chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported: A fast heartbeat; Dizziness and weakness; Fever        CHIEF COMPLAINT:  FEVER (pt received second dose of covid vaccine on 1/20 at 1800, fever and chest tightness, history cardiomyopathy); presented to ED following day at 04:30 AM.   Briefly this is a 24-year-old with hypertrophic cardiomyopathy myopathy without obstruction presenting with fevers, chest tightness, and rigors after her 2nd COVID vaccine yesterday.   She took Tylenol at home yesterday and on presentation this morning she already felt better.    Her chest tightness was no longer present on admission and did not recur. EKG relatively unchanged from prior studies. She was febrile with an initial temperature of 39.3° C and tachycardic to 110. She was given 1 g of Tylenol and 15 mg Toradol as well as 2 L normal saline.  Her temperature came down to 37.1 and her heart rate came down to 90. Subjectively she felt a lot better and was comfortably sitting upright in her bed. Her blood pressure on admission was 105/58 and had dropped to 91/45, she was given an additional 1 L of normal saline (for a total of 3L) and her blood pressure improved to 103/46.  She was able to ambulate without dizziness.   She was discharged home with instructions to return if she significantly worsened, developed shortness of breath or experience recurrence of her chest tightness.
I started running a fever and body ache after vaccine. On 27th loss taste and smell.
RN was administering Monkeypox Jynneos vaccine intradermally to client in L lower forearm and some of the vaccine leaked out.  Then, RN readminisered Monkeypox Jynneos vaccine 2 inches away from original site successfully intradermally.
An hour after receiving vaccine, I started itching terribly and felt sick to my stomach. I called my doctor's office and told to take Benadryl, which I did. It did not touch the itching at all. It continued to itch for 2 days. I woke up at 2:30am shaking uncontrollably. I couldn't warm up. I started vomiting and ended up vomiting multiple times. I shook for 1.5 hours. Temp 102 with ibuprofen on board. I couldn't sleep for more than 5-10 minutes at a time. Each time I tried to move, the pain was awful. Even my ribs hurt breathing. I got a migraine also. Late Friday, I got so tired I couldn't stay awake. I slept for 14 hours straight and then slept off and on for 4 days. My husband had to keep waking me up to make sure I was ok.
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 67-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 08:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ARDS" (unspecified if ongoing); "SCA" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing); "Allergy: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: May2020, stop date: 13May2022. Past drug history included: Oxicodone, reaction(s): "Known allergies: oxicodone"; Codeine, reaction(s): "Known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment brand: Pfizer, treatment start date: 15May2022, treatment stop date: 19May2022 Indication: Treatment of COVID-19
This spontaneous report as received from a pharmacist refers to 5 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (strength, dosage schedule and lot # were not reported). On an unknown date the patients experienced unspecified injection site reactions after receiving ZOSTAVAX from the same unspecified lot #. The outcome of the event was unknown. Additional information has been requested.
Pfizer-BioNTech, Dose 2, 04/13/2021, Lot EW0150; I began to feel unwell around 12/22-23/2021 and I began to feel a scratchy throat, head pressure and by the 12/23/2021 was feeling very run down, fever chills. I subsequently went to urgent care to be tested and COVID-19 tested with a rapid test which was negative and was also given PCR test or longer test that took three days to turn around and was diagnosed COVID-19 positive on COVID-19 12/26/2021. Care plan after diagnosed was told to take allergy and Flonase and antihistamine, which was not prescribed but was medication that I purchased or had on hand. They recommended treating it like allergy symptoms, I was able to recover by the 12/26/2021 except a stubborn cough that lasted a week or two weeks later, no other symptoms were present or presented.
A 32-year old patient received haemophilus influenzae type B vaccine; This literature marketed report has been received from the authors in a  published literature article titled as stated below, concerning a 32-year-old female patient, with medical history that included occasional ingrown hairs and folliculitis, family history of cardiovascular disease. Information regarding the patient's concurrent conditions included hypertension, tobacco smoking of 10 pack a year, she rarely consumed alcohol and did not use illicit drugs. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DPT VACCINE).  On an unknown date, the patient received a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, administered for unclear reasons (Product used for unknown indication)(strength, dose description, lot #, expiry date, and route of administration were not provided) (drug use in unapproved population).  A copy of the published article is attached as further documentation of the patient's experience.
