chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness that is spreading and getting bigger; itching; when she touches the site of injection she feels a slight bump under the skin; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness that is spreading and getting bigger), PRURITUS (itching) and VACCINATION SITE SWELLING (when she touches the site of injection she feels a slight bump under the skin) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tendon injury (Torn tendon in left arm.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced ERYTHEMA (redness that is spreading and getting bigger), PRURITUS (itching) and VACCINATION SITE SWELLING (when she touches the site of injection she feels a slight bump under the skin). At the time of the report, ERYTHEMA (redness that is spreading and getting bigger), PRURITUS (itching) and VACCINATION SITE SWELLING (when she touches the site of injection she feels a slight bump under the skin) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported
Lymph nodes above the left collar bone and into neck on the left side started to swell during the night of August 1/morning of August 2nd.  The area around the swelling was very sore the first few days.  The swelling and soreness starting going down around August 6th.  A rash was starting to appear in the same area around August 5th, and gradually got worse, peaking around August 8th, then started to get better on August 9th.  The rash and swelling was completely gone by August 13th.  Doctor looked at it on August 6th.  No treatment was done, just waited it out until it was gone.
Hi, I received the 2nd Pfizer vaccine on May 3rd. In Mid June, I began having tightness in my chest. I went to a hospital in the middle of the night when the tightness persisted. They took and EKG and an MRI but didn?t find anything that stood out.   On November 3rd, I began having heart palpitations. They were on and off. Went away Nov 6th but back on Nov 10th. The palpitations then turned into tightness. This has been on and off up until today. About 4 days ago on December 22nd, I began having shortness of breath when I try to take deep breaths.   I met with my doctor in late November and they took an EKG and blood test but thought the palpitations may be related to stress. They did notice the fluttering heartbeats. They prescribed me Metoprolol to help with the palpitations and that has helped but it is still happening although it is more tightness than palpitations now.   I then met with a cardiologist and wore an EKG monitoring device that I could activate when an event was happening. They said my heart was ?operating as it should.? This was late November into early December. I am meeting with the main cardiologist to run some more tests next week and to get his opinion.   Thank you for reading and for your hard work during these difficult times. It is a difficult and complicated topic and I appreciate you working to get this right.
9/19/21 pt to ED with SOB, fevers, cough x 3-4 days; family member with COVID; pt tested positive for COVID; O2; dexamethasone, ABX; pt rapidly deteriorated; DNR; pt passed away due to COVID pneumonia
Patient reportedly developed tachycardia to 125, fever to 102 degrees F and flailing/posturing, lasting 24-48 hrs. He is improving. His mother reports a similar but less severe reaction last year after flu shot, symptoms began within 24 hours of him receiving immunization.
Information has been received from a  legal firm regarding a case in litigation concerning a male child with a history of possible jaundice who on 09/06/1995 was vaccinated with MMR vaccine. Concomitant therapy included ActHib #1 07/29/1994, #2 09/22/19994 and dose #3 11/18/1994; hep B vaccine #1 05/18/1994, #2 06/24/1994, #3 11/18/1994; Tripedia 11/17/1995, Orimune #1 07/29/1994, #2 09/12/1994, #3 02/14/1995 and varicella vaccine. It is alleged that the pt was born healthy and with normal APGAR scores. Beginning as early as 05/18/1994 through 12/07/1995, when the pt was approximately 18 months of age, he was administered not less than 14 vaccines at the office of his pediatrician with vaccinations containing the mercury-based preservative thimerasol. It is alleged that these cumulative doses of toxic ethylmercury were the direct and proximately cause of the pt's mercury poisoning and his sustaining devastating neurological injuries that are permanent in nature. It was reported that prior to completing the schedule of Thimerasol-containing vaccines, the pt had been developing normally and meeting his age-appropriate development milestones. He began to regress at 18 months of age and now suffers from disintegrative autism of Autism spectrum Disorder and pervasive developmental disorder allegedly caused by the mercury toxicity resulting from his exposure to Thimerasol. The pt is currently receiving treatments to removed the mercury from his body. It was reported that as the mercury levels in his body have decreased, the pt's parents have noted some improvement in his symptoms. Despite his improvement, it is alleged that the pt's severe neurological and other ASD related disorders are permanent in nature. Upon internal review, the pt's autism, neurological injuries, mercury poisoning and pervasive developmental disorder were considered other medical events. Additional info has been requested.
