chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My upper left arm muscle is still painful in the area of the injection when the left arm is first moved.  I rate the pain at a 2.5 on a 10 scale.  It is in no way getting less painful over time as of today's date on 10-07-2020.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. the patient came back for her second vaccination and reported that she experienced pain at the injection site after her first vaccination. Subsequently, the patient recovered from pain at the injection site. Additional information has been requested.
No pain when shot was given. Within one hour arm was painful. Arm now red and swollen and hot. Put ice bag on inj. site. Pt. is not feeling sick. No fever.
SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain) was resolving.            Patient's husband had cancer. Relevant concomitant medications were not reported.  On unknown dates, the patient took second shot of Moderna COVID-19 Vaccine and felt arm hurt.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623780 (Patient Link).
Extreme muscle and joint pain,  fever , fatigue and swelling at injection site.  Dizziness and lethargy
Patient stated arm got swollen and hurts. I instructed patient to take BENADRYL, as soon as possible.
Information has been received from an office manager concerning a 13 month old female with no medical history or allergies who on 23-SEP-2008 was vaccinated with a dose of MMR II. Concomitant suspect vaccine therapy included a dose of VARIVAX (MSD). On 01-OCT-2008, the patient developed a mild fever (101.9 F) and diarrhea. The patient was being evaluated by the physician at the time of the time of reporting. No treatment was reported. The outcome was reported as not recovered/not resolved. A product quality complaint was not involved. Follow-up information was received from the physician's office. It was reported that they are not sure who the patient was and that they do not administer the MMR II at their facility. The office requested that they would not like any further contact regarding this adverse experience. Due to the inflammation received in follow-up, VARIVAX was changed to the primary suspect vaccine and MMR II was changed to the secondary suspect vaccine. No further information is expected.
Severe hives on face and torso 4 days past injection, getting worse by the day. Cough/congestion starting 3 days after injection continuing to one week (today).
Pt vacc. w/ Engerix-B developed felt hyper, nausea, nervousness, tinny taste, burning sensation.
Pt recvd 3 doses of Engerix-B & 3OCT91 titers were checked & the vax was found to exhibit seroconversion but not seroprotection, a weakly positive result was observed; pt was considered a non responder & will be revaxed;
8-7-2021 Upper Respiratory Infection  9-2-2021 Treated for Outer  Ear Infection  9-15-2021 Treated for Vertigo, Tinnitus with Prednisone and Meclizine. Referral to PT for Vestibular Therapy 9-21-2021, 9-29-2021, 10-27-2021.                          Referral to Audiology for hearing test 10-14-2021. Referral to Otolaryngology 10-14-2021. Hearing loss, Tinnitus, Labyrinthitis.
Approximately 24 hours after vaccine had chills and shaking, also bad headache. Right arm/vaccine site was swollen with red streaks from it. To ER and was admitted for ABX and control of HA per pt.
This case was reported by a healthcare professional and described the occurrence of red sores-hands in a 68-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included bug bite. Concurrent medications included PREMARIN, PROTONIX, PEPCID, ZOCOR and WELCHOL. In 2008, the subject received a dose of Influenza vaccine (unknown). In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced red sores-hands, sores on feet, hand pain, itching and rash. The subject received influenza vaccine approximately six to eight weeks prior to this report, specific vaccine was unknown. The palms of the subjects hands and bottom of feet were red and blanched when pushed in. Her feet and hands are painful. With this facility, the only difference from normal was her IgG was elevated. Prednisolone was prescribed and was not helping according to subject. The subject also had a bug bite two to three months ago. The bug bite was treated by primary care with antibiotics. The subject previously received flu shots before with no reaction and no allergy. It started as itchy and now back and forth between itchy to painful. Rash appeared one to two days after injection. Rash became worse during the day and then improved "like in a cycle". The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Influenza vaccine.
