chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant regarding a 15 month old patient. Information on the patient's past medical history, other concurrent conditions, drug reactions or allergies and concomitant medications were not provided. On 28-MAR-2019, the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration were not provided) with batch/lot # R028762 and expiration date for prophylaxis (product administered to patient of inappropriate age). No adverse effects reported.
The client received pneumococcal vaccine on left arm. Within three hours of post vaccination, the pt's arm from shoulder to elbow was red, swollen and tender to touch. She called her doctor and was advised to take Ibuprofen.
Patient called pharmacy to state that she still felt pain in shoulder and neck. She believes from flu vaccine. Reporting for safety.
This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation.  Medical history included hypo thyroid, lupus, sjogrens. The patient had a history of allergy to penicillin, contrast dye and percocet The concomitant medications included amphetamine (ADDERALL), levothyroxine (SYNTHROID), acetaminophen (TYLENOL), ibuprofen (ADVIL), loratadine (CLARITIN) and vit (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17March2021, the patient experienced headache, neck pain, heart palpitations. No therapeutic measures were taken for the reported event. The clinical outcome of the headache, neck pain, heart palpitations were not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Pt had a very large and painful localized reaction. She also has lymph node swelling and axillary pain
Patient describes body aches, tingling in lower jaw, and chest tightness. Symptoms onset after 30 minutes of receiving vaccine. Patient called to discuss symptoms and how best to manage. Spoke with patient and assessed situation. Patient stated that she was able to breath with no labor, was speaking in full, complete sentences. Patient did have diphenhydramine at home. Instructed patient to first take diphenhydramine 25 mg oral liquid by mouth. Checked back with patient via phone after 15 minutes of taking and patient stated that symptoms were slightly better/the same, not worsening. Informed patient that she may take another dose of diphenydramine 25 mg by mouth at that time for total dose of diphenhydramine 50 mg one time. Instructed patient to call 911 with any worsening symptoms and/or difficulty with breathing. Patient verbally expressed understanding.
Mom called stating patient woke up the morning after varicella vaccine with a red 3 inch circle, swelling and pain at injection site. They applied ice and stared BENADRYL. Redness and swelling still present 72 hours later, but improving. No fevers.
The patient was given the vaccine at 1200 noon on 3/9/21 The patient reports left side facial swelling and upper lip swelling. The patient was prescribed benadryl 25 mg  1 tab po q 6 hours The patient was instructed on using a cool pack The patient was instructed on 911 precautions for worsening swelling of face, lips tongue or throat or shortness of breath or trouble breathing
17JUN03 pt recvd vax felt warm 18JUN, sz 19JUN, temp in ER 99.4 R family hx of sz; pt was on Amoxil; throat infect;
Complained of headache, tachycardia heart rate greater than 100 resting, and walking heart rate 150.   Fever 103.0, resolved after 24 hours.  BP 138/83 until 4/3/21. Went to emergency room 3/31/21 .
pt recvd 3 doses of Engerix-B AUG90; JAN91, DEC91 titer result was 0.9;
Withing 10 minutes of vaccination experienced generalized pruritis and welting on back. Benadryl 50mg taken with relief from all symptoms within 30 minutes.
Broke out in papules scattered on torso, back and arms..seen in office dx with atypical varicella.
Patient was given high dose fluzone instead of regular dose.  Parent reported she had a runny nose the day after the vaccine.
Loss of speech, loss of eye contact, hyperactivity, sleep disorder, multiple sensory deficits, bowel. Diagnosis of autism in January 1995. Treatments: ABA, Speech, OT, Special Diet.  Annual follow up on 01/28/04: "Vaccine recipient has not recovered from adverse events.  Neurological deficits in language and social development, gastrointestinal disorder, chronic constipation/poor digestion, endocrine disorder, poor acid/base homeostasis, low thyroid function
Sore upper left arm and arm pit when I woke up on 3/4/21.  Thought I slept funny.  Used ibuprofen not much help.  Woke up on 3/5/21 with same pains.  Saw an article about Moderna rash.  Noticed swelling of left arm pit.  On 3/6/21 not as much pain but increased swelling of left arm pit and left side of left breast.  That evening noticed rash like area on upper arm that itched a little.  Used Benadryl.  Had appointment with my doctor on 3/12/21 for annual check up.  Still some swelling and rash was still present.  Doctor explained that my system was responding and that I should get the second shot.  All symptoms are almost gone today.
Patient is a 36 y.o. male who received the Pfizer vaccine lot number ER8737 on 4/9/2021. The patient experienced the following reaction(s) during the immediate  of observation: 9:51am Patient vaccinated. 9:59am Patient c/o feeling faint and dizziness. Patient assisted to treatment area. Patient was treated/managed as follows:    10am Patient lying down on mat with legs elevated. VS BP 128/72, HR 68, RR 18, O2 sat 98% on room air. Patient alert and verbal. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 10:10am Patient reports symptoms resolving. VS BP 117/72, HR 75, RR 18, O2 sat 98% on room air. 10:18am Patient reports symptoms have subsided. Patient escorted to door accompanied by RN.