Dizziness, coughing, weakness & malaise, two degrees of fever 7th & 8th night, nausea through 11-03-2014. Symptoms waxed and waned, dizziness [room spinning] with ear canal pain and discharge most often, headaches and occasional migraines.
pt c/o immediately following vax dizziness, scalp "crawling", facial flushing, facial hot, BP 170/100, P76 pvt MD in trendelenberg, Clortrimeton give & observed x 1/2 hr;
Pt had vaccine 5/5/10-returned to office on 5/7 with reaction on left arm at subq injection site. Dx'd as cellulitis by doctor vs reaction to immunization. Treated with ice to area and Keflex 500mg tid.
No adverse event; 4 doses were administered past the expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date) 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 EXPIRED PRODUCT ADMINISTERED (4 doses were administered past the expiration date).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. This case is reported for patient 3 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733816 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733816:master case
Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  On 13-Jan-2022, the vial was initially stored in the refrigerator.  It was reported that as per the healthcare provider, the vials were set to expire on 12-Feb-2022 based on the stickers put on them. The healthcare provider was not sure and did not have the exact expiration date of the vial itself. The healthcare provider asked if they are going to revaccinate the patient or not.
This spontaneous case was reported by a nurse and describes the occurrence of BREAST PAIN (pain in breast), DYSPHAGIA (difficulty swallowing) and LYMPHADENOPATHY (pain in gland neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0N520A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Deep in Skull,found in CT Scan) and Fusion lumbar spine on 20-Aug-2020. Concurrent medical conditions included Hypothyroidism (Under control with medication and blood work), Hodgkin's lymphoma, Latex allergy, Allergy to antibiotic (Bacitracin), Allergy to antibiotic (Biaxin/Septra), Drug allergy (Codeine), Drug allergy (Vicodin), Drug allergy (Elavil), Drug allergy (Ultram), Drug allergy (Morphine), Drug allergy (Fentanyl/HCL), Drug allergy (dilantin), Drug allergy (Darvon), Penicillin allergy, Drug allergy (Sulfa), Allergy to antibiotic (Neosporin), Allergy to antibiotic (Polysporin), Drug allergy (Oxycodone), Allergy to antibiotic (Clarithromycin), Drug allergy (Omeprazole), Allergy to antibiotic (Oxdrocodine), Drug allergy (Meperidine), Drug allergy (Phenytoin), Drug allergy (Tramadol), Gluten sensitivity and Drug allergy (Levofloxacin 500). Concomitant products included ONDANSETRON for Nausea, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 29-Mar-2015 to an unknown date, CLOPIDOGREL, METFORMIN from 09-Jan-2021 to an unknown date, KETOROLAC TROMETHAMINE (TORADOL), TEMAZEPAM (RESTORIL [TEMAZEPAM]), LORAZEPAM (LORAZEPAN), LEVOFLOXACIN (LEVAQUIN), CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]), HYDROXYZINE, HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]), MIDAZOLAM HYDROCHLORIDE (VERSED), LEVOFLOXACIN, KETOROLAC, FAMOTIDINE, CLINDAMYCIN, DEXAMETHASONE, MUPIROCIN, CEFIXIME (FLEXERIL [CEFIXIME]), METHYLPREDNISOLONE and AZITHROMYCIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced BREAST PAIN (pain in breast), DYSPHAGIA (difficulty swallowing) and LYMPHADENOPATHY (pain in gland neck). At the time of the report, BREAST PAIN (pain in breast), DYSPHAGIA (difficulty swallowing) and LYMPHADENOPATHY (pain in gland neck) had resolved.        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.   This case was linked to MOD-2021-329115 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up contains No New Information On 08-Oct-2021: Additional Information received and medical history was updated
My husband 's mouth got numb and tingly like he had Novocain This feeling lasted about 20 minutes..
I start to feel pain on the upper part of the chest, which gets worse when breathing. Over a period of two to three days, the pain gets worse and I start to get a low level fever of 101-102 degrees F. After 4 or 5 days both these symptoms get worse and eventually end up in the hospital. Treatment has been to use Albuterol, Symbicort, Ibuprofen
Very sore upper arm, difficulty raising arm, fatigue, and for an hour or two after all nausea. Upper arm problem is continuing on the 2nd day.
Night following vax child had high pitched scream, chills, & his eyes may have "rolled back in his head". Pt refused to eat or drink. Pt is normal now.
