chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nerve damage in her spine and both legs; Legs feel Heavy; Right shoulder was black and blue after receiving the injection; Had trouble walking / cannot walk without assistance; Leg felt numb; Leg was Weak; Slight temperature; Did not feel good; This case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included aortic aneurysm (Aortic aneurysm that required surgery on aortic valve two years ago from this December, 2019). Concurrent medical conditions included osteoarthritis.   On 29th August 2019, the patient received the 2nd dose of Shingrix. On 24th September 2019, 26 days after receiving Shingrix, the patient experienced lower extremities weakness of and numbness in leg. On an unknown date, the patient experienced slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. On an unknown date, the outcome of the lower extremities weakness of, nerve damage and heaviness in leg were not recovered/not resolved and the outcome of the slight temperature and feeling unwell were recovered/resolved and the outcome of the skin discoloration, numbness in leg and walking difficulty were unknown.   It was unknown if the reporter considered the lower extremities weakness of, slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration, numbness in leg and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Less tha 2 months after vaccination with dos eof Shingrix, The patient had slight temperature, nerve damage, feeling unwell, heaviness in leg, skin discoloration and walking difficulty. The reporter styated that, the patient had trouble walking so used walker to help to move around because, the patient thought might be the leg had gone to sleep. However, this has continued since then and both legs were involved. The patient could not walk without assistance. The patient notified to physiscian and ordered test for the patient. The patient had MRI with normal result and other tests which indicated that, the nerve damage in the patient's spine and both legs. The patient experienced slight fever and not felt good after vaccination for 1 day. The patient stated that, the right shoulder was black and blue after receiving the vaccination. The reporter stated that, the patient got lightheaded when gets up but had this before getting the vaccine. The reporter did not consent to follow up.      Lab Comments: On an unknown date lab test performed
Severe pain in region beginning 4 hours post injection - 72 hours after. Pain has lessened but still restricts movement and ability to perform basic functions (lifting, pulling).
Swelling of lower eyelids, cheeks and nose; This is a spontaneous report from a contactable physician. A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 20Feb2021 at 15:45 pm (Batch/Lot Number: EL9266) as dose number unknown, single dose for covid-19 immunization (at the age of 55-years-old). Medical history included asthma from an unknown date and unknown if ongoing and had known allergies from an unknown date and unknown if ongoing. Patient had not taken any other vaccine in four weeks and not received other medications in two weeks. The patient's concomitant medications were not reported. Patient had no covid prior vaccination. Patient had not tested for covid post vaccination. It was reported that on 21Feb2021 the patient experienced swelling of lower eyelids, cheeks and nose. Therapeutic measures were taken as a result of swelling of lower eyelids, cheeks and nose with steroids, famotidine and Zyrtec. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was not recovered from the events.  Follow-up attempts completed. No further information expected.
Illness >> May 3, 2021 11:52 AM reporter wrote:   Does the patient have current symptoms of illness? Yes    Date symptoms started: 04/29/21   1.         Does the patient have a fever (subjective or confirmed)? Yes (not currently)   2.         Does the patient have a new onset of cough? No   3.         Does the patient have a new onset of shortness of breath? No   Patient is also experiencing runny nose and sneezing   He did have first Covid-19 vaccine on 04/23/21   Please advise on scheduling Thank you
Flared up my chronic lower back pain, which flared up my nerve/sciatic pain. At its worse, it was so bad I couldn?t walk.
The patient remained in her chair for 5 minutes after the vaccine was administered. When she left the pharmacy she spoke to the pharmacist and was feeling fine. She went home and had a normal evening. The next morning (approximately 12 hours later) she began to have pain in her armpit and the underside of the vaccinated arm. She lifts moderately heavy objects at work so she left early to rest her arm. After 24 hours she visited with a physician about the pain and was diagnosed with a strained deltoid muscle. She was provided a prescription for naproxen and told to rest the arm for several days. At no time did she have a fever, experience shortness of breath or have any other symptoms other than the arm pain.