Pt states rash on face day following administration of GARDASIL. Also a cough.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
1st day after, I developed swelling in my salivary glands under my tongue.  2nd day after, swelling in salivary glands under tongue and also slight swelling salivary in jaw.  3rd day after extreme swelling in jaw and still occasional under tongue.  I was started on antibiotics and also on the 3rd day given steroids.  by 4th day (today) the swelling seems to be going down.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-OCT-2011, the patient received ZOSTAVAX (lot number, dosage, and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 18-NOV-2015. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a further tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, a diminished quality of life, physical impairment and injury, and other losses and damages. Shingles outbreak was considered to be disabling. Additional information has been requested.
Thinks that liquid came out when they were administering the vaccine, so maybe didn't receive full; Only feel sore when I press the whole, not the area of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Thinks that liquid came out when they were administering the vaccine, so maybe didn't receive full) and MYALGIA (Only feel sore when I press the whole, not the area of the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concomitant products included EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), SIMVASTATIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), OLMESARTAN, METOPROLOL and URSODIOL for an unknown indication.    On 10-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Thinks that liquid came out when they were administering the vaccine, so maybe didn't receive full) and MYALGIA (Only feel sore when I press the whole, not the area of the vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Thinks that liquid came out when they were administering the vaccine, so maybe didn't receive full) and MYALGIA (Only feel sore when I press the whole, not the area of the vaccine) outcome was unknown.            Treatment medicines were  not provided Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-074611 (E2B Linked Report).; Sender's Comments:  MOD-2021-074611:first dose
6/4/00 Injection Site red, hard, hot to touch. Applied ice 3-4 x/day. 6/5/00 worse. Anterior upper arm to 3" below elbow red, hot to touch, puffy, itchy.  No sign of infection upon exam by physician. Benadryl prescribed. "Allergic reaction, no ANA-Phylaxis." Follow-up appointment schedules 6/8.
Stomach is really sore; Back pain; On the right side by the kidney it hurts a lot like someone hit me there; Headache; Nauseaous; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain), RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there), HEADACHE (Headache) and NAUSEA (Nauseaous) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nauseaous) and CHILLS (Chills). On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain) and RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there). The patient was treated with PARACETAMOL (TYLENOL) on 08-Mar-2021 for Headache and Chills, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) in March 2021 at an unspecified dose and frequency. On 10-Mar-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach is really sore), BACK PAIN (Back pain), RENAL PAIN (On the right side by the kidney it hurts a lot like someone hit me there) and NAUSEA (Nauseaous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-June-2021 and event outcome updated to resolved/recovered
patient started experiencing feeling off balance as though the floor was moving 2 weeks after her second dose on Jan 30. on Feb 12, she had a second episode of spinning and vertigo on Feb 12th, placed on Meclizine and Epley maneuver performed. Dizziness resolved but then she had persistent swaying and bobbing and feeling of unsteadiness.
VEINS IN LEGS; CRAWLING FEET; This spontaneous report received from a patient concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced veins in legs, and crawling feet (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the veins in legs and crawling feet was not reported. On an unspecified date, patient received additional non-company suspect vaccine BNT 162 (Pfizer) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination (Dose number in series 2). No known events were reported after vaccination (dose number in series 2). This report was non-serious.
Initial consumer report received on 15 Dec 2009: It was reported that the patient had received with FLUVIRIN on an unknown date and while giving vaccine in right deltoid, the plastic syringe began to bend and leaked down her arm and leg. The patient was administered another 0.25ml dose by the nurse. No further information reported at the time of the report.
Muscel became hard- for a day or 2 and then begin to itch, minor swelling/red and felt warm... looked like hives. Lasted for almost 4-5 days, and finally, the itch lessened, and the redness/hardness dissipated. I did not report it- since it was not life-threatening. Both my husband and I reacted to the Moderna.
From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
One week followng my injection (January 7), I noticed a hard knot with a little temperature in the location of the injection.  It was slightly sore.  They next morning.  The area was red and swollen.  It was a little more uncomfortable with movement  suspected from the swelling in the area.  The area measured approximately 2" X 1.5".   The redness continued to spread slightly (1/4")  the remainer of that day (January 8).  The redness and induration slowly began to resolved the next day (January 9.) and was not noticeable a week later.  The only residual symptom today is very minor  "tightness" in this area- likely small amount of inflammation.
covid vaccine had not been mixed yet with the diluent when I gave the vaccine.  I  had asked lab staff if it was ready to use and was told that it was fine.   called patient after aware of what happened.  she did come back in to the office and vitals were rechecked and information give.
