chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches; Fatigue; Feeling sick; chills; increased depression; unable to get out of bed/off balance; unclear thinking; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 15Feb2021 at 13:30 (at age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and minor chronic kidney disease. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), citalopram hydrobromide (CELEXA), quetiapine fumarate (SEROQUEL), carbamazepine (TEGRETOL), clonazepam (KLONOPIN) and lisinopril (MANUFACTURER UNKNOWN); all for unspecified indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 at 09:00, the patient experienced aches, fatigue, feeling sick, chills, increased depression, unable to get out of bed/ off balance and unclear thinking. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events aches, fatigue, feeling sick, chills, increased depression, unable to get out of bed/ off balance and unclear thinking was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Reports Guillain-Barre Syndrome secondary to Moderna COVID vaccine. Completely bed ridden then transferred to hospice.
Swelling and erythema on right lateral thigh at the site of Prevnar immunization noted the following day (uncertain what time). Size 6 cm. Underlying firm nodule. Able to walk without difficulty. Not painful unless palpated.  Mom called the office to report the swelling on Monday and child got the vaccine on Friday. Of note, child got 2 vaccines one week prior, due to preschool requirement. Mom insisted on getting these done a week later due to preschool requirement - as the preschool would not allow child to attend without these vaccines and would not accept a "vaccine in progress" note.
Vaccine given 5/18/2010, next day Pt developed an injection site reaction. She was concerned and so I'm filling out VAERS. Next day about 1 inch pink "rash" developed w/ fever x 2 days. Pt took BENADRYL. "Rash" increased slightly that day then subsided. Description from other pharmacist -> small pink area - not on injection site.
On January 16, 2016, my left ear suddenly lost the hearing ability with consistent noisy sound and dizzy when I wake up.  When visiting the ENT specialist and examining my left ear, he found nothing wrong at the visible area. After checking my medical history, he considered the cause of this hearing lost was from the Zoster(Shingles) vaccine I was immunized on Nov. 4, 2015. The reasons to consider from Zoster vaccine because: 1). The vaccine is the live virus. 2). This virus only infects the nerves. 3). The relationship between Shingles infection and hearing lost was clear. 4). The symptoms I had were typically like the hearing lost after shingles infection. 5). Under certain circumstances, my body's immune system was weak, and let these viruses easily recovered and infect the nerves controlling the oranges related to hearing and body balance. The ENT specialist gave me large dose of prednisone for two weeks, but nothing changed, then he referred me to another specialist for directly injecting the Dexamethasone to my left ear totally for 6 doses, still useless. After that I received Hyperbaric Oxygen Therapy for total 16 sessions, still no anything improved.
From telephone contact received at manufacturer on 11/12/02, it was reported that a 15 month old male had been vaccinated with Fluzone SV 2002-2003 USP on 11/01/02 in the right deltoid.  The mother of the pt reported a 4x3 inch area of bruising and warmth at the site.  Initially, there had been only redness prior to bruising.  No other symptoms were noted.  The pt has no bleeding disorders.  The reporting physician received this information via a telephone call from the pt's mother; the child did not have an office visit for this event.
This 79  year old  black female received the Moderna Covid shot on 1/30 /21    and went to the ED on  2/8/21     and was admitted  on 2/9 /21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) (HCC) N17.9 - Acute kidney failure, unspecified
Chills, fever, fatigue, headache, sore arm, swollen and sore lymph nodes
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine that shows as expired 14-Aug-2021 but also expired on 14-Oct-2022.  No concomitant medication and treatment drug were reported
Dad called approximately 30 h after administration; c/o redness, knot, swelling of leg where vaccines given 48 h after administration fever increased 102, swelling worse. OV recommended tx-ADVIL, BENADRYL, cold compress.
Covid Arm; Coloration of a couple of inches on the injection site; Irritation on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm), VACCINATION SITE DISCOLOURATION (Coloration of a couple of inches on the injection site) and LIMB DISCOMFORT (Irritation on the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm), VACCINATION SITE DISCOLOURATION (Coloration of a couple of inches on the injection site) and LIMB DISCOMFORT (Irritation on the arm). At the time of the report, VACCINATION SITE REACTION (Covid Arm) and LIMB DISCOMFORT (Irritation on the arm) outcome was unknown and VACCINATION SITE DISCOLOURATION (Coloration of a couple of inches on the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history information was reported. No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Pt states since the day of vaccine on 8/20/21 since now 9/16/21 she has had extreme joint pain in shoulder and elbow on the same side as vaccination (Right arm). It has been inflamed and painful with arm weakness.
On 4/18/00, the pt noticed a sore area over injection site. Area felt "hard" to the touch. On 4/19/00, the pt had a painful armpit, pain in right shoulder, no fever noted at this time. On 4/24/00, the injection area still slightly sore to the touch.
