chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was hurting; A little fever; Nausea for at least 1 week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), PYREXIA (A little fever) and NAUSEA (Nausea for at least 1 week) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting), PYREXIA (A little fever) and NAUSEA (Nausea for at least 1 week). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), PYREXIA (A little fever) and NAUSEA (Nausea for at least 1 week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported. No treatment information was provided.  The reporter was calling on behalf of their daughter who received both the doses of the Moderna COVID-19 vaccine in April. The patient immediately after receiving the first dose of the vaccine stated that their arm was hurting, had a little fever, and nausea for at least 1 week. The reporter was not sure if the patient took any treatments during this time.   This case was linked to MOD-2021-346454 (Patient Link).
About 30 minutes after the injection, my throat felt tight like it was closing up. Then I started to have a funny taste, almost like metal in my mouth and my tongue started to fatter as though it was swelling. I never lost the ability to breath but felt a little constricted in my throat. The "puffy tongue side effect lasted for about 15 minutes and drinking water seemed to help. The throat constriction went away after about 5 minutes. We were already away from the vaccine site so we did not see any health professional for these symptoms but would have if they did not go away.
Each one made me sick I missed five days of work each time I got the shot; it was nasty and it was horrible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, I had the three shots from the Pfizer (Covid-19 vaccine). I had the first two and then I had the booster shot. Each one made me so sick I missed five days of work each time I got the shot.), for Covid-19 immunization, reaction(s): "Each one made me so sick I missed five days of work each time I got the shot."; Bnt162b2 (Dose: 1st), for Covid-19 immunization, reaction(s): "I have covid". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Each one made me sick I missed five days of work each time I got the shot; it was nasty and it was horrible". Therapeutic measures were not taken as a result of illness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201056718 same patient, event and product, different dose;
pt recvd vax & w/in 6 hrs p/vax exp fever 103 for 48 hrs; pt was sen by MD;
Dose #1 was on 1/20/2021. Dose #2 was on 2/10/2021. On 2/15/2021 drenching night sweats, fatigue, chills, low grade fever, shortness of breath noticeable. PCP visit with Dr. on 3/22 confirmed irregular heart rhythm and aflutter. Chest xray on 3/23/2021 confirmed large left pleural effusion. 2 days later, left thoracentesis yielded 1.8 liters of fluid, non diagnostic. Pleural effusion returned, drained again 1 week later, 1 liter, non diagnostic. In the interim, aflutter controlled with large dose beta blocker. 2 weeks later PET scan unremarkable. 4 weeks later, left pleurectomy and decortication completed successfully. Final pathology (after second opinion pathology review) determined diagnosis of "chronic pleuritis" with no signs of infection or malignancy. Ultimately, patient was weaned off beta blocker, aflutter has resolved, and pleural effusion has not recurred. No other health issues or comorbidities have occurred since pleurectomy.
Case number PHHY2015US159839 is an initial literature report received on 24 Nov 2015. The author assessed the adverse events after FLUCELVAX reported to the Vaccine Adverse Events Reporting System (VAERS). This report refers to a 44 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date. It was reported that nine days after vaccination, the patient had onset of neurological symptom which was further described as Guillain Barre syndrome (GBS). GBS developed met Brighton criteria level 3. The outcome of the event was not reported. The report was reported as serious. The author stated that during the first two influenza seasons (2013-2014 and 2014-2015) following licensure of FLUCELVAX, approximately 5.6 million doses of vaccine were distributed in a specific country and the crude reporting rate for GBS cases was 0.7 per million doses distributed. Moreover, no disproportionate reporting for GBS was observed in the present study using Empirical Bayesian (EB) data mining. The author concluded the article stating that the review of VAERS reports did not identify any concerning pattern of adverse events after FLUCELVAX. Injection site and systemic reactions were the most commonly reported adverse events. Reports following FLUCELVAX in persons less than 18 years highlight the need for education of healthcare providers regarding approved FLUCELVAX use.
Still having significant right arm muscle pain and burning that is causing me to limit movement in my right arm. Hands, fingers and feet have pain. Initial injection reaction after 2nd dose occurred 10 hours after injection and included fever of 101 f, headache, nausea and vomiting and extreme chills.
