chrisvoncsefalvay/vaers-outcomes huggingface dataset:
coughing, belching, swelling head to toe, n/v/d, dizziness, itching, sweating, chest tightness and rapid pulse. all symptoms started about 3-4 hrs after first injection and then progressed. PCP notified and placed on prednisone and benadryl the next day.  symptoms were controlled, but never resolved.  The pharmacist recommended me going to my pcp office to receive second vaccine. Second vaccine given at the hospital on 09/27/21. Moderna (040c21a) injected into left arm.  Within 5 minutes had extreme chest and neck tightness with coughing, sob and swelling. within 3 hrs i had the gi symptoms and the dizziness had returned. i ended up having to visit the ed the next night due to sob. I have been on multiple rounds of steroids since, but no complete resolution of any symptoms yet. I am currently on multiple allergy meds and steroid cream daily, and being seen my several specialists to try to help resolve some/any of the symptoms.
A patchy hive like rash started at the site of injection and then slowly moved in a rolling wave effect over my entire body. The patches/splotches were raised, hot to the touch, red and itchy.  Moving from left arm, across back and chest to right. About the time it dissipated from the initial site it was still at my mid back and left arm. It went up my neck but not my face. It got to the ear/back jaw area and on my scalp. It made its way all the way down to my feet. But the last flare up to appear was on my left knee cap. Over all the episode lasted 4-5 hours. Each flare lasting about an hour. When it started I took a Claritin but nothing changed. I was out to dinner and just had to go back to the hotel because I was so uncomfortable. The only other thing I did was apply cortisone cream liberally. The cortisone only slightly relieved the itching.
Area is red, very tender to touch and slightly swollen. She does not complain of itching or fever. She used a heating pad yesterday, today she will ice the area and take ibuprofen or NAPROSYN.
Week of  April 24, 2022 I had severe back pain, 4/27- the end of May shoulder, left leg and could barely walk due to pain. May 23rd went to hospital ER could no longer tolerate pain. June 1st went to OB/GYN, bladder was enlarged. Hospitalized from 6/1- 6/4. Also, shingles in right eye. 7/5-7/6  went to ER for right side face pain. Was given eye drops.
PATIENT WAS GIVEN THE MODERNA VACCINE INSTEAD OF THE PFIZER VACCINE FOR PT'S <18YO.
Developed minor Covid symptoms and tested positive on antigen test; Developed minor Covid symptoms and tested positive on antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have survived cancer twice - 28 years ago and 7 years ago." (unspecified if ongoing), notes: I have survived cancer twice - 28 years, ago and 7 years ago.; "Had splenectomy as a result." (unspecified if ongoing), notes: Had splenectomy as a result; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "not recovered" and all described as "Developed minor Covid symptoms and tested positive on antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive; (05May2022) Positive; (03May2022) Negative. Therapeutic measures were taken as a result of covid-19.Clinical Course: Adverse event: Developed minor Covid symptoms and tested positive on antigen test on 27Apr2022. Began Paxlovid the morning of 27Apr2022 and completed course evening of 01May2022. While taking Paxlovid, patient symptoms resolved and he felt fine. patient tested negative on an at-home antigen test on 03May2022. On 05May2022, Patient developed the same Covid symptoms as patient had started with runny nose, sinus pressure, low grade fever, sore throat, some body aches. Patient tested positive again on an antigen test and called to doctor the following morning, 06May2022 and pateint asked if he could retake Paxlovid, however, he was unsure if this was advised or not and has suggested he tough it out. Known allergies was reported as no.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Moderna vaccine given expired 10/24/2021-  monitoring- vitals stable, no complaints at 1400
Patient came in for 4 month old check up. Patient was due for Infarix .5mL dose, and was injected with Kinrix (GSK) 0.5mL suspension. The order was initially placed correctly by physician, the wrong vial was pulled from the refrigerator.   Medication administered to or used by the patient  Yes  Type of staff made initial error Medical Assistant  Reporter's recommendations Review of Sound alike Look alike medications, reviewed policy on verifying orders are entered prior to pulling, as well as what is pulled is correct. Stop Think Act Review (STAR) was discussed as well. Thoroughly identify location of vaccines based on ages
