition. Other tests include relevant test for thromboembolic events with thrombocytopenia. Antibody test to platelet factor IV on 25Mar2021 showed 138.8. Various lab test was conducted after dose 2 including basic no diff on 25Mar2021, basic metabolic panel on 26Mar2021, US Abdomen limitation on 20Apr2021, Beta 2 glycoprotein on 22Apr2021 which were all normal. On the same date, Cardiolipin auto abs and free light chains showed blood clot and blood clots genetic.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number L001325 and expiry date 13-JAN-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with vaccinated with (Oka/Merck) VARIVAX was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Pain in (R) arm from armpit to wrist - swollen lymph nodes under arm. Flat red rash on face - neck - (rash resolved 11/8/13). Dizzy, blurred vision - problems with urination - Had S.O.B x 2 days - resolved 11/7/13 fever.
Breakthrough covid infection. Acute respiratory failure requiring intubation on 5/23/2022
No adverse events. Patient age 16 vaccinated with FLUCELVAX: approved for 18+ y/o.
This case was reported by a pharmacist and described the occurrence of injection site soreness in a 40-year-old female subject who was vaccinated with Engerix B for prophylaxis.  In June 2007 the subject received 1st dose of Engerix B (20 mcg, unknown, right deltoid).  At an unknown time after vaccination with Engerix B, the subject experienced injection site soreness, injection site warmth and bumps around injection site.  At the time of reporting the events were unresolved.
palpitations; fever of 102.; This case was reported by a consumer via call center representative and described the occurrence of palpitation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced palpitation and fever. On an unknown date, the outcome of the palpitation and fever were unknown.   It was unknown if the reporter considered the palpitation and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and experienced palpitations and fever of 102 degree fahrenhiet. The reporter did not consent to follow up. Limited demographics and details due to caller's refusal to provide information for safety report.
Pt was immunized @ approx 10 am - went directly to her PCP where her husband was scheduled to have a thallium stress test. She c/o R arm having a "hot sensation" which traveled across her chest - syncopal episode. States she "passes out" if she's in the sun too long and has h/o feeling light headed if she doesn't eat when taking her DIOVAN.
Polymyalgia rheumatica; decline in health; sick more or less; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER2613) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "sick more or less"; POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "decline in health". Therapeutic measures were taken as a result of polymyalgia rheumatica, illness. Clinical course: The patient needed to get into a vaccine study. She had been sick more or less since Apr2021. She had been on prednisone since Apr2022. She was diagnosed with polymyalgia rheumatica. She was still sick. She sees a relationship between the vaccine and her decline in health. She had never been diagnosed with Covid19.
Person giving vaccine "stuck" twice, claimed needle on first injection malfunctioned.  Vaccination was given very high on my left arm over my nearly-non-existent deltoid muscle. I pointed out it wasn't a good site.  But second injection in same spot. My shoulder soon began to hurt, got worse each day, now extreme pain during normal daily activities when I raise my elbow or entire arm. Think the needle stuck my rotator cuff tendon or a bursa or acromion or other unintended location.  Initial eval by orthopedist 10/7/14, x-rays were normal but he could not diagnose injury and referred me to shoulder specialist for further diagnosis on 10/14/14. Pain wakes me at night, shoulder aches when I steer my car.
Rash Narrative:  Developed quarter sided redness/swelling around injection site associated with mild induration day after vaccination, which persisted for another  two days. No associated warmth, pruritus, or sloughing. No therapies tried or  applied. No other adverse effects noted.
The patient experienced nausea, vomiting, upset stomach and dry mouth the next day of the vaccine administration.
Day 7, intense headache for no reason that lasted for 3 hours, with chills. 3-4 hours later experienced tingling on lip and within 15 minutes a large cold sore developed on the lip, along with a tender node under chin beneath the sore, leading up to  a sore throat.   Also noticed the day after both shots I was highly sensitive to the sun  and my forehead got discolored blotchy red/brown (similar to a bad sunburn but without the pain) that took a day to mostly go away, but still has hints of it.   Cold sore is subsiding but expect it to last at least a week. Haven?t had them in a long time, but recognize it.
Erythema on right thigh 15cmx20cm. Not tender. No warmth. Afebrile. Hospitalized 9/28/02 - 9/30/02 for cellulitis. Treated with Ancef 500mg IV Q 8 hours. Discharged medicines - augmentin 350mg PO BID for 7 days. Completely recovered. Possible significant local reaction.
I have a large red rash at the injection sight. About a three inch diameter circle. The area is very red, raised, slightly bumpy, itchy, and hot to the touch. It seems to be some sort of allergic reaction. I did not have this reaction with my first Moderna dose.
Two hours after injection I felt like passing out. About 12 hours after the vaccine I developed a fever...first was 99.7 and about 3 hours later had gone up to 100.7 at which point I took a Naproxen followed by TYLENOL because the Naproxen was not reducing my headache. By about 7AM that morning I felt much relief. I must note here that the pharmacist did warn me that having a bad reaction was quite common even though I have never had reactions to other types of immunizations. He told me that apparently this one is different.
Child Given VAcciNE thAt MAY hAve hAd teMperAture EXCURsioN (DAtAa LOGGeR FAilure) With StABle FriDGe teMps Before + AfteR. Agency determine the VACCiNe to Be At RISK + ADViSED RepoRtiNG + RevACCINAtion ChilD HAD NO ill Effects thus FAR
Two days following his initial vaccination he developed a red, vasculitic, tender rash on his lower legs.  The rash seemed to only involve his lower legs for about 10 days, after which the rash progressed and involved his entire body.  he also developed a headache and vague abdominal pain at that time.  He was diagnosed at the hospital with Henoch Schonlein  Purpura and placed on a Medrol steroid dosepack.
Body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided
First tiny soreness left shoulder Second dose like having Covid which i did in December. Sever headache,  severe muscle pain thighs back arms shoulders neck, minor nausea , major fatigue to exhaustion  for about 40 hours
Patient experienced syncopal episode immediately after receiving the vaccine. Patient woke up less than 1min later, assessment and vitals were normal per Guardsman attending patient. Patient was observed for additional 30min prior to release from clinic. Patient noted has exhibited this behavior before with needles.