chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 2 days post vax, the pt reported experienced a severe headache and flu symptoms. He was seen in the ER on 8/30/00 where unspecified labs and cat scan of the head were performed. He was placed on antibiotics. As of 9/5/00, the events were slowly resolving.  Follow up on 02/21/2001: "Follow up was received from a physician.  His physician noted that the patient also developed myalgias, arthralgias, and a slight cough, noted as mild.  The physician felt the events were possibly related to Lymerix but also noted they may have been associated with an upper respiratory infection.  Information received from the physician on 02/08/2001 reported that the events resolved.  Arthralgias do not meet ICH serious criteria but are being submitted as an expedited report by special request per the 06/08/2000 letter.  The initial section of this report was submitted on 09/07/2000."
Chills, fever, headache, body aches. My arm had a 6 inch rash that was hot and itchy.  Sore arm. Fatigue.
AE filed as it has been greater than 37 days since first dose.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (AE filed as it has been greater than 37 days since first dose.).    Concomitant medication was not provided.  Treatment information was not provided.
pt recv vax 16APR96 & 26APR96 pt exp vesicular lesions some of which were fluid filled & fever;No further details were provided
Shortness of breath, hoarseness, tired feeling, headache; ibubrofen was taken and it helped some per patient.  Told to call doctor.
From telephone contact with reporting LPN hat a 5 year old patient received a Tripedia vaccination Lot # UO532DA administered in left deltoid on 08/21/01. The patient's entire  arm from shoulder to elbow became red, swollen and itchy. The next day 08/22/01 with a 19.5 cm area. Physician saw the patient and prescribed Benadryl and Keflex. By 08/23/01, redness, swelling & itchiness were relieved.
Nodule at injection site with redness. Itchiness and took Benadryl.  Rosacea also flared up.
Informaiton has been received from a female consumer with no known medical history or allergies who on 9DEC2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. Subsequently, the consumer reported that she developed very painful burning and inflammation on her arm. No further information is available.
Patient has been experiencing a headache and also mentioned that when she went to take a shower she almost passed out.
MODERNA COVID VACCINE #3 GIVEN 11/8/21, LOT #076C21A; 2/13/22 pt brought to ED with AMS; unresponsive, tachypnea, tachycardia; was intubated; pt had a positive COVID test on 2/12/22 at nursing home, but rapid COVID test was negative on admission; septic shock; metabolic and respiratory acidosis; given ABX, antivirals; experience cardiac arrest twice; pt expired after second cardiac arrest
Hospitalization due to COVID-19 Reported per Moderna COVID-19 Vaccine,
6X6INCH RASH ON RIGHT BICEP AREA. ITCHY AND SWOLEN, RED AND HOT NOT AT INJECTION SITE.
Cellulitis below area of needle pokes with area approximately 4 inches of induration. No symptoms of infection.
swelling at injection; fever 102F; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection), PYREXIA (fever 102F) and CHILLS (chills) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at injection), PYREXIA (fever 102F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling at injection), PYREXIA (fever 102F) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
Pt requested and received a second dose of this vaccination today 11/13/2023. She had received a dose of this vaccination on 11/1/2023.  It is possible pt was confused and was requesting an RSV vaccination. No adverse reactions were noted while in the clinic
The patient reports still feeling unwell from his covid booster he received on 12/7/2021.  He is worried about having to miss another day of work.  He says his symptoms started Wednesday morning at 5am and he was in so much pain, he could hardly walk until about 1pm that day.  He had a fever of 103.1 but has since gone down to 100.4.  He is still having chills but overall is improving from the worst of his syptoms. He is self treating with otc meds.  He reports experiencing a similiar reaction to his first COVID shot, which was Johnson and Johnson.  Pfizer was a booster for him.
no second vaccination taken; swelling of left side of neck; swelling of left arm (injection arm); swelling of lymph nodes in left armpit/swelling of left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (no second vaccination taken), SWELLING (swelling of left side of neck), VACCINATION SITE SWELLING (swelling of left arm (injection arm)) and LYMPHADENOPATHY (swelling of lymph nodes in left armpit/swelling of left side of neck) in a 22-year-old female patient 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, the patient experienced PRODUCT DOSE OMISSION ISSUE (no second vaccination taken), SWELLING (swelling of left side of neck), VACCINATION SITE SWELLING (swelling of left arm (injection arm)) and LYMPHADENOPATHY (swelling of lymph nodes in left armpit/swelling of left side of neck). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) at a dose of UNK dosage form and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL) at a dose of UNK dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (no second vaccination taken), SWELLING (swelling of left side of neck), VACCINATION SITE SWELLING (swelling of left arm (injection arm)) and LYMPHADENOPATHY (swelling of lymph nodes in left armpit/swelling of left side of neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) upper body.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Information has been received from a physician and a woman in the physician's office concerning an 8-year-old male who on 29-MAR-2000, at 3 years of age, was vaccinated with a first 0.5 mL dose of varicella virus vaccine live (Lot #632276/1454J). There was no concomitant therapy or illness at the time of vaccination. The physician reported that on 12-SEP-2005, the patient developed breakthrough chickenpox characterized by approximately 200-250 small lesions. Unspecified medical attention was sought. In September 2005, the patient's breakthrough chickenpox resolved. Additional information is not expected.
