chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severely painful (eventually reaching 8 on the pain scale - unable to focus on anything else) cramping in calves and thighs, exacerbated by involuntary tensing due to cold; Severely painful (eventually reaching 8 on the pain scale - unable to focus on anything else) cramping in calves and thighs, exacerbated by involuntary tensing due to cold; Severely painful (eventually reaching 8 on the pain scale - unable to focus on anything else) cramping in calves and thighs, exacerbated by involuntary tensing due to cold; Severely painful (eventually reaching 8 on the pain scale - unable to focus on anything else) cramping in calves and thighs, exacerbated by involuntary tensing due to cold; severe fatigue (difficult and eventually unable to cross apartment); headache; flare-up in pre-existing carpal tunnel syndrome; flare-up in pre-existing carpal tunnel syndrome; This is a spontaneous report from a contactable consumer (patient).  A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number was not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 12:00 (at the age of 26-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included carpal tunnel syndrome (ongoing), ADHD (attention deficit hyperactivity disorder), depression and anxiety. It was unknown whether patient had any allergy. Concomitant medication(s) included Venlafaxine 150mg, Bupropion 300mg, Naproxen 375; all taken for an unspecified indication, start and stop date were not reported. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination. On 12May2021 at 02:00, the patient experienced severely painful (eventually reaching 8 on the pain scale - unable to focus on anything else) cramping in calves and thighs, exacerbated by involuntary tensing due to cold, severe fatigue (difficult and eventually unable to cross apartment), headache, flare-up in pre-existing carpal tunnel syndrome. It was reported that the patient had Severely painful (eventually reaching 8 on the pain scale - unable to focus on anything else) cramping in calves and thighs, exacerbated by involuntary tensing due to cold. Also presented severe fatigue (difficult and eventually unable to cross apartment), headache, flare-up in pre-existing carpal tunnel syndrome. She took 400mg ibuprofen, followed 4-5 hours later by 600mg; she felt some improvement and eventually slept. When she woke, she was down to about a 4 on the pain scale and manageable fatigue (probably could not go to work but could care for self). The patient underwent lab tests and procedures which included pain assessment: 8 on 12May2021 (eventually reaching 8 on the pain scale - unable to focus on anything else), pain assessment: 4 in May2021. Patient received treatment for severely painful (eventually reaching 8 on the pain scale- unable to focus on anything else) (pain) and no treatment was received for other events. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Smallpox vaccine on 3/4/03 (Tuesday) non productive cough started Friday 3/7/03, fever 100 degrees, Saturday 101.9 fever Sunday 3/9/03 (+) notes L lower lobe-rash? to back to abd. presented to  ER on 3/9/03. Still in hospital. 3/10/03 reported by infection control nurse at the hospital-site of vaccination looks good. She relates no rash or any complications related to smallpox she is aware of. Dx LLL pneumonia with non productive cough. Pt was admitted on 3/9/03 was placed on respiratory isolation today 3/10/03-isolation discontinued.
R09.02 HYPOXIA 8/19/2021 PNEUMONIA R09.02 HYPOXIA 8/19/2021 CANCER METASTATIC TO INTRAABDOMINAL LN R09.02 HYPOXIA 8/19/2021 OVERWEIGHT ADULT, BMI 28-28.9
allergic reaction; first dose was months ago; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was months ago) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was months ago). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported .  No treatment information was provided by the reporter.
feeling crummy; This is a spontaneous report from a contactable other healthcare professional and consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) at the age of 81 years old as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that following the injection of the second dose of COVID vaccine on 11Mar2021, the patient was feeling crummy. Unsure if MD was aware. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
inflammation n my body decreased to the point where I had the best mobility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "I have mixed connective tissue disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "inflammation n my body decreased to the point where I had the best mobility".  Additional information: Patient have mixed connective tissue disease, when got second shot, 2 weeks later the inflammation in body decreased to the point where patient had the best mobility with the lowest pain than had for years. (benefit lasted for almost 8 weeks) 2 weeks ago Patient got the booster, and beginning to see the same response. Patients Doctor is stumped.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bruise at injection site DTaP, large area of erythema just distal to injection site later on day of immunization.