Sores on his legs / have spread to his entire body /  like moon craters; The sores itch; Combination of scars and sores; First / vaccine in November, 2019 / Consumer just took the first dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of skin ulcer in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 2 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced skin ulcer, pruritus, scar and incomplete course of vaccination. The patient was treated with loratadine (Claritine). On 13th April 2021, the outcome of the skin ulcer was not recovered/not resolved. On an unknown date, the outcome of the pruritus, scar and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the skin ulcer, pruritus and scar to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received 1st dose of Shingrix on November 2019. After one and one half to two week later he experienced sores on his legs the sores were itchy and were spread to entire body except the genitals. The patient describe them as looking like moon craters and they were a combination of scars and sores. The patient was taking Claritin for the sores, but it was becoming less effective. The patient was advised to see a physician. The patient did not received 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Moderna administered at 10:30, at 1035 pt was at checkout and started feeling flushed and dizzy, sat down in waiting room, and notified staff  Immediately, 3 nurses attended to pt, brought her to exam room and got her up on exam table. Initial vitals were 180/136, O2 100%, pulse 101. Public safety officer called.  Pt reported itchiness in throat, and epi pen was given to pt, and she self administered dose as at 10:40. Vitals 160/104, 102, 79%, placed on 4L O2 nc. within seconds, pt started feeling better, talking in complete sentences, relaxing, and joking while waiting EMT arrival at 10:49. Vital at 10:55 139/78, 85, O2 100% on 4L. Once pt was sitting on stretched, she started to vomit, and then again became SOB, asking for 2nd epi pen, given to emt and was administered. Then they wheeled pt out to ED.   In ED Note,  Patient is a 40 year old F with PMH multiple allergies, asthma, POTS on metoprolol presenting from clinic after her first dose of Moderna. She states after the injections she felt her throat closing in. She was given an epipen by staff and EMS arrived. She was given another epipen by EMS after she endorsed more throat swelling. EMS reports she did not have any wheezing, stridor, or rashes.    Pt presents to trauma room hyperventillating.   Primary Survey Airway patent speaking clearly w/o stridor breath sounds present bilaterally normal HR and normal BP satting well GCS 15   Lungs are CTAB bilaterally with good movement to the bases and no wheezing. No rashes noted on the skin.    Pt states she felt dizzy with 50mg benadryl. She was also given 125mg solumedrol.    EKG shows sinus tachycardia with HR 108. No STE or TWI.    Plan to observe.    1429  Pt feeling well, has had no respiratory distress. No wheezes noted on repeat eval. Pt has had no wheezing, rashes, or oropharyngeal swelling. Pt states she has epipens for other allergies and will follow up with her PCP. VS remain wnl. Plan to discharge.
T103, warmth, erythema around inj site area circled-Duricef given;CBC & blood culture both nl;mom didn't get duricef script filled gradually went away;
Patient was HPV neg.  Was given series of 3 GARDISIL vaccines summer of 2008. Aug 2008 PAP ASCUS and positive for high risk HPV PAPs previously were normal HPV neg.
Initially had injection site pain (mild), fatigue, headache. She states these symptoms ceased and than around day 7 she developed left arm injection site redness, swelling, and pain that radiated into her elbow. With ibuprofen and ice this seemed to alleviate the symptoms. The past 24 hours the redness and swelling surrounding injection site is back; deep aching  from shoulder into her elbow. The swelling is very localized.
Hearing lose Left Ear, 3 Wks. after 1st dose. (Shot in left arm) Have had for one week now. Also chills for about 2 weeks. (cleared now) The hearing is why I am reporting.
Patient vomited a massive amount while sleeping on her back. When I lifted her out of her bed, she continued to vomit a massive amount. Definitely was not spit up. Patient does not frequently spit up. And this was far in excessive and more watery than anything she's previously spit up.
Nausea, Dizziness , Fainting, lost control of bladder and Jerky movements of upper body.
