chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed itchiness and a big welp around the injection site; a "big knot" and it is hot and itchy; big welp around the injection site, describes it as "big knot"; Itching in different places of her body; a little bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different places of her body), CONTUSION (a little bruise on the injection site), VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot") in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (Itching in different places of her body) and CONTUSION (a little bruise on the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot"). At the time of the report, PRURITUS (Itching in different places of her body) and CONTUSION (a little bruise on the injection site) had resolved and VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-JUL-2014, the patient was vaccinated with an unspecified stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" with lot number J009689  and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 3312 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
I had persistent daily headaches. I have development migraine with brain stem aroha and haptic headaches. I have had multiple hospital stays and ER visits. And I have also had hemiplegia as a results of the migraines. I been hospitalized once and 6 trips to the ER. Still receiving ongoing medical care.
MDV Polio (Ipol) was exposed to a temperature excursion and may have been given to a patient, no adverse event; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA137200, 2019SA139568 and 2019SA139569 (same reporter).  This case involves male patient of an unknown age who received vaccine IPV (VERO) [IPOL] lot P1A171M, expiry date: 24-Apr-2020 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  Vaccine stored at temperature outside the recommended range. Vaccine stored at temperature outside the recommended range ((Ipol) that was exposed to a previously reported temperature excursion and was given to patient).  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sleep Disturbance, Dizzy, head ache, High Bp-145/90, Fast heart rate- 04/18 5:10 AM Urgent care, evaluated as Vertigo- 04/18 2:30 PM Sleep disturbance, High Bp-160/100, Dizzy, difficult breathing- 04/19 11:30 AM ER-12:30 PM, evaluated as vaccine side effects, given Meclizine, Ibuprofin for 7 days
Patient received 2 vaccines in his left deltoid region last week. Within 2 or 3 days he developed increased redness warmth and tenderness as well as fever sweats and chills. Area of erythema is gradually enlarging.
Patient passed out and fell off from pharmacy bench, remained unconscious for 1-2 minutes. Patient was able to regain consciousness after approximately 2 minutes. Skin looked pale and cold to touch and sweaty.
On 5/2/2022 at around 7PM, I came back from my bike ride. Shortly thereafter, I heard a high-pitched hum. I couldn't tell in which ear I heard it. Whenever I would cover one ear, I still heard the sound, regardless of which ear I covered. The sound has persisted ever since. I went to an otolaryngologist on 5/11/2022 at 3PM. Both ears were examined. No moisture, excess wax, or signs of infection were detected. The doctor could find no obvious cause for the tinnitus, and when he asked me if I felt any discomfort or pain, I said no. My blood pressure was checked, and it was 144/64 and the heart rate was 70. He then told me he wanted to arrange a full-scale auditory test, and I have an appointment to undergo it on 6/9/2022. At the time of this writing, I have been retired for a year and 4 months, though I previously worked in an environment in which there were extreme noise levels. The company had a hearing conservation program, which I participated in. I consistently wore foam ear plugs while at work, and I also had my hearing examined during every yearly physical, and a baseline level for my hearing was determined and recorded. I plan to provide this information to the otolaryngologist when I go to my appointment for the auditory test.
Patient states that since receiving her vaccine her arm hurts when eating protein. All other times it feels fine.
Had a temperature the whole day; Feeling fatigue; Laziness; Pain started in the left arm; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications in two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 18:00, the patient experienced pain started in the left arm. On 09Apr2021 at 22:00, the patient experienced fatigue/laziness. On 10Apr2021 the next day, the patient experienced temperature the whole day. Therapeutic measures were taken as a result of the event fever which included treatment with Dolo-650 mg tablet. The clinical outcome of the events pain started in the left arm, fatigue, laziness and temperature was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient was given two Rota Teq due to the fact the patient spit up the entire first dose attempted. Patient also spit up entire second attempt given.   No adverse events occurred since the date vaccine was given.
This spontaneous report was received from a nurse and refers to a 32-week-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were not reported. On an unknown date (reported as "four days after the patient past the age of 32 weeks"), the patient received a third dose of ROTATEQ orally (strength, dose, lot # and expiration date were not reported), for prophylaxis. No symptoms were reported. No product quality complaint (PQC) was reported. Additional information is not expected since the reporter did not wish further contact.
