chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt mass or nodule near the injection site; felt mass or nodule near the injection site; This spontaneous report was received from a physician concerning a female patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, lot # and expiration date were unknown), intramuscularly for prophylaxis.         On an unknown date, about one or two months after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination, the patient felt mass or nodule near the injection site. The physician did not see the patient. The treatment given for the events was unknown. The outcome of the events was unknown. The causality assessment was not provided.      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA008168:
right leg started hurting; have a rash on the right leg; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 09Apr2021, as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 09Apr2021, the patient right leg started hurting, it was the same side where patient took the vaccine. It was reported that patient took shower and had a rash on the right leg. The HCP advised the patient to take Benadryl through phone and a cortisone cream and if that doesn't help in 2 days to call her back again for follow up. Therapeutic measures were taken as result of events. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient came in on 09/22/2022 with her mother to receive her second dose of the Pfizer covid vaccine. Forms were handed out to patients mother upon arrival. I called patient in, and her mother asked if she could come as well. Once roomed I asked for reason of visit, and mother stated it was for second covid shot. I went to draw vaccines came back asked patient if she was allergic to any medication, and how did it go on her first dose, her response was, no known allergies, and nothing more than a swore arm after her first shot. Once her arm was prepped I administered the shot on her right deltoid I turned around to throw out the needle in the sharps bin, grabbed a gauze and a band-aid, and placed it on her arm, I
"Covid arm" -- redness, rash and hardness 8-9 days after injection,
Feelings of having a fast-beating, fluttering, or pounding heart. Most typical in the evening when laying down to rest / sleep. Lasted 1-2 weeks after both doses of vaccine. Dismissed after the first dose as a fluke, but occurred again after the second dose. Last 1-2 weeks as well. Both doses were Pfizer (EN6202 and ER8727). Second dose administered on March 31 2021. No adverse symptoms now several months later.
Persistent LUQ pain, fatigue and weight loss since administration of first GARDASIL vaccination. Pt and pt's mom did not report these symptoms. Pt received second dose of GARDASIL on 10/10/08 - mom reports original sign and symptom much worse with severe abdominal pain. Symptoms reported 10/30/08. Monospot and pain/ fatigue persisted - referred to GI.  4/9/09 MR received from PCP. Well check 7/11/08. HPV#1 given (0279X). Returned for 2nd HPV shot 10/10/2008 with lot #U2687AP recorded (see vax rec).  Returned 10/30/08 with c/o 3 wk hx of nausea, pallor, sore throat, H/A and LUQ pain.  Feeling tired and dizzy. PE (+) for palpable ridge of spleen, LUQ tenderness. Sent for CT. Returned 11/6/08 with report of one episode of passing out. Out of school all week. Assessment:  Mono. Seen 11/24/08 for Mono with viral pharyngitis. By 12/4 08 parent reporting pt still ill with viral URI, still fatigued. Recheck 12/25/08. Reporting more frequent dizzy spells. No LOC. PE (+) for LUQ tenderness. Seen 1/13/09 for sore throat, sinus congestion, and R ear pain x 2 weeks. Still with abdominal tenderness.  Some good  days some bad. Referred to GI. 4/14/09 GI consult received.  Initially seen 2/209 with c/o 3 month hx of abdominal pain, tiredness, fatigability, chills, H/A fever, lightheadedness and LUQ discomfort. Now daily sx with ~ 10lb weight loss. ROS additionally (+) for malaise, night sweats, recurrent sinus congestion, joint pain and stiffness, balance issues, dizziness, and new onset acne. PE (+) for epigastric tenderness.  Assess:  LUQ pain-discomfort of ? etiology. S/P mononucleosis syndrome.  F/U 3/12/09 with continued sx. Impression:  Chronic LUQ pain and nausea ?? etiology.
Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. That was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021.  No treatment details were reported.
t104 @ noc p/MMR given & had febrile sz; prob unrelated to MMR;
Severe fatigue started 6 hrs after vaccine Aggregated my chronic nerve pain and made it worse New Stabbing muscle and nerve pain throughout body New joint pain especially worse in knees and fingers Difficult to move body because of so much pain
In April 2022 I noticed that I had stiffness in my right arm.  I do yoga regularly.  Now I am unable to stretch and do poses as normal due to this stiffness.  It doesn?t feel like muscle or joint pain.  It feels more like fascia.  The pain itself is very jarring.  It is not constant but happens intermittent when I move certain ways.  I start physical therapy soon.
Around 9 pm patient started to experience frequent urination, then progressed to fever, sweating, chills, body aches, and fatigue.