sinus infection; cannot see out of her right eye; sick; terrible terrible splitting headache on her right temple; can't sleep; pressure behind her right eye; head is all fuzzy; mind isn't good; throat hurts; jaw hurts; little off balance; she walks she falls into things; she walks she falls into things; can't see things hardly in her right eye; pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history was not reported.  Concomitant medication included atenolol for blood thinner.  The patient previously took first dose of bnt162b2 for Covid-19 immunization and experienced no adverse event. The patient stated that she received the second dose of the vaccine on 04Feb2021 and has been sick ever since. She has a terrible terrible splitting headache on her right temple and can't sleep and was having so much pressure behind her right eye. She stated she can't even lay her head on a pillow. She stated she had no reaction to the first shot but this time her head is all fuzzy, her mind wasn't good and when she sets things down she can't remember where they are. The second shot was really giving her a fit. Her throat hurts, jaw hurts, head hurts, and feels like she is running a temperature. She is a little off balance, when she walks she falls into things because she can't see things hardly in her right eye. She stated she can't put up with the pain any longer, it is terrible behind her temple and eye. She thought it was a sinus infection but now she thinks it was from the shot. She stated she almost had a wreck today because she cannot see out of her right eye because of the shot. She hit a telephone thing and almost wrecked 3 or 4 times. She tried to get tested for Covid but she didn't have an appointment and she cannot go to work until she finds out about the virus. She was going to get tested tomorrow but was going to have to call the rescue squad because she can't drive and she was not putting her son through this if she has the virus. The patient asked if she was allergic to the second shot or if these were normal symptoms. She asked what she should do. She stated she takes Atenolol, a blood thinner, and thyroid medicine. She stated she was taking Tylenol but it doesn't help any and nothing seems to help. All the events occurred on Feb2021. Outcome of all the events was unknown.   Information on the lot/batch number has been requested.
According to the grandmother of pt, pt had a slight fever on 08/23/04 after receiving three immunizations. Pt was given Tylenol and the temperature went back to normal. No adverse events occurred on 08/24/04.  On 08/25/04 at 9AM, one leg appeared larger than the other leg and pt had a fever of 102. Seen at ER and admitted with fever and infected leg.  08/26/04 at 9:45AM, child is doing OK according to the hospital.  Which leg is infected is unknown at this time.
redness...on their left shoulder down their bicep; left shoulder down their bicep...itches; firmness on their left shoulder down their bicep; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (redness...on their left shoulder down their bicep), VACCINATION SITE PRURITUS (left shoulder down their bicep...itches) and VACCINATION SITE INDURATION (firmness on their left shoulder down their bicep) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD), ZINC, VITAMIN D NOS and CALCIUM for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness...on their left shoulder down their bicep), VACCINATION SITE PRURITUS (left shoulder down their bicep...itches) and VACCINATION SITE INDURATION (firmness on their left shoulder down their bicep). At the time of the report, VACCINATION SITE ERYTHEMA (redness..on their left shoulder down their bicep), VACCINATION SITE PRURITUS (left shoulder down their bicep..itches) and VACCINATION SITE INDURATION (firmness on their left shoulder down their bicep) had not 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.   The patient reported additional concomitant product of female hormone replacement therapy,   Treatment of events was reported as none.
Menquadfi administered too soon.  Last meningococcal vaccine administered 3/22/2022, Menquadfi administered 8/5/2022
Large area of urticaria right arm injection site onset 3/14/2021 spreading to arms, legs, chest and back on 3/15/2021.  Currently taking loratadine.