I was vaccinated seven months ago, so I'm unclear on the timeline. But I believe after my first injection, and shortly before my second, I developed three severe cold sores on my lips for the first time in my life. A few days later, all three cold sores became covered in yellow crust and were itchy ? I'd later be informed this was impetigo. After two weeks of antibiotics not having any effect, at one point I was able to wipe the crusting off of my lips, along with the skin, from then on I developed severe and unrelenting cheilitis to this day. Then after three days of no impetigo, I developed a red rash all over my face, and red dots began to pop up all over my arms and my back with some appearing on my chest, stomach and legs. The rash on my face and rashes on my arms and back were horribly itchy and irritated and within days they were all covered in yellow. The impetigo was severe and the ones on my back and arms became bloody and appeared to look like sores (my dermatologist later hypothesized this was nummular eczema while infected. After over a month of antibiotics the infection was gone, but I still suffer from these red dots, rashes, and have since dealt with two bouts of impetigo on my ears and my mouth. Before this vaccine, I had never had a bacterial infection or eczema as severe as this in my life.
some of the vaccine trickled down arm; A spontaneous report was received from a consumer concerning a 55-year-old patient who received Moderna's COVID-19 vaccine and experienced "some of the vaccine trickled down arm".  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, on the same date of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M2OA) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021 patient received first dose of vaccine but wasn't sure if the full dosage was administered because some trickled down their arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event "some of the vaccine trickled down arm" was considered resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 011M2OA.  There were no reported AEs associated with this case of Incorrect dose administered.
Information has been received from consumer concerning her 7 year old son with asthma and seasonal allergy who on 04/19/04 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647655/0869N).  Concomitant therapy included cetirizine hydrochloride (Zyrtec) and montelukast sodium (Singulair).  Prior to vaccination the pt was treated for chronic sinus infection with amoxicillin/clavulanate potassium (Augmentin) 875mg and an unspecified steroid for duration of 20 days.  On the night of vaccination, the pt woke with fever 104F, screaming in pain from a large, hard, red, hot golf ball size area on his upper right arm at the injection site.  He was treated with tub baths, acetaminophen (Tylenol) and ibuprofen (Advil).  On 04/20/04 he was seen in the office and a chest x-ray and CBC were performed.  The pt's fever continued and he also had a deep cough and headache.  The physician called to confirm that the pt was treated with amoxicillin/clavulanate potassium (Augmentin) and the medication was finished on 04/16/04.  He also confirmed that the pt had a severe local reaction and cough as per his visit on 04/20/04.  There was no chest x-ray report yet and CBC results included; WBC 13,000 and neutrophils 80% with 2% bands.  He reported that the child would be seen again on 04/21/04 and would probably be restarted on amoxicillin/clavulanate potassium (Augmentin).  The pt had no previous reaction to vaccinations and did not receive pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) in the past.  There was no product quality complaint involved.  Additional information from the pt's mother on 04/23/04 indicated that the pt had cellulitis of the affected arm.  He was not able to move it and his arm is in a sling.  He continues his amoxicillin/clavulanate potasssium (Augmentin) and will be seen by his doctor again today, 04/23/04.  The pt's mother reported that "the area of the injection was not cleansed prior to the injection by the allergists nurse".  Her son also had "15 allergy tests in the other arm on the same day as the vaccination and the syringe with the (pneumococcal 23v polysaccharide vaccine) was carried on the same tray as the allergy test syringes".  Upon internal review, cellulitis and not able to move his arm were determined to be other important medical events (OMIC).  Additional information has been requested.
Extensive swelling, redness, itchiness and limited elevation of the L arm on vaccine site (MENVEO / FLUARIX) administered on 2/13, reaction started 8 hs after vaccination, peaked on 2/15. Symptoms improved with cold compresses. Today at PE, FROM of the L arm, mild erythema of the external aspect of the L arm, no tenderness, no swelling.
No adverse symptoms at time of shots. After second Moderna shot February 23, 2021 I suffered a stroke seven day later on March 2, 2021.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # K010523, expiration date 25-FEB-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Patient states that her right arm hurts from her first vaccine, patient has already gotten 2nd dose but states she had no problems with 2nd dose.
swollen lymph node in armpit of arm where injection was received (lasted for 16 days after injection), sharp burning nerve-like pain to touch down arm of injection site onset 10 days afterward.  Lasted about a week from there.  Felt a lot like nerve pain.  Got evaluated at Urgent Care for possible shingles.  Diagnosed a negative.
Itchy all over, feels warm all over Benadryl 20 mg PO @ 9:45 self administered.
sores all in her mouth; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; gums are swollen; oral lesion through out my mouth; teeth is hurting as well as her gums/pain in my teeth and in my gums; teeth is hurting as well as her gums/pain in my teeth and in my gums; everything hurts; can hardly talk; I cannot even eat/barely eat; her teeth are throbbing; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWQ175) via an unspecified route of administration on 25Aug2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced teeth was hurting as well as her gums/pain in my teeth and in my gums. On 29Aug2021, she developed sores all in her mouth and there were some patches and streaks. She described the patches that some was white while some were yellowish which was also present in the back of her throat. On Aug2021 she can hardly talk and barely eat/ I cannot even eat and that everything hurts. Her teeth are throbbing and on 28Aug2021 her gums were swollen. She feels her teeth will out since her gums was swollen. She also mentioned that she has developed this oral lesions. Nurse stated, "I had the vaccine on Wednesday, the Pfizer vaccine the first dose and yesterday 3 days after I started feeling pain in my teeth and in my gums and I have oral lesion through out my mouth and my gums were swollen." Nurse stated that she was scheduled for endoscopy and colonoscopy. The outcome of all events was unknown.