Information has been received concerning an 8 month old female with a history of diarrhea following previous immunizations with rotavirus vaccine, and poliovirus vaccine. On an unspecified date, the pt's mother reported that her daughter had received the second dose of rotavirus vaccine on 07/03/1999 and had subsequently experienced a generalized rash and fever. On 07/06/1999, the pediatric pt was vaccinated with hep B vaccine recombinant and her second oral dose of rotavirus vaccine. On 07/13/1999, the child had developed conjunctivitis and was seen by her physician. At that time, the pt was placed on therapy with amoxicillin. On 07/14/1999, the pediatric pt experienced a generalized rash and fever (103.8 deg. F). It was noted by the reporting physician that the pt's fever and rash began the day after amoxicillin therapy was initiated. The fever resolved after 5 days. The rash resolved after approx. 1 week. Follow-up info on 08/15/1999 from the reporting physician revealed that the infant was vaccinated on 07/06/1999 with the above cited vaccines. The pt experienced diarrhea following vaccination with haemophilus B conjugate vaccine. This was originally reported by a physician. No further info is expected.
patient called to complain  of a red ring that developed around her arm the day after receiving pneumovax. She also complained of some discomfort and chills which she said were improved from the previous evening. Advised her to to take Tylenol and see dr if symptoms did not improve or worsened. Pt said symtoms lasted until the sunday after receiving the shot (3 days), and have resolved completely.
The patient was given a Pediatric Bivalent Booster (5-11) and it was not diluted.
Pt stated she experienced pain, redness at the injection site. She also has a lump measuring 5.5 cm at her injection site. it is "hot" to the touch. Pt also experienced a fever the following day after receiving her Moderna Covid Vaccine. Received Covid injection at 11:30 am and started having a reaction by 6:00pm on 12/31/20.
This morning the pain has dropped to my right buttock and is radiating down my right leg; This morning the pain has dropped to my right buttock and is radiating down my right leg; a weakness in my right leg; right leg has buckled a couple times; Weakness; tiredness; Chills; right flank pain that seemed to be over the right kidney; It seemed to me to be muscular so I dismissed it. This morning the pain has dropped to my right buttock and is radiating down my right leg; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 10Feb2021 (at the age of 71-years-old), for COVID-19 immunization. There was no medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications and no other vaccine was administered on the same date. Exactly one week after the injection, on 17Feb2021, the patient began having routine symptoms including weakness, tiredness, and chills. The unusual and unexpected symptom was a right flank pain that seemed to be over the right kidney. According to the patient, it seemed to be muscular, so he dismissed it. On the morning of 21Feb2021, the pain had dropped to his right buttock and was radiating down his right leg. The patient also reported a weakness in his right leg and that his right leg had buckled a couple times this morning (21Feb2021). The patient did not receive treatment for weakness, tiredness, chills, right flank pain, muscular (pain), pain had dropped to his right buttock and was radiating down right leg, weakness in right leg, and right leg had buckled. The clinical outcome of weakness, tiredness, chills, right flank pain, muscular (pain), pain had dropped to his right buttock and was radiating down right leg, weakness in right leg, and right leg had buckled was not recovered.
12 hours after vaccine I started a fever of 100 F and this fever held for about 8 hours even after taking Tylenol 3 times.   Adverse reaction started at about 6:30pm on 2/19/21 and it was a rapid heart rate while laying down. The bpm fluctuated between 125-150 and would not stop racing. I took 12.5 mg of metoprolol (which I no longer take) on my own decision to try and lower this heart rate. The rapid rate lasted over an hour and came down within 1.5 hour of taking beta blocker.
7/7/20 mom called questioning a possible vaccine reaction  She reports patient up around 535am complaining of not feeling well. Took motrin, showered. While in shower yelled to mom  "I can't move" was on shower seat with legs straightout then eyes open & unresponsive x 3 seconds per mom. Mom noted slight tremor in patient hand. She assisted  patient back to bed. Patient felt chilled.  Mom says no seizure history. Did faint once years ago.  At noon patient reported eye pain. By 1pm no symptoms &  patient was out with friends. Mom declined in office/virtual/telephone visit after encouragement from triage nurse.  (see patient chart phone notes 7/7/20 & 8/16/2020)
The week following getting my covid booster I started getting migraines 2 times a week. I have almost never had a migraine except related to my hormonal cycle the first day of my period. Also, my menstrual cycles is totally off.  I now am getting my period every 3 weeks and it is lasting for 2 weeks and I have a Mirena IUD  so I should not be getting a period at all. I started getting a period after receiving my first two doses 1/21 & 2/21. Before this I did not get a monthly period. The Moderna vaccine has definitely had a negative impact on my body/hormones and am now left to deal with horrible weekly migraines.
