chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UPTICK IN MULTIPLE SCLEROSIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 42 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: knee surgery, back surgery, gall bladder surgery, lumbar (l5) discectomy, post traumatic stress disorder, fallopian tube removal, and bladder urgency, and concurrent conditions included: depression, anxiety, muscle spasms, tremors, restless leg syndrome, low vitamin D levels, pain, sleep issues, and tactile sensation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient was fully vaccinated but contracted covid and experienced suspected clinical vaccination failure and on an unspecified date, the patient experienced uptick in multiple sclerosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uptick in multiple sclerosis, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191183.; Sender's Comments: V0: 20210851690-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS   20210851690-Covid-19 vaccine ad26.cov2.s-Uptick in multiple sclerosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Diarrhea; Chills; Nausea; Fever 100.2 F; Fatigue; Body Aches; Headache; Pain Injection Site; Itching on the Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever 100.2 F) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-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) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever 100.2 F), FATIGUE (Fatigue), MYALGIA (Body Aches), HEADACHE (Headache), VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE PRURITUS (Itching on the Injection Site). On 05-Feb-2021, CHILLS (Chills), PYREXIA (Fever 100.2 F) and MYALGIA (Body Aches) had resolved. On 06-Feb-2021, HEADACHE (Headache) had resolved. On 09-Feb-2021, VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE PRURITUS (Itching on the Injection Site) had resolved. On 10-Feb-2021, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
received dose 1 of Pfizer at SFS on 2/12/2021, dose 2 scheduled for 3/5/2021 which is 21 days later, but he returned one week early by mistake and  received dose 2 on 2/26/2021 instead of on 3/5/2021 No one at Stadium caught it that he was a week early for dose 2 when he checked in, and no one caught it when they signed his vaccine card for the second time.  The patient experienced a sore arm for one day after dose 2, but no other vaccine side effects.
Getting COVID After the Vaccine; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting COVID After the Vaccine) and PYREXIA (fever) 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 (Getting COVID After the Vaccine) and PYREXIA (fever). At the time of the report, COVID-19 (Getting COVID After the Vaccine) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Tired for 1 day; This is a spontaneous report from a Pfizer- sponsored program via a non-contactable consumer (patient). The patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced tired for 1 day on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
child recv vax & 14 days later child's mom contracted chicken pox during 36th wk of pregnancy;the estimated date of delivery is 29NOV96;results of PCR analysis revealed that a specimen was wild type virus;
40 mm soft indefined lump at (L) deltoid-tender only today pressure- (not red) - bad redness and DTaP given-swelling has remained.
Significant pain and limited ROM of left arm not improved by supportive measures such as ibuprofen and rest.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 24-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
She came in today broken out in hives which she said were getting worse day by day - directed her to go to ER or urgent care took BENADRYL but still getting worse.
Patient said that she has pain in her left arm. Pain that radiates all the way to her breast. Her arm is red and inflamed. She also has a bruise. Arm is tender and is warm at touch. I advised patient to go to her doctor.
Post vax on 10/12/2001 the patient was feverish. The patient's left leg was red, indurated and sore. The pediatrician advised cold compresses, Tylenol, Advil and Benadryl. On 10/15/2001 the patient's leg is improved but still has a large hard area about 3" x 3".
Patient has had continuous pain in her injected arm.  She states that she can not lift her arm above her head.  She spoke with a Tele Doc and then made an appointment with a provider
Area near injection site swelled up to size of small bean. Red and inflamed on that area. Time given at 6:30pm. No fevers. Patient been informed to seek physician to follow up.
Patient received Moderna vaccine at age 17. Moderna is only approved for ages 18 and older. Patient was unclear about her age at time of vaccine with no ID.
After 30 minutes-Swelling of right side of lower face and swelling of right side of tongue and this stayed the same for 5 hours. Then it subsided gradually over the next few hours.
Fever, chills, muscle pain, fatigue, cough - lasted over 2 1/2 months!
My arm still hurts almost 5 months later. I have shooting pains up to my shoulder and down my arm when I try to straighten it out. I wake up in pain every morning. I cant sleep on it. I do not have full range of motion.
Five months after vaccine, patient reported severe pain in the right hip. She started breaking out again with shingles. Patient reports this is the worse case she's experienced (shingles outbreak 6 times in 6 years).  Patient was treated with gabapentin for nerve pain and Valtrex for the virus.
Mom states child had fever 104, headache, Chills, Nausea,  Fever comes down to 99.5 with motrin
4-6 painful swollen lymph glands in left armpit. Can see redness as well as a physical lump of several.  Treating with advil & hot compress to relieve pain.   Noticed tenderness in armpit 1-2 days after vaccine #2, then went away. But has since returned worse than previously.