PATIENT RECEIVED A PFIZER VACCINE THAT WAS NOT DILUTED ON 12/15/21 AROUND 9:30 AM. PATIENT HAS BEEN CONTACTED AND IS NOT EXPERIENCING ANY ADVERSE EVENTS AND WAS INSTRUCTED TO MONITOR FOR SYSTEMIC SYMTPOMS SUCH AS FATIGUE, FEVER, SWEATS, CHILLS AND REPORT IF SHE EXPERIENCES ANY OF THESE.
I had breakthrough COVID-19 infection in January 2022.  My symptoms were fatigue and headache. My headache worsened and I had low grade fever, high 90s. The next few days I had 101 fever but broke after a few days.  Still headache and fatigue and also, I had a sore throat. About the 4th day I had fever again about 100 and then it broke.  I was never nauseous. Overall, the symptoms lasted about one week.
I woke up suddenly feeling very sick and feeling the need to throw-up. I walked to my restroom and vomited. Then I started to blackout so I dropped to the bathroom floor and passed-out. When I came to, I was in a cold sweat and got the chills. It was like that for a few hours. Then the rest of the day, yesterday, I had a really bad headache. I was noxious all day, went from cold to hot and I had a hard time being able to walk around without feeling dizzy.
Fever, chills, rigors, "shocking" sensation in elbow, muscle aches, nausea/vomiting, headache, dizziness.  I've called doctors office but have not heard back yet.
Swelling, pain at injection site; began hours after injection on 10/15; still sl. swollen & painful. No fevers.
Pt started w/ fever-sent home-woke up from nap began shaking and lips appeared blue. Advised probably viral-could be MMR reaction.
Decreased appetite, irritability and restless sleep. Doctor treated infant for otitis media, thrush and pharyngitis on 2/13/01. Doctor advised against continuing Prevnar.
Within minutes - sneezing, hives, itching. Protracted vomiting. No respiratory problems or swelling. Received steroids, Benadryl, Tagamet in ER. No Epi needed.
Sleepy; Felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (Sleepy) and FATIGUE (Felt tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 034F21A, 031M20A and 013L20H) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: influenza (Other vaccine given within 1 month prior to Moderna COVID-19 vaccine: Influenza probably). Past adverse reactions to the above products included No adverse event with influenza. Concurrent medical conditions included Allergic to cats (Cat allergy), Hypertension (No recent change in status such as improvement or worsening.), Alcoholism (No recent change in status such as improvement or worsening.), Kidney failure (No recent change in status such as improvement or worsening.) and Gastric disorder. Concomitant products included OMEPRAZOLE for Gastric disorder, AMLODIPINE for Hypertension.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced SOMNOLENCE (Sleepy) and FATIGUE (Felt tired). At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (Felt tired) had not resolved.     Patient did not seek any medical care and experienced a similar event in the past.  After Second booster patient drank whiskey on 16-Jun-2022, on 17-Jun-2022, felt tired, sleepy and did not know if had fever. No treatment had been given for symptoms.   This case was linked to MOD-2022-590911, MOD-2022-591120 (Patient Link).
