chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and RASH PRURITIC (Itchy rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and RASH PRURITIC (Itchy rash). At the time of the report, PAIN (Pain) and RASH PRURITIC (Itchy rash) outcome was unknown.            No concomitant medications were provided by the reporter.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up received on 31-Jul-2021, indicated reporter's address, no other new information was provided.
Initial unsolicited report received from a nurse on 20-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient couldn't able to lift her arm. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
April 19 felt like a charlie horse in my leg, I went to the ER on 05/03/2021 and was advised that I had blood clots in my left leg. They did not check my right leg but I also didn't have any pain in that leg.  About 2 or 3 years ago I was subject to blood clots because I traveled alot but when I experienced this I was not traveling or anything just staying home
tinnitus on her R ear; dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), intramuscularly on the left arm on 23Dec2020 at 13:30 at a single dose for COVID-19 immunization administered at the hospital facility. Relevant medical history included rheumatoid arthritis, bipolar disorder, anxiety, and depression; all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included unspecified anti-depressants. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 at 07:00, about 18 hours after the vaccine was administered, the patient experienced tinnitus on her right (R) ear and dizziness, which were assessed as non-serious. She had never experienced these combinations of symptoms before even when she was taking her anti-depressants. The patient had a Covid test post vaccination (test type: Other, Rapid) with unknown results on an unspecified date in Dec2020. The patient also had a Covid test on 18Dec2020 with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via rapid test. Unspecified therapeutic measures were taken as a result of tinnitus on her R ear and dizziness. The patient was recovering from both the events.  Information on the lot/batch number has been requested.
Per health department VAERS, patient mom notified by Dr. of vaccine error-no reaction expected, mom to observe and contact if any adverse reaction noted, VAERS completed.
I had a pretty horrible headache following vaccination for a few days. Then for about 6 months, my menstrual cycle was unbearable.  I experienced extreme fatigue and headaches, with a heavy flow and cramps. This made it almost impossible for me to work during my period.  I finally went to my doctor who said that this has been happening to women post vaccination but should even out eventually and go back to normal. My last cycle felt relatively normal for the first time but... She switched me to the non brand name version of Sprintec birth control, which resulted in breast tenderness,  nausea, and swollen lymph nodes. She switched me back to name brand sprintec and all of these symptoms went away besides a lump under my armpit which I am getting an ultrasound of tonight. I did receive a Moderna booster, but that was almost a month after the onset of these symptoms.
Severe itching from top of head to the top of feet. Itching also causes large red whelps on skin lasting at least 2 days
Red knuckles on hands; Itchy knuckles on hands and a bit on feet; Red and itchy feet; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 06Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) and fexofenadine hydrochloride (ALLEGRA), all from an unknown date for an unknown indication. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunisation. 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 07Apr2021, the patient experienced red and itchy knuckles on hands (mostly the left hand which is the side of the vaccine) and also a bit on feet. No therapeutic measures were taken as a result of the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red hands, itchy and redness on legs was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
pt recv vax 6JAN98 on 21JAN97 broke out w/4 chickenpox like lesions;mom reports low grade fever for wk prior to breakout;
Hives on neck and elbow; Red rash on upper back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on neck and elbow) and RASH ERYTHEMATOUS (Red rash on upper back) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LZ019) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced URTICARIA (Hives on neck and elbow) and RASH ERYTHEMATOUS (Red rash on upper back). At the time of the report, URTICARIA (Hives on neck and elbow) and RASH ERYTHEMATOUS (Red rash on upper back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
03/07/2021 at 9:38 am Patient complained of having nausea and felt light headed and dizzy. Got patient water and snacks bar and had her to lay down fer close observation. V/S BP 109/80 (lying down)  and HR 68. After patient sat fer additional for 20 minutes at 10:00 am patient felt good enough to depart.
sore arm, chills, feverish  The sore arm developed around 5 o'clock on Feb. 27 and lasted until March 1.  Chills started and ended on Feb. 28. Slight fever started and ended on Mar. 1. I took Tylenol.
I shoulder pain in the joint.; This is a spontaneous report from a contactable other HCP, the patient. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 31Dec2020 at 10:15 (at the age of 52-years-old) as a single dose, via intramuscular route of administration in the left arm for COVID-19 vaccination. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 18:00, the patient experienced l shoulder pain in the joint. The patient did not receive any treatment for the event. The clinical outcome of the l shoulder pain in the joint was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
02/01/21: 2pm slight chills then went away. 9pm-3qm same night, extreme body aches, extreme shaking, bones hurt balyd, joint hurt badly, low fever, scratchy throat, nauseous. This was the WORST i have ever felt in my entire life rolled into 1 night.  I had Covid ib October 2020 and this was FAR WORSE than anything I have ever experienced or could have imagined.   02/02/2021: roughtly every 2- 4 hours still low temp but very cold and achy. Each time is passes but comes back several times a day. Just flu like symptoms now, not like night #1 experience.  02/03/2021: Achy/cold spells every 5 or so hours, but getting slightly lighter each time. Still happening as of 8pm this evening.