Burning; I have bunch of fresh ones and they appears on my thighs, on my legs, on my arms, on my back, all over my body except my face and they itch like crazy and I continue having fresh ones; Rounded wounds and they are swollen and itchy like crazy, they itching me; Rounded wounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administration date 17Aug2021 (Lot number: FC3182) at the age of 62 years 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, SINGLE), for Covid-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), outcome "recovering", described as "Burning"; IMPAIRED HEALING (non-serious), outcome "unknown", described as "I have bunch of fresh ones and they appears on my thighs, on my legs, on my arms, on my back, all over my body except my face and they itch like crazy and I continue having fresh ones"; PRURITUS (non-serious), outcome "recovering", described as "Rounded wounds and they are swollen and itchy like crazy, they itching me"; WOUND (non-serious), outcome "recovering", described as "Rounded wounds". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of burning sensation, pruritus, wound.  Additional Information: Consumer stated, got fever at worst from working till hours, end up missing both of knees so ended up having on knees, test osteoarthritis (not clarified on the call). Consumer was taking the Allegra but run out of it (further clarification was unknown) and the doctor gave this medication for itching, it is called Hydroxyzine, it's 25 mg.  Follow-up attempts are completed. No further information is expected.
Administered  booster dose of Moderna (blue top).  Person should have received Moderna Bivalent booster (blue top).  No adverse event occurred.
Pt developed fever of 100-102 2 days post vax. Three days post vax, fever was 103, and parents took pt to ER where he was treated with Ibuprofen and Benadryl. Pt taken to MD the next day and fever improved that day. One mo later, pt developed a rash over torso, legs and neck, described as red and raised. The duration was 3-4 days and he had a fever of 101.
This is a spontaneous report from a contactable physician received via a sales representative. A 91-year-old female patient of an unspecified age and ethnicity received PREVNAR 13 0.5 ml, single via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. Two days after injection the patient experienced cellulitis, pain, tenderness, all on an unspecified date with outcome of unknown.
Took 1st and 2nd Pfizer vaccine in May 2021 and immediately patches on the sides of my head started to get bigger and bigger, until I was completely bald and now I have alopecia universalis! No hair, eyebrows or lashes. No supplements, steroids, or medication helps with help growth.
Diagnosed with Cellulitis of (L) upper extremity on 02/05/2021.  Injection site red, hard , with blisters. Diffuse red, warm to the touch rash from one side of arm to the other.  Arm painful, and itchy.  Started on Cephelaxin along with Benadryl and Claritin D.  Entire area was marked and traced by MD.  Returned to MD on 02/10/2021 for intense itching, redness that spread past the tracings and also to the inside of the (L) arm which started on 02/09/21. The itchiness woke me up at 4 am on 02/10/21.  Prescribed an additional antibiotic, Doxycycline and Betamethasone ointment.  Area within the original tracing was less warm, blisters reabsorbed, but the new red areas were warm, and very red in color like a sunburn.  MD took pictures at this visit.   Scheduled to receive vaccine # 2 on 02/24/2021.
Off-label use; Booster; low fever; headache; breast tenderness; continues with blister at injection site; This is a spontaneous report from a contactable other hcp. A 52-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on 07Sep2021 (at the age of 52-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccines include bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number was not reported), dose 1 as DOSE 1 SINGLE and dose 2 as DOSE 2, SINGLE on an unspecified date for COVID-19 immunisation. On 07Sep2021, Off label use and booster. On an unspecified date in 2021, patient experienced low fever, headache, breast tenderness and continues with blister at injection site. The outcome of the event continues with blister at injection site was not recovered and for rest of events was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Initial unsolicited misuse report received from a physician on 15 Jun 2016. This case involves a 55-year-old female patient who was vaccinated with second dose of MENACTRA (batch number, expiry date, dose, route and site of administration were not reported) on 15 Jun 2016. The reporter stated that her medical assistant gave the patient MENACTRA for a second time in 2 weeks. Patient's medical history and concomitant medications were not reported. Illness at the time of vaccination was reported as none. On 15 Jun 2016, unspecified time since the first dose and same day after receiving the second dose, the patient experienced diarrhea and a stuffy nose. The reporter was planning to see the patient some time later in the day to evaluate. It was also a case of extra dose administered. Lab data and corrective treatment were not reported. The patient required ER/ Doctor visit. The outcome of the events diarrhea and stuffy nose was unknown. List of documents held by sender: none.