Tested positive after receiving the Moderna Covid 19 vaccine Bivalent; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive after receiving the Moderna Covid 19 vaccine Bivalent) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient does not have allergies.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (previous doses were from Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 10-Sep-2022, 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 12-Sep-2022, the patient experienced COVID-19 (Tested positive after receiving the Moderna Covid 19 vaccine Bivalent). The patient was treated with MOLNUPIRAVIR (LAGEVRIO) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive after receiving the Moderna Covid 19 vaccine Bivalent) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Patient was in his 80s. Concomitant medication: Heart Medication, statins and High Blood pressure medication.   This case was linked to MOD-2022-651005 (Patient Link).
Woke up with Very sore arm (painful to touch in shot area), a general headache (which I normally do not get), and achiness all over. I had received the shot less than 24-hours before.
COVID-19 Vaccine EUA?  Mild Fever, slight dizziness, fatigue, sore injection arm
mom took pt to ER t105 & rash on arm & neck;alternated Motrin & APAP as tx;went to MD next day;
bruising of torso on the right side, area felt like "pins and needles", on trunk area turned red, itching all over body, difficulty talking, the following day difficulty breathing, stuffy nose, metal taste in mouth
Child inadvertently given VARIVAX instead of PROQUAD. No adverse reactions noted from parent/child.
I was unaware I was pregnant at the time of the first vaccination shot, and may not have been yet. It was after my second shot that I recognized my period was late and took a pregnancy test and it was positive, then I preceded to get a negative test a few days later, and did blood work to learn I had a miscarriage after my second vaccine shot.  For someone who had been trying to start a family for 2 years now this was devastating and I regret getting the vaccine since it is too early to know how it impacts every individual body, but the shot was mandated by my place of employment.
Pt is known asthmatic and received nasal mist despite mom informing them of this. Had severe wheezing after mist.
This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 25th January 2019, 210 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient woke up with bell's palsy. The patient's 2nd dose was due after 29th August 2018, but the pharmacy was in short supply of the vaccine for a while. The patient still did not receive her 2nd shot of SHINGRIX. At the time of reporting, the patient was concerned about the bell's palsy. The patient wanted to know, if it would had some kind of effect on her if she receives the 2nd shot of SHINGRIX at the time of reporting. The patient asked, whether it would be safe for her to take it or wait until the bell's palsy had gone away. The patient understood that bell's palsy could last from 3 to 6 months so it would be longer than the 6 months that was recommended to take the 2nd dose.
Gave patient a full dose of Moderna (0.5ml) as a booster on 4-11-2022 around 11:45am. Patient went home after waiting for 30 minutes and was stable with no complaints. Patient notified on 4-12-2022 of error and patient reported that he was fine and has not had any adverse reactions.
low grade temp / spouse developed a low grade fever (99.5F); This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2020, the patient received the 2nd dose of Shingrix. On 14th May 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The husband reported for her wife. The patient received Shingrix and had low grade temperature and temperature was recorded 99.5 degree F. The reporter wanted to know was that something we need to worry about as he read that was a common symptom. The reporter consented to follow up. This case linked with US2020AMR082449 and US2020082513, reported by same reporter.
Patient received the [1st] COVID vaccine Pfizer lot #EW0171 and expiration date 04/24/21 at 4:00pm . Client walked up to  EMT and reported that his arm was itchy. RN responded. Client escorted to observation area. Client walking with steady gate and placed in semi-fowler's positions. Client reports intermittent itchiness at the injection site. He denies pain or swelling, itchiness in any other body part, swelling, shortness of breath, chest pain, dizziness, palpitations, weakness, or other symptoms at this time. Client is alert and oriented to person, place, date and event. Right arm appears with in normal limits without swelling, redness or hives. Client denies medical history, allergies or taking medications at this time. VS at 11:08am HR 58, BP 126/82, SPo2 99%RA, RR 18.  Client offered diphenhydramine. Client denied and stated that the itchiness is no longer present and resolved at 11:21am. RN provided client with education on side effects of vaccine and signs and symptoms that indicate mild to sever allergic reaction. RN informed client of ER precautions. Client advised to follow up with PCP regarding incident. Client verbalized understanding. VS at 11:20am HR 60, BP 120/78, SPo2 100%RA, RR 18. Client observed for additional 30 minutes. Client verbalized that he felt well and did not have any other complaints. Client walked out of site with steady gait.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medications and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified dose of improperly stored LIQUID PEDVAXHIB (lot # L006545, expiry date 16-NOV-2017; lot # L012838, expiry date 10-MAR-2018) (strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.