I started to have fever, chills, headache, body aches the next day after the injection, I went back to the occupational health nurse and she took my temperature and it was 98.2 so she gave me some ibuprofen, and I went back to work the symptoms resided and I was able to finish my shift. But called in sick on Friday because of the same symptoms that returned when I got home that evening.
Arm they shot me is extremely swollen; Little bumps are forming on skin; Very itchy; Hot/fevered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm they shot me is extremely swollen), RASH (Little bumps are forming on skin), PRURITUS (Very itchy) and PYREXIA (Hot/fevered) 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 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced RASH (Little bumps are forming on skin), PRURITUS (Very itchy) and PYREXIA (Hot/fevered). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm they shot me is extremely swollen). At the time of the report, PERIPHERAL SWELLING (Arm they shot me is extremely swollen), RASH (Little bumps are forming on skin), PRURITUS (Very itchy) and PYREXIA (Hot/fevered) outcome was unknown.            No concomitant medications were reported.  Treatment taken was reported as PII(32):AQPe2qajnrpINIXa02Sr1UOiU19n77po and, reportedly, was no help.
11/17/22 presents to EC ED for "cough and dyspnea". PMHx of "HTN,  CAD s/p LAD stent placement (2006), T2DM, base of tongue cancer s/p R tonsillectomy and excision of base of tongue  (2012) followed by chemo/radiation therapy(2015) s/p PEG tube placement, diverticulitis with abscess and colovesical fistula s/p sigmoid colectomy (2011), atrial fibrillation, bilateral DVT, and carotid artery stenosis s/p R endarterectomy (2013)"
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were unspecified. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB lot # L051123, expiration date: 13-OCT-2018 (dose, route of administration and anatomical location were not reported). The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000770: US-009507513-1706USA008487: US-009507513-1707USA000767: US-009507513-1707USA000768: US-009507513-1707USA000794.
Swollen left arm, red rash on whole left arm, warm to touch, pt. went to MD and given ALLEGRA to reduce reaction. Pt. received PREVNAR 13 in 2016 w/no reaction.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
upper lip swelling and pain, lasted for 2 days, not responsive to Benadryl, self-resolved. Also associated with fever
Fever 101.5 degrees- 22 vesicles, nausea. Pt. developed headache. Duration of adverse events- 5 days.
PREVNAR 13 1st dose on 8-28-15 lt deltoid Flu shot 0n 8-28-15 rt deltoid pain lt deltoid persisted till 5th day (9-1-15) and became swollen rt upper arm with redness, induration and tender, warm , spread to axilla, and down forearm and back to scapula. Requiring medical treatment with prednisone x 5 dy and antibiotic x 3 day resolved 3rd week 9/21.
Severe swollen lymph nodes within hours of 2nd Moderna Vax on 3/17/21. Severe pain for over 5 days (nearly bed ridden). Lymph nodes are still slightly swollen as of 5/4/21 and SEVERE Fibromyalgia flare up/pain that has lasted longer than any previous flare up. I just want the overall body pain and "fibro fog" go away!
Patient arrived for the Pfizer COVID Bivalent Booster. Instead he received the Pfizer pediatric monovalent  dose.  The event was reported to patient's pediatrician.
PATIENT STATES HER ARM HAS HURT FOR 1 MONTH SINCE THE VACCINE. IT WAS GIVEN IN THE RIGHT SPOT IN THE CENTER OF THE DELTOID MUSCLE.
No additional AEs were reported, no further information provided; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 17 month old patient of unknown gender.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-FEB-2023 the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot # W020525 and expiration date 14-DEC-2023, (anatomical location and route of administration were not provided) for prophylaxis (Product storage error). The suspect vaccine was improperly stored in temperature of 30 Fahrenheit degrees (F) for 3 hours 15 minutes. There was no previous temperature excursion. No additional adverse event was reported.
