chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt experienced a macular, papular rash with edema to left arm. Herpes culture pending. Facial rash was also experienced. Possible urticarial reaction
Extreme arm soreness that got progressively worse throughout the day, becoming so bad that I could not lift my arm, and had difficulty sleeping.  The pain receded the next day, but has ebbed and flowed since November 2021.  At the moment, I have difficulty lifting objects and even pulling up my pants without pain in that left arm, approximately at the location of the injection.  Exercising the arm (even doing house work) seems to exacerbate the problem.
pt. vax'd w/ 1st dose of hepatitis B vac. & exp. paresthesia of left buttocks,thigh,& vagina w/ fever,emesis & left leg weakness.difficulty walking up stairs,& burning sensation of left leg.
p/vax pt devel diff breathing, chest & throat tightness, eye pain, nausea, h/a & multiple red wheals on effected arm which extended to back;tx w/DPH;pt still exp intermittent chest tightness that goes into throat along w/occasional nausea;
This spontaneous report as received from a Registered Nurse concerning a 6 month old patient on 14-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Redness, swelling, hot to touch. Got worse from day 2 until day 4 when I went to urgent care. I was given an antibiotic and steroid. This happened with my first dose but was much more delayed.
Hives all over my body, like a rash and they kind of turned into hives; Hives all over my body, like a rash and they kind of turned into hives; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), second dose via an unspecified route of administration on an unspecified date single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on an unspecified date single for covid-19 immunisation. On an unspecified date the patient experienced hives all over body, like a rash and they kind of turned into hives. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
improperly stored (48.0F) and was administered; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number ABXB26AB, expiry date 20th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 age at vaccination was not reported. Nurse reported that one dose of Bexsero was improperly stored on 18th November 2021 (at 48.0 degree F for 1 hour 26 minutes and 0 seconds) and was administered to the patient on 22nd November 2021, which led to incorrect storage of drug. Permission to contact the patient's physician was provided.  No further information was provided.  No product quality complaint was reported.
Ongoing breakthrough bleeding and spotting since time of vaccination. Light red to brown discharge, with only 1-2 days break between periods of bleeding. 5 months later and still the case. Uterine cramping, with an increase in pain with exercise.
CHILLS,FEVER, BODY ACHES,FEELING LIKE THE FLUE, HEADACHE, FOR OVER A WEEK.  EYES STARTED NOT BEING ABLE TO FOCUS-BLURRED VISION AND BURNED-WITH THE FACE FEELING NUMB ON THE LEFT SIDE. SENT TO SEE AN EYE DOCTOR, ALSO FOR MRI OF THE BRAIN, AND HAVING TO DO ANOTHER  MRI OF THE BRAIN.,
On Saturday prior our children started feeling not well. I then felt off and stuffy. By that day I was able to start PAXLOVID. I had a little fever, congestion, and little achy. I just didn't feel well.
Adverse events occurred after Christmas Day, 2021 and before New Year's Day, 2022:  Woke up in morning with the following adverse reactions:  sore throat, esophageal tightness, chest tightness, scalp and ears:  tingling, burning, itching, red, swelling, hives followed by the same on my upper and lower torso, arms, hands, legs, thighs, feet and face.  All symptoms intense - from a number standpoint, 10's across the line.  I then noticed extreme fatigue, blurred vision and joint pain in my knees and fingers.  On day two of these symptoms I went to Urgent Care and was prescribed 5 days of prednisone, Benadryl and topical anti itch cream (cortisone and calamine).  I am still experiencing all of these symptoms as of today (1/31/2022).  After 3 days of still experiencing the symptoms with no relief, I went to ER.  My treatment consisted of intravenous water, Benadryl and steroid.  Prescribed more steroids and Benadryl for home.  Still, nothing.  Symptoms remained.  Decided to go again to ER because of no change and was given the same thing and told there was nothing else they could do - told to make an appointment with doctor and allergist.  Made appointment with family doctor and was put on Dosapin a medication used for depression.  Doctor told me that he was getting one or two people a week coming in with the same symptoms as was told that it could be from vaccine and that his some of his patients were having luck with this medicine.  I was told to take for three months and then come back for follow up.  The dosapin helped a bit but put my entire body on lock down, mentally and physically, I could not do anything except sleep and felt like I was not coherent at all.  I immediately called the doctor and he said to go off it and take Benadryl and anti itch cream and prescribed me to also take Zytec.  Nothing was relieving my symptoms still!  I decided to go to an allergist, whom I found out, suffered the same symptoms!  The doctor prescribed me what he took - Benadryl, Zyzal, Zyrtec, Pepcid and anti itch creme (cortisone and calamine).  I also made an appointment, per his request, for allergy testing.  I was told that I had to go off all histamines for 7 - 10 days prior to testing.  I was on my second day of not taking the histamines and I felt like I just wanted to die!  All of the above symptoms were multiplied by 2 - they were so intense and unbearable.  I called the testing site and told them I would have to wait until I was cleared up due to the face that my symptoms were so unbearable without the antihistamine medications prescribed.  As of today (1/31/2022), I am still having the same symptoms - they come and go and decide where they want to go on my body - there is no relief.
