chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 1st dose, 2 weeks after, Pain in right arm with tingling in right hand  After 2nd dose, 1 week after, experiences full paralysis of right side (arm and leg) and trunk, 80% paralysis on left side (arm and leg)   Diagnosed with Tranverse Myelitis, Inflammation of my Cervical spine, C2-C7
Department of Health mass immunization clinic at elementary and high school to provide meningococcal vaccine in a large group setting.  Patient received vaccination at 10:00 am was monitored in the same area for 20 minutes post vaccination.  Patient went back to class.  Teacher called school nurse up to room at 11:00 am. Stating child was light headed.  School nurse immediately call 911 and brought child back to immunization area in stretcher/chair.  VS: Pulse 68.  Patient semi in and out of conscious.  Ambulance arrive. Parent called by school nurse.  School nurse escorted child in ambulance and transported to hospital. Pt same day transfered to another Hospital. 6/24/08-records received for DOS 4/30/08-C/O pain in right upper arm after vaccine. Dizziness when standing up after vaccine. Some weakness in legs. While at school pushed by another student and had mild bump on head no LOC. PE:WNL, upper extremity (R) at injection site mild edema, tenderness. Neuro exam WNL. Assessment:probably reaction to injection now fine
On 11/27/21, Patient presented to clinic to receive both Pfizer COVID booster vaccine (after receiving J&J COVID vaccine 06/05/2021) as well as flu vaccine. Pt was sitting in chair and became nervous before vaccine administered. Denied any issues with prior vaccines. After Flublok vaccine was administered in left deltoid at 4:11pm, pt quickly became pale and clammy. Pt continue to have vasovagal response, but provider able to hold patient up in chair. After only a minute, patient able to speak but still felt clammy with tingling in hands and light-headed. Pt was told to lie down on exam table with feet up and cold towel placed on forehead. Pt was able to speak but was told to rest for a bit. Door left open so staff could assist as needed. After 10 minutes or so, patient stated he still wanted to receive COVID vaccine booster. While pt was lying down, Pfizer booster administered in right deltoid. Pt did not have vasovagal response and radial pulse remained strong and regular. Pt was told to remain reclined for a few more minutes. After an additional 10 minutes or so, pt able to leave clinic with steady gait.
Injection site red, raised, warm/hot to touch. Area 2 inches diameter. Ice applied to area. Advised to see provider if not better in 24 hrs.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 30-OCT-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot# and dose not reported) which was expired on 19-OCT-2014. No adverse effects were reported. Additional information has been requested.
Pt with hives, pruritic, raised rash over extensive surface's arms and legs, neck, and back and face with response to benadryl.
Pt recvd vax & esp extreme soreness; Because of this experience, the 2nd dose was administered SC;
01/01/2022 History of Present Illness  The patient presents with altered mental status. The pt was said to have garbled, incoherent speech multiple times throughout today starting at around 0400. Speech was described as mumbled or as if pt had a very dry mouth which has recurred throughout the day. EMS assessed the pt and found him to be well-oriented and thusly elected to have him sent to the ED. Pt now said to have returned to his baseline. Last night the pt had an episodes of weakness described as "too weak to sit up".
7/21/2021  Patient showed up at vaccine clinic wanting a 2nd dose of J & J vaccine .  Patients vaccine card shows 1st dose J & J at mobile transit  clinic 3/26/2021 vaccine  card has written medical error on it on that date .. This person writing report unsure if received a  full dose 3/26/2021 or or any  dose or any part of a dose.  Covid Vaccine Branch Manager and Clinic Site Manager ok'd patient to receive an full dose J & J  7/23/2021.
Patient is a 58 year old female who began having shortness of breath, nausea, extreme headache and coughing 10 min after receiving her JJ COVID-19 vaccination.  She was brought in to the Urgent Care, noted to be having an allergic reaction and was immediately given 50 mg of Benadryl, 8 mg of ondansetron and observed for 5 min.  She continued having worsening symptoms with coughing and shortness of breath, 125 mg of Solu-Medrol were given IM and she was placed on 12 L O2 non-rebreather mask. The patient reported feeling progressive throat tightening and chest tightness and her coughing fits increased.  Epinephrine 0.3 mg was administered to the left lateral thigh and the EMS system was activated.  After the epinephrine her symptoms improved, however did not fully resolved.  EMS arrived  Within 10 min and received report transporting the patient to ER for further evaluation.
Pt woke on 10/12/01 with a red area on left thigh. Throughout the day, area became indurated, very dark red and is appearing to blister. Pt was to see private MD on 10/12/01.
Became red, irritated at injection site on right shoulder and eventually a small nonhealing wound appeared which slowly grew in size
Muscle pain; swelling of upper arm; body aches; headache; chills; slight fever; This is a spontaneous report from a contactable consumer reported for himself. A26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 12Jan2021 16:00 at single dose for COVID-19 immunisation. The patient received the vaccine at workplace clinic. Medical history included Penicillin allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced muscle pain and swelling of upper arm, body aches, headache, chills, slight fever on 12Jan2021 23:30. No treatment was received for the events. The events did not result in Emergency Room visit or physician office visit. The outcome of events was recovered.   Information on the lot/batch number has been requested.
