chrisvoncsefalvay/vaers-outcomes huggingface dataset:
C/o whole body aches, sore neck hurts and can't turn head/neck (either direction). All joints hurt.  No redness or swelling in arm shot given into. No fever measured not sure if she felt warm.  Also c/o of nausea and diarrhea (which started on 08/28/2013.  States she took 500 mg Tylenol but it didn't touch the pain.  Also used ice.  Still hurts after icing.
PATIENT'S HUSBAND CALLED AT 5:35 PM REPORTING THAT Patient HAD SEVERE CHILLS AND SHIVERING WITH HEAD BOBBING. I CALLED Patient AT 6:30PM TO SEE HOW SHE WAS FEELING. THE SHAKING HAD CEASED AT 6:15PM. SHE SAID SHE HAD A HEADACHE AND VERY FATIGUED. ADVISED PATIENT TO CALL 911 IF SYMPTOMS BECAME SEVERE. SHE WAS ABLE TO TALK LUCENTLY AND ARTICULATE HOW SHE FELT. ADVISED HER TO CALL US IF SHE HAD ANY OTHER FURTHER QUESTIONS OR CONCERNS. Another co-worker FOLLOWED UP WITH A CALL TO SEE HOW SHE WAS FEELING ON SATURDAY
Pale, Unresponsive - 4 hrs p/DTP observation of Pulse & BP.
Experienced severe headaches, pain at injection site, and tiredness (slept 14 hours first night, 12 hours second night)
approx 3 days p/vax pt broke out w/bumps on both knees, lower extremities & both arms; do not itch or seem to bother pt; appear as single lesions, sometimes they coalesce & are not red;
Redness/line at injection site and rash covering a large area of lower back. Patient just notified. The pharmacy of reaction on 5/23/18.
No treatment other than waiting it out. Faver 101.7, muscle aches, joint aches, site pain, headache, fatigue
Fever spiking to 101, with 99-100 fever steady for 24 hours from onset. Fever onset was 15 hours from time of injection.
Day 1-3: fever, chills and whole body ached, especially left shoulder pain, headaches, nausea. It was very hard to eat. Day 4- 18: left shoulder pain, nausea, headaches, a feeling of being sick.  I had a televisit with Dr.'s Physician Assistant and she said I had Covid Arm Syndrome. she referred me to Physical Therapy. I haven't been able to go due to another illness. Day 4-present day:  left shoulder, left side of neck, left arm and hand with pain and difficulty doing everyday tasks (combing hair, lifting arm, reaching objects, reaching back, etc.).
administered dose that was 12 hours left at room temperature so it is technically expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose that was 12 hours left at room temperature so it is technically expired) 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 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose that was 12 hours left at room temperature so it is technically expired). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered dose that was 12 hours left at room temperature so it is technically expired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.No treatment information was reported.
Pneumonia; Vaccine breakthrough infection; Hidradenitis suppurativa; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4503127-00.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1155991), subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIDRADENITIS (non-serious) with onset May2022, outcome "unknown", described as "Hidradenitis suppurativa"; PNEUMONIA (medically significant), outcome "unknown"; VACCINE BREAKTHROUGH INFECTION (non-serious), outcome "unknown". The action taken for adalimumab was dosage permanently withdrawn.  Clinical information: Solicited report by a consumer (patient) with events of non-serious hidradenitis suppurativa flare up and reaction to first covid vaccine ended up getting pneumonia with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced reaction to first covid vaccine ended up getting pneumonia. In May2022, the patient experienced hidradenitis suppurativa flare up. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of hidradenitis suppurativa flare up, reaction to first covid vaccine ended up getting pneumonia unknown onset and reaction to first covid vaccine ended up getting pneumonia unknown onset was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) of hidradenitis suppurativa flare up was not provided, reaction to first covid vaccine ended up getting pneumonia unknown onset and reaction to first covid vaccine ended up getting pneumonia unknown onset was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pneumonia, Hidradenitis and Vaccine breakthrough infection and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
she has felt thirsty for 6 days; fever for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of POLYDIPSIA (she has felt thirsty for 6 days) and PYREXIA (fever for 1 day) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced POLYDIPSIA (she has felt thirsty for 6 days) and PYREXIA (fever for 1 day). On 27-Mar-2021, PYREXIA (fever for 1 day) had resolved. At the time of the report, POLYDIPSIA (she has felt thirsty for 6 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
In the evening of 6/28, patient started vomiting with fever present. Vomiting and fever continued into 6/29. Diarrhea started later that day and patient not eating and became more lethargic. Taken to hospital and recieved diagnosis of aspiration pneumonia.