Guillian Barre Syndrome; Trigeminal Neuralgia; Vestibular Neuritis; Nerve Pain; Trunk Ataxia (Berg score 14/56)
arm started to itch again and was red again; small little red itchy spots; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (small little red itchy spots) and VACCINATION SITE ERYTHEMA (arm started to itch again and was red again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (small little red itchy spots). On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm started to itch again and was red again). At the time of the report, PRURITUS (small little red itchy spots) had resolved and VACCINATION SITE ERYTHEMA (arm started to itch again and was red again) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment Arthritis Strength Tylenol and prescription strength ibuprofen along with using an ice pack and cold compress
After patient was given the flu vaccine, her blood pressure drop, she was sweating and pale skin.  Patient remained in a sitting position until she fainted and then 911 was called. No CPR or EPI PEN shot was given. No signs of allergy was noticed. This all happen in a 30 minute period.
for 6wks joint pain in shoulder area;ache on upper arm & inability to lift arm past a certain level (d/t pain) 22SEP-30OCT sxs persist;23OCT pain progressed to shoulder & neck area, sl fever x 2 days;cramping in arm 6NOV;tx APAP, Ibuprofen
severe pain in hands; tingling down both arms; constant muscle aches and pains; constant muscle aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing); "double mastectomy" (unspecified if ongoing), notes: double mastectomy; "hysterectomy" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing), notes: diabetes type 2. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer/BioNTech, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, administrator route=Intramuscular, dose number=1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "severe pain in hands"; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling down both arms"; MYALGIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "constant muscle aches and pains". It was unknown if therapeutic measures were taken as a result of pain in extremity, paraesthesia, myalgia, pain. Additional information: Reported Event: Patient received 2 Pfizer doses reported severe pain in hands following second dose - feeling similar to that of hitting your hands hard against a table; tingling down both arms; constant muscle aches and pains. Symptoms started within days after receiving second dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination but unknown which medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19:Unknown.  Follow-up attempts completed. No further information is expected.
Pt recv vax on 7/7/98; on 7/14/98 pt awoke w/ fever, no energy, &pale.  Pt seen by M.D. 7/16; fever (105), a few scattered lesions, no appetite. On 7/17 pt exp numerous lesions entire body &inside mouth for 10 dys. Tx=Cephalexin &Atarix
Arm hurt right away, felt like a rock in my arm for about a week.  Arm is still hurting during certain range of movements.
Received vaccine at 4:40pm. Approximately 8pm I started with stomach cramps and had those for a few hours. During the night I tossed and turned and my hips were very achy.  I woke with a fever that went as high as 101 and was very shivery all day.  Fever reduced with Ibuprofen around 6 in the evening. Seemed to feel better. Very restless though the night and hips achy and awoke with a fever. Took Iuprofen. Fever reduced and slight headache. Tired but much better today.
10/27/2021 - Full body ache, tired, leg heavy. 10/28/2021 - Full body ache,  tired, sore legs, muscle soreness in both legs, back pain 10/29/2021 - Full body aches, legs very heavy hard to go up and down stairs, bad back pain feel like someone is sticking me across the kidneys with a hot poker, very tired every-time I sit down fall asleep, stuffy head and sinuses, feel cold I do not have a fever, dry mouth.
Anxiety Dizzy Bp 146/93 HR 50 Held 1 hour Improved
Pt was waiting for 15 minutes after Moderna vaccine. Then her daughter noticed pt had slurred speech and called pharmacist over to check. When I came over and asked her some questions, she report no anaphylactic reaction. I measured her blood pressure, was normal at 122/76. She was able to say her name clearly when asked. But when I asked for her DOB, or what date is today, pt was just mumbling and couldn't say the numbers. Her daughter wanted us to call paramedics, then arrived within 5-10 minutes. I gave her a bottle water and she felt and talked better after that. When paramedics arrived, pt was checked out and she was better. She reported feeling fine after that.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-JUL-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX lot # L042266 (dose and route of administration were not reported). Additional information has been requested.
Both my eyelids are swollen and I have red puffiness under the eyes. My symptoms occurred a couple hours after my booster. I received Moderna for my first two shots but did not have a reaction like this one.