Information has been received from a nurse for the pregnancy registry for GARDASIL, concerning an 18 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who on an unspecified date was vaccinated with the first dose of GARDASIL. On 27-MAY-2008, the patient was vaccinated with the second dose of GARDASIL. On 26-NOV-2008, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included YAZ. It was reported that the patient was subsequently determined to be pregnant. Last menstrual period was the end of October 2008 and estimated date of delivery was 07-AUG-2009. At the time of the report the patient had a urine pregnancy test done. No problems reported. The patient sought medical attention. Follow up information was received on 13-FEB-2009 from a Licensed Practical Nurse concerning a female patient who on 27-MAY-2008 was vaccinated with the first dose of GARDASIL (Lot # 660389/1968U). On 29-JUL-2008 was vaccinated with the second dose of GARDASIL (Lot # 660620/0571X) and on 26-NOV-2008 received the third dose of GARDASIL (Lot # 660618/0572X). It was reported that the patient had no previous pregnancies. Last menstrual period was on 15-OCT-2008, estimated date of conception was 31-OCT-2008, and estimated date of delivery was 23-JUL-2009. On 31-DEC-2008 an ultrasound was performed (normal results). Follow up information was received from a Licensed Practical Nurse (L.P.N) concerning an 18 year old female patient with no previous pregnancies or concurrent conditions reported who on 27-MAY-2008, 29-JUL-2008 and on 26-NOV-2008 was vaccinated with the first, second and third doses of GARDASIL (Lot # 660389/1968U), (Lot # 660620/0571X) and (Lot # 660618/0572X) respectively. Concomitant therapy used during the pregnancy included doxycycline and MACROBID 100 mg twice a day for vaginal infection, YAZ for birth control and ZOFRAN for nausea and vomiting. It was reported that an ultrasound was performed on 31-DEC-2008 and it showed that was within normal limits. On 10-FEB-2009 a Maternal Serum Alpha-Fetoprotein test (MSAFP) was performed and it was within normal limits. On 01-JUL-2009 another ultrasound was performed and it was determined that the baby was slightly small for gestational age. On the same date, 01-JUL-2009, it was determined that the Amniotic Fluid Factor (14) was within normal limits. On an unspecified date a Maternal Serum Screen 4 test was performed and showed that it was within normal limits. The patient experienced episodes of dizziness during pregnancy but there were no complications during labor. It was reported that on 15-JUL-2009, at 39 weeks of gestation, the patient delivered a normal female baby (weight 5 Lb and 11 ounces, apgar score were 8 at the first minute and 9 at the 5 minute). It was reported that there were no congenital anomalies. Additional information has been requested.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. Post vaccination the patient had sore arm. This case was linked to another case US2020AMR003672 reported for the same patient (2nd dose).
Six days after receiving the live zoster vaccine I started to develop a cold sore.  Of course, I can't swear the events are related, but I am not normally prone to cold sores and probably haven't had one in the last twenty years.  I promptly called my doctor and got a prescription for Valtrex which I took and the cold sore, which had already started to blister, seems to be healing nicely.  Just wanted people to know this occurred.
