chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax & devel inj site rxn of swelling & tenderness. Pt also devel "diffuse erythema & mild edema" both arms, & " sunburn-like redness between breasts". This is 1 of 2 pts from this site to exp adverse rxn.
Information regarding PREVNAR 7 was received from a healthcare professional regarding a 3-year-old male patient who experienced pneumococcal bacteremic pneumonia. The patient received a dose on an unspecified date. The patient experienced pneumococcal bacteremic pneumonia on 30-Nov-2009. The patient was hospitalized and treated with unspecified IV antibiotics. The patient recovered. No additional information was available at the time of this report.
Began with mild itching under left and right armpits and itching along groin area. Itching at scalp, neck, under armpits, under chin, stomach area, inside thighs, groin area. Hives under armpits and in groin (bikini line) spreading to inner thighs and underside of arms. Symptoms prevalent throughout the day but itching increases in the evening and during sleep. Hives are red, inflamed, appear as tiny dots. I've been keeping the area clean and dry. I will see my doctor next week.
Redness in entire upper left arm around injection site. The day after the injection I experienced Shivering for 2 1/2 hours followed by temp of 101.6 and I slept the entire day. The second day after the injection I continued experiencing pain in my upper arm and redness and extreme tiredness. Again slept most of the day. The third day less pain in my upper arm but still tired most of the day. The 3rd day after the injection I continued experiencing pain in my upper arm and redness and extreme tiredness. Again slept most of the day. The third day less pain in my upper arm but still tired most of the day. I received my injection of the SHINGRIX vaccine subcutaneously instead of intramuscularly.
This spontaneous report as received from a 45 year old male patient regarding himself. On 02-AUG-2017 the patient should have vaccinated with PREVNAR 13 first only vaccinated the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOCOCCAL VACCINE, POLYVALENT (23-VALENT)), intramuscular in the left deltoid (strength, dose, lot#, expiry date was not reported) (wrong vaccine administered). On 02-AUG-2017, patient is immune-compromised and now the vaccine had been given therefore the damage had been done. The outcome of the event was unknown. Causality of Immunodeficiency was not reported. Upon internal review, the event of immune compromised was considered to be medically significant.
10/11/2022 Productive cough with green sputum, sore throat and malaise. I took 2 COVID-19 tests and was positive. I scheduled a telehealth appointment and was referred to the ER. They prescribed a 3 day course of IV Remdesivir.  Symptoms went away after 2-3 days.
Mom noticed a golfball sz. knot, redness, and warm to touch to (L) arm at injection site.
10 hours after shot, back pain started then body aches and chills. Fell asleep then woke up feeling like I was on fire but not sweating. Body aches continued through the night. Took Tylenol at 945pm and again at 845am. I went back to sleep and by 1130am I only had a mild headache.
