chrisvoncsefalvay/vaers-outcomes huggingface dataset:
permanent damage to the cranial nerve that goes to the mouth; secondary hearing loss; permanent burning and a bitter taste in her mouth; bitter taste in her mouth; Hearing loss on the left side with tinnitus; The second shot made it worse.; The initial case was missing the following minimum criteria: No Adverse Event. Upon receipt of follow-up information on 03Sep2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 16Feb2021 10:00 (Batch/Lot Number: EN6200) as single dose, second dose on 09Mar2021 (Batch/Lot Number: EN6199) as single dose (age at vaccination 65 year old), both via an unspecified route of administration for covid-19 immunisation. Medical history and concomitant medications unknown. Patient explained that she has sustained what appears to be permanent damage to the cranial nerve that goes to the mouth. She has permanent burning and a bitter taste in her mouth that makes it painful to talk. She is miserable and hurts all the time. This started within 36-48 hours after the first shot (Feb2021). After the second shot it was amplified 100 times and it has stayed terrible ever since. The second shot made it worse. The nerve damage has spread throughout her mouth. It's to the tip of her tongue, lips, it's tingling, painful, and she has difficulty talking.  It is very aggravating to do it. She also feels that she has had secondary hearing loss. She has hearing loss on the left side with increased tinnitus in the left ear. She started to have buzzing in the ear after the first shot, but the second shot just made it worse. She is having this crippling problem with her mouth. She is a teacher and she has to talk. It is very painful. The nerve goes to the tongue into lips and through her jaw; her jaw is damaged.  She also has this persistent bitter painful taste in mouth. She cannot eat 90% of what she used to it. She can only eat very bland things. Most times she does eat very much. Her mouth hurts all the time except when she is sleeping. She has seen the doctor several times since this, but there is no real treatment due to it being nerve damage in the mouth. There is no real fix. She commented there is medication that can be prescribed, but it would just make sleepy and stupid. It would sloe the nerve impulses down. Name of medication not specified or provided by caller. She mentioned this is an untreatable side effect; it's very serious and life altering. Stated this is life altering and untreatable.     Follow-up attempts are completed. No further information is expected.
Patient's wife called pharmacy on 8/9/2020 to report patient had been experiencing fever and soreness of the injection site since 8/8/2020. Patient was given vaccination on 8/7/2020, and asked to wait in pharmacy area for 10-15 minutes to monitor for any immediate adverse reactions. Patient waited, and did not exhibit any immediate adverse reaction from the vaccination.
Swollen tongue; swollen around  the mouth; hot flashes; shaky; nausea; fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), MOUTH SWELLING (swollen around  the mouth), HOT FLUSH (hot flashes), CHILLS (shaky) and NAUSEA (nausea) in a 23-year-old female patient 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 was provided by the reporter.  Concomitant products included CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue), MOUTH SWELLING (swollen around  the mouth), HOT FLUSH (hot flashes), CHILLS (shaky), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Body aches). At the time of the report, SWOLLEN TONGUE (Swollen tongue) and MOUTH SWELLING (swollen around  the mouth) was resolving, HOT FLUSH (hot flashes) and CHILLS (shaky) outcome was unknown and NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 028A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 12:26 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 12:26 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022 at 12:26 PM, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  No Adverse events were reported.
No adverse event; Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7168B and 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jan-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023) 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 EXTRA DOSE ADMINISTERED (Shot 5: Bivalent Booster on 03OCT2022, Shot 6: Bivalent Booster on 06JAN2023).    No concomitant drug information was provided.   Patient had received 4 monovalent doses. Dose 21 JAN2021 with Lot no 013L20A, Dose 2 on 15FEB2021 with Lot no. 016M20A, Dose 3 (First monovalent booster) 16NOV2021 with Lot no. 067F21A  and dose 4 (second monovalent booster) on 09MAY2022 Lot no. 001M21A  It was reported that the patient had received 6 Moderna doses.  The patient told the reporter that her doctor told her to go ahead and get another booster. Reporter  stated that the doctor must have not checked her vaccination card.   No treatment drug information was provided.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. The vial was stored at the refrigerator at the time of the temperature excursion. The temperature excursion issue occurred on 10-Mar-2022. Maximum temperature reached by the vial was 64 degree Fahrenheit and excursion duration was approximately 7 hours. No changes were noted in the vaccine state. At the time, the vials were unpunctured. The transfer date was reported as 15-Mar-2022.
headache; Fever; Pain in the bones; Hotness; Stomachache; diarrhea; Flu-like symptoms; Malaise; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in the bones), FEELING HOT (Hotness), ABDOMINAL PAIN UPPER (Stomachache), DIARRHOEA (diarrhea) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise) and CHILLS (Chills). On 15-May-2021, the patient experienced BONE PAIN (Pain in the bones), FEELING HOT (Hotness), ABDOMINAL PAIN UPPER (Stomachache), DIARRHOEA (diarrhea) and PYREXIA (Fever). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 14-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise) and CHILLS (Chills) had resolved. At the time of the report, BONE PAIN (Pain in the bones), FEELING HOT (Hotness), ABDOMINAL PAIN UPPER (Stomachache), DIARRHOEA (diarrhea), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not take any concomitant medications. Action taken with mRNA-1273 in response to the events is not applicable
32 y.o. female, pregnant, 30 weeks gestation, rc'd inactivates flu vac 1/6/12 IM, (L) deltoid. C/O rash to bil. underarms & thighs, since 1/6/12 approx. 12:50 pm. Claims "rash getting better" did not apply or take any meds. Referral issued by clinician to see PMD.