Redness; Swelling; Knot; Heat generating; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot), FEELING HOT (Heat generating) and FATIGUE (Tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was provided by the reporter.  Concomitant products included METFORMIN, LOSARTAN, SPIRONOLACTONE, SERTRALINE, CALCIUM CITRATE, SIMVASTATIN, HYDROCHLOROTHIAZIDE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and DIPHENHYDRAMINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Tiredness). On 19-Mar-2021, the patient experienced ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot) and FEELING HOT (Heat generating). At the time of the report, ERYTHEMA (Redness), PERIPHERAL SWELLING (Swelling), LIMB MASS (Knot), FEELING HOT (Heat generating) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19-Mar-2021, the patient observed her left arm was swollen, red and had a knot in it. The skin is also generating heat. These side effects had not subsided and are still present at this time.  No treatment medication was reported.
Today I have really bad stomach cramps and diarrhea.  Yesterday I had a temp 101.2 with tylenol, chills, joint pain and really bad headache
Mom states fever began w/in 4-5 hrs p/DTP; fever ranged from 101-103; Rash began 5APR92 maculopapular started on chest & back & spread to all other area of body; additionally noted to sleep more;
Leg Pain: Bilateral; heavy and achy especially to lower legs. Having generalized weakness and lack of energy. Associated sx: sob with rest/exertion; worse with exertion and dry cough. Onset of sx over Easter weekend and continued without improvement. Reports she had her COVID19 Vaccine (J&J,  March 20). Onset of sx approximately 15 days from J&J COVID vaccine.   Further c/o increased edema to BLE. Usually wears her stockings but cannot tolerate them d/t pain. Reports family hx of CHF in mom. She further has a hx of varicose veins.  Tx: labs and imaging - see below.
COUGH, RIGORS, NAUSEA, VOMITING, URINARY URGENCY/FREQUENCY, DYSURIA - FOUND TO HAVE LLL PNEUMONIA, CONCERNING FOR POSSIBLE CYRPTOGENIC ORGANIZING PNEUMONIA
Information has been received from a 20 year old female with a food allergy to salsa and a history of pap smears, who was vaccinated with a three dose series of Gardasil vaccine via injection. Concomitant therapy included NuvaRing. The patient had a pap smear and a HPV test done back in JUL-2007 and both test came out negative. She completed all three doses of Gardasil vaccine and had taken another pap smear and HPV test in NOV-2007. The HPV test came back as "high risk". The pap smear did come back as normal. The patient wanted to know if the Gardasil vaccine may have something to do with the change of test from negative to positive. No lot number was provided. No further information was provided. No further information is expected.
I woke up with a sore right shoulder and wondered if I had done something the day before that would make it ache.  As the day went on (hour by hour) my right shoulder and upper back ached really bad, and by the time I went to bed that night, I had to have my husband help me lay down.  The pain was terrible, and it felt like my shoulder and upper back weighed 500 pounds.  It really hurt to have my shoulder touch the bed, and then after I got situated, it was okay until I had any movement.  The pain was almost unbearable!  This lasted for one week, and then slowly subsided.  Four months later, I can still feel some discomfort when I roll over in bed.  I was able to work during this time (office job), but I had to be really careful not to brush my back up to anything.  Please note that I have had shingles before (about 10 years ago).
2 seconds after vaccine felt like boiling water had been poured on shoulder.  Vaccine was given up on top of shoulder bones. Aching followed immediately.  Next two days could not lift arm.  Since that time have had aching in shoulder, arm muscles wrist, thumb hips joints ankle and joints in feet.  Never had these before.
9AM- ACCORDING TO EMPLOYEE, SHE STARTED HAVING SYMPTOME OF SHORTNESS OF BREATH, WHEEZING, SORE THROAT, AND CHEST TIGHTNESS. THESE SYMPTOMS BECAME WORSE BY THE EVENING AND SHE WENT TO THE ER. THEY TREATED HER WITH ALBUTEROL AND SOLUMEDROL. THEY DID CHEST XRAY AND LABS. SHE WAS DISCHARGED HOME AND THEN RETURNED TO ER 10/03/23 WITH N/V.
patient received the covid pfizer monovalent vaccine in error and was supposed to get the pfizer covid bivalent vaccine
Pt had two myoclonic jerks; episodes occur both awake and asleep; had 3-4 episodes overnight; temp at time of first episode 100F no subsequent fevers; episode described as a sharp jerk. EEG ordered at hospital 7/21/05.