Left upper arm (deltoid) noted to be reddened and swollen with heat after DTaP given.
Patient states that he woke at 01:00AM on 03/02/2021  to go to the bathroom. He reports that he was unable to move his arms or legs and had to call out to his daughter to assist him. His daughter had to physically assist him with sitting up on the edge of his bed. Symptoms lasted approximately 15 minutes. When he regained use of his arms and legs he was unable to void or have a bowel movement.  Patient states that his symptoms have resolved and that he currently reports feeling fatigued.
Received first dose of COVID-19 Moderna vaccine on 11Jan2021 at approximately 1130. Patient did not experience any adverse reaction or any type of reaction the same day. The following day, 12Jan2021, at approximately 1800 after patient returned home from work, patient began experiencing slight foot pain on right foot, on the top of the foot. Before going to bed, around 2200, pain was slightly more intense, patient woke up around 0100 during the night, patient felt feverish and diaphoretic. Foot felt "tingly with burning sensation on top". Patient hydrated with water, went back to bed. Woke up at 0630, patient no longer felt feverish/diaphoretic, however, symtpoms have continued with right foot. Discomfort has not impaired ambulation.
Face swelling, eye swelling, right arm inflammation from elbow to top of shoulder to  the mid back.  bruise at injection site for 7 months.   The face/ eye swelling lasted for 3 months.  The eye swelling was severe enough that I could not wear contact lenses. I still have face swelling in my cheek on the left side of my face.  For my arm, I saw  an orthopedic doctor who ruled out any joint/tears/ bone issues and diagnosed  inflammation and recommended exercise and massage to reduce inflammation.
patient received first dose of GARDASIL 9 on 08/15/2017 and second dose of GARDASIL 9 12/20/2018; This spontaneous report has been received from a medical assistant referring to a 19 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 15-AUG-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis. On 20-DEC-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).
Patient called on 10/03/22 to report feeling pain in her right arm starting the evening of the date she received her influenza immunization (9/23/22). Patient states when she raises her hand, pain shoots down through the bicep down to the elbow. On 10/05/22 during a follow up call to check on the patient, the patient reported she has been taking Ibuprofen every 6 to 8 hours which relieves a little bit of pain but not much. The patient reported her right arm may be a little larger than the left but was not certain. The right arm is not red nor is it warm. Patient experiences the pain in the right arm when lifting her arm to chest level or above.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2), as dose number unknown, 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 "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid.  Clinical course: Reporter stated that she have an adult niece and an adult nephew who both recently tested positive for Covid. They had received the Pfizer vaccine.  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-202200846772 Different patients, Same reporter, drug, event.;
Fatigue, dizziness, headache, pain at injection site, generalized all over aches, nausea, backache
High temp up to 103-105 deg F for two days. Possible seizure for one min on 1/28/03 pm no more since than. UTI was noted on 1/31/03.
Body was okay after vaccination, ate, slept, then woke up in the afternoon with intractable crying for 1.5 hours. Right thigh slightly warm and pink. Rocked and fell asleep here.
Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red splotches over chest and neck. C/o difficulty swallowing and some GI upset. Began to shake uncontrollably. Initial BP was 149/99 and HR 118. O2 sats at 99%. Administered 25mg of benadryl and monitored patient for approximately 1 hour. After about 30-45 minute, her vitals stabilized at 120/80, Pulse 90, O2 at 100% on room air. D/C'd home at 1:32pm. 24 hours later patient c/o of hives and flushing off and on. Also complained of some GI upset and fatigue. Pt was able to return to work on 1/3/2021.
Dizziness, nausea, headache, and chest pain. Gave zofran and water. Did EKG that was abnormal. Sent to ED via EMS.
My vision was fuzzy/One of my co-workers also had this happen to her.; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:30 (Batch/Lot Number: EL9264) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 14:30 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included hypertension and concomitant medications were not reported. Known allergies to sulfa drugs, z pak. The patient experienced visual changes, her vision was fuzzy for a few days after receiving first and second dose of vaccine. First dose it was 2 days before vision was back to normal. After second dose, it was on the 4th day when her vision was back to normal. It took about 3-4 days before she was able to focus her vision like normal. She is normally near sighted and wear glasses. Her vision has now returned to normal. One of her co-workers also had this happen to her on an unspecified date with outcome of unknown.    Information on the lot batch number has been requested  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Suspected Vaccination failure; came down with shingles this week; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2021, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she took the shingles vaccine 2 years ago and the patient came down with shingles on the week of reporting. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation for shingles was not provided.
Fevers to 102 for 1st 2 days, lethargy. Fevers again day 5-7 after vaccine, then rash day 11 after vaccine plus still lethargic.