DVT right upper leg PE Right Pulmonary Artery Shortness of breath Lower leg swelling, pain,  heat,
Patient presented with some anxiety prior to vaccination. Reported no adverse events to past vaccines. About 20 min after vaccination, patient notified staff of itching and pain to her throat. Vital signs normal - slight tachycardia and hypertensive. Discharged to ED.
Pt called to report adverse reaction from Shingrix vaccine including fever, chills, body aches, weakness. Within 24 hours s/p vaccination, pt passed out (syncope) and fell while ambulating to the bathroom at home. Pt hit her head, elbow, and hip. Evaluated in ER. No broken bones. Blood work, XR, Echo, EKG all WNL. CT scan of head/neck negative. Pt has scheduled follow-up with Cardiology and PCP.  Background: Pt received Shingrix Dose #2 vaccine on Monday, 7/11, at Facility.  Fall occurred Tuesday, 7/12, AM.
pt recv vax 2OCT95 & 22APR96 pt devel approx 10 pox, mostly on trunk, described as pruritic papules & vesicles in various stages;no addtl pox surfaced, & no fever was reported;pt recovered;
Went to ER on 2/12/14 for worsening heart palpitations. Noted to have freq. PVC's, chest tightness and SOB. On morning of 2/13/14 pt had RLE weakness and Bil. UE weakness. Transferred to another hosp. for cardiac ablation procedure. Brace on RLE due to foot drag/drop. Home RN and PT. Possible GBS.
0955 - states metallic taste and some numbness of lower lip, declined benadryl. 1000 - states symptoms have resolved 1011 - states feels totally fine. going home to husband, not working today.
Flu Symptoms; cold symptoms; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu Symptoms), NASOPHARYNGITIS (cold symptoms) and ARTHRALGIA (Joint pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) tablet for Prostate cancer.    Concurrent medical conditions included PSA increased (Rising PSA for treatment for malignant neoplasm prostate) and Malignant neoplasm of prostate (Rising PSA for treatment for malignant neoplasm prostate).   On 07-Aug-2021, the patient started ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) (Oral) 160 mg once a day. On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu Symptoms), NASOPHARYNGITIS (cold symptoms) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Joint pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA (Flu Symptoms) and ARTHRALGIA (Joint pain) was resolving and NASOPHARYNGITIS (cold symptoms) had resolved.            No Concomitant medications were provided.  Patient received Tylenol for joint pain which was a 3 on scale of 0.10. Patient stated that soon after woke up in the morning feeling pretty good. No lab test information was provided. The flu symptoms lasted for 36 hours, cold symptoms lasted for a couple of days  however it was reported that flu symptoms and joint pain was recovering.
1st. night was severe coughing, swollen and itching at the sight of injection, got less until 6 days after 1st. injection my shoulder swelled up ,fire red, severe itching, arm pit very swollen and painful  this is 13 day and most of the swelling in my arm pit has receeded, the redness is still on my shoulder and the itching is less as long as I take anantihistomine
Right arm. Patient felt pain upon administration. Pain continued to worsen, arm bruised and unable to lift arm. Black and blue from shoulder to elbow. 8/28/17 went to MD told has cellulitis referred to surgeon.
Eight days following vaccination my arm began to itch near the injection site. It became very red, swollen, hard and bumpy. I used topical benedryl cream and it subsided within a few days, although it does still, intermittently, mildly itch. I had NO other reactions.
Left deltoid red, swollen, no infection.  Given Augmentin, worsens over weekend.
24 hours after vaccine left arm swollen, red, hot. Dx cellulitis. Rx'd with antibiotics after 48 hours. Hot compress failed.
Swelling and redness at site, Warm to touch. Swelling from shoulder to Elbow, TX with Ibuprofen ice.
Rash, similar to poison ivy/sumac, but without the oozing or pussing. Itching over a very large portion of my body including but not limited to biceps, thighs, under arms, hips.  Treated with calamine to soothe the itch (because I thought it was poison ivy/sumac)  After ~48-72 hours I woke up and the rash was completely gone with no symptoms
Hives on chest and arms.  Lump in right armpit and back of right knee.  Muscle weakness/heaviness.