Infanrix vaccine administered prior to four to six month interval. Administered at 3mo, 1weeks. No adverse reaction from patient.
trouble breathing, rash all over my body, passed out for 10 days straight, couldn't eat, chest pain, could not use toilet for 15 days, weak for almost 2 months, rapid heart rate, trouble keeping fluids down, elevated temp for 15 days, dizzyness for 15 days, couldn't take prescribed medication, couldn't take any over the counter medication, trouble speaking and being understood, extreme anger for 15 days, took almost 2 months to recover from
Sore arm, headache, decreased appetite, body aches, hot and cold flashes with sweating
Client received a dose of Janssen &Janssen COVID vaccine on 8/30/21 at 1:30 PM that had frozen in transport and experienced a temperature excursion. RN called and informed client. Client denies any issues. APRN reached out to Johnson and Johnson in regards to the temperature excursion and dose being administered from vial that experienced excursion. Johnson and Johnson have conducted an investigation and determined that there is no harm in administering a dose of Janssen & Janssen COVID vaccine that has experienced as temperature excursion like documented in this case, but stated the dose administered may not be as effective due to the excursion. Johnson and Johnson stated that nursing staff may use clinical judgement to determine if a second dose is needed. After speaking with the client the client declined wanting and additional dose.
10OCT91 vax recvd & 12OCT91 sore arm, h/a, fever, chills; MD put on symmetrel x 5 days; 25OCT91 stated temp down very weak could not stop coughing; Prescribed med by MD;
Redness and swelling in arm within several hours; hard lump and feverish type sweating persisting for 3 days. Family physician recommended taking Tylenol or Alleve or something similar to treat symptoms.
Given Varivax and given Hep A with incident. Sister passed out. Then patient became dizzy and pale. Laid down and color and dizziness improved after 5-10 min. Pulse reg. No LOC.
The day following the vaccination I woke up with severe arm pain 2 inches down from the injection site. My arm had swollen about 3 inches in diameter. It was so painful that I could not roll over, I could not lift my arm, and I was in inconsolable tears. It was a deep stinging pain, as though I was repeatedly being stung by a hornet. My left hand was going numb off and on. I went to the doctor because I was incapable of lifting my arm, and the doctor identified that my lymph nodes and my left ear were swollen and enlarged. He recommended ibuprofen and ice for the lump. The second day after receiving the vaccine I had a mild headache, and my arm was only slightly swollen. The third day after receiving the vaccine my arm was still slightly swollen and sore, but the pain was manageable without pain medication. The fourth day after receiving the vaccine I woke up with a deep cough and dizzy spells lasting throughout the day.
Reactive axillary lymph node / it is no longer visible/ enlarged lymph node; Lymph node / which was painful; My temperature peaked at 101.7; Fever symptoms / achy joints; Fever symptoms / sensitive skin; Fever symptoms / tremendous headache; Fever symptoms / chills; Experienced redness / at the injection site; Experienced / swelling / at the injection site; Experienced / pain at the injection site; Injection site / itchiness; This case was reported by a other health professional and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of injection site pruritus (1st dose received on unknown date, refer case US2021AMR069495).   On 18th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injection site itching, fever, joint pain, sensitive skin, headache and chills. On 20th March 2021, the patient experienced lymphadenopathy axillary and lymph node pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain, injection site itching, lymphadenopathy axillary, lymph node pain, fever, joint pain, sensitive skin, headache and chills were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injection site itching, lymphadenopathy axillary, lymph node pain, fever, joint pain, sensitive skin, headache and chills to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. After receiving 2nd dose of Shingrix vaccine patient had quite a robust immune response, that included temperature peaked at 101.7, and had all the usual fever symptoms, including achy joints, sensitive skin, tremendous headache, and chills. Additionally, patient experienced redness, swelling, and pain at the injection site, followed a few days later by itchiness. Two days after the vaccination patient also experienced a reactive axillary lymph node, with it being larger than a golf ball and visible through her skin, and which was painful. The size of the lymph node had decreased to less than pea sized, and although patient could feel it, it was no longer visible. The patient knew that these were all part of an immune response, but she did not find anything on company's website about the itchiness or the enlarged lymph node, so wanted to report it to GSK (not as an adverse reaction, since although she felt pretty cruddy she knew it was just her immune system doing what it was supposed to do). The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069495:Same reporter, Same patient. 1st dose.