Pt recvd vax & devel inj site rxn of baseball size area of swelling & redness. Child seen by MD 1 day p/vax. 1 of 3 pt from this facility to exp adverse rxn p/vax of Acel-Immune, different lots.
5/26: fatigue, difficulty with thought, insomnia, headache 5/27: awakened with loud screeching sound, constant. About 11khz. Appears to be tinnitus. Headache, less fatigue but still difficulty with thought.
Mother returned to clinic with child on 5/20/08 to report bumps and fever.
Chills, fever, muscle weakness and feeling exhausted. Pt given 600mg ibuprofen and IV fluids.
Erythema noted below vaccine site 4 days after PREVNAR injection. Appeared to be cellulitis, antibiotics prescribed.
2/4/21 Vaccinated at 1:15 pm.  At 5:30 pm patient's throat began to swell and he could not hardly swallow water.  At 10:00 pm, he noticed that his face was a little numb but proceeded to go to bed.   2/5/21 Patient feels better.  He can swallow and eat.  Face is not longer numb.
heart pounding st segment irregularities, pain in upper back & shoulder & chest pain in pt who recvd flu vax; not feeling quite right; pt awoke again 6AM w/heart pounding & not feeling quite right; pt went to the ER & was treated;
Initial report received from a consumer (Patient's husband) on 29 Jan 2010: This patient was vaccinated with FLUVIRIN intramuscular, dose unknown 02 weeks ago (exact date not reported). The patient developed rash on thighs within 24 hrs of vaccination. The outcome of the event was reported as condition Unchanged.
10-15 min after vaccination pt. c/o throat felt tight and closing, blurry vision, faint/ pale, slow to process cognitive and respond/ Pt . put in supine position/ given Benadryl 50 mg PO with no response.  Epinephrine 1mg IM/RD / color improved, shallow, rapid respirations, lung sounds CTA in all lobes.  EMS arrived 32 min after covid vaccine given.  Pt. transferred to Hospital.
24 hours After receiving this vaccine I thought I just had a sore arm & tiredness.  The first week I did feet just tiredness  but then the second week tiredness became  fatigue & I required naps after work and sleeping all night, Headaches ,Chills, Achy. Herpes breakouts are now occurring monthly,. CREST symptoms are worse, I feel exhausted most of the time, several times each hour I have Loss of circulation in hands, feet & gut.  This is Painful & causes numbness,tingling,heaviness in my  arms & legs.
Pt developed sensitivity (to touch) area below left ear - to neck to left shoulder.  Left deltoid - site of injection ecehymotic -  Approx 2.5 X 3 cm.  Pt took ADVIL X 2.
This spontaneous report was received from a pharmacist via company representative refers to a 63 years old female patient. On 18-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On 26-MAR-2013, the patient reported to the pharmacist that she experienced feelings of sleepiness, sensitivity in her arms and tingling after receiving ZOSTAVAX. The outcome of the reported events were unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-JUL-2014, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at an urgent care health facility, for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Thrombocytopenia, petechia. Tx - IV Immune globulin.  2/9/09 Received hospital medical records of 11/8-11/9/2008 FINAL DX: thrombocytopenia Records reveal patient experienced mild abdominal pain x 1 week, bleeding gums & petechial rash x 1 day.  Saw PCP & labs revealed dx.  Tx w/IVIG.  Improved & d/c to home w/serial labs.
Lymphadenopathy. Sweeling. Pain. Redness. No treatment. No medicine. Only resting
Client complained of "heartburn" like sensation and was sent to medical center. They diagnosed him with "allergic reaction " to flu vaccine. This was on 11/18. Client became unresponsive on Sunday 11/21 and had begun to show "red bumps" on face. He was alert in the morning, ate breakfast then fell ill. He was transferred to another hospital when he fell into a coma and passed away 11/23/04. Discharge Summary revealed patient had confusion and respiratory failure.
Information has been received from a physician concerning a female with no allergies or medical history who on 05-SEP-1996 was vaccinated with the second dose of MMR. Subsequently the patient experienced a low titer (< .91) for mumps. Medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 10Nov2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension, controlled" (unspecified if ongoing); "History of depression" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 09Apr2012; TELMISARTAN, start date: 10Jan2016. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result, notes: Treatment of COVID-19; (10Jul2022) Negative, notes: Test negative on July 10; (17Jul2022) Positive, notes: Rapid test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information:  If vaccine received: Yes, other medication in 2weeks: Yes, if treatment ae: Yes and ae treatment: Paxlovid course 2 started. known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202200966836 same reporter/patient, different drug/event;
Shortly after underarms began to swell. In the last few weeks I have experienced headaches, migraines, achey calves, tired , foggy, chills, nausea, upset stomach, and fatigue. 8/28 I woke up with swollen eyes and face(red and itchy) my blood pressure was 177/117. I have never had that issue. My left breast where I had Cancer and radiation is swollen and uncomfortable. 8/13 had to leave  due to diarrhea.