Pt has dizziness and then pass out at the office. She was kept for observation her; VS were stable and then discharge home. She still feeling dizziness after later phone call.
A nurse reported pt received vaccine on 11/13/00, the next day pt developed injection site reaction characterized by a 4" area of redness, warmth, and swelling.
Dizziness, Headache, Myalgia, Arthralgia & Fever Narrative: DAY 1-3 Injection site pain, temp of 99.8, chills,body aches,dizzy headaches. 2 weeks after vaccine reported temp of 99.8, chills and Body aches, unknown length of time.
This spontaneous report was received from a nurse practitioner regarding unknown patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with unspecified number of improperly stored doses of M-M-R II (lot# L040960, batch/lot# M008588, expiry dates and dosing details not known). The lot# L040960 was stored at 9.6 Celsius(C) for 46 hours and batch/lot# M008588 was stored at 9.6 Celsius(C) for 19 hours. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
The patient walked in to the pharmacy for a Janssen Covid vaccination along with family. Patient was advised post vaccination administration to sit in observation for 15 minutes but did not comply and as he was walking away from the pharmacy fainted. Parents reported he did not hit his head and pharmacy was alerted post fall of what had happened. We approached the patient as he was getting to his feet and we advised again for him to come back to pharmacy to sit in a chair for further observation. His parents told us he always has fainting issues post any vaccination or blood work (no prior issue reported to vaccinations on consent form). The patient continued to decline going back to pharmacy and as he walked fainted again, he was able to hold on to shopping cart which lessened severity of fall. Pharmacy staff advised him to remain on floor and after he regained consciousness he was able to answer accurately his name, where he was and what day of week it was. At that time a nurse not employed by Company was shopping near by and began to help care for the patient. The patient and his parents continued to decline calling an ambulance, and after several minutes sat against a wall. He was starting to sweat profusely and heart rate was rapid (approximately 145 bpm per nurse) so we had him remove his coat and provided a cool compress for his head and neck. He was breathing rapidly but was able to slow his respiration upon our direction. The patient did not seem to be improving and the nurse helping advised calling EMS which we did. The patient continued to lose consciousness for brief periods awaiting and during EMS aid. EMS ran the patients blood pressure, blood sugar nd ran an ECG prior to taking patient away to hospital (results unknown to pharmacy as we stayed in area to provide information on patient vaccination administration but had no active assistance  care at that time.
PT STATES SHE HAD PFIZER COVID VACCINE IN MARCH, 3 WEEKS LATER, PT GOT SHINGLES, AND 2 WEEKS AFTER THAT, PT GOT MONO. BOTH PRESCRIBER OF NUCALA, ALLERGIEST, AND GP PROVIDER ARE AWARE OF THIS.
Beginning approximately 2 minutes after receiving shot, experienced the following in sequential order: - Mild but Sharp pain (2-3 on pain scale) in my right elbow (same side as injection) - Slight lightheadedness - Sweating Profusely  - Extremely blurred vision - Muffled hearing/Deafness  I recovered within 10-15 minutes and was sent on my way by the paramedics.   Was not particularly nervous about getting the shot, and I don't have any history of fainting.   Felt perfectly fine the rest of the evening.
inflammation is right thigh, excruciatingly painful, started May 6, 2021, pain is still present. Was unable to drive so unable to work as usual, I did however do work virtually, but affected my life fairly significantly. Couldn't walk, used crutches, used a walker. Due to incorrect gait, I developed an issue with the IT Band on right leg and a Gluteus Mininus tear is the opposite hip which is painful.
On day 7 I started getting body aches  mild temp. On day 8 I had a fever of 101.8-102, while taking Tylenol.  I had ear pain, headache, serve fatigue, nausea and short of breathe while walking.  This lasted for about 2 days, then everything started getting better about the next 3 days.  During this time I had 3 Covid test and one Flu test, all were negative. Over the next three weeks, I was very fatigue and I had decreased exercise tolerance.
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
Severe Pain and swelling in left arm, started to get better after 5 days. Could not even lift the arm. Severe fatigue. Could not get out of bed for 3 days. Fever up to 102 deg. for 3 days.  Chills,  Nausea Headache
covid vaccine breakthrough case  dose 1 Moderna 1/27/21 007M20A dose 2 Moderna 2/24/21 010A21A
Headache, Myalgia, Fever, Palpitations & Tachycardia Narrative:
On 01/14/2001 the patient developed symptoms of varicella. The patient developed a rash on her face which then spread over her trunk, lasted 1 day with 10 spots altogether. On 01/16/2001 the patient was seen in a doctor's office and was diagnosed with varicella, with approximately 25 lesions on her body. It was noted that the patient recovered. No further information is expected.
Bladder infection; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received first dose of the Pfizer vaccine on 05Feb2021, however he may or may not had bladder infection for which he may or may not require antibiotics. He stated he does not believed that it was related to vaccine at all. He wanted to know whether antibiotics will have an effect on covid vaccine. He was informed on how to report AE for future reference. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.