chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very adnormal and not right; could not stand or dress myself.; Dizziness; Hypersensitivity reaction; body aches; headache; nausea; Chills; 103 degree fever; Fatigue; Severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain), FEELING ABNORMAL (Very adnormal and not right), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to nuts (Reactions - Itchiness, Throat tightening/constricting, esophagus pain, stomach pain, vomiting), Fish allergy (Reactions - Hives, itchiness, throat constriction, stomach pain, vomiting) since March 2015, Drug allergy (Reaction - Severe hives), Anaphylaxis and Hypersensitivity.   On 11-Feb-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 4:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Very adnormal and not right). In March 2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.), DIZZINESS (Dizziness), HYPERSENSITIVITY (Hypersensitivity reaction), MYALGIA (body aches), HEADACHE (headache), NAUSEA (nausea), CHILLS (Chills), PYREXIA (103 degree fever) and FATIGUE (Fatigue). On 11-Mar-2021, FEELING ABNORMAL (Very adnormal and not right) had resolved. In March 2021, DIZZINESS (Dizziness), HYPERSENSITIVITY (Hypersensitivity reaction), MYALGIA (body aches), HEADACHE (headache), NAUSEA (nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (Severe arm pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.) and PYREXIA (103 degree fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 103 degree 103 degree fever.         Symptoms of Hypersensitivity reaction include Itching/pruritus (The Skin on my throat started to get very itchy), Swelling of upper airway (lips, tongue, throat, uvula, or larynx), Stridor, Unusual taste(very strong metallic taste in mouth)  Event description includes tongue and mouth felt very strange and abnormal, about twelve hours later (around 7:30 am), side effects hit like flipping on a light switch.  It was reported that By 5 pm, the symptoms of patient began to resolve followed by severe fatigue for a day and half.  No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-420991 (Patient Link).
Pt presents eleven days s/p varicella vaccination with a papular rash spinkled over the abdomen, back, face and into hair at nape. Rash was just emerging on legs. Pt was given BENADRYL .25 tsp q6-8 hours PRN itching.
30May90 pt vax w/ hepta B; exp some soreness.  Pt vax 2nd dose on 29Jun90; exp slight swelling & knot the size of b-b shot.  04Dec90 recv 3rd vax; right arm was swollen & hot to touch.  Arm became very sore & tender.  See worm...
Mother called on 6/16/2000 and stated that the child had been seen at MD office due to an infection of the leg where the injection had been given. She stated that it had started at the site and spread to back of the leg. The doctor had prescribed antibiotics and Motrin.  Follow up on 12/22/2000: "Impossible to provide time of event."
When the patient laid down and took a deep breath, she experienced a sharp pain in her chest.  When she sat up, the pain lessened but did not go away.  The pain was continuous and sharper when breathing in.
no side effects or symptoms reported; Medical Assistant called to report expired PROQUAD was administered to a patient, no side effects or symptoms reported. PROQUAD that expired on 9/4/2023, was given yesterday 9/11/2023 to one patient. Confirmed no previous temperature excursion. Produ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 11-SEP-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W007746, expiration date reported and validated as 04-SEP-2023) as prophylaxis (expired product administered). No side effects or symptoms reported. Confirmed no previous temperature excursion.
INJECTION SITE INFLAMED AND HOT WITH LARGE LUMP.  TREATED AT PHYSICIANS OFFICE IN THE EVENING. GIVING CEFTRIAXONE INJECTION IN OFFICE AND KEFLEX 500 TID X7 DAYS ON 3/18/14.
Dose 2 COVID Pfizer, given 4/27/21, Dose 1 Pfizer given ER8733
reaction to booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to booster) in an 81-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to booster). At the time of the report, VACCINATION COMPLICATION (reaction to booster) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.
Mom reported redness, warmth and swelling in affected extremity: instructed to use ice, TYLENOL or MOTRIN and to seek medical attention if needed.
MMRV administered. Rash flat, confluent, red, extended from later side of left eye, to mouth spread to ear, back of neck, hairline with extension to right side of face. MMRV site red, welts, at site.