first dose of Modernas COVID vaccine on 17Apr2021 and received Pfizers COVID vaccine yesterday, 19May2021; first dose of Modernas COVID vaccine on 17Apr2021 and received Pfizers COVID vaccine yesterday, 19May2021; vertigo; throwing up; severe pain on the left arm (where vaccine was administered); This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19May2021 as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of MODERNA COVID-19 VACCINE (Batch/Lot number was not reported), on 17Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On 19May2021, the patient experienced first dose of Moderna's covid vaccine on 17Apr2021 and received Pfizer's covid vaccine yesterday, 19May2021, on an unspecified date in 2021 patient experienced vertigo, throwing up, severe pain on the left arm (where vaccine was administered). Patient wanted to know if this was something he should be concerned about or if this is normal and clarified if these side effects are normal even if he had received a Moderna vaccine as the first dose. The outcomes of events were unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Pt had immun 9AM w/APAP, w/APAP fell asleep x 2 hrs then woke up screaming @ 11AM & had fever of 101; pt screamed more than 3 hrs, but mom didn't call MD because grandma is RN & was not alarmed;
Sore arm up into neck, headache,  racing heart that felt like I could pass out, fatigue, heart palpitations frequently, tongue went numb, and burning sensation in hands and fingers, with joint stiffness.
fatigue; chills; mild fever; muscle aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3 unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 26Sep2023, outcome "recovered" (2023); FATIGUE (non-serious) with onset 26Sep2023, outcome "recovered" (2023); PYREXIA (non-serious) with onset 26Sep2023, outcome "recovered" (2023), described as "mild fever"; MYALGIA (non-serious) with onset 26Sep2023, outcome "recovered" (2023), described as "muscle aches". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia, myalgia.  Additional Information: This was the patient's fourth dose of COVID-19 vaccine. The patient did not experienced COVID prior to vaccination and was not tested for COVID post vaccination. Events were reported non-serious, did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating nor resulted to congenital anomaly/birth defect.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
headache; feeling like finger prick in his right hand; woke up in the middle of the night perspiring; his right fingers are purple every time; Strong pain on his right fingers; chest pain; difficulty breathing; red spot in his finger; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feeling like finger prick in his right hand), NIGHT SWEATS (woke up in the middle of the night perspiring), SKIN DISCOLOURATION (his right fingers are purple every time), PAIN IN EXTREMITY (Strong pain on his right fingers) and CHEST PAIN (chest pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scleroderma (Diagnosed with scleroderma five years ago.) since an unknown date. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), AMLODIPINE and OMEPRAZOLE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA (feeling like finger prick in his right hand), NIGHT SWEATS (woke up in the middle of the night perspiring), SKIN DISCOLOURATION (his right fingers are purple every time), PAIN IN EXTREMITY (Strong pain on his right fingers), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing) and RASH MACULAR (red spot in his finger). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Headache, at an unspecified dose and frequency. On 21-Jan-2021, CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing) had resolved. On 24-Jan-2021, NIGHT SWEATS (woke up in the middle of the night perspiring) had resolved. At the time of the report, PARAESTHESIA (feeling like finger prick in his right hand), SKIN DISCOLOURATION (his right fingers are purple every time), PAIN IN EXTREMITY (Strong pain on his right fingers), RASH MACULAR (red spot in his finger) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Severe ringing in ears started about 12 hours after shot. That lasted about 2 hours and then became loud ringing in ears and headaches.
Left thigh redness, warmth - appears like cellulitis/abscess with some induration. Treat with Keflex and Clindamycin.
Customer received two doses of Moderna Bivalent Booster in error on the following dates: 10/9/22 and 1/6/23.  She reports no adverse effects or events following vaccination when speaking with her on 1/6/23 or on follow up on 1/7/23.