On day 2 an itchy painful rash surfaced on the back of my head, middle of my back, back of armpits, abd buttocks
Post clinic it was discovered that client was inadvertently vaccinated with Moderna and client was only 17.  Client registered thru new electronic registration system.  System has since been updated to prevent underage clients from registering.  Nurse recalled that this client verbally told him she was 18 but he stated he did not compare it to the birthdate.  Going forward he will confirm age and date of birth. Per CDC guideline, client will be scheduled for second dose.
There may have been temperature excursion and vaccines were administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There may have been temperature excursion and vaccines were administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There may have been temperature excursion and vaccines were administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There may have been temperature excursion and vaccines were administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The reporting physician mentioned that both 1st and 2nd doses of Moderna COVID-19 vaccine were administered to about 120 patients (estimated number) from several different vials that may have suffered temperature excursion over several different days.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up document received on 15-Jun-2021 does not contain any significant information. The reporter provided additional email address.
Vaccine administered on 10/3/03. Patient presents in office on 10/6/03 c/o arm "puffy and red and warm to touch" near sight of injection.  Patient reports symptoms started one day after immunizations.  Doctor describes 11cm by 8cm are distal to injection site.  Pale - Pinkish red. No raised area, slight warmth,no tenderness.  Injection site in deltoid shows no sign of irritation.
A non-serious spontaneous report of FLUMIST went into eye was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient . On 18-Oct-2011, while administering FLUMIST in the second nostril the patient jerked his head and some went into the eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Rash, swelling, redness, pain, hives, heat at sight of injection. Mom sent photos to confirm reaction Dr looked at the photos and confirmed it was a reaction advised mom to use supportive care ice/warm compresses, ibuprofen.
FLU LIKE SYMPTOMS/FEVER/CHILLS/ACHINESS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced flu like symptoms/fever/chills/achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms/fever/chills/achiness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211229198.
TIA Stroke (transient ischemic attack); loss of memory for 15 minues could not spell the word "side" nor "effect"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) in a 60-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.     No relevant medical history was reported.     On 03-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 TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) (seriousness criterion medically significant) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect"). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included vitamin-c and fish oil  Company comment: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.
Case says she had adverse reaction to the vaccine that lasted for one week. Her symptoms were Sore arm, Cough, Body aches, Flu symptoms, Sore throat and Bloody nose.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-SEP-2006, the patient was inoculated with the ZOSTAVAX vaccine at a location as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-SEP-2013, the patient was treated at urgent care facility for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Hives; Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy; Sore Left Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH ERYTHEMATOUS (Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy) and VACCINATION SITE PAIN (Sore Left Arm Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (Hives), RASH ERYTHEMATOUS (Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy) and VACCINATION SITE PAIN (Sore Left Arm Injection Site). At the time of the report, URTICARIA (Hives), RASH ERYTHEMATOUS (Red Rash all over her body, Red when Scratching. When not scratching it looks Lumpy) and VACCINATION SITE PAIN (Sore Left Arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported. Patient said that she is doing fine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-jul-2021 contains significant information-Updated  Event outcome ;recovered.
Patient presented with left sided chest pain about 12-24 hours after the administration of the first vaccine.  He had chest pain that worsened with respirations.  Laboratory studies included elevated troponin levels consistent with myocarditis.  A 15-lead electrocardiogram showed pericarditis.  By 48 hours the patient had reduction in pain while being treated with ibuprofen, 400 mg by mouth 3 times daily.  3 days after the vaccination he received an echocardiogram showing normal left ventricular function.
severe myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2021, the patient received Shingrix.On 22nd November 2021,4 days after receiving Shingrix, the patient experienced myalgia. On an unknown date,the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were reported as follows: This case was reported by the physician for his wife. The physician stated his wife received the Shingrix vaccine on 18th November 2021 and then on the 22th November 2021 noted onset of myalgia and patient still had severe myalgia today,the 29th. The reporter consented to follow up.
Anthrax, TDAP, Typhoid inj given - at 1205 reported not feeling well - increased mucus in mouth and throat - no rash, no resp. distress - VS 1205 = 182/100, HR 74; 1210 = 160/100, HR 74, - 1215 170/100 - 74. Pt took own BENADRYL 25 mg po. 1222 Pt state feeling better.