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL vaccine (yeast) INJ. After receiving GARDASIL vaccine (yeast), the patient experienced a dizzy episode. At the time of the reporting the patient had recovered. The patient sought unspecified medical attention. No additional information is available.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756554A, A0756556A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
First covid vaccine on 3/3 and presented to the ER on 3/22 with CP. Second covid vaccine on 4/3 and presented to the ED on 4/15 with complaints of shortness of breath, lower extremity swelling, and 20 pound weight gain x 2 weeks.   ED Workup: NT Pro BNP: 558 Hs-cTroponinT: 17>16 CXR: No acute findings EKG: NSR First Degree AVB D-Dimer: 1830 CTA: negative for PE  Admitted for HFpEF exacerbation. Treated with IV diuretics, ECHO ordered. Stress test for CP with exertion - negative. Patient still admitted on 4/17/21. ECHO pending.
Patient is a 40 y.o. female who presents for evaluation of adverse reaction to Johnson and Johnson COVID vaccine (received on 4/11/21).  She received the vaccine on April 11th, around 2:30 p.m. at 8:00 p.m. that night she developed fever with temp 100.4°, chills, headache, nausea and body aches.  At 10:00 p.m. that night she developed palpitations, heart racing, shortness of breath, tightness in her throat and chest.  She was unable to sleep that night.  The next day on April 12th, she continued to have low-grade fever with temp 99°, shortness of breath, chest tightness.  She reports taking a pregnancy test at home which revealed a faint positive pink line.  That night she took Tylenol which helped relieve some of her symptoms.  On April 13th, she continued to have shortness of breath and chest tightness, her heart palpitations improved slightly.  She reports retaking the home pregnancy test and this time it was negative.  On April 14th, she had a same-day clinic visit, labs that day revealed slightly elevated D-dimer and normal chest x-ray.  She continued to have shortness of breath and on April 16th, she presented to the ER due to sudden onset of bad headache, nausea, diarrhea and heart palpitations.  She was discharged from the ER with close follow-up with her primary care doctor.  Her symptoms did not improve and subsequently on April 20th, she began to have left-sided facial numbness.  On April 21st, she went to the ER and was found to have left-sided facial weakness and suspected Bell's palsy.  She was admitted for further diagnostic workup (CT Brain normal, MRI Brain normal, and MRV Brain with no evidence of venous sinus thrombosis, carotid doppler normal, MRA Brain normal, MRI sella (pituitary) normal), and treatment was initiated with prednisone and antiviral medications.  On April 23rd she developed left arm weakness as well. She was discharged with closed follow up with her PMD and specialists. She recently was seen by pulm Dr and scheduled for PFTs. She is nearly completed with course of prednisone and valacyclovir, left facial weakness slightly improved but not resolved, has follow up with neuro this week.
About five days after my first shot I started to have upper abdominal pain, nausea and vomiting. The pain and GI issues that took place were similar to when I had experienced pancreatitis previously, so I contacted my PCP and GI/Liver doctor. The issues cleared up within about 4-5 days of being on a clear liquid diet and rest. I had blood work 01/14/21 and an ultrasound 01/19/21, both showing no signs of common bile duct blockage or pancreatic issues.
feel ill; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves patient (unknown demography) who feel ill (malaise), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious feel ill (malaise) usually for one or two days (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. The reporter stated that the patient was vaccinated with 3 doses of GARDASIL injection (exact doses, route of administration, lot# and expiry date were not reported) off the prescribing information schedule: the patient received the first dose on an unknown date in August 2014, the second dose on an unknown date in June 2015 and the third dose on 12-NOV-2015. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who between 10/22/2004 and 10/25/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647655/0869N).  Subsequently, started immediately with redness, warmth and swelling at the site.  The patient was treated with diphenhydramine HCL (Benadryl).  The patient recovered.  Follow up information was received from a registered nurse who mentioned that she did not know there would be a follow up inquiry.  She reported that the physician has since retired and no further information is available.  It was also reported that 4 out of 5 patients have had injection site reactions after receiving pneumococcal 23v polysaccharide vaccine from the same vial.  The doctor questioned the vial and lot number since all doses were from the same one.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.  No additional information is expected.