Moderate to severe pain in left shoulder which started after the injection and grew in severity for an hour or two. Shoulder pain was treated with ALEVE, but lasted for roughly 24 hours, with mild pain after that for another 6-8 hours. Headache, all-over muscle aches, and fatigue occurred on the morning following vaccination at about 6am (12 hours after vaccination). Headache was treated with BC (aspirin and caffeine), muscle aches (and continuing shoulder ache) was treated with ALEVE. Was not able to perform normal activities that day - went back to bed and slept. When out of bed was sluggish and achy, as with the flu. Symptoms abated the following morning (approx 36 hours after vaccination) and were mostly gone about 48 hours after vaccination.
Diagnosed with Breast Cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER FEMALE (Diagnosed with Breast Cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced BREAST CANCER FEMALE (Diagnosed with Breast Cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER FEMALE (Diagnosed with Breast Cancer) outcome was unknown.            Company comment: This is a spontaneous case concerning a 74-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event Breast cancer. Gynecologist found a lump in patient's breast after the 1st dose of mRNA-1273 and was diagnosed with breast cancer two weeks after the second dose. Treated with chemotherapy on her 6th infusion. The reporter assessed the event as unlikely related to the vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  Concomitant product use was not provided by reporter. It was reported that patient's gynecologist found a lump in patient's breast after the 1st dose. She stated that the lump was there before she received the 2nd dose.  She was diagnosed with breast cancer two weeks after her 2nd dose in Feb 2021. Patient further conveyed that she did not thought the vaccine caused the cancer.  She had 6 infusions of chemo and her last chemotherapy was 29 Oct 2021. She was scheduled to see her doctor on 02 Dec 2021 to discuss further if she should get the booster or the third dose.   This case was linked to MOD-2021-403863 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event Breast cancer. Gynecologist found a lump in patient's breast after the 1st dose of mRNA-1273 and was diagnosed with breast cancer two weeks after the second dose. Treated with chemotherapy on her 6th infusion. The reporter assessed the event as unlikely related to the vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
I got COVID; it was very mild case; I got COVID; it was very mild case; Headache; I was extremely fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER3732, Expiration Date: 26Mar2021) at the age of 68 years as dose 2, single and administration date 25Feb2021 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included infection (unspecified if ongoing); smoker (unspecified if ongoing), of 54 years; surgery (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Flu shot, for Immunization. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 2021, outcome unknown, SUSPECTED COVID-19 (medically significant) with onset 2021, outcome recovered (2021); it was very mild case; HEADACHE (non-serious) with onset 2021, outcome unknown; FATIGUE (non-serious) with onset 2021, outcome unknown. The patient underwent the following laboratory tests and procedures covid-19 positive. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19, headache, and fatigue.  Consumer further stated, I have something to tell you too. You know I got COVID. But it was very mild case because I had both of the vaccinations and I got it from my son and he got it from my nephew who never had COVID (Further clarifications unknown), but was a carrier and I have an open wound it is been like that for rough six years because I have an infection and they have to do surgery and this was that my weird part and it was a creepy part I got leeches (Further clarifications unknown) and don't ask me how I got leeches because I have no idea. Leeches on my foot and after you know they were there for a while because I do not know they were there and my foot always wrapped. But I think that day wasn't wrapped really tightly and after this the leeches removed some blood, I got rid of my COVID, my COVID symptoms.  Follow-up attempts are completed. No further information is expected.
pt recv vax 22JUL94 & mom noticed Tetramune was given SC; 4 hr later the leg (entire interior side of thigh) in which Tetramune was given was tender/red/swollen; Also knot @ inj site; pt recovered; no rxn @ Hep B site;
With the week of 03/15/2021, you experience Flashes in her eyes in the dark especially right eye, in the dark and blurring  vision. This issue of the  flashing of light and blurry vision , did not go away so he scheduled appoint with ophthalmologist and he did a scan and said was not a macular hole and she said it may come with the age, but patient was concerned with the timing with having her recent COVID vaccination.
That evening, developed a large red pruritic papular rash over left upper arm. The area of redness increased over the next 4 days. The papules had the appearance of small wheals but may have been papules, Uniform in appearance.   On 10/29, rash is less red, the papules are smaller. On exam, fine dry papular rash, not follicular, no vesicle, no pustule, no scabs. No diffuse erythema as there was on photo taken 10/26.
Client is an 11 yr old caucasian male whom recieved his first dose of pediatric Pfizer.Client was waiting in recovery area and started complaining about nausea and feeling flushed to parents. Nurse arrived to car and EMS was assessing client already whom was reclined back in back seat of parents vehicle. Client was cool to touch, pale in color, A/O x3. 11:15 AM V/S: B/P: 98/62 HR:78 O2:98%. Nurse instructed client to elevate feet and drink a Sprite as well as eat a snack. 11:25 AM Client states that he feels better. Per client Nausea has subsided, Client is warm to touch and normal skin color has returned. Nurse/ EMS did teaching with parents on monitoring for worsening s/sx (i.e. anaphylaxis) and to take to E.R. Parents verbalized understanding and client states he is feeling much better and safe to go home.