COUGH, WEAKNESS, BODY ACHES, DIARRHEA, SHORTNESS OF BREATH, MILD CHEST DISCOMFORT
"may have had blood clots" but this may not have been about her"; chest pain; "nausea"; "105 fever"; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS ("may have had blood clots" but this may not have been about her") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS ("may have had blood clots" but this may not have been about her") (seriousness criterion medically significant), CHEST PAIN (chest pain), NAUSEA ("nausea") and PYREXIA ("105 fever"). At the time of the report, THROMBOSIS ("may have had blood clots" but this may not have been about her"), CHEST PAIN (chest pain), NAUSEA ("nausea") and PYREXIA ("105 fever") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 105 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medication has been reported.  Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-278420 (Patient Link).   Reporter did not allow further contact.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question).    Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
pt tested positive for COVID 7/12/21 s/p 2 doses of Pfizer (2/26/21 & 3/19/21); received Regeneron infusion 7/13/21; of note, pt is immunocompromised d/t transplant and on immunosuppressants
Approx 2:10 pm, 01/19/10 Pt was administered a ZOSTAVAX vaccination. Pt passed the screening process and stated that she had not exhibited a reaction to any previous vaccinations. After vaccination she was advised that she needed to stay in the pharmacy for 15 minutes following the vaccination for observation. Approx 2:20 pm pt complained of dizziness. She was advised to sit in a chair. Over the next 5 minutes, her condition became worse. Initial assessment indicated marked anxiety, shallow/rapid respiration, confusion with out loss of consciousness, rapid/weak pulse, weakness, confusion and apprehension. Pt was placed in the shock position with legs elevated. EMS contacted and assistance was requested from the medical staff. In house emergency equipment was brought to the scene. Initial vitals, BP: 130/75, pulse rapid and shallow at the radial artery, carotid pulse in excess of 100. Resp: 64. Approx 2:27 staff RN and others arrived on scene with an EPIPEN, adult 0.3 mg and oxygen. Oxygen applied with mask at 4L per min, Pt increased in apprehension, pulse remained rapid, BP: 109/55, respirations rapid and shallow. Assumed anaphylaxis. EPIPEN administered anterior lateral thigh. 0.3 ml of 1:1000. Pt improved within 4 minutes. Approx 2:35 pm. EMS arrived. Patient respiration slowing, confusion and apprehension decreasing. BP: 185/95, resp:25, pulse not taken. Pass of to EMS. Pt was transported via ambulance to hospital ER. Held for observation and released after 7PM, 01/19/10. Pts practitioner, was consulted and told of pt's sisters report. That had several episodes of dizziness and ashen skin pallor while shopping. Pt's practitioner recommended that the patient make an appointment to be seen as soon as possible after release.
26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient received first booster dose. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-548975 (Patient Link).
Early menstrual period, heavier flow, painful cramps. I had not had a period in three months. Age 53. I haven't had cramps since I was 25
nurse gave a child ACT-HIB vaccine that was two weeks expired. with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via  Medical Information (Reference number- 00708642 and 00708732) and transmitted to Sanofi on 803-Aug-2021 in United States.  This case involved 4-month-old male patient gave HIB (PRP/T) VACCINE [ACT-HIB] that was two weeks expired (expired product administered)  The patient's past vaccination(s) included ACT-HIB on an unknown date in May-2021 with last dose.  Relevant medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination  On 02-Aug-2021, the patient received second 0.5ml dose of suspect HIB (PRP/T) VACCINE [lot: UJ354ABA and expiry date: (two weeks expired) 18-Jul-2021] (Frequency = once) (Strength = standard) (Form: solution) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  It was reported that, "Caller wanted to know if there was any time after an expired vaccine so that they do not have to repeat the vaccine".   This was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nausea, headache, extreme tiredness, muscle and joint aches, and chills.  Swelling and rash, soreness on injection arm.  Injection site warm to the touch.
Pfizer Bivalent vaccine for ages 5-11 was administered in error to patient. Patient was due for second dose of Pfizer primary for ages 5-11. A vial of the Bivalent vaccine was placed in the box for the Primary vaccines by another unknown employee on a previous date. The family was notified. Per CDC guidelines, no follow up treatment is due at this time. Also per CDC guidelines, the patient is able to be scheduled for Pfizer Bivalent booster dose in 8 weeks. Patient reports no reaction or symptoms besides the expected soreness at injection site.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-APR-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 408 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 248 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
After the shot I had a headache and on my left side my lymph nodes were large and painful. My doctor prescribed me a Z pack and 3 months after I noticed it was gone.
This spontaneous report was received from a physician via company representative refers to a 15 year old female patient. No pertinent medical history and drug reactions or allergies were reported. On 09-SEP-2016, the patient was vaccinated with GARDASIL (lot, expiry date, dose and frequency were unknown) intramuscularly. No concomitant medications were reported. On 09-SEP-2016, after receiving a dose of GARDASIL, the patient experienced syncope in the physician's office. The patient sought medical attention by contacting physician. The outcome was reported as recovered. The causality assessment was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.
Initial and follow-up information has been received from a nurse concerning a 16 year old male who on 22-JUL-1997 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 18-AUG-2008 at 2:57 pm, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) Lot number 660673/0332X, 0.5 mL, subcutaneously in the right thigh and the patient was also vaccinated with the first dose of HAVRIX IM into the left thigh, Lot # B264AA. It was reported that on 06-SEP-2009 the patient was experiencing fever and runny nose. In follow-up information the nurses reported that the patient's mother called on 10-SEP-2008, approximately 3 weeks post vaccination stating that on 06-SEP-2008, child's rash appeared on 3-4 locations on his chest, then several more appeared on his face. It appeared as spider bites. At the time of the initial information reported the patient was recovering. It was also reported in follow-up information that when the patient's mother reported the rash, the patient had no fever. At the time of the follow-up information reported, the outcome of the patient's rash was not reported. The patient sought medical attention, called the practice. Additional information is not expected.