BLOOD CLOT IN CORONARY REGION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: Unk) dose was not reported, administered on 10-APR-2021 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 APR-2021, the patient experienced blood clot in coronary region. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in coronary region was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a male, unspecified age,  unspecified ethnicity, who experienced blood clot in coronary region after he received the COVID-19 vaccine ad26.cov2.s on an unspecified date. No other details given. The information provided precludes a meaningful medical assessment. Additional information requested.
Patient had swelling, redness, and rash at and around injection site sometime (later in the day) after receiving vaccine. Patient reported event to me approximately 1 week later.
Bleeding under the skin in foot and hand accompanied by some dizzyness, shortness of breath, fatigue. Pain and numbness at sites of hematomas. Saw primary care doctor who evaluated and referred me to hematologist. Saw Oncology who ordered lab work and when reviewing the results with me communicated no known cause for the hematomas which were by then resolved and have not recurred.  Additionally, my menstrual period was due around 10/09/21, the same day of my vaccinations. I did not get my period when it was due, and the start of my next menstrual cycle was 126 days later, on 01/16/2022.
Felt electrical "zing" when vaccine administered. Has had a chronic deep ache in deltoid for the following month. painful, but not limited range of motion.
I had the vaccine at 2:15 in the afternoon. After the 15 minute wait, drove home and felt fine. Within an hour my right arm was sore. Had some dinner, went to take my temperature and I was feeling warm. I'm usually at 97.5. I was too warm for that temperature at 10:00PM. Took the temperature with an ear thermometer and was 101 by midnight. By 2 am I was at 102 or 103. We used some cold compresses and ice packs wrapped in towels to see if it would calm me down and it seemed to help. I also took two tabs of Tylenol. It gave me some relief. In the morning I was soaking wet from sweating all night. Also took Advil and I couldn't move from bed. By about 4PM that afternoon, my temperature rose as high as 104 and got nervous. Contacted my doctor. He said to ride it out and alternate the medications every 6 hours between Tylenol and Advil. By Wednesday at noon, the temperature went down to 99. By Thursday, I was better. Friday 01/29/2021 I had no temperature. Saturday the 30th, I was still really wiped out. Sunday the 31st. I did a video call with some friends and I was feeling better. It took almost that amount of time and I was back to normal activities.
COVID 19 Treatment; COVID 19 Treatment; 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 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 27 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: GN6205), in right arm, on 29Mar2021 as dose 2, single (Lot number: GR8732) and on 26Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: other medical history: ADHD; "bronchiectasis" (unspecified if ongoing), notes: other medical history: bronchiectasis; "pectus excavatum" (unspecified if ongoing), notes: other medical history: pectus excavatum; "unspecified chronic lung disease" (unspecified if ongoing), notes: other medical history: unspecified chronic lung disease; "dysmenorrhea" (unspecified if ongoing), notes: other medical history: dysmenorrhea; "suspected endometriosis" (unspecified if ongoing), notes: other medical history: suspected endometriosis; "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After a week post vaccination, I started experiencing muscle pain in my neck and back. Then it slowly crept down to my biceps and triceps including the joints in my elbows. It got to the point where I was getting pain in my thighs and calves. Around the 26th of December, the pain had progressed to all over the body. It was debilitating. I was then being diagnosed with polymyalgia rheumatica and was prescribed hydrocodone and 10mg of prednisone. By the next day muscle pain was gone and joint pain was gone. Since then I have been treated with prednisone, and am now adjusting medications to keep it under the control. Symptoms are still there if I do not get treatment and take prednisone.
It started Monday morning at around AM I had right leg cramping, body ache, muscle spasm, fever, chest tightness and very short of breath and I made an appointment because I couldn't breathe.
Chills, Body aches Fever Headache Symptoms began at 9pm on 01/23/21 - symptoms gone by 6:pm on 01/24/21
Shot was given at 11:12 a.m on Monday. By 3:00 p.m. fatigue and headache started. That night at approximately 11:30 fever started along with chills and muscle aches. Fever lasted approximately 28 hours. Headache started going away when the fever broke. Fatigue, muscle aches and stiffness lasted a total of roughly three and a half days.
Starting 16 hrs. Post vaccine;  sniffles, fever 102 F. , mild bloody nose,  arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore.  February 23rd most symptoms gone except lethargy and cold sore.
Redness/swelling/warm at injection site 1" x 2 1/2" whelp.
I had allergy reaction symptoms like running nose, sneezing, and coughing.  I also had some fatigue.  These lasted for about 2 and half weeks.  On Jan 28th, I tested positive for Covid-19.  I have recovered from all the symptoms except the cough.