The day after my vaccination I experienced saturation the typical aches but also shortness of breathe with my oxygen saturation on home pulse ox of 92 % which quickly resolved.  Approximately  1 week later I developed a cough that got progressively worse for 5 days so I  went to my doctor feeling bad with a slight fever and a worsening cough. He ordered blood tests and a chest x-ray and diagnosed bacterial pneumonia.  He started me on 2 antibiotics. After a week I was feeling a lot better and 3 weeks later my chest x-ray was clear.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
pt had soreness in muscles from balls of wrist up to neck muscle & muscles in rt hand had knot in arm; can be felt but not seen; went to MD;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fingers on Right Hand are Swollen; Peripheral Edema; severe skin rash, most severe on left leg, migrated to right arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Fingers on Right Hand are Swollen), OEDEMA PERIPHERAL (Peripheral Edema) and RASH (severe skin rash, most severe on left leg, migrated to right arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No medical history reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced RASH (severe skin rash, most severe on left leg, migrated to right arm). On 30-Apr-2021, the patient experienced PERIPHERAL SWELLING (Fingers on Right Hand are Swollen) and OEDEMA PERIPHERAL (Peripheral Edema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Apr-2021 at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Fingers on Right Hand are Swollen), OEDEMA PERIPHERAL (Peripheral Edema) and RASH (severe skin rash, most severe on left leg, migrated to right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Action taken withmRNA-1273 in response to the events were not applicable
Both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash; look like a sunburn; Both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash; look like a sunburn; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Lot Number: EN9581), via an unspecified route of administration on 03Feb2021 17:15 as 1st dose, single dose for I don't want get covid. The patient's medical history and concomitant medication were not reported. On 03Feb2021, the patient experienced both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash; look like a sunburn. Consumer stated, I had my first dose of Pfizer vaccine yesterday and 5:15 PM ,  okay at 5:15 PM 03Feb2021 (yesterday). Felt fine, looked fine, got home and of course everyone worldwide is wearing a mask now so when I got home and took the mask off, my both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, it looked like a rash and I thought well maybe because I had the mask on, you know all day long and so got that, well it really look like a sunburn, so you know when you are out in the sun too long and your skin gets burned instead getting brown, so I monitored it all night it never improved, again this morning after lying down seems like it improved, but within minute after being upright again it gets bad again so this morning again I have what looks like a red rash or sunburn on my left cheek and on right cheek and my forehand, left cheek worse, it's very modeled looking and needless to say I am little bit concerned, so what you can tell me about this kind of reaction, has it been reported before, or is this the first time you are hearing about it. Still experiencing the event: consumer stated, yes this morning, still. Outcome of event: consumer stated, it persisting and it's little bit better, than it was last night when I went to bed, but the longer I am awake the more it is looking like it did yesterday. Treatment: consumer stated, no, I did not take anything because I was not sure if I should or what I should, so that's another question can I take advil or something or does that think can help, advil is over the counter I am sure you know, so what you recommending it terms of over the counter, okay I need to talk to the medical people. The patient did not receive any treatment for the events. The clinical outcome of the both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash, look like a sunburn were not recovered.  Follow-up attempts are completed. No further information is expected.
Per client's vaccination card, first dose was administered 04/12/21.  Second dose was administered on 04/28/21 which is five days before the 21 day due date.
Patient felt lightheaded and dizzy after receiving the vaccine. Patient was told to sit down and lost consciousness on the way to the chair. Patient did not fall or hit the ground, pharmacist on duty caught patient and sat her down. EMS was called and patient came to a few seconds later. Vitals were taken and patient was given water, she was released to go home and no hospitalization was required.
Received 2nd dose of COVID-19 vaccine on 3/3/2021.  On 9/3/2021, I was advised following routine lab testing go to to the Emergency Room and was newly diagnosed with diabetes type 2  and new diagnosis of hypertension - had pounding headache, lethargy, diabetes symptoms. My blood sugar was 467 and blood pressures had been >150/>100. My A1C (3 month average of glycosylated Hemoglobin was 9.6%), which suggests that I had been experiencing these disease states issues for months. I am not sure if either is related to the Moderna Vaccination for Covid-19, and have not raised or discussed the topic with my doctors at the Emergency Room, and while I do not perceive there to be causation, I am reporting in case there is any possibility of similar cases.
administer an expired ADACEL to a patient, with no reproted adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 years old female patient who was administered an expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], with no reproted adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jun-2022, the patient received 0.5 mL dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (lot: U6612AA, expiry date: 19-Mar-2022; formulation and strength not reported) via intramuscular route for immunization.   On an unknown date, the patient was administered an expired diphtheria-2/tetanus/5 AC pertussis vaccine, with no reproted adverse event (expired product administered).  Action taken was not applicable.  Outcome: Unknown  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.
