chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having some muscle spasms to full debilitation to where I could barely walk and it was not manageable that time , muscular felt more like core of spine, felt like arthritis and could not move. incapable of lifting. Drop everything that I had and could not move. Couldn?t carry bag and purse and couldn?t move. Used to be just spasming in right shoulder blade to all of this ache pain down my spine into my left hip.  Had been experiencing a little bit of muscle spasms before vaccine, after the vaccine, came the onset of aching pain down from my spine into my left hip. Spine felt like it was cemented and could not move. Excruciatingly painful. Started in Physical Therapy and that seemed to help a little bit with the hip, but the core of spine never went away. Shoulder spasms never went away either. After getting the 2nd vaccination, it started all over again with the debilitating pain.   I had physical therapy, massage therapy, chiropractor. 5 MRIs and multiple blood tests within a few months, PCP was giving me some hydrocodone medication and muscle relaxer medication that didn?t seem to help and seemed to make things worse. And gave me another medication gabapentin. I started on a kind of manageable medication thing there. My spine doctor said that there wasn?t too much showing up on the MRI that showed an obvious sign of something. Something was showing up elevated which was inflammatory markers. The Rheumatologist said we had to take more blood work and tested for a gene, and it came back positive. He was the one who diagnosed me on the hla-b27 gene - Ankylosing spondylitis on 04/30/2021. C-reactive protein which is CRP ? that was the one inflammatory marker that came back elevated. Still elevated to this day. Also saw an endocrinologist and she noted that something else was also elevated A1C ? was climbing. Prescribed injectable Humera and Ozempic. My PCP also upped my dosage of the Gabapentin, so now I?m taking more of that than what I originally was.
Hives and serious redness at the vaccination site that appeared 6 days after vaccination (arm had looked completely fine for the first 5 days after vaccination). On day 1 -  skin looked like it was burnt by nettles + was red (~20 cm long). Next days - only redness; it started to be smaller on day 4 (~15cm), but then got bigger again on day 6 (exceeded 20 cm again). Resolved completely on day 8. Fatigue and drowsiness on days 2 and 3 (after the skin allergy appeared). Oral anti-histaminics didn't help (levocetirizine tried). Topical hydrocortisone didn't help either.
Shingles developed on April 14,2021- eight days after vaccination. Burning pain through left side back to left breast with rash left breast, enlarged lymph nodes left side and left neck,  extreme pain which was treated with valtrex, gabapentin, two courses prednisone, Advil, capzacin cream. May 1,2021 pain continues. Seen in  Hospital ER April 20,2021 for confirmation diagnosis.
12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia, abdominal pain, nausea, headache, back pain
This spontaneous report was received from a physician referring to 16-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 26-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot# N008823, and expiration date: date 26-MAY-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 19-JUL-2017 until 12-AUG-2017, the vaccine was exposed to various temperature excursions ranging from 34 degrees Fahrenheit (F) to 48F for the period of up to 46 hours at a time. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA007325:
PT WAS NERVOUS WILL RECIEVING THE VACCINE. DURING MONITORING PERIOD, PATIENT LOST CONSIOUSNESS. THIS OCCURRED APPROXIAMTELY 5 MINUTES AFTER RECIEVING THE VACCINE. GAVE PATIENT AN ICE PACK AND TRANSFERRED HER TO THE FLOOR TO EXTEND HER LEGS. PATIENT QUICKLY REGAINED CONSCIOUSNESS. CONTINUED TO MONITOR FOR ANOTHER 15 MINUTES.
R arm swollen indurated with itching 2 d post hep a and DTaP injections. Small bruise noted in R deltoid area. Benadryl 12.5/mg 5ml 2tsp q 6 hrs prn.
Elevated bilirubin; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced elevated bilirubin. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248 same reporter/drug/AE, different patients (1st of 3 patients)
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male patient of an unknown demographics who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiration date, dose, and route of administration was not reported for both vaccines) in arm NOS. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to underdose. It was reported that remnants of product dripped down to patient's arm so it might not have entered his system so the actual amount was unknown. It was also reported that there was a poor documentation in the medical records of the vaccination so the reporter did not know whether there was an actual issue with the FLUZONE HIGH-DOSE product and/or with the needle used. It is also a case of exposure via skin contact. It was unknown whether the patient had any adverse event. 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.
Within 24 hrs had fever to 102.4 and erythema at injection site. In next 24 hrs had extensive anterior swelling, redness, warmth of entire left upper leg length.
Increased Heart rates; A spontaneous report was received from a consumer (patient) concerning a 43-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced increased heart rate.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, 14 hours prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (batch: 032M20A) Intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, experienced increased heart rate. Her baseline heart rate is usually 60-80 bpm, it went up 120-130 bpm. On 9 Mar 2021, she went to an urgent care. On the same day, electrocardiogram (EKG) was normal. On 15 Mar 2021, the patient followed-up with her doctor and was asked to get some lab work done which she planned to do on 16 Mar 2021.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of event of increased heart rate was unknown.   The reporter did not provide assessment for the event of increased heart rate.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Since the vaccine I have experienced tingling of lips and face. The past few days I have started experiencing more tingling/twisting  sensations on left side of body and some weakness of left side of body as well as twitching of left eye.
