chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Harsh pain on injection. That night it felt like I got slugged in the arm. By morning my arm was stiff and swollen. I was having pretty intense nerve pain that was getting worse instead of resolving.  By nightfall my elbow was excruciating and badly swollen. I called my doctor the next morning. He prescribed steroids. A six day treatment. And referred me to orthopedics. The steroids helped with the swelling but I was in intense pain. And I'm left handed. So I could not do simple tasks like eat. Wash my face or hair. Dress myself. I had to relearn to to everything with my right hand. And I tried to keep my left arm quiet to avoid the pain.  Ortho sent me to physical therapy where I had my arm pulled on and twisted for several weeks. It was excruciating but I did regain significant mobility and eventually the pain was becoming manageable. I just didn't move my arm in ways that caused me pain. After the initial round of physical therapy I went back to Ortho. I was still having significant pain in my shoulder and intermittent nerve pain if I moved my arm in twisting motions like reaching to pull out my wallet...or turning off the water in the shower. And I couldn't lift anything heavier than a coffee cup. I couldn't swing a golf club or play my guitar. Ortho doctor gave me a shot in my shoulder. It helped. For a few weeks. I hadn't slept through the night since I got the shot. I was getting a little desperate. Depressed even. Ortho sent me to nuerology. The doctor there was going to do an emg test but couldn't get his machine to work. So my ortho sent me to another doctor to do it. Dr. By now there was a significant amount of atrophy. Dr did a physical examination and ran me through a few simple physical challenges and said he didn't think an emg test would reveal anything he didn't already know by examining me. He said I had 'frozen shoulder' combined with Parsonage Turner. He suggested the key to my recovery was more physical therapy. Which I did. Several more weeks. In the end I had shown some progress but still could not do everyday tasks like swing a club or play my guitar. My are was just this weak, atrophied, throbbing mess if I tried to do anything that required strength and mobility. But I could at least eat and wash my hair. Dress myself. My primary care physician said I had a brachial plexus injury and sent me to see Dr. Another neurologist. He was very good. And smart. He agreed with Dr that an emg test would tell him anything he did already know by examining me and running me through a few physical challenges. I had a shoulder injury (SIRVA) combined with Parsonage Turner. He said the key to resolving the Parsonage Turner was to free up the shoulder so he's sending me back to physical therapy. He said I still have a chance to regain the strength in my left arm but it could take months...if not a couple of years. And there is a chance I will never regain full use and may have to settle for small gains. And it may come back in the future. He prescribed Gabapentin so I could sleep at night without the throbbing nerve pain. And that's where I'm at as of May 9, 2020.
My D-dimer became elevated; requiring me to have a chest ct scan to rule out clot.  My left eye became inflamed and has been red for the past 3 months.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 14-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Nausea, dizzy, fast heart rate, excessive LARGE swelling in lymph nodes on R side of neck, sharp chest pains
felt shakey; nasty hangover; menstrual cycle had just finished and it has started again; kept falling asleep; Horrible headache; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm  on 06Apr2021 at 13:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) for unspecified indication and fluticasone propionate (FLONASE) for allergy; both from unknown dates. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and adhesive and cats (as reported); all for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 09:00, the patient experienced horrible headache for at least 12hrs, felt shakey, nasty hangover, nauseous, kept falling asleep and menstrual cycle had just finished and it started again after being off of it for 3 days. The patient had bleeding again, and the blood was a darker color than usual. The clinical outcomes of the events headache, shaky feelings, hangover, nauseous, sleepy and irregular menstruation were recovered with sequelae on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recv vax on 9/8/97; on 9/12/97 pt exp rash w/ erythema, weeping sores &itching of entire body; dx=erythema multiforme.  Pt seen by dermatologist; tx=Claritin &ointment
A non-serious spontaneous report of inadvertent administration to an 85-year old was received from a physician concerning an 85 year old female patient. Upon follow-up inquiry, the reporter confirmed that no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 21-Oct-2008 and incorporated into the narrative: Confirmation from the reporter that no adverse event occurred from the administration of FLUMIST to an 85-year old.
Within 5 minutes I had of the flu shot, a fast heart beat. It lasted 1 hour.
Vaccine was mixed incorrectly. The lyophilized ge antigen component was mixed with sterile diluent (water) instead of the adjuvant suspension component. The vaccine was administered to pt on 5/29/19 @ 4:40pm, pt report no adverse effects.
PATIENT WAS GIVEN FIRST PFIZER DOSE IN SERIES ON 04/20/2021. PATIENT WAS THEN GIVEN SECOND PFIZER DOSE IN SERIES ON 05/04/2021. PATIENT DID NOT WAIT THE RECOMMENDED 21 DAYS BETWEEN DOSES.
3 days after administration client began to scratch site (R) thigh. Site began to swell 11/19/12 am. No treatment . Client also has rash which may have precipitated pruritus 2 secondary to parents changing diaper brand.