~17 hours after injection onset of worse headache I've ever had, violent shaking/shivers/chills, extreme fatigue, temperature 100 degrees. Violent shaking subsided after about 40 minutes. Headache /fatigue mostly resolved after 12 hours, though not completely. Also pain at injection site.  I wasn't counseled nor did I receive any information mentioning the extremely high incidence of side effects as well as severity. They were so severe I'm contemplating not receiving the second shot of the series. ONLY in the package insert which patients don't typically receive is the side effect profile described in adequate detail. I was only told "your arm may be sore." Even CDC's own website downplays the incidence by saying "About 1 out of 6 people who got SHINGRIX experienced side effects that prevented them from doing regular activities.' Again, my side effects, while not life threatening,  were SEVERE. I suspect an extremely number of people will forego the second in the series. And with vaccine on demand, how will you know how many drop out?
Chills, excessive tiredness, excessive thirst, headache, general overall achy and not feeling well at all! I took tylenol, which seemed to help some with headache. My symptoms started by noon of the day of vaccine, lasted over the weekend. On the following Monday I started to feel better.
NauseaVomiting Narrative:  Developed fever, headache, abdominal pain and cramping 14 hours after 2nd dose of vaccine. Fever and headache resolved in 24 -48 hours but abdominal bloating ,gas and cramping persist 7 days post immunization
bad stomach flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:00 (Lot number: ER2613) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure measurement" (unspecified if ongoing), notes: for 5 years ; "crippled" (ongoing), notes: for about 2 years, she is on walker . The patient took concomitant medications. The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "bad stomach flu". Therapeutic measures were not taken as a result of gastroenteritis viral. Additional information: It was reported that the patient had Benzpriel (20 25 every day once a day by mouth, for blood pressure) as concomitant medication.   No follow-up attempts are possible. No further information is expected.
After shot received at 0830 on Oct 7,2008, arm became very sore.  That evening, had body aches.  I felt a little achy in the morning but by 11am, my back was really hurting from the rt shoulder down to the middle of my back.  Became dizzy and nauseated.  Stayed home the next day, unable to straighten up, back from mid to kidney level pain was intense.  Felt like a baseball bat was being swung at me.  By midafternoon on Thursday, I had become short of breath, unable to take a deep breath, intense back pain, dizzy, and nausea.  I had not been able to sleepdue to the pain. Unable to eat since I felt I wanted to throw up, no longer feeling the aches all over my body, just shoulder,mid and lower back.  The next morning, had increased difficulty breathing, short of breath when I talked, bent over at waist seemed to help increase air flow.  I went to Urgent care,they did an EKG, something sl abnormal.  Sent me to the ER.  EKG,chest xray, bloodwork done.  They gave me perocet that seemed to help.  They sent me home with perocet, felt it was a muscular sprain.  Sat and Sun, symptoms remained the same, just laid in bed.Perocet not working, just caused me to itch.  Monday went to my MD, intense pain on pressure on back, pushing and pulling of hands.  Pain also intense right at the sternum.  tight band around chest, unable to breath.she started me on Naprosyn and Nexiumum.  she said it was a reaction to the flu shot and added to my allergies. Tuesday, I actually felt I could get a good breath in, pain still present but decreased some.  Wednesday, I started to eat again.  Pain was better.  Thursday at present....I can stand almost straight up, still short of breath but feel I can get more air in. Voice sounds short of breath.  Pain down rt shoulder blade,across midback and down and around my rib cage.  I feel like my diaphram is not able to extend as it should. Pain level is back to an 8.  I have a call into my doctor to find out what I should do.