Pt developed atrial fibrillation unresponsive to outpatient beta blockers.  He required an admission for atrial fibrillation with rapid venticular rate and congestive heart failure with a BN Peptide of 1022. His EKG and Chest X-Ray were consistent with rapid atrial fibrillation and CHF.  He ultimately had a cardiac ablation and required a biventricular pacemaker.    Recent study published shows an increased risk of an acute cardiac event from 11% to 25% over 5 years.  Pt's cardiac status has been stable for years and he has not felt well since his second COVID Vaccine injection.
Stroke like symptoms day after second dose. Went to ER sent me home. I have had worse problems with my autoimmune disease since
This is a spontaneous report from a Pfizer-sponsored program COVAX US Support via a contactable consumer or other non-healthcare professional (patient).   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (age at the time of vaccination was 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension (Blood pressure high), blood triglycerides increased (triglycerides high) both from an unknown date and unknown if ongoing. Concomitant medication(s) included progesterone (PROGESTERONE 40mg) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced hip cramping, pain in her hip, pain in her hip or by the gluet area, leg hurt a little bit on the right side but she is not hurting right now. Reportedly, the patient received the vaccine on 22Mar2021 and the following week the patient got up on the middle of the night and had pain in her hip or by the gluet area, it was cramping, it came on so suddenly she didn't think she was going to be able to stand. She woke up the next day and she was fine. She said last night, 08Apr2021, this event of cramping happened again, the same pain in the same area. She said this morning her leg hurt a little bit on the right side but she was not hurting right now. She enquired could this be from the vaccine. Reportedly, the event was persisting. Reportedly, the patient took the 1st dose last 22Mar2021 and the 2nd dose will be on 12Apr2021. She had experienced cramp on her gluteal area after a week. She said she would like to know if that is a side effect of the vaccine. Investigation Assessment was reported as no. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt developed a hard mass approximately 3" x 3". She had redness, swelling, very hot to the touch, incredible itching, rash up the arm, itchy legs and joint aches. Pt tried BENADRYL and cortisone with little if any relief. Symptoms developed hours after the shot and have not gone away 3 days later.
Pt. obtained COVID vaccine and passed out. Upon waking, patient reports feeling fine and VS are WNL. Pt. reported this hasn't ever happened before. Pt. examined by physician and discharged home with ER precautions given.
BODY SORENESS, ACHES AND TIGHTNESS FOR DURATION OF 2 DAYS
pt recvd vax & 21JAN93 began to exp joint pain; 25JAN93 began to exp fever 101.6 which resolved; 29JAN93 was found to have erythema nodosum; addtl exp iritis;
Numbness and weakness in the right leg that began the night of receiving the 2nd Pfizer covid vaccination. It has continued to the present day.
Information has been received through a pregnancy registry from a registered nurse concerning a 18 year old healthy female with no concurrent medical conditions who on 11/26/03 was vaccinated with a dose of varicella virus vaccine live. Subsequently, she became pregnant. It was noted that it has been an unremarkable pregnancy as of 5/5/04. Laboratory diagnostic tests performed on 2/23/04 included an MSAFP that was negative and on 3/12/04 an ultrasound that was negative and revealed 19.3 weeks. The LMP was 10/27/03 and the EDD was 8/2/04. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information indicated that the patient gave birth to a normal male live born infant weighing 280 grams on 7/21/04 at 39 weeks from her LMP. There were no congenital anomalies and no other complications. There were no complications during pregnancy. It was noted that the patient was induced for cholestatic jaundice of the pregnancy. Laboratory tests during pregnancy included A CBC on 7/19/04. An alkaline phosphatase was 262, alanine aminotransferase was 70, aspartate aminotransferase was 46, bilirubin was 0.51, and creatinine was 0.6. Medications used during pregnancy included prenatal vitamins once daily (not further specified). The infant had no feature of congenital varicella zoster syndrome. No further information is expected.
Excess Sinus drainage, body aches, headache, very sore and red at vaccine site, fever, (highest recorded was 100.7) minor sinus symptoms in first 24 hours, body aches and fever on day 2 and 3 much better by day 4.
Invalid 3rd dose administered. Patient is under nursing supervision in a skilled facility. Per nurses at the facility, patient has exhibited no adverse reactions to this dose.