Fever of 104, body aches, nausea, headache, and cough.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M016193 exp date 24-APR-2018) (route and dose not reported). The detail of the storage was a temperature excursion to 35 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA001796: US-009507513-1701USA006147.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with ROTATEQ (strength, dose number, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No adverse effect was light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Resident Received 3rd dose of vaccine on 10/8/2021 , resident expired on 10/15/2021
Hyporesponsive reaction to immunization. Patient took child to ER 10/30/13 at 730 PM. Per Mom body went limp, she didn't respond and eyes rolled back - when she came to acted funny for a bit, fine now.
Patient was seizing for roughly 20 seconds a few minutes after receiving both vaccines. Patient has a prior history of fainting and feeling dizzy after vaccines and was sitting in the lobby as instructed. Patient has no prior history of seizures or brain disorders. Patient was guided to the ground and lying flat for a few seconds and then the seizing stopped and then was able to sit up on their own. 911 was called throughout this process and they arrived a few minutes later. Patient was able to ambulate and sit down elsewhere, and there was no need to go to the hospital.
Patient came back to pharmacy two days after she received the vaccine and admitted that immediately after receiving the vaccine, her heart was racing and she was having feelings of swollen throat and tongue. However, at the time, she did not say anything and went home after 30 minutes of observation. After the vaccine, her arm was first sore and a couple of days later, the soreness turned into an itching. The itch is local around injection site on left arm. Potential allergic reaction, lasting for days post injection.
Developed chest pain and pounding heartbeat 3 days after vaccine. 6 days after vaccine was hospitalized with suspected myocarditis. Chest pain subsided 1 week after onset but pounding heartbeat and low energy are still present 1 month after vaccine.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach) and SNEEZING (Sneezing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroidectomy in 1981. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach), SNEEZING (Sneezing), PYREXIA (Fever) and CHILLS (Felt chills). On 31-Jan-2021, the patient experienced PRODUCTIVE COUGH (Coughing up stuff). At the time of the report, PAIN (Aches), ERUCTATION (Burping), DYSPEPSIA (Indigestion), ABDOMINAL DISCOMFORT (When driving got an upset stomach), SNEEZING (Sneezing), PRODUCTIVE COUGH (Coughing up stuff), PYREXIA (Fever) and CHILLS (Felt chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other concomitant medication included: 2.5 mg Steroid. It was reported that after the first dose on 27Jan2021, patient had fever, aches that lasted a couple days then felt better, then days later felt crappy and contacted primary care to consult on if she should get the second dose. After both doses she experienced burping, indigestion and when driving got an upset stomach. Then she felt sick to her stomach but was not vomiting and had a fever with a high of 102-103 degrees Fahrenheit and then had a normal low grade fever and stared sneezing. she felt like this for four days then then stared coughing up stuff and felt chills and had to wrap herself in quilt. No treatment information provided. This case was linked to MOD21-091277, US-MODERNATX, INC.-MOD-2021-138791, US-MODERNATX, INC.-MOD-2021-138805 (E2B Linked Report).; Sender's Comments: MOD21-091277: US-MODERNATX, INC.-MOD-2021-138805: US-MODERNATX, INC.-MOD-2021-138791:
Patient is a 70-year-old male with past medical history of seizures, (on phenytoin) and PE, (on Xarelto) who was brought in by EMS with altered mental status and weakness. Patient was unable to give full history so obtained from patient's wife. PCP notes in epic reviewed and extensive workup as outpatient before coming to ED. As per wife: Patient received first dose of Pfizer vaccine on 8/6/21, followed by muscle tremors and had fever on 8/7 which resolved with Tylenol. Patient started vomiting on 8/7 which lasted for a full 24 hours. Wife brought patient to an urgent care; COVID and flu were both negative. Patient was sent home with Toradol for headaches and Zofran for nausea. On 8/10 patient ate breakfast, but started getting disoriented in the afternoon and went to clinic. He had a another negative Covid swab, had unremarkable blood work, had a normal CT of the head, saw the primary doctor and neurology who ruled out Guillain-Barre. They ordered head CT which was normal. After returning home from the clinic, he was unable to get out of car due to weakness and waxing and waning consciousness, and only able to recognize his wife, losing orientation to place (stated he was traveling abroad) and time. He needed assistance to walk to the front door and collapsed. Soon after she called EMS. Of note, patient is independent of ADLs at baseline. Recent 25lb weightloss over 10 weeks, on a strict keto diet.Patient admits to headache and weakness. Patient denies any fevers, chills, n&v, chest pain, SOB, cough, abdominal pain, issues with bowel movements, urinary symptoms, or numbness and tingling. He received a single dose of ampicillin, ceftriaxone, and vancomycin in the ED before he was admitted.