Patient received second dose of flu shot at 3 weeks instead of 4 weeks. No adverse reaction noted per mother
About 6 hrs. after Td Vax, developed mild indigestion & wheezing sensation, also, his face & anterior chest became beet-red and felt that his lwr. lat. lip was swollen & numb. He took Triaminicin, an OTC antihistamine & felt better. Next
Information has been received from a registered nurse (RN) concerning a 23 week old male who on 28 Dec 2006 was vaccinated PO with the first dose of Rotateq. It was unknown if medical attention was sought. No problems were reported. Additional information has been requested.
He is 10; He is 10; mild injection site pain; what could be mild swelling in his armpit; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "mild injection site pain"; SWELLING (non-serious) with onset 2021, outcome "recovered", described as "what could be mild swelling in his armpit"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OFF LABEL USE (non-serious) all with onset 06Oct2021, outcome "unknown" and all described as "He is 10".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Large lump at injections sight, size approximately 9cm round, tender to touch first day after injection, 2nd day area itchy and much less tender.
It's been hard to use my right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: ER8731) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Family history included: "stage 4 lung cancer" (unspecified if ongoing), notes: Mother got the shot as well, is doing fine.She has stage 4 lung cancer she found out a few yr ago. Concomitant medication(s) included: MELATONIN; FEXOFENADINE taken for hypersensitivity; AMLODIPINE taken for blood pressure measurement; BENADRYL ALLERGY/CONGESTION taken for hypersensitivity; ALBUTEROL SULFATE taken for asthma; SYMBICORT; IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE. Vaccination history included: Bnt162b2 (1st dose, Vaccine Name: Covid 19 vaccine, first dose, Lot No: EN6207, Exp Dt: unk, Anatomical Location: left arm), administration date: 01Apr2021, for COVID-19 immunization; Tetanus (tetanus shot), for immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "It's been hard to use my right arm". Therapeutic measures were not taken as a result of limb discomfort.  No follow-up attempts are possible. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The coordinator reported that, the patient vaccinated with the powder component of Shingrix reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter could not identify the patient or the vaccination date, but found 3 AS01B Adjuvant. The reporter consented to follow up. This case was linked with case US2021248441 and US2021AMR250027 reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021248441:Same reporter.
Sore throat. Severe chills, body aches, headache, along with fever of 101.9 and nausea, vomiting. Severe left arm pain (site of injection).  Home from work on January 6th, day of initial dose. Started with chills after arriving  home at approx 8pm.  Went to bed and woke sometime around midnight with the above described symptoms. Symptoms  cont throughout the day (January 8th) . Finally out of bed by evening and was able to hold down food. Back to bed and woke sometime around 3 am after breaking a sweat. Fever was gone and my body cooler. Up that morning around 9. Normal, tolerable body aches, mild headache and left arm very sore but could tolerate it being touched.   Side Note: I had contracted the virus in March 2020.  The symptoms from the vaccine were so much worse than the actual virus. I am too scared to get the second dose.
A non-serious spontaneous report of received expired vaccine was received from a physician concerning a six-year-old female. Neither past medical history nor concomitant medications were reported for this patient. On 17-Nov-2010, the patient received the first dose of FLUMIST. On 12-Dec-2010, the product expired. The patient received the expired FLUMIST on 15-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 06-Jan-2011: No adverse events were reported.
hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it ) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced MYALGIA (hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it ). At the time of the report, MYALGIA (hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it ) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that M-M-R II (dose and route not reported, lot# J006953, therapy type unknown, expired date 07-JUN-2015, also reported as 07-JUL-2015) was administered to a 20 year old patient on 03-MAR-2014. This is case 3 of 3 patients which were exposed to M-M-R II. This case was linked to cases: 1403USA006581 and 1404USA015674. Additional information has been requested.
My left arm was red, swollen, & hot to the touch for two days. I noticed the arm was swollen, but the redness went away.  Six days later I scratcedh my arm because it was itchy. The next 3 days my left arm was swollen, red, & hot to the touch again. I was advised to see a doctor. I am currently being treated for cellulitis at the site of my injection.
Sore throat and chills started about 2 days after shot (10/18). Temp not taken. Cough began 10/21. Had neg rapid strep test, culture not back yet. Bruise at injection site.
With the third dose, the pt experienced pain and inflammation at the injection site. The pt's symptoms subsided.   In follow-up the states the pt now has drug allergies she did not have prior. The pt reported that this event happened around 1990 when she was 23 years of age. The pt states that she recovered. No further information is expected.
3" diameter, itchy rash around the injection site 3 days post injection.  This was his 2nd dose of J-VAX
Patient's arm swelled and bruised in that area of injection. Swelling was the size of a baseball.