This spontaneous report as received from a healthcare worker refers to three unspecified patients of unknown demographics. No information about medical history, drug reactions or allergies were specified. On an unknown date in 2013 (reported as "last year" on unspecified dates) the three unspecified were vaccinated with PNEUMOVAX23 (lot #, dose, route not reported) and FLUVIRIN (manufacturer: Novartis) concomitantly. The healthcare worker reported that on an unknown date in 2013, "last year" on unspecified dates, three unspecified patients developed fevers after receiving the doses of suspect vaccine. The outcome of the events is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
Pt's arm got swollen, hot to touch, and had hardened tissue. It was also difficult to lift her arm.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medication history information was reported.  Concomitant products included AMOXICILLIN for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided   This case was linked to MOD-2021-214827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information was received and reporter information was updated. On 04-Aug-2021: Follow Up received- No new information for dose-1 related event.
3 days after injection (Tdap), noticed swollen lymph nodes right side of neck, axilla and clavicle. No fever. Took ibuprofen. Swellings have subsided as of 8/15/07.
Information has been received from a health professional concerning an 18 year old female , who on 21-MAY-2007 was vaccinated with a second 0.5 dose of Gardasil vaccine (lot# 653938/0954F). Immediately after injection, the patient experienced lightheadedness and had a blood pressure of 104/60. The patient was placed in Trendelenburg position with her legs up and she felt better after 5 minutes. She was also given a snack and water. The patient recovered that same day. Subsequently, the patient recovered from lightheadedness. Additional information has been requested.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 11/9/2022 ATHEROSCLEROSIS OF AORTA
Mastitis in left breast. Currently breastfeeding, and on third day after vaccine, felt flu-like symptoms and had wedge shaped redness and pain in left breast. Had clogged duct that took a few days to resolve. Had blood in clogged duct that had to pass. Milk supply on left side was impacted for several days. Took antibiotics to address mastitis and the issue was completely resolved in a few days.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 17-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 20-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No concomitant medication was reported.  Patient six month to five years of age received a Moderna COVID-19 bivalent vaccine from pink cap (10 microgram) instead of blue cap (25 microgram), when blue cap was indicated. No adverse effects noted. Appropriate vaccine was scheduled or given as indicated by the CDC.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Patient received a second bivalent booster after receiving their first on 9/16/2022.
1st Moderna shot was 1/4/21.  Had a syncope episode/potential seizure on 1/13/21 - unwitnessed loss of consciousness for a short period of time with loss of urinary continence.   2nd Moderna COVID shot on 1/29/21 with no reactions.  My doctors evaluating me did not consider this as a COVID vaccine reaction, even though it did occur after the first vaccination.  I am a nurse with a doctorate degree and do not believe the seizure was the reaction of the COVID vaccine.  I was under extreme amounts of stress at work at the time.  I also have a prior medical history of syncope episodes when I was a teenager (25+ years ago).
bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis. Concurrent medical conditions included Skin discoloration, Weight gain and Blurry vision. Concomitant products included PREGABALIN (LYRICA) and OCRELIZUMAB (OCREVUS) for an unknown indication.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising). At the time of the report, CONTUSION (bruising) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.
24 hours after injection - site warm to touch, 2 1/4 inch area of induration with some discomfort & numbness.
Pt stated he started to feel numbness and tingling in lips 5-10 minutes after receiving vaccine. Pt then started to feel dizzy around 3:46 PM and a provider was brought over to immunizations clinic to evaluate patient. Vital signs were taken over the course of events, and patient maintained normal vitals. Provider had patient remain in clinic until 4:15 when patient stated that symptoms were subsiding.
Patient has had a temperature consistently since getting vaccine. On Friday it was 102.6. Today it is. 100.4
Aches and pains experienced during positive covid. Aches of necks and shoulder. Naseua and throwing up.  Weak and tired and cold.
stomach pain; needle came off of the syringe and she only received part of the dose / given another full dose; This case was reported by a nurse and described the occurrence of stomach pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) and Shingrix (intramuscular). On 16th December 2020, less than a day after receiving Shingrix and Shingrix, the patient experienced stomach pain and accidental underdose. On 17th December 2020, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the stomach pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was a nurse. The patient received the second dose of Shingrix vaccine in the left arm and while it was being administered the needle came off of the syringe and she only received part of the dose, which led to accidental underdose. The patient was then given another full dose of the Shingrix vaccine on the same day in the right arm. Patient did not have lot number or expiration date information to provide. The patient had stomach pain that lasted 1 day, started a day before reporting and finish 17th December 2020. The reporter did not consent to follow up and did not give consent to follow up with health care professional.