ARM HURT; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm hurt, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and headache on APR-2021. This report was non-serious.
I experienced painful swollen lymph nodes, high fever 102, fatigue, and I missed 2 days of work. My symptoms lasted for a week, and I'm having recurrent swelling in my lymph nodes that my doctor has attributed to the vaccine. My Doctor stated I had reactive over sensitive lymph nodes post vaccine. The recurrent swelling in my lymph nodes has been at random intervals since the vaccine.
Pt reported fever of up to 100-101 with muscle aching, chills and pain at injection site (shoulder) 2 days after receiving vaccination.  Pt has received several other vaccines (i.e. cholera, yellow fever, etc.) but has never experienced symptoms before.  Pt has received pneumonia vaccine previously in 2002 with no complications.
Feverish, sweaty, (L) arm- warm, red, swollen - 11 x 11 cm, site itchy
Shingles - Herpes Zoster rash affecting forehead, scalp and left eye Tx: Valcyclovir, Gabapentin, Tramadol
quadruple bypass; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: CORONARY ARTERY DISEASE (medically significant), outcome "unknown", described as "quadruple bypass".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stood up from mtrs lap, with 1 min after vaccination pt fainted, caught before hitting floor by nurse. while lying on floor, pt experienced violent head shaking of arm less than 5 secs. BP 100/60, coke given alert within 1 min left within 30 min.
Swollen area to Left thigh area, now 12 days post vaccination with DTAP #4, Flu #1 to that leg.
I had fatigue 2 days after the vaccine.  My fatigue was getting to the point where I couldn?t work.  The next day I had pain on my left side in my chest and arm.  I started to have severe chest pains.  I went to the ER; they did an EKG.  They gave me heparin due to maybe having a blood clot.  They ran some other test, and they found an infusion.  I was admitted for 5 days to run tests.  My pain level was severe.  Once my inflammation went down evenly.  I was discharged to go home but I have to follow-up with a pulmonologist.  I have had high blood pressure and tachycardia in the hospital, I was also on oxygen.  I may have to go on FMLA due to not being able to go back to work at normal capacity.  I still have pain I my left shoulder and my left side of my chest.  I had a course of antibiotics that I took which was 10- days.  My bladder was inflamed and both my lungs.  I was diagnosed with partial lung collapse on the left and right due to fluid on the lungs.
Fever, chills, muscle aches, and headache. Symptoms caused insomnia. No treatment. Symptoms subsided in 16 hours.
Starting Friday 01/22/2021: Hives, Rash, Itchy hands by Sunday 07/24/2021 felt that she had internal burning on her hands and difficulty breathing - went to ER was given Magnesium and Benadryl and started on steroids. Tuesday 01/26/2021 her legs developed red welts and she could not feel them, had numbness and more difficulty breathing and went back to the ER. She was told that if it does not get better and she goes back that they will admit her to the hospital.
pt recvd vax; pt arm swelled at inject site & was hot to touch; pt arm ached from shoulder to wrist; when pt had 2nd & 3rd dose same rx occured & arms were very painful;
Patient is a 92 year old male who has past medical history significant for full vaccination with COVID vaccine a few months back. Patient also has history of essential hypertension. He also has past medical history significant for history of dyslipidemia and prostatic hypertrophy. Patient comes into the hospital for the reason of shortness of breath. He claims that he has been having cough and fever for last few days and has been increasingly short of breath. He was evaluated ED for the same reasons as he was brought to the hospital and was noted to have COVID positive status and was recommended admission. He was also hypoxic and his sats were in low to mid 80s on room air. He denies any chest pain. Denies any loss of sense of smell or taste. He denies any relieving and aggravating factors and he thinks that he might have been exposed to COVID at charge upon further questioning.  He does have dyspnea on exertion and no significant orthopnea otherwise.
Redness, swelling, pain, limited range of movement to Left upper arm at site of VARICELLA injection, antibiotics, steroids reported on 7/4/16
booster; had received positive COVID tests; had received positive COVID tests; This is a spontaneous report received from a non-contactable consumer from a sales representative. The reporter is the patient. A 50-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant), outcome unknown; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome unknown. The patient underwent the following laboratory tests and procedures COVID tests positive. Reporter was male and relayed that he and his wife have been vaccinated with Comirnaty, 2 doses and booster. But had received positive COVID tests. Symptoms are mild and resolving.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s) US-PFIZER INC-202101850213 different patient, same product, and events.