3cm induration, erythematous. Mildly  tender, afebrile. 3 days after administration of vaccine. went to ER 12/12/2008 given PREDNISONE and AATARAX.
This spontaneous report as received from a 70 year old female patient refers to herself. On 04-DEC-2013 the patient was vaccinated with her one time dose of ZOSTAVAX, subcutaneous in the left arm. The patient stated that on 05-DEC-2013 she was dizzy and had itchiness at the injection site on her left arm after receiving the ZOSTAVAX vaccine. The patient did not sought medical attention. The patient was given no treatment for AE. The outcome of dizzy and had itchiness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
nausea started around 3pm on 11/6 followed by fever, chills, and headache around 10pm. Fever and chills lasts about 14 hours and the headaches lasted around 36 hours. The nausea and diarrhea has yet to stop and it?s now 11/10. I can?t do any normal activities or go to work because I?m too weak from not being able to eat much and the dehydration.
I started to have a pressure headache & I felt a strange fullness in my head at work, I work as a nurse in a hospital. After work I relaxed to see if HA would go away. About an hour later I took my blood pressure & it was elevated 151/102. My normal pressures are in the 120/70 range. As far as I know I had any hypertension. I went to bed and when I awoke I took my BP again & it was 153/99. My BP was elevated with systolics of 140's to 150's & diasolic of 99 to low 100's until 12/14 when it returned to normal. I call the occupational health nurse at my hospital during this time but she couldn't give my suggestions. The only thing that was different that week was the immunization of the H1N1.
After the shot my arm was very sore, swollen, very red and painful. Used ice and took ADVIL. Lasted 4 days. That same night, I was dizzy, hot and cold was sweaty and had chills. Upset stomach (for over a month). Severe joint pain - stayed in bed for two days. Had headaches for over a month, around my eyes and temples. They lasted for over a month and then decreased. I went to my Dr. for advice as to whether I should get the second shot. I have not decided. I get a flu shot every year - no problem. I got the first shingles shot when I was 60 yrs old no problem. I had two pneumonia shots - no problem.
02/24/2021 within 11-12 of receiving the vaccination at 09:00pm, high fever, chest pains, muscle aches, deep right calf pains to the point of being worried about blood clout, felt really hold had hard time regulating body temperature, spiked a high fever of 103.5 and very sever and throbbing headache for a week and d aches and took a week to get over. Tele visit over the phone with physician. Homeopath medicine. Pain was 9 out of 10. Lack of sleep due pain level. Took a full week to recover from the issues after dose 2.
Experienced chest pain with shortness of breath, numbness in the arms and hands, and burning pain in the upper back
Rash consisting of small red bumps, similar to chicken pox. On 3 separate occasions. Each a week apart. First rash starting on her upper back, lasted about 5 days. Second rash on her legs & 3 dots on her chest 2 on her arm. Lasted 3-5 days. 3rd rash started on her lower abdomen, currently 15 dots on her left side of her torso, 4 on her upper back/ neck. Itchy and slightly raised. Currently on day 2 of her 3rd rash.
Headache, Myalgia, Fever, Fatigue, chills Narrative:
started at 2 in the am I woke up with headache and nausea lasting all day, I tried alternating tylenol and ibuprofen didn't help. EOD I was having severe body aches chills headache and nausea no fever, Saturday symptoms were worse, saturday night i added vomitting and temp spiked 101.3 or something like that. Continued low grade temp through wednesday running 99.3 99.8... and I didn't not work those days I stayed home, I was tested for covid and came out negative, I worked thursday and Friday and for the next week I continued with a low grade fever, I went to my primary after and he said it was most likely a reaction to the vaccine.  3 weeks total until I was back to normal.
Inj. 4-16-13. 4-17-13 - soreness. 4-20-13 - shoulder/muscle pain (L) limited movement. 4-23-13 - no chg - instructed to see private physician - was seen afternoon of 4-23-13. 4-23-13 Tx: Exercise steroid pack. 4-24-13: Called above client decreased pain increased movement - to return to work either Friday 4/26 or Monday 4/29 - pt to call physician if any changes.