TC 5/16/05 from mother, that pt had fever of 103, chills, diarrhea, and vomiting that started Friday evening 5/13/05. Still has symptoms today with fever of 102. TC 5/18/05 Saw Dr, not imm. related, still vomiting, no diarrhea or fever.
I experienced a variety of symptoms including darkened veins, head pressure and headache, tingling/ numbness in bottom left half of face, heart palpitations and chest tightness, sleepy/ restless legs, and a bruised/ sore left orbital the morning after the shot.  The heart palpitations occurred on the 4th day after the vaccination.  Most symptoms persisted over the course of three weeks.
This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 05Feb2021 08:30 at the age of 50-years-old at single dose for COVID-19 immunization. Medical history included obesity, inflammatory lung disease. No known allergies. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 on 15Jan2021 at the age of 50-years-old for COVID-19 immunization. The patient experienced 6 out of 10 pain, tenderness and mass of some sort behind left collarbone pain radiating toward shoulder and neck, injection site minimally sore on 05Feb2021 20:00. Pain resolves with ibuprofen, no treatment received for the other events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.
Pt given hep A shot on 10/30/09. The night of 10/31/09 she had a fever to 106 and a febrile seizure and developed nephrotic syndrome. She is currently on oral steroids and followed by nephrologist.
Pt vaxed w/Hep B vax (recomb) one half the usual dosage on 30OCT90 & 31OCT90; On 27NOV90 pt recd 2nd dose of Hep B vax (recomb) 1ml; @ time of report there was no adverse rxn; No further details were provided;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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: "Ankylosing spondylitis" (unspecified if ongoing), notes: Ankylosing spondylitis and Crohn's disease; "Crohn's disease" (unspecified if ongoing), notes: Ankylosing spondylitis and Crohn's disease. There were no concomitant medications. No Known allergies. Other medication in 2 weeks was reported as No. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral Paxlovid started on 18Jul2022 with lot number GC8326.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The mother thinks was in injected too high in shoulder or in the shoulder joint; Arm pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "The mother thinks was in injected too high in shoulder or in the shoulder joint"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain".  Additional Information: Caller was a registered nurse that was calling about the 12 plus adult dose of the Pfizer Covid-19 Vaccine and had a question. Caller reported that they had a 17 year old that had the vaccine and it may have been injected too high and into the shoulder joint. She said that she is not 100 percent sure that it did happen and declined to complete a report at this time. The patient's mom said that is what she thinks happened.  Follow-up attempts completed. No further information is expected.
Fever 100.9, started about 10 hours after vaaccine.  Lasted all night and most of next day.   I finally took Tylenol about 24 hours after vaccine.   chills, started about 10 hrs after vaccine and lasted 5 hours.  aches all over body, lasted from 10 hrs after to 30 hours after Extremely sore arm at injection site.   Started about 8 hrs after vaccine and lasted til 24 hrs after vaccine headache, fatigue, started 8 hrs after vaccine and lasted for 36 hrs after vaccine.
Quarter size lump R. leg sm Lump on L Leg. Temp. 101.8 very cranky.
fever, body aches, and lymph node in my left armpit got really large (baseball size)
Braking out both legs slightly above both ankles /  big clusters and small clusters near ankle; looks like chicken pox; This case was reported by a consumer via call center representative and described the occurrence of skin breakout in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 16th October 2020, the patient received the 2nd dose of Shingrix. On 21st October 2020, 5 days after receiving Shingrix, the patient experienced skin breakout and vesicular rash. On an unknown date, the outcome of the skin breakout was not recovered/not resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the skin breakout and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Consumer reported and received 2nd dose of Shingrix last Friday from date of reporting and began breaking out on Wednesday on both legs slightly above both ankles that looks like chicken pox.  First assumed to be a mosquito bite, but then spread and concluded not a mosquito bite.  Break out extended midway up right leg big clusters and small clusters near ankle.  On left leg couple of clusters in middle of leg.  Breakout was not sore, painful or itchy. The reporter consented to follow up. This case was 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212045:same reporter US-GLAXOSMITHKLINE-US2020AMR212682:same reporter