Fever 102.5 for 2 days. Mouth and tongue swelling like anaphylaxis
shingles outbreak; This is a spontaneous report from a non-contactable consumer. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included lung issues and rheumatoid arthritis with rheumatoid factor of multiple sites from an unknown date and unknown if ongoing. Concomitant medications included tocilizumab (ACTEMRA) taken for an unspecified indication, start and stop date were not reported. On the week after vaccination, it was reported that patient experienced shingles outbreak. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial unsolicited report received from nurse on 26-Oct-2015. This case involves a 25-year-old female patient) who was vaccinated with an intramuscular dose of Fluzone QIV (batch number- UI463AA, expiry date- 30-Jun-2016) in left deltoid on 26-Oct-2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Other medical history and concomitant medications were not reported. On 26-Oct-2015, 40 minutes after vaccination, neck and stomach were reddened. Patient did not experience hives, difficulty breathing and other symptoms. Patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: none. Follow up information received from nurse on 26 February 2016. On an unspecified date, following the vaccination, the patient had experienced rash. The patient had received Benadryl, Pepcid and prednisone as corrective treatment. On 26 October 2015, the patient was recovered from events.
Left ear tinnitus; This is a spontaneous report from a contactable Consumer (Patient). A 39-Year-old Male patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot/batch no: EP7534) via an unspecified route, administered in to Left Arm on 2 16Mar2021, 12:30 PM as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant drugs were taken, but the medications prescribed were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and didn't had a COVID-19 test since vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and he is not Allergic to medications, food, or other products. The patient experienced Left ear tinnitus on 16Mar2021, 10:00 PM. No therapeutic measures were taken for the event. The clinical outcome of the Left ear tinnitus was not recovered. No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse practitioner concerning a 13 year old female who on 05-Jan-2008 was vaccinated IM with a first dose GARDASIL (Lot #6553271/1287U) "in the glute." Shortly after vaccination the patient experienced arm pain, joint pain, and chest wall pain. On 01-MAR-2008 she was vaccinated IM with a second dose of GARDASIL in the deltoid. The patient did not inform the physician of the adverse events associated with the 1st dose until after the administration of the 2nd dose. The "pain was still there from the 1st dose when the 2nd dose was given." The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
After receiving the vaccine, she verbalize feeling different in her head and headache.  She was evaluated onsite by Fire Rescue and Dr. onsite and released home at 10:50 am feeling better.
This spontaneous report was received from a pharmacist refers to a 21 year old female patient. The patient was a chronic, every day cigarette smoker and had no known drug allergies. On 05-AUG-2015, the patient had an uncomplicated cesarean section. On 06-AUG-2015 (also reported as her first day postpartum), the patient was vaccinated with PNEUMOVAX 23 (dose number, route and lot # were not reported) by an unspecified healthcare provider. Concomitant medications were none. On 06-AUG-2015, the patient experienced a fever of 101.1 F with redness, warmth and swelling at the unspecified injection site within 12 hours of receiving the vaccine. The patient sought medical attention and was treated with antibiotic gentamycin and clindamycin. The patient's fever and redness, warmth, and swelling at the unspecified injection site improved with antibiotic treatment and the patient was discharged at the normal length of stay for an uncomplicated cesarean section (length of stay and discharge date was unspecified). The outcome of the events was reported as recovered/resolved. The reporter did not provide the causality between the events and the suspect therapy. This is one of the several reports received from the same reporter. Additional information has been requested.
Dermatographia, Dysphagia; Treated with Prednisone, Loratadine, Famotidine.
Patient reported feeling dizzy  12 minutes following vaccine. Patient sitting in chair. Vital signs assessed: 0915 - BP 106/72, HR 90, O2 sat 96%. 0921 - BP 112/61, HR 85,O2 sat 97%. 0927 BP 107/62, HR 87, O2 sat 98%. Patient assessed by his PCP who works onsite. MD had patient taken back to an exam room to lie down and be monitored.
You were due on March 30th and took a required COVI19 test the day before surgery. There had been no symptoms or signs of being COVID-19 positive and I was surprised that, I was positive. I did have the coughing but it seemed more like a cold, I had a small sore throat but it was not enough to really bother me. I did have a slight fever but never really that bad. Had I not been tested for the surgery purposes I would not have known I was coming down with COVID-19.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2006 (date as reported), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health care facility/office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated (by an unspecified health care professional) at a health care facility/office for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Left axillary lymph node swelling after 1st day. Subjective fever and chill after 1st day. 1-2nd day with left deltoid pain, stiffness at injection site. 2nd day with reddened raised wheals 4-5 areas around injection site about 1cm. TYLENOL given, warm compresses.
extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HAV (Havrix) (batch number 943Y2, expiry date 05-MAY-2025) for prophylaxis.   Previously administered products included Havrix (dose one was given on 8th July 2022) and Havrix (dose two was given on 9th January 2023).   On 06-JUL-2023, the patient received the 3rd dose of Havrix. On 06-JUL-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 Medical Assistant stated that a patient was inadvertently given a third dose of Havrix in error, which let to extra dose administered. The vaccine administration facility was the same as primary reporter. No further details given, and medical assistant did not consent to follow up from safety.
doses were frozen and then rethawed; it was frozen, rethawed, and administered to patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (doses were frozen and then rethawed) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (it was frozen, rethawed, and administered to patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses were frozen and then rethawed) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (it was frozen, rethawed, and administered to patient). At the time of the report, PRODUCT STORAGE ERROR (doses were frozen and then rethawed) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (it was frozen, rethawed, and administered to patient) outcome was unknown. Not Provided      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.   No concomitant and treatment medications were reported.