had pain in her knees while sitting, walking/the pain is consistent and has not left; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9269, expiration date: 31May2021), via an unspecified route of administration, administered in arm right on 11Feb2021 as dose 1, single (at the age of 63-year-old) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration, administered in arm right on 04Mar2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hypertension from 2006 (diagnosed about 15 years ago), knee replacement surgery from 2015 (surgery was 6 years ago) and ongoing blood cholesterol increased from 2006 (diagnosed about 15 years ago). Concomitant medications included meloxicam and tramadol both taken for knee pain from an unspecified start date and ongoing. On 12Feb2021, the patient experienced pain in her knees while sitting, walking. The pain was consistent and had not left. The patient had both Pfizer Covid vaccines, first dose was 11Feb2021, second dose was 04Mar2021, caller states she has experienced knee pain after the first dose, states she has had knee replacement surgery but had no issues until that first vaccine, states the pain is in both knees, the replaced knee, and the other knee, states it has been persistent since the first dose through the second dose. States it does not matter what she is doing, walking, standing, climbing moving, it is always there, nothing makes it worse.  Patient wanted to know if this could be a side effect of the vaccine. The outcome of the event was not recovered.  No follow-up attempts were needed. No further information was expected.
Covid Positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive after vaccination) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid Positive after vaccination). At the time of the report, COVID-19 (Covid Positive after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.
PATIENT HAS MUSCLE PAIN THAT STARTED IN HER HIP AND HAS NOW SETTLED INTO HER CALF. SHE ONLY NOTICED IT AFTER SHE GOT THE VACCINE.
Janssen COVID-19 Vaccine EUA Severe chills/shivering, fever, headache, muscle ache/soreness, fatigue. Chills and fever lasted off and on for 4 hours. Headache lasted for 6 hours. Muscle ache/soreness and fatigue lasted 24 hours.
After the 1st dose vaccine, the next day when I woke up, I had upset stomach with diarrhea and abdominal cramping. I had the abdominal symptoms for 2 weeks. I did not see the doctor at that time. However, I also started having  episodes of dyspnea and having difficulty breathing. I did go see my doctor and he did give me the ok to go ahead and get the 2nd dose if I wanted. My symptoms did start to improve slightly and got the 2nd dose 6 weeks after the 1st dose. I got my 2nd dose on 2/24/2021 ( lot 013L20A IMLA). With the 2nd dose, I had headaches, chills, body aches, which resolved after 24 hours. Shortly after, I started to notice pain in my lower back both sides. I would take a few Advil if the pain was severe. I did go see a spine and sport specialist. I have been doing  physical therapy training program to strengthen my back muscles. On a scale of 1-10, the pain can range from 5-8. The pain has not resolved.
Patient approached the counter about 15 minutes after her second Pfizer Covid Vaccine and stated that her tongue was swollen and her throat may have been a little swollen.  I gave her a dose of 25mg of Benadryl and requested remain with me for longer observation.  We discussed the protocol for epinephrine use.  Patient was still breathing normally and was not having any worsening of symptoms.  Approximately 30 minutes after the antihistamine dose, she stated her throat felt a little better, but still did not feel completely normal.  She remained at the pharmacy for a little over 2 hours.  Since she had not had any worsening of symptoms during that time, I told her that she could leave, but to notify her husband that she was on her way home and recommended famotidine and Benadryl tonight.  Additionally, if she did start having any worsening of symptoms, then call 911 and activate the emergency response.  We will follow up with her in the morning.
Breakthrough case admission after 2 vaccines Pfizer 9/9/21 Lot# ER8732;  Pfizer 10/5/21 Lot# FF8839
Shot was in RIGHT arm. In the subsequent weeks I grew on my LEFT shoulder-blade a hump that I was afraid would turn out to be a chondrosarcoma but probably is not. X-rays pass through it and so there is no shadow on the film as there would be if there were bony or cartilaginous material in the hump. It is also very smooth, featureless, and widely-angled compared to a chondrosarcoma which can rise from the surrounding area quite "vertically" while my hump's rise from the surrounding area is quite broad and thus at a lower and smoother angle. Also, I have the impression (perhaps wrong?) that a chondrosarcoma would make me A LOT more uncomfortable when I sit in a chair or lie on my back, as, being bone, it'd be like lying on a rock.
32 year old female with 2nd Moderna dose 4/27/21. Left arm is hurting and skin is peeling with some bruises. Very difficult to move arm. Nothing tried for treatment so far. No similar reaction from first dose, just mild injection site pain. Unsure if feverish, doesn't feel great, but not all the way sick.
severe vomiting for 36 hours that led to dehydration; loss of sodium and potassium; lack of mobility and hospitalization
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
This spontaneous report was received from a registered nurse and refers to a 22 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
HEART RACING A LITTLE BIT; FEVER; This spontaneous report received from a patient concerned a 20 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination.   No concomitant medications were reported. On 06-APR-2021, the subject experienced heart racing a little bit. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart racing a little bit was not reported. This report was non-serious.