Pt has redness and swelling of the left bicep (approximately 5 inches long and 2 inches wide. Pt came to pharmacy to ask for recommendation. I recommended that he apply a cool compress and take benadryl to see if that would take care of the rash. Asked pt to follow up with us if the rash proceeded to get worse or not improve. The rash seems to present below the PNEUMOVAX vaccination site.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On 13-NOV-2015, the patient was inadvertently vaccinated with (Merck) VARIVAX [lot # K007976, expiry date 03-JUN-2015] (Dose: 0.5 ml, Route: subcutaneous) instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with expired dose of VARIVAX (Merck), 0.5 ml (lot # H018459, expiration date 09-OCT-2014) subcutaneous. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
THE MORNING FOLLOWING THE VACCINE, HER ARM WAS SLIGHTLY SWOLLEN, SORE, AND ITCHY. SHE USED ASPERCREME AND TYLENOL WHICH ALLEVIATED THE SYMPTOMS SOME. SYMPTOMS HAVE SUBSIDED MOSTLY AFTER 4 DAYS. SHE REPORTS THIS DID NOT HAPPEN AFTER THE FIRST ONE
11-09-21 - Start of Hives on arms. 11-10-21 - Hives Spread to Arm, Chest, and Back. 11-11-21 - Hives spread to Legs, Buttocks, and Stomach. 11-12-21 - Hives spread to Face, Neck, Eye Lids, Feet, and Hands. Went to ER and was given Prednisone injection, Prednisone RX, Epinephine injection, RX Epie Pen, Benedryl 50mg, Pepcid 20mg. Hives lasted 6 days.
Menveo was administered using sterile diluent instead of the supplied diluent; Menveo was administered using sterile diluent instead of the supplied diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA928A, expiry date 31-MAY-2024) for prophylaxis.   On 22-AUG-2023, the patient received Menveo. On 22-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo was administered using sterile diluent instead of the supplied diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo was administered using sterile diluent instead of the supplied diluent).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
On 07/17/07 pt is a previously healthy 3 m.o male admitted to medical center with a two (2) day hx of fever, irritability and rash on arms, legs and face. Child was noted to have bilateral conjunctival injection, oral mucosal changes, swelling of extremities with palmar and plantar erythema. ID dx'd pt with atypical Kawasaki. IVIG and high dose aspirin started 7/19/07.  09/05/2007 MR received from hospital for DOS 7/17-21/2007.  Infant presented with fever and rash as well as a 1 1/2 week hx of cough and rhinorrhea. PO intake has been decreased as well as fewer wet diapers and BMs.  PE (+) for significant maculopapular rashes all over his body, (+) irritability, conjunctival injection.  PE done by ped ID also (+) for dry, cracked and bleeding lips, extremity swelling and palmar and plantar erythema.  TXd with IVIG and high dose ASA with resoulution of sx. Discharge DX: Kawasaki Disease.
My husband noticed my that my arm near the injection site was red and raised last night, January 2nd - over one week after the vaccine.  Then I was woken up around 1 in the morning January 3rd (today) with fairly intense itching at that site.  Today it is raised, red, and mildly itchy.  We took pictures to show the difference in arms.  Of note, the pain from the vaccine was so severe I couldn?t even pick up a water glass or put a shirt over my head with that arm.  It was only that bad on 12/27 and rapidly improved. I am just mentioning this in case people who have had itching over one week also had severe pain after the injection.
I woke up on 6/20/21 with a fever and shaking chills (no thermometer in the house). By 6 PM  developed redness, swelling, and skin dimpling on the front of my right lower leg. I had had a small wound on the 3rd right toe, caused by a hammertoe, and that toe was also hot, swollen and painful. I am a retired RN and recognized the onset of cellulitis. I used tylenol to control the fever. I visited an Urgent Care clinic on Monday the 21st of June and was seen by a nurse practitioner. She prescribed a 10-day course of doxycycline and suggested that I see a podiatrist because the toe wound seemed to be the source. After the 10 days, the leg cellulitis was resolved but the toe remained swollen. I then saw a podiatrist, who prescribed a 10 day course of Levaquin. I have had frequent visits with the podiatrist to treat the toe wound, which is finally resolved.
8MAY mom called stating lower lip & one side of jaw swelled; pt had mild temp, irritable & trouble taking bottle due to swelling; Seen by MD gave Decaron inject & DPH; 12MAY mom stated pt improved next day; MD states ? rxn to pertussis;
First dose after a couple of days, I started feeling the shortness of breath and it started getting worse especially in the evening. I would be gasping for air sometimes and would occur every few minutes throughout the day and eventually tapered off after a couple weeks with it occasionally happening again. As per treatment, I had a visit phone visit 4/29/2021 about shortness of breath and chest tightness. The day after or the day after that, I went to the urgent care, and they did an echocardiogram of my heart. They said everything was fine. I asked if I should see a pulmonologist and the urgent care doctor said sure. 5/5 I went to the pulmonologist, he chatted with me about the symptoms and ran some tests. He prescribed me an inhaler, but I was scared to use it because I was breast feeding. I also did a blood test, and everything was normal with that as well. Complete blood test, D-dimer, and a little anemic I have been for a while. June 23, pulmonary function test normal. I did do a COVID-19 test on 5/7 and it was negative as well. 6 days after the dose, it looked like I had a bite on my arm and spread over the night that turned into a large pink rash. I messaged my dermatologist about it, and they said that it was a normal reaction for the Moderna shot. Went away after a few days.