Headache, Arthralgia, chills, headache Narrative:  Other Relevant History:
Information has been received from a physician concerning a 5 year old male patient with no known allergies who on 03-JUN-2008 was vaccinated with a dose of PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and had an anaphylactic reaction immediately after vaccination.  Before the patient left the pediatrician's office he experienced tightness in the chest, shortness of breath, tightness in the throat, urticaria, and flushing.  The patient was administered epinephrine, BENADRYL, 30 mg prednisone PO, and XOPENIX via nebulizer.  The adverse experience improved after treatment.  The physician may have filled an adverse experience dermatology report for this case.  The physician will most likely be performing skin sensitivity testing in the future.  No additional information was provided.  No product quality complaint was involved.  The adverse experience was considered an important medical event upon internal review.  Additional information was received from the physician who indicated that the patient had also developed rapid breathing.  The patient was treated with ORAPRED.  He did not have any redness at the injection site.  He has not had any prior reactions to vaccines.  Follow up information was received from the physician who reported that the patient had a prior episode of RAD requiring nebulizer treatment with XOPENEX (date unknown).  The patient received a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (rHA) Lot # 658165/0040X) in the right arm and a second dose of VARIVAX (Lot # 660658/0173X) (previously reported as PROQUAD (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck)) in the left arm at 1:20 pm on 03-JUN-2008.  On 03-JUN-2008 (also reported as 02-JUN-2008) shortly (less than 10 minutes) after the vaccines were administered, the patient developed anaphylactic reaction with stridor, urticaria, expiratory wheezing and hypoxia (pulse ox 92%).  Medical attention was sought while in the physicians office.  The patient required subcutaneous epinephrine and nebulized XOPENEX.  The patient recovered on 03-JUN-2008 (also reported as 02-JUN-2008).  Anaphylactic reaction was considered to be immediately life threatening.  A lot check has been requested.  Additional information has been requested.
This was for the Shingrix shot. First shot I had a 4" diameter welt that was itchy and painful. The welt lasted 3 weeks.  Second shot I experienced congestion, bad headache, fever of 101, nausea, body aches, lethargy, sore throat in less than 24 hours after the shot. Could not go to work. Day 2 I have cold-like symptoms, lethargy.
Pt vaccinated developed swollen glands under axilla & generalized malaise. Developed small lumps under her chin, bilateral knee & wrist pain w/swelling of lt knee. Also redness of rt eye w/slight ocular pain.
Patient rec'd vaccine on 9/17 and on 9/21 experienced vomiting on 4 occasions and reports "feeling feverish". Patient went to ER 9/21 and was prescribed ondansetron for nausea and released. No other tests given. Patient presented to pharmacy 9/28 inquiring whether or not this could've been vaccine related. Claims NOT dx with Guillain-Barre in past. Patient feeling well since 9/21.
He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster; He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster; He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster; Sore Arm; Feeling Fatigued; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) from medical information team.  A 48 year-old male patient received bnt162b2 (COMIRNATY), administration date 02Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "fatigue" (ongoing); "myalgia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (first primary dose), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "He was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore Arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Feeling Fatigued". Additional information: It was unknown if patient had any prior vaccinations (within 4 weeks). The stage of medication error (overdose) was preparation and administration. Lack of communication and the RN that administered the dose may have some underlying condition that should have made her not allowed to be administering vaccines. The RN was going out on company to address the condition. Reporter specialty: occupational medicine, physician, MD. Patient was administered with a full undiluted vial of the adult formulation of the Pfizer-BioNTech COVID-19 Vaccine as booster. Caller said that the patient had Moderna as the first primary dose.  She was asking further guidance. Complete only if a 3rd dose was administered. Check one option Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Patient has not reached out to the reporter recently, so she did not have much additional information to provide. She provided the facility information where he was vaccinated and reported that he had a sore arm and was feeling fatigued but could not provide further information as she did not have first-hand knowledge and had only been passed along the information to report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
given a Shingrix Vaccine and then the nurse discovered it was expired; Dispensing an expired medication; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11-MAY-2023) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular). On 10-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: given a Shingrix Vaccine and then the nurse discovered it was expired) and drug dispensing error (Verbatim: Dispensing an expired medication).The outcome of the expired vaccine used and drug dispensing error were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter called to report that a patient was given a Shingrix vaccine and then the nurse discovered (dispensing an expired medication) it was expired, which led to expired vaccine used and drug dispensing error. The patient had not called with any side effects from this expired vaccine, however adverse event was filed on the pharmacy behalf.  The reporter consented to follow up.
Had reaction where skin was exposed to sun about a 1/2 hour after Injection skin turned red developed hives
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 18-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient's parent wrote  on the vaccine consent form to make the child 12 years old and eligible for the Pfizer vaccine. The patient's true date(11 years old- not eligible for the vaccine). This was found when our central processing team recognized that  was already a patient of our pharmacy under the true date