This spontaneous report was received from a medical assistant (healthcare worker) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M017983 with expiration date: 30-MAY-2018; lot # M016193 with expiration date: 24-APR-2018; lot # M013636 with expiration date: 15-FEB-2018; lot # L026602 with expiration date: 19-OCT-2017; (strength, dosage and route unspecified). Temperature excursion details are as follows: temperature of 53.2F for time frame of 4.75 hours (285 minutes). There was no previous temperature excursion. Call was because of a data logger. No adverse effect reported. No product quality complaint involved. No additional information available. This is one of several reports received from the same reporter. Additional information has been requested.
HAD GRAND MAL SEIZURE  19 HOURS AFTER MODERNA BOOSTER VACCINE. NO PREVIOUS HISTORY OF SEIZURES. TAKEN TO ER. FOLLOWUP RECOMMENDED. NO FURTHER SEIZURE ACTIVIY.
11 days after my second vaccination (which was 4/19-21), I woke up at 3 a.m. with severe vertigo and strong heart palpitations. These symptoms continued throughout the morning. I ultimately called clinic for advice and a triage nurse directed me to call emergency number. I did that and EMTs arrived at my home and found that my blood pressure was very high. I was taken by ambulance to hospital, where I remained for several hours while I was evaluated.
Information has been received from a physician concerning a 12 or 13 year old female who was vaccinated with all three doses of GARDASIL. The physician reported that the patient had not had her menses since administration of GARDASIL. Her last menses was "about 6 or 7 months ago", in approximately October 2010. It was reported that she may have received other vaccines in the last 6-7 months. Additional information has been requested.
On 05/02/2022 I took a PCR covid test at pharmacy since my son was coming home for the weekend which came back negative. The next day I had stomach cramps and diarrhea which I attributed to medication I'm on but I wanted to get tested again so I took another home test and that was positive. I did a second test which was negative, I then did a third which was positive again. I then began to isolate and called my doctor in the morning and had a telehealth appointment with a doctor. She prescribed Paxlovid for 5 days which has worked wonders. I have had no fever, loss of senses , or congestion. I've just been fatigued.
Purpura de Schonlein-Henoch, sweeling of blood vasels in legs,arms atomach.shortness of breath fatigue.Ichie./ prednisone 15mg/5ml,triamcinolone acetone cream 0.1%
The patient developed hives on her arms, legs, abdomen, chest and lips and experienced itching.
Patient is a 3-year-old female with no significant who was inadvertently administered a 0.2 mL of undiluted pediatric Pfizer vaccine yesterday. No adverse events are noted to date.
This spontaneous report was received from a registered nurse refers to a 29 year old male patient. No medical history was reported. On 11-APR-2013, the 29 year old patient was vaccinated with a dose of PROQUAD (merck) (lot#, expiry, dose, route not reported). No adverse effect reported. Additional information has been requested.
The diagnosis was sick sinus syndrome; This spontaneous case was reported by a patient and describes the occurrence of SINUS NODE DYSFUNCTION (The diagnosis was sick sinus syndrome) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 013L20A and 012L20A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, 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 experienced SINUS NODE DYSFUNCTION (The diagnosis was sick sinus syndrome) (seriousness criterion medically significant). At the time of the report, SINUS NODE DYSFUNCTION (The diagnosis was sick sinus syndrome) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Heart rate: 54. On 08-Mar-2021, Heart rate: dropped to 43.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  On 14Jan2021, she had the first dose of Moderna vaccine. Four days later on 18Jan2021, her heart rate was 54, which is very normal for her, at her doctor's office. On 8Feb2021, she got the second dose of Moderna. One month later on 8Mar2021, she went back to her doctor, and the heart rate dropped to 43. She had to wear a halter monitor, and her heart rate would drop to 30 at certain times of the day. Then on 21May2021 she got a pacemaker. The diagnosis was sick sinus syndrome. She is not saying that the Moderna vaccine caused this. She is reporting that all of this happened within a very tight window.  Company comment: This spontaneous case concerns an adult female patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of sinus node dysfunction (sick sinus syndrome). The event occurred approximately 1-3 months after the second dose of mRNA-1273. As reported, one month after 2nd dose of mRNA-1273, patient went back to her doctor, and the heart rate dropped to 43 (previously 54 after 1st dose of Moderna vaccine, described as normal for the patient). Patient had to wear a halter monitor, and her heart rate would drop to 30 at certain times of the day. Reportedly, 3.5 months after 2nd dose patient got a pacemaker. The diagnosis was sick sinus syndrome. The patient is not associating Moderna vaccine as the cause but reporting that all of mentioned happened in a very tight window. The patient received booster dose 6 months after pacemaker insertion. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a healthcare worker concerning a 2 month old patient who was vaccinated with ROTATEQ vaccine live (human-bovine). It was reported that the next day the patient developed diarrhea that lasted about a week. It was reported that the patient's stools were positive for rotavirus. Medical treatment and current patient status was not reported. A product quality complaint was not reported. Additional information was not available. This is one of two reports from the same source. Additional information has been requested.