Site: Redness at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Other- rash next to injection site-Medium
After being vaccinated, the patient presents rashes on both thighs, specifically in the area where the immunization is performed. The patient remains in the room for observation. It does not present any additional complication and a reduction in the rash which is observed. After several minutes waiting, mom is instructed to visit her pediatrician for follow up.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series.  52 days after 2nd dose.  Patient received 2nd dose of COVID vaccine on 2/12/21.  Tested positive on 4/5/2021.  NOT hospitalized. Unknown exposure type. Symptoms reported: diarrhea;  symptom onset date: 4/4/2021
Developed  intense hives and itchiness all over body. Would also get red spots and scratches. Started Zytrec and Pecid AC on day 2 and seems to control the hives and itchiness. Still take zytec 10 mg 2x day and Pepcid 20 mg 2x day. However, still get breakthrough dermatographia and red blotches. Unable to go off of the antihistamines.
HE START WITH LEGS PARALYSIS AND THEN CONTINUE COMPLETE BODY AND ARTICULATIONS PARALYSIS HE RECEIVED FAST TREATMENT IN THE HOSPITAL AND HE WAS IN THE HOSPITAL 3 MONTHS FOR RECOVERY AND 3 PLASMAPHERESIS TREATMENTS.
patient complained of chest pain, body aches, and felt like he was going to die.  Patient was advised to see his doctor or go to the Emergency Department, but declined to follow the advice given.
The pt received influenza vaccine during AM hours. The pt seemed fine for several hours but was found unresponsive by a neighbor that afternoon. Resuscitation efforts failed and the pt was pronounced dead at 17:52 on 11/14/00. Her death was felt to be sudden cardiac death with a history of diabetes and hypertension. Please not the date of the event, 11/14/01, is the correct date. The pt died on the same day he received influenza immunization.
Immediately after shot pain radiated from left deltoid region to elbow to hand. Patient had difficulty moving arm. Around 3 pm noticed slight swelling in that hand.
Left forearm diffuse erythematous area deltoid to elbow with diarrhea & vomiting.
54 YO F REVACINEE 7D POST-VAX FATIGUE, BACK PAIN, CHILLS, NAUSEA; PT HAD CARDIAC ECHO 11D PRIOR TO VACCINATION, F/U ECHO 19D POST-VAX; BEING FOLLOWED BY CDC CLINICAL TEAM, WORKING DX: FATIGUE.
p/vax pt exp inj site rxn;pt sought medical attention;p/a couple of days pt recovered;
Patient received the flu vaccination on 10/3/2020 and called doctor on 10/4/2020 about swelling on the upper left leg, thigh felt hard, no redness, limping on the left leg 2 hours after received vaccine. Patient was seen in the office on 10/5/20 with swelling on the left thigh and limping on the left leg still.
just a sore arm; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer reported for a female patient (friend) A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. he patient medical history and concomitant medications were not reported. The patient experienced just a sore arm at the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
This is a spontaneous report from a contactable consumer (patient) through a Pfizer sales representative. A female patient of an unspecified age and race received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced upper respiratory cold symptoms. She had no local reaction, no pain neither swelling. Clinical outcome of the adverse event was unknown at time of this report.
01/20/22 inpatient on IPR with "Pelvic abscess in female". PMHx of " colon adenocarcinoma on CHEMO , dyslipidemia, hypertension, remote cerebrovascular accident august of 2021 with Rt hand residual weakness , hypothyroidism"
Flashes of lights in my eyes, burning pain in my legs, my ankles were on fire. Totally fatigued, could hardly walk and had to walk with a cane and hold onto wall. Just plain pain all over, I felt nauseated but never threw up. I took anti-nausea pills and pain pills.
Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and eosinophilic esophagitis presenting s/p allergic reaction. Patient received his first dose of the Pfizer COVID vaccine around 17:30 today and states that he developed hives down his left arm and was having difficulty swallowing. He does have a known egg allergy and states that he has had prior anaphylaxis reactions to the flu vaccine. Patient was given PO Benadryl with complete relief of his symptoms. He has no complaints at this time and states that he feels "perfectly fine". At bedside for initial evaluation. Discussed plan for continued Benadryl throughout tomorrow and follow-up with his PCP. Patient is agreeable. Plan for discharge. The patient is comfortable with further observation of his symptoms at home.  I discussed our workup, answered all questions and made sure there were no other concerns.  I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.