No adverse effect; improperly stored doses of ROTATEQ were administered; Route of Administration: intramuscular; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 24-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R033255, expiration date 26-JUN-2020, intramuscular (dose, frequency and anatomical location were not reported). The vaccine was stored in temperature above 47 Fahrenheit degrees for 2 hours. The temperature was measured by "data logger". There was no previous temperature excursion. No adverse effect was reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009902: US-009507513-1906USA009882: US-009507513-1906USA009880: US-009507513-1906USA009914: US-009507513-1907USA002467:
within 45-60 min of getting flu and meningitis vaccines, symptoms increased rapidly from nausea, to feeling hot, to heart racing and then throat closing. Went to ER where was given Steroids, Benadryl, nausea meds and fluids
Recombivax HB vaccine was given IM in the RAT. After administering, nurse noted that the vaccine had expired on 6/4/21.
Administered Shingrix in R deltoid. Area began to swell up to "quarter size". Called provider to evaluate. Provider circled swollen area. Provider instructed pt to use warm  compress + call office with any increase in size or further s/s. Pt stated he felt fine.
MENVEO vaccination is a two component vaccination that contains active vaccination in each vial. The vials are very similar in size and look. We have had a couple instances that we are aware of (probably more have occurred) where either the pharmacy has sent only one vial or only one vial was administered because the healthcare provider was not aware that it was a two component vaccination. In each instance the powder vial was reconstituted with a sterile water diluent instead of the active vaccination contained in the diluent vial included. Our facility believes the manufacturer needs to take further steps in clearly identifying that it is a two component vaccination on their outside packaging and on the individual vials to prevent these errors from occurring. We have taken internal steps in our pharmacy to mitigate this error. To start we are packaging the vials together using a packager to make sure the vials are sent together in one package. Additionally, our Medication Use Safety Team (MUST) has put together a flyer to send out to our clinics and hospital departments to post for educational purposes.
I experienced a macular hole in my left eye four days after I received my second injection of Moderna. This required emergency surgery and has a long term effect on my vision. I had to miss 3 months of work due to poor vision.
Initial and additional information has been received from a 20 year old female with allergy to metals who in April 2011, was vaccinated with a dose of GARDASIL. Secondary therapy included ethinyl estradiol (+) etonogestrel since February 2011 (also reported as 10 months ago) vaginally, "3 weeks in 1 week out", for birth control (duration and dose not reported). On 22-APR-2011, the patient stated she started spotting. The patient reported that she had been using ethinyl estradiol (+) etonogestrel since February 2011 and never experienced irregular bleeding or change in her cycle time. The patient stated that received GARDASIL and in April 2011, a few days ago, two days after receiving GARDASIL she got her period 10 days earlier than she normally would while ethinyl estradiol (+) etonogestrel was still inserted. At the time of this report, the patient had not recovered. The patient reported she was also experiencing vaginal secretion similar to what she felt was a yeast infection. The patient was informed of the PI's information on use of anti-yeast products with the ethinyl estradiol (+) etonogestrel and referred to health care provide. Additional information has been requested.
Arm is hurting/Arm is really sore; Limb discount; A Spontaneous report was received from a consumer, concerning herself, a female patient of unknown age, who received Moderna's COVID-19 vaccine (m-RNA-1273) and experienced the events, arm is hurting, arm really sore, can't even lift it.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273, intramuscularly in the left arm. On 01-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly, in the left arm, for the prophylaxis of COVID-19 infection.   On 01-FEB-2021, the patient experienced the events, arm is hurting, arm really sore, can't even lift it. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, arm is hurting, arm really sore, can't even lift it, was unknown at the time of this report.  Based on MSA comment Pain in extremity coded as Vaccination adverse reaction and Limb discomfort coded Vaccination site movement impairment
an unspecified amount of fluid was leaking out of the injection site; This spontaneous report was received from a pharmacist and refers to a patient of unknown age, gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.   On 03-JUN-2019, the patient was vaccinated with on dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S000132 with expiration date on 02-JAN-2021 (strength, frequency and route of administration were not reported) for prophylaxis. Other suspect therapy includes sterile diluent lot number S000977 with expiration date on 14-SEP-2021.  On the same date, during the administration of the vaccine an unspecified amount of fluid was leaking out of the injection site (vaccination site extravasation). The outcome of vaccination site extravasation was unknown.  The relatedness between the event occurrence and varicella virus vaccine live (Oka/Merck) (VARIVAX) administration was not reported.
patient is experiencing severe bruising &  discoloration with induration, redness low grade fever...area covering from elbow to shoulder
Moderna COVID-19 Vaccine  fever, chills, body aches, and fatigue for about 36 hours in addition to the general soreness at the site of injection