Patient received Pneumovax IM in left deltoid on 3/23/05.  The next morning, patient had limited range of motion in left arm and site of injection was swollen red and very tender to touch.  Constant and radiating pain in left arm.  Patient evaluated.  Treated empirically with Keflex x 7 days for cellulitis vs drug reaction.  Patient did not return for worsening of symptoms.  Symptoms presumed to have resolved.
After initial soreness in arm (3 days), high fever (103+ for 3 days) and fatigue for 4 days I have had continual nasal drainage and metallic smell and taste that has not subsided.
patient broke out into hives 15 minutes after receiving the covid vaccine.Gave patient two doses (10ml dose) of benadryl, monitored patient. She felt better and left after an hour
CHILD BROKE OUT IN RASH APPROXIMATELY 1-2 WEEKS AFTER VACCINATION WITH VARICELLA DOSE #2,  WAS SEEN BY PMD AND DIAGNOSED WITH CHICKEN POX. PARENT BROUGHT CHILD BACK TO OUR CLINIC, 2/13/2017. FATHER STATES THAT CHILD GAVE CHICKEN POX TO HER 1 YEAR OLD UNVACCINATED SISTER.
I experienced a breakthrough case of COVID-19 with fever, body aches, fatigue and also contracted pneumonia.
pt recv vax 21APR97 4PM;@ 10Pm while changing diaper pt became white, limp & unconscious;will call 911 immed & w/in 12min of arrival pt started coming around;
Tdap given 8/6/07. Next morning: pain, redness left upper arm. Area of redness about 12cm around.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received SHINGRIX. On 24th April 2018, the patient received SHINGRIX (intramuscular). On 24th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with ALEVE. In April 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in arm. This case was reported by the partner of the patient. The patient could not lift her arm the very beginning after receiving the injection. The patient put ice on her arm to help her with the symptoms. It was gradually got better. The patient still had pain and achiness at the site of injection. This case has been linked with case US2018075815 and US2018075819, reported by same reporter.
Hospitalization: 1/11/2023 - 1/13/2023 (2 days) Presentation to the ED: dehydration.  COVID + date: 1/11/2023 Treatment: no indication for treatment.  Discharge to: home.   EW186 5/23/2021. EW0178 6/20/2021
Patient stated that her left arm remained sore and painful since getting the 2 shots. She stated that the skin was very irritated. She saw a physician on 9-10-18 and he diagnosed her with cellulitis. She received 2 antibiotics.
woke up with fever Tmax 104F improved to 101.4F after taking advil, bodyaches, runny nose, left arm sore at injection site. Patient reports first dose of vaccine gave him similar side effects, which resolved in 3 days
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 18-MAY-2016, the patient was vaccinated with improperly stored (temperature: -11 Celsius for 216 hours) ZOSTAVAX vial 19400 plaque forming units (PFU) lot # L037791 (expiry date: 30-DEC-2016) (dosage not reported). No previous temperature excursion reported. No adverse symptoms reported. Additional information has been requested.
Stomach ache, then sore throat, aches, feverish, puffy eyes, cough, severe cold--I am the patient, and I'm still quite sick.  Inputting this so you get feedback.
Left arm swollen, warm, painful, and red from injection site in the left deltoid muscle to above the elbow. Client experienced chills and flu like symptoms. 9 days from vaccination and symptoms are starting to dissipate.
Soon after 1st vaccine dose, lymph nodes in my left armpit became tender and swollen and stayed that way for several weeks. Also, my left big toe became swollen, red, and painful which persisted for many weeks. I also had joint pain and a general feeling of malaise and inflammation throughout my body. After the second dose, my other lymph node in my right arm pit became swollen and tender for a few weeks. After several months of joint pain and inflammation, I saw my dr for testing. Presently, my toe feels better but foot near toes is sore and achy.  My right index finger is stiff, achy, and a bit swollen and my wrists and joints feel achy.
The second dose of Covid Vaccine knocked me out completely :  headache, fever ,chills and pain at the injection site  . Duration of effects: 48 hours
This spontaneous report was received from a nurse, concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route, oral liquid. Co suspect and concomitant therapies were not reported. The nurse reported that an unknown number of patients were inadvertently administered ROTATEQ that had been improperly stored. No adverse effects reported. This is one (1) of 2 (two) reports from the same source  (MARRS 1408USA009360 and 1408USA013091). Additional information has been requested.
Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.
mom reports fever (unk temp) & high pitched screaming; states also had lump in thigh for couple days; seen by MD 13JAN93; MD states no further pertussis;
Fatigue within a few hours. A few headaches here and there.   Extreme stomach pains and diarrhea beginning at 2:30 am. On and off very frequently until 6:30 am. Diarrhea continued with less frequency for 24 hours or so. Stomach pains still continue ( I?m on day 4) with less frequency.