Pt was supposed to receive her last dose of hep A, instead, pt received Heplisav-b by mistake. She already finished her Hep B series with Engerix 2 months ago. Followed up with patient 2 days later, pt did not present any harm or adverse effect
Cellulitis, itching. Linezolid 600mg po ordered to treat cellulitis. BENADRYL 50mg TID prn - received 4 doses ordered to treat itching. Prednisone 60mg po x 1 dose 12/03 at 1600.
Patient reports swollen lymph nodes in right arm, the area where shot was administered is hard, swollen and hot the touch.  Patient also reports itching at the site of injection and pain under the arm.  Patient was advised to take Benadryl (50mg) and Ibuprofen (600mg) every 6 hours.  Patient admits a similar reaction with pneumovax
This spontaneous report as received from a nurse refers to a 58 year old female patient with no Pertinent Medical History and no Drug Reactions/Allergies. On 03-OCT-2013 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # J003805, expiration date 03-JUL-2014), subcutaneously. Concomitant therapies included atorvastatin, hydrochlorothiazide (manufacturer unknown), homatropine methylbromide, hydrocodone bitartrate, PREVACID, LORAZEPAM, metformin, PROAIR, VIVELLE-DOT. On 03-OCT-2013, the patient experienced 5 by 3 cm induration and warmth at the injection site after receiving a dose of ZOSTAVAX. The physician also prescribed BACTRIM DS for unknown reason for the patient on 18-OCT-2013 (reported as "today"). No Lab Diagnostics Studies Performed. The patient sought medical attention via came to the office. Ice, TYLENOL, ibuprofen was given for treatment. The event outcome was reported as recovered. Additional information has been requested.
got the shot for covid and died a few weeks later; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient got the shot for covid and died a few weeks later on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal.  Information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: got the shot for covid and died a few weeks later
Adverse event occurred in the observation area, 15 minutes post vaccination. Patient: 18yo female who received first dose of Moderna COVID-19 vaccine.  At 9:28am, patient and mother were getting ready to leave observation, mother stated, "my daughter is passing out." Pt was sitting in chair, head back, not responding to mother or RNs. Pupils dilated bilaterally, skin pale, sweaty. Pt unable to say name. 9:29am EMS was called, Pt moved to floor, laying supine with legs elevated on chair. While laying, Pt began responding to RNs- able to say name, DOB, but unable to say where she was. 9:31am- moved to sitting position. 9:32am- RN passed ammonia inhalant approx 5 inchs from Pt nose, Pt denied SOB or difficulty breathing.  RN offered juice, and Pt began drinking with no difficulty. 9:34am- HR 90 weak. 9:36am- HR 80. 9:38am EMS arrived, 9:39am EMS took vitals: BP 98/58, O2 93%, HR 116, lung sounds clear, Temp 97F Blood sugar 111. 9:47am Pt reported she was feeling sick, and agreed to go to hospital for evaluation. 9:48am- Pt was able to stand with assistance from EMS, and was transported by EMS to Hospital for further evaluation.
While at pharmacy my lips started feeling tingly and itchy, thought it was just from mask. After 15 minutes I was told I was fine to leave, so I left and headed home. Almost halfway home my throat began to feel swollen and tighter, like a rock was in it. My lips and face continued to itch and tingle. My face also was bright red. I have experienced anaphylaxis before, and was on Bactrim for days before I had the reaction. I waited it out to see if I needed to go to the hospital, but felt I was okay. The next couple days however I still felt like there was a rock in my throat and it was still a little tight, but no longer itchy or feeling hard to swallow so I didn't take myself in.
Body aches; Chills; Diarrhea; Nauseous; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nauseous), PYREXIA (Felt feverish), MYALGIA (Body aches) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MONTELUKAST for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced NAUSEA (Nauseous) and PYREXIA (Felt feverish). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 23-Mar-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at a dose of 1 UNK. At the time of the report, DIARRHOEA (Diarrhea) had resolved and NAUSEA (Nauseous), PYREXIA (Felt feverish), MYALGIA (Body aches) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99 (High) Feverish.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt states she is not feeling normal after getting her second dose of the vaccine. Pt does not have any rashes, hives, swelling, difficulty breathing. Pt states she has a history of anxiety and believes she is having a panic attack. Pt's vitals are stable. Pt sat and talked with EMS for 10 minutes. Pt states she is feeling better and would like to leave. Pt did not require transport to hospital.
I got my first moderna vaccine on February 4th the next day I started having chills and cold feet which lasted for 20 days then it went away then I got my second shot on February 4th and the cold chills and cold feet came back on the 5th also on the 5th 6th 7th and 8th I was in bed all day because it felt like I was beat up with the baseball bat but I still currently am having chills and cold feet 15 days after second vaccine I'm hoping that it goes away in 20 days like it did with the first vaccine
Reddened area below the injection site, with tenderness and warmth to the area. Denied itching or drainage at the time.