Loss of appetite; Fever 101F; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain; muscle, bone, joint, nerve pain.; muscle, bone, joint, nerve pain.; Difficulty walking; Severe Headache; Patient received booster dose; Patient received booster dose; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: FF8839) via an unspecified route of administration, administered on the left arm on 27Sep2021 10:00 (at the age of 67-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose on an unspecified date and second dose in 2021 of BNT162B2 for COVID-19 immunisation and experienced being sick. The booster was given 7 months after dose 2. On 27Sep2021 22:00, the patient experienced Fever 101F, muscle, bone, joint, nerve pain; difficulty walking, severe headache, loss of appetite. Duration continuing. "Was the sickest I ever felt. Much worse than the two prior doses. Even worse than any illness I have ever had". No treatment was received for the events. Events were considered non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Flu shot side effects reporting I received the Fluarix Quad PFS 2020-2021 #0.5 shot in my upper left arm at my pharmacy on 11/11/2020. I do have (usually mild) egg allergies. At the 36 hour mark I had redness and puffiness at injection site about 1-1/2 inch long oval. Left armpit swollen and sore. Woke up around 8 hours later to increased armpit swelling and soreness extending down inner arm to elbow. Soreness slowly crept in the next few hours down to wrist and tingling fingers. Could not fully extend arm or open elbow without inner arm pain. Chest tightness mild. Sore left side of neck, constant headache. Tongue numbness and tingling. Facial puffiness. Lip numbness. Sinus area of face sore. I am now at 6 days 4 hours out from the flu shot. Armpit and upper arm are still mildly swollen and sore but not as severe. Headache is mild. Tongue however has gotten increasingly very numb as other side effects have subsided and tingling and edges of tongue are not smooth but bumpy all the way around. Lips still tingling.
mild solitary erythematous rash on face & extremities, low grade temp & herpetic type lesions on tongue;rash is resolving;
Mom contacted PCP office on 12/7/22 to say patient's left upper arm is swollen and hard to the touch (indurated). Onset of swelling was 12/6/22, and on 12/7/22 the affected area is more swollen and spreading to the left shoulder. Patient's left arm and shoulder with normal range of motion, per mom. Occasional c/o discomfort. Advised topical cold pack and administration of ibuprofen.
1 cm wheal at injection site 5 minutes after injection.  Mom states maternal uncles children had similar reaction to varicella vaccine.
I noticed a "crawling" sensation in my left breast a few days (FOR DAYS) following my vaccination.  My left breast is now sensitive  swollen and hard as a rock, and will require surgery to fix.  I developed capsular contracture in my left breast for absolutely no reason.  Capsular Contracture NORMALLY occurs weeks after surgery.  My implants are 8 years old and I have never had a problem until after the vaccination.  I am highly suspicious that is was due to the vaccine.  I have had breast implants for over 25 years and have NEVER had a problem.  I also developed immediate arthritis in my left finger (after the vaccination) that lasted for three weeks PAINFUL weeks.  There is knot on my finger (two months later) and I don't believe it's going away.  My left breast remains hard as a rock.  My vaccination was in my left arm.  Highly suspicious...
Shortly post/vax, within 1 wk, pt began having staring episodes, which were dx'd as epilepsy. She went on to have several severe seizures & was put on Depakote. We are weening her from this med & seeking natural remedies.
Patient developed new onset tonic clonic seizure within 1.5 weeks following first dose of Pfizer vaccination.
pt recvd vax 22JUL92 but reaction was only reported t day; mom states the day p/vax given; pt had a reaction; had rash around shot area; rash lasted 2-3 days;
Right arm no erythema injection site, yellowing skin (ecchymosis). Slight edema distal arm with mild erythema. No further treatment warranted.
4/16/21- very dizzy, pre-syncope for about 5 seconds 4/21, 22, 29- dizzy spells, few seconds each
Patient recieved 4th injection in facility.  At 1405 RN documented, Dr. notified of patient pruitis following rabies injection.  Patient then discharged to home from facility.
Immediately became pale, dizzy, with tingling in throat, difficulty speaking, mind "fuzzy", difficulty hearing, nauseaus, difficulty breathing.  Called doctor, took Benedryl, went with parents to ER where she received IV fluids, anti-nausea medications, steriods.  Stayed in ER for 6 hours, continuing to be tired, nauseaus, dizzy 9 days later.