Dizziness, fever, chills, leg stiffness and pain, difficulty walking, nausea.  Symptoms lasted from 11 PM October 7 through 3 PM October 8.  I rested at home and was unable to travel by train for an appointment.
Note: I do not know the exact time of onset of her pain.  Patient has experienced intermittent left shoulder pain that has not improved since she received her shot.  She has had PT, injections and is now scheduled for arthroscopy 11/13/2012.
Mom calls today, stating she took patient to urgent care on Sunday, 07/24.  Saturday patient woke with red area localized, swelling on left arm, by evening was more swollen.  Gave Benadryl, no benefit.  By Sunday area was swollen from shoulder to elbow, red, hot to touch and hard.  Advised to use Advil, cool compresses.  Follow up if symptoms don't resolve.
Patient given Pediarix, IPOL, Menactra, Adacel and Menactra ordered.
Starting 36 hours afterward and lasting for 48 hours: whole torso non itchy rash (neck to pubis) sciatica (bi-lateral)
This case was reported by a pharmacist and described the occurrence of itching in an adult subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2008 the subject received unspecified dose of FLUARIX (unknown). In 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced itching, increased heart rate, rash and trouble breathing. The pharmacist considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated in the emergency room. Treatment was not specified. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with FLUARIX. A product complaint was reported. The pharmacist reported that 5 to 7 adults (exact number unknown) who are employees of the hospital experienced reactions to FLUARIX. The events known to the reporter were documented above. It was noted that there could be additional events. All of the subjects had to be treated in the emergency room. Details of the treatment were not specified. Limited subject information was known at the time of reporting. The pharmacist only knew one lot number, but there may have been others (unknown at the time of reporting). These 5 to 7 subjects are out of a total of 22 doses of FLUARIX given. Due to the high rate of reactions, the hospital stopped using the FLUARIX because they feel the reactions are due to a quality issue with the product.
Dizzyness, headaches, flu-like symptons, sleeplessness, cold chills, sweaty, exhaustion.
A vaccine was injected in my left deltoid that should not have been.  The RN administering this vaccine had not pulled my chart or asked my name and this is why I raised the question asking what I had just been injected with.  I had in fact been there to receive a Varicella booster to be ready for my nursing courses at school, but all the staff had written down for me to receive that day was "vaccine." Adverse symptoms are temporary, but include arm pain beginning from the injection site to my left cubital fossa and a low fever.
17 YO M, received Moderna Covid-19 vaccine (1st dose) on 01/19/21. Pt falls under the unauthorized age group for Moderna vaccine administration. On 02/22/21, pt returned to vaccination site for 2nd dose, 2nd dose was not administered d/t age requirements. Nurse Manager spoke to pt and father regarding deviation of vaccine administration. Pt nor father reported any adverse s/s after pt received 1st dose of Moderna on 01/19/21.
Approximately 14 hours after the shot I woke up with extreme shivers (2:30am). I had shivers for 45 minutes until I climbed into a warm bath. The shivers stopped and I became extremely tired. I got out of the bath and had to climb back to bed because the room was spinning and I was nauseous. I did not have a fever at this time. I was able to go back to sleep. I woke up about 2 hours later sweating and with a fever of 100.7. I slept for another 3-4 hours and woke up symptom free. My morning went on normal. Ate breakfast and hung out. I was tired in the early afternoon and took a 4 hour nap which is not normal but expected since I didn't get a good night sleep with symptoms mentioned above in the middle of the night.   I also missed my period that month. My period was supposed to start March 30th and it never came. Confirmed I am not pregnant. Period returned in April on normal schedule.
Sharp pain in upper arm that feels like I am being stabbed. It radiates from my shoulder to my elbow.  I do not have a complete range of motion moving my arm at the shoulder and cannot reach my arm behind my back. Ice has been applied 3x per day since the injection and ibuprofen does not help.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "known allergies: Cephalosporins" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Dec2016. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2023) Negative, notes: rebound case of covid 5 days after testing negative following Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.Paxlovid was taken from 22Mar2023 to 27Mar2023.  No follow-up attempts are possible. No further information is expected.