2 weeks later developed DVT (leg pain, also found to have ACL tear of unknown duration), loss of appetite, and bilateral stiffness in hands. Hospitalized for DVT on blood thinners since  Diagnosis: Acute embolism and thrombosis of unspecified deep veins of right lower extremity ; Unspecified abdominal pain ; Nausea with vomiting, unspecified ; Strain of muscle, fascia and tendon of the posterior muscle group at thigh level, left thigh, initial encounter ; Essential (primary) hypertension
Headache, nausea, extreme chills, extreme fatigue.  Not able to work the following day mostly bed rest. Feeling better the 2 days later but still mild headache, some heart palpitations, nausea, some fatigue.
Numbness in both arms/hands beginning in bicep and down, and numbness in left foot
TC from patient 4:45 pm, 11/18/2008. States received AFLURIA on 11/17/2008 off site clinic. Complains of headache, chills, fatigue, and loss of appetite. Recommended patient go to physician, patient refuses.
Chills, sweats, sick headache, vomiting (3 a.m. to 11 a.m.), diarrhea. Administered anti-nausea medicine by doctor. Stabilized within 30 hours after vaccine.
Rash all over with diarrhea x 2 wks. Refer to dermatologist.
Red and warm rash to vaccine site with central clearing after four days and still warm with erythema ring at day 13 after injection
Redness; Swelling; Burning at the injction site; Swelling in the arm at the injection site; Redness at the injection site; Very hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Very hot), ERYTHEMA (Redness), SWELLING (Swelling), VACCINATION SITE PAIN (Burning at the injction site) and VACCINATION SITE SWELLING (Swelling in the arm at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING HOT (Very hot), VACCINATION SITE PAIN (Burning at the injction site), VACCINATION SITE SWELLING (Swelling in the arm at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 03-Apr-2021, the patient experienced ERYTHEMA (Redness) and SWELLING (Swelling). On 29-Mar-2021, FEELING HOT (Very hot) had resolved. At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), VACCINATION SITE PAIN (Burning at the injction site), VACCINATION SITE SWELLING (Swelling in the arm at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  Concomitant medications included medicine for Thyroid, medicine for Blood pressure. Treatment information included Ibuprofen on 27Mar2021 and Tylenol on 5Apr2021.
no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 12 months old of patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 11-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U014992 was confirmed to be valid, expiration date: 29-OCT-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin (rHA)) (M-M-R II) (lot #U006488 was confirmed to be valid, expiration date: 26-FEB-2023) (dose, dose number, site and route of administration were not provided for both vaccines) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccines were improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005825: US-009507513-2204USA005826: US-009507513-2204USA005827: US-009507513-2204USA005828:
Scratchy throat but I was able to sleep okay. Tuesday was the worst i tested negative. but had flu like symptoms with a temp of 11. The cough was getting worse with body aches i felt lethargic. Light headache and then i had night sweats. That ran for a couple of days. By Thursday i started coming out of it. By Friday i was feeling a lot better.
Chills, Restlessness, Nausea, Headaches, Shortness of breath, Dizziness, Muscle and joint pain, chest pain
Immediately within two minutes, strange disoriented feeling, heavy sweating and weakness.  Sitting down I lost vision in my right eye (just dark grey with a tiny blurry spot of light in the center).  Left eye could not focus.  After about twenty minutes,  both eyes became very sensitive to light (like a pupil dilation test in an eye exam).  This lasted about  additional 10 minutes.  I remained pretty weak for the next hour but was then ok.  The next day I felt 100%.
vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was reported.
Received Pfizer vaccines on  2/24/21, 3/17/21, 8/24/21, 4/28/22; positive for COVID by PCR on 5/5/22; admitted to hospital on 5/18/22 d/t altered mental status, h/o recent COVID pneumonia. Underlying A-fib, heart failure, CAD, sleep apnea, immunosuppression d/t rheumatoid arthritis meds.
Patient was given half of the J&J booster dose. 63-year-old male came in for J&J booster. Patient was given 0.25mL of J&J instead of 0.5mL. MD notified and recommended no additional doses needed.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 27th February 2018 10:00, the patient received the 1st dose of SHINGRIX. On 27th February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. In March 2018, the outcome of the pain in arm and injected limb mobility decreased were recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient reported having a very sore left arm following the injection. It was so sore that she could not lift it for days. The soreness lasted 3 to 4 days. The patient had denied permission to contact their physician. This case has been linked with US2018120811 (reporter's niece), reported by the same reporter.
Low grade fever, irritable, decreased appetite. 8/6/06 Hives on trunk, neck. Resolved with Benadryl x2 and resolved local redness and swelling.
10 minutes after receiving injection, felt sudden onset heaviness and tingling in left arm from shoulder to fingertips in addition to dizziness and mild confusion. was monitored at site for 1 hour. Fatigue within the next several hours, accompanied by muscle spasms/twitching in left arm. 12 hours after vaccine, muscle spasms in left arm had worsened. 21 hours after vaccine, awoke to numbness in left pinky and ring fingers (worse in pinky), and continued left arm muscle spasms. Severe headache began approximately 21 hours after vaccine. Now at 22 hours and numbness in fingers and muscle twitching continue, along with headache.