Significant pain in arm where flu shot given DX of tendonitis. Cannot raise arm. RX for ibuprofen and will begin physical therapy. Initial call to pharmacy on 9/18/16, Tendonitis DX 9/23/16.
diarrhea; did not have a voice at all / whispering; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and APHONIA (did not have a voice at all / whispering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced DIARRHOEA (diarrhea) and APHONIA (did not have a voice at all / whispering). On 17-Jun-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, APHONIA (did not have a voice at all / whispering) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Information has been received from a CMA concerning a 45 year old female with a drug allergy to PCN, codeine and a "vaccine preservative" who in 1995 was vaccinated with a first dose and on 11/11/03 was vaccinated IM with a second 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 646322/0530N). Concomitant therapy included levothyroxine Na (Synthroid), fexofenadine hydrochloride (Allegra) and "nerve medicine". Two hours after the vaccination, the pt developed a local reaction that was described as her arm was raised, warm and painful at the injection site. The pt put ice on it and took fexofenadine hydrochloride (Allegra). She reported that it felt a little better. No prescription drug was required. No diagnostic studies were performed. The physician's office requested an investigation into this lot number. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed a local reaction with redness and swelling of her arm (WAES #0311USA01956).  Additional information has been requested.
Two days after the vaccine I began having chills and nausea, after that day I?ve felt queezy all the time,, however waves of extreme nausea pass over me with chills. I have been hoping each wave is the end.  Reading  ?side effects? it should be gone in 3 days. However today, 10 days later,  was worse than ever . I spent the whole day in bed nauseated and vomiting, chilled with  4 blankets over me. My temperature was not high (97). I keep hoping the side effects are finished, but this has gone on longer than your information predicts. This is too long to feel this way.
No adverse events noted.  13 year old inadvertently administered a booster dose of Pfizer COVID-19 vaccine, which is only approved for 18+.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L006384, expiry date 25-FEB-2017, (dose, frequency and route of administration not provided). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
On going chest discomfort, shortness of breath, heart fluttering since the 4th day after 1st dose.  When having an episode, while lying down, laying on either side seems to make it worse. After the initial 72hr episode, symptoms subsided for about 10days.  Just prior to me scheduling 2nd shot, symptoms returned Friday Aug 27th and have remained.   This is as of this report on 9/9/2021.  No treatment besides keeping activities light, yard work and occasional walking on days with no issues.   Have not worked out or ran since vaccine.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/28/2021 and 5/19/2021. Presentes to ED on 9/2/2021 with complaints of illness for 5 days with symptoms of nausea, vomiting, diarrhea, chills and subjective fever. Also reports COVID-19 exposure. Patient admitted. At time of admission no respiratory symptoms, SpO2 of 98%. Patient reports dyspnea on 9/6, with need for O2 via nasal cannula. Patient experiences desturation on 9/11 requiring 7 L/min (SpO2 = 93%). On 9/12 requiring 60L FiO2 70%. On 9/13 60L FiO2 86% with an SpO2 of 100%.  On 9/14, while receiving HFNC at 50L 80% patient desats to 80%. Patient transitioned to comfort care. Patient expired on 9/16/2021.
Fibromyalgia, TMJ pain and limited range of jaw, upper body muscle, joint and tendon stiffness, soreness, pain
After receiving her first vaccinations, the patient became light-headed, fainted, fell to the floor and suffered a head laceration. She has since reported chronic neck pain.
p/recv vax pt became quite somnolent, taking very little formula. pt seen in ER, no distress was noted according to ER rpt. p/ 10-12 pt acting normally
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 10-MAR-2016, the patient was vaccinated an improperly stored dose of VARIVAX (Merck) (Lot number L035124, expiration date (exp) 14-SEP-2017), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in VARIVAX (Merck) immunization series were improperly stored in a temperature of -5.9 degrees C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccines involved included VARIVAX (Merck) private stock: L035124 exp 14-SEP-2017 and VARIVAX (Merck) VFC stock: L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Dose administered after more than 1 temperature excursion; Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 65.92 No concomitant medications were reported. The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. Vial was stored on cooler 1 , on 27-FEB-2021, No treatment information was provided.
Dizziness while sitting; Arm feeling painful; Large red ring around injection site; Itching; injection site the size of a golf ball; A spontaneous report  was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine and experienced arm feeling painful, large red ring around injection site, injection site the size of a golf ball, itching, dizziness while sitting.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020 around 4:00 to 5:00 pm, the patient received the first of two planned doses of mRNA-1273 for COVID-19 infection prophylaxis.   On 31 Dec 2020, the patient reported that her arm was feeling painful, and that there was a large red