Presented to the ED today with sudden onset chest pain, recently received his Pfizer booster vaccination does 2 days ago on 1/5/22 (primary series completed 6/4/21). Then yesterday post-vaccine only had some mild fatigue and dizziness. Then chest pain occurred this am upon waking up. The chest pain was retrosternal and worse with taking a deep breath.   Admitted to a local healthcare facility for myopericarditis.
Patient (babysitter), fully vaccinated since February with the Pfizer shot, was tested positive; Patient (babysitter), fully vaccinated since February with the Pfizer shot, was tested positive; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients. This is report second of two reports. This consumer reported for herself and for her babysitter. This case refers to babysitter.  A patient of an unspecified age and gender received two doses of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), both on an unspecified date, in Feb2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not experienced COVID-19 prior vaccination. It was reported that the 3 kids of the reporter were tested positive for COVID. The patient (babysitter), fully vaccinated since February with the Pfizer shot, was tested positive on an unspecified date, in Apr2021. Clinical outcome of the events was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421956 same reporter/drug/event, different patients
3/20/2021 developed painful lump in lymph node in left armpit; took about a month to go away 8/18/2021 a lump was found in my breast during routine mammogram.
Pt ran 104(R) T, on & off for 3 days /p vax.Was continuously giving APAP per PMD.
Chest pain, brain fog, facial/body rash that burns, headache and difficulty catching breathe.
the patient began to experience shakiness; Feeling faint; Diaphoresis; This is a spontaneous report from a non-contactable health care professional. A 42-year-old female patient received first dose of her BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration on 22Mar2021 (at the age of 42-years-old) as a dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. During 15 minutes of her waiting period on 22Mar2021, the patient experienced shakiness, feeling faint and diaphoresis and denied of events like rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures for diaphoresis, shakiness and feeling faint included water and rest. Follow up response to treatment with excellent, the patient discharged with stable condition and planned to follow up with primary care physician. The clinical outcome of the event diaphoresis, shakiness and felt faint was resolving at the time of this report.   No follow-up attempts needed. No further information expected  Amendment: This follow-up report is being submitted to amend previously reported information: Country US added for patient in patient tab. Final sentence in analysis tab updated to No follow-up attempts needed. No further information expected
Husband called for help past 10 minutes in 15 minute wait area. Pt appears slumped and unconscious but aroused immediately. No resp distress. Pulse 56 and strong. R -20. Patient states she has a history of fainting. Voiced understanding to go to PMD or ER if needed.
pt was walking out of the building after getting the vax she had a headache right away along with ringing in both ears.  The vax administrator told her to try the medicine Similasan for the ringing in her ears.  She says it only helps temporally.  She had these same symptoms after taking the 1st covid vax and they went away after 27 days.   She will contact her PCP and get a referral  an ENT if these symptoms to do go away after a this time frame.
Patient came into pharmacy 3-31-2019 and showed me a rash around her waist and across her back that she said started to appear about a week after her first SHINGRIX vaccine on 3-16-2019. Outside of a sore arm for a few days she had no problems around the injection site.
Complete body/muscle lock up - Was rendered useless on hallway floor for 15 minutes while my body locked up with muscle spasms Extreme Migraine morning after - Continues to be an issue as the days go on - Not getting worse, but each day is a headache Extreme Muscle pain from left collar bone area to the left ear Minor/Medium pain behind my eyes every so often Shortness of breath at times with no strenuous activity prior
Developed signs and symptoms of Brachial Plexus Neuritis: Intense burning pain my right shoulder and upper arm. This began spontaneously after I got up Sunday morning Oct 28th. 2 days later I developed intermittent parathesias in my right hand and upper arm. I consulted with Dr who referred me to a neurologist. I was treated with Prednisone.
Fever, no energy, rundown feeling, headache, sore injection site, nauseous, and blood vessel in finger burst.