pt recv vax w/2 doses of vax;pt eval revealed an antibody titer of less than 0.91, which considered non-immune;
Pt presented to clinic on 04/21/22 and received her prevnar 20 vaccine. She recounts experiencing chills, headache and 100.4-100.9 F fever for the first two days. On 4/24/22 she noticed swelling and redness at the injection site on her right arm. Her swelling continues to worsen. Reports her fingers have swollen to the point where she can no longer wear her wedding ring. Describes her arm is hard and tight. Denies any dizziness, SOB, fatigue, or chest pain. Pt has been treating her symptoms with tylenol, icing and massaging her arm. Denies adverse reaction to her first vaccine.
Arm pain at first, tiredness, fever, belly pain, fast heartbeat, dizziness, headache symptoms started approximately 14 hours after the vaccination, except the arm stiffness/pain which started within 2-3 hours. I ate and took 800mg of Ibuprofen. The next morning I was very tired. By the time I started my job at school I was getting colder and the nausea had started which turned to belly pain. I also felt woozy off and on. I visited the school nurse. She took my temp and I was sent home with a fever. I ate and took another 800mg of Ibuprofen. I went to bed. An hour later I checked my pulse which seemed to be pounding. It was 100 per minute laying in bed, not moving for an hour. A slight headache started in the late afternoon. I'm really wondering if I should take the 2nd dose in a couple of months.
Body aches - severe, tyleno eased Temp: 101 degrees - Tylenol sweats - uncovered, chills - covered - body as needed headache - Tylenol weak on standing - lasted about 24 hrs.
Received HAVIX, 1.0ml in left deltoid at 2:15pm and FLUVIRIN 0.5ml in right deltoid approx. 2:20pm.  At 2:35pm patient reported feeling "faint" , "anxious" and "a little tightness in my chest", vital signs: BP 140/60 sitting, radial pulse 100, respirations 20 breath sounds clear. 911 call initiated at 2:40pm, nursing supervisor and district nurse manager notified.  EMS arrival at 2:50pm, EMS Departure 3:05pm.  Pt remained alert and oriented throughout incident.
No additional AEs reported; Patient received booster shot of PEDVAX HIB too early / Patient received dose at 2 and 4 months and received booster at 6 months; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in January 2022 (reported as at "2 months"), the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis. The second dose was administered on an unspecified date in March 2022 (reported as at "4 months") (strength, dose, lot #, expiry date, and route of administration were not provided).  On 05-MAY-2022, the patient received a booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U034520, expiration date: 29-MAR-2024) 0.5 mL (strength, and route of administration were not provided) which was administered too early (Inappropriate schedule of product administration). No additional adverse events (AEs) were reported.
Expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number kg4m7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient was administrated with an expired dose of Infanrix, which led to expired vaccine used.  No adverse event was reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
10JUL91 noted lump @ site of DTP, no opening or scab present; 15JUL91 no change in lump but mom reported a small scab formed & fallen off; No redness or warmth noted; 17JUL91 seen by MD & culture done of drainage @ site; admitted to Hosp;