About 9 hours after receiving the vaccination (11:30 pm on 1/6/21), I developed fatigue, fever of 100.0 F, body aches, bone pain, mild chills, and mild nausea.  I also have moderate left arm pain where I received the vaccine. It is now 3:00pm 1/7/20 and the fever, chills, nausea, and body aches have subsided, however the fatigue and left arm pain still persists.
Patient returned to clinic with hot itchy rash over entire body. The patient did not have any wheezing, cough or shortness of breath.  Pt was given 25 mg of diphenhydramine intramuscularly and monitored for 30 minutes. Patient was released after monitoring and has had no further complications.
High blood pressure. Not consistent with past BP. Not gradual rise. From perfect to now it?s 150/160 since vaccines
9/20/07 pm - TC from mother. Lt. arm sore today. Looks like "one big hive" around where shots were given. Hive appeared about an hour after shots were given. Otherwise, feeling ok. Told to take a dose of Benadryl. 9/21/07 pm - TC to mother to see how client was doing. Stated school just called and client has hives from head to toe. Instructed mom to take her right in to PMD/Urgent Care/ER. 9/24/07 TC to residence. Left message. No response. 9/25/07 TC to residence. Left message. No response. 10/9/07 - TC to mother. Stated PMD was not available so went to Urgent Care Clinic. Was told to keep on Benadryl q4-6h (2 tsp) X 4 days. Mom reports hives went away within a day. Took about 6 days for "the big hive" on lt arm to go away. When it started to go away, white circle noticed around area and then turned to a bruise. Mother plans to make a "Well Child" appointment with PMD to discuss situation and future shots.
Pt reports that she started feeling fussy in the head and her left arm started tingling.  Pt also reported an odd taste in her mouth.  Pt reports that she has had a busy morning seeing her chiropractor and having a massage and has not drank any water for hours.  Pt was given water to drink and symptoms resolved.
Vomiting and diarreah from Jan. 16 through Jan. 21. Visited emergency room for IV fluids and medications on Jan. 21. Started feeling better on Jan. 23. Back to work on Jan. 26
My wife tested positive previously and I kept with my normal activity because I wasn't showing any symptoms. I ended up testing positive 5 days later, on 12/23/22. I woke up on 12/23/22, with a tight chest, cough, congestion, body aches, and runny nose. I just felt bad, I contacted my doctor and was prescribed 5 days worth of PAXLOVID. My symptoms started to improve after taking PAXLOVID.
Throat tightening and hyperventilating, lightheaded. Treated in ED with po Benadryl 25 mg x 1 with resolution of symptoms. No additional treatment was required.
fatigue, chills, headache, sore arm.  Patient recovered with tylenol and rest.
Redness around injection site "hardness" warmth to touch. Injections given on Wednesday. Father did not notice symptoms until Friday morning. Father brought child to doctor, child was treated with antibiotics for infection. Follow up call from Dr.'s office says client says doing better after treatment.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX. On 21st March 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 21st March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown administered by other route was unknown. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anymore. This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX vaccine on the left arm subcutaneously rather than intramuscular route, which led to incorrect route of vaccine administration. The patient's arm had a sore spot approximately the size of a silver dollar where the vaccine was administered, just above the elbow on back side of the left arm. This case was linked to case US2018049216, reported by the same reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dental fillings. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pruritus, facial swelling and rash. On an unknown date, the outcome of the pruritus, facial swelling and rash were recovered/resolved. It was unknown if the reporter considered the pruritus, facial swelling and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced itching, a rash on her chest and jaw swelling at an unknown time after receiving SHINGRIX. The patient also had a dental filling and the patient reportedly believed that it was related to SHINGRIX. The reporter was not at work at time of call and did not have any other information. The pharmacist stated, dental filling was a routine procedure.
This spontaneous report as received from a health care worker refers to a unspecified number of patients patient of unknown age and gender. The health care worker reported that VARIVAX (merck) vials were exposed to temperature as high as 24. 1F from 20-MAY-2012 to 13-AUG-2012. During this times, only 3 days had recorded temperature of below of 5 F and rest of days were above 5 F and it was determined that VARIVAX (merck) were not stable from the original call she made. Specific number of patients involved were unspecified. No adverse effects reported. No concomitant medications were reported. Additional information is not expected.
The next day after the booster vaccine I have experience numbness in my thighs that has now spread to my arms and hands. Constant numbness in my arms and hands throughout the day. Soreness and warmth in my left arm at the injection site. Feeling of heaviness and slight pressure in my head. I'm currently still experiencing the majority of these reactions although the numbness in my thighs has become less and less.
On day 5 got slight swelling and pain in the left axilla now it?s day 9 and pretty much gone.
Mental Fog (some dizziness) and extreme tiredness for 18 hours. 2-2 1/2" rash, slightly raised and itchy, appeared on right arm six days post shot.
Dizziness, nausea, floating above ground, demonstrating that this register is not evidence for anti-vaccination.
Lower lip angioedema. Patient has history of angioedema caused by ACE inhibitor and lip fillers also
Pt experienced vasovagal syncope within 15 minutes after vaccination. Supportive care provided and pt recovered without incidence.
Severe tinnitus and loss of hearing in right ear.  Moderate tinnitus in left ear.
7 x 10 cm area of erythema, early cellulitis, placed on augmentin and Benadryl and f/u on 03-11-06 erythema and swelling fading, no apparent distress, no tenderness. cont with augmentin and warm compress f/u prn.
Phone call from school secretary, on 2/17/11. Patient c/o (L) sore arm, has a red, little raised, hard lump about size of a quarter, itchy, back of (L) arm.
Narrative: COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/19, Pfizer, dose #2 08/20 pt cc: cough, diarrhea, rhinorrhea, dyspnea, sore throat exposure: unknown 08/26 COVID swab, result: detected
Information has been received from a pharmacist concerning a female of unknown age who "2 days ago" in March 2011, was vaccinated with ZOSTAVAX (Merck) (dose and frequency unknown for an unknown indication). Relevant medical history, relevant past drug history and relevant concomitant medications were unknown. The pharmacist reported that the consumer came in with a very bad red rash. She wondered if it could be shingles given the fact that ZOSTAVAX (Merck) is a live vaccine. It was unknown if there was any relevant laboratory data. As of 25-MAR-2011, it was unknown if the consumer will continue on ZOSTAVAX (Merck) and the status of her rash was unknown. No further information is available.
This spontaneous report as received from a nurse refers to a 76-year-old female patient with asthma, iodine and codeine allergy. Concomitant therapies included levothyroxine sodium, simvastatin, aspirin, cholecalciferol, budesonide (PULMICORT), gabapentin, rabeprazole sodium, pioglitazone hydrochloride and "Nebulizer"(no details about the product were provided). On 12-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, 1 dose (0,5ml)(lot # R012976, expiration date 25-JAN-2020) for prevention of pneumonia. On the same day, the patient experienced redness, soreness and swelling in her arm. The patient's arm was hot to the touch, descending towards her elbow. The patient also reported fever and body aches. Unspecified treatment was given for adverse events. The patient sought medical attention by visiting the doctor. No laboratory diagnostics and studies were performed. The outcome of the events was reported as recovering/resolving. The relatedness between the events and PNEUMOVAX 23 was not provided.
Tenderness at injection site; Swelling at injection site; Stiff neck and shoulder; Bad headache; Nausea; Very tired; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for herself. A 61-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 25Feb2021 15:30 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), sarcoidosis, cancer survivor, known allergies Penicillin from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In Pharmacy or Drug Store most recent COVID-19 vaccine was administered. The patient experienced tenderness at injection site, swelling at injection site, stiff neck and shoulder, bad headache, nausea, very tired on 25Feb2021 17:30. No treatment was received for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Jaw pain began next morning after the third dosage of Moderna vaccine. Cannot open jaw wider than one finger. Extreme pain on bottom right jaw leading up to temporal mandibular joint. Pain has not subsided in 5 days.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EN9581) at the age of 77 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot (When he takes the flu shot, he is sick all winter), reaction(s): "Sick". The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "From both elbows to up his shoulders and 4 inches across his back, has had a dull pain". Relevant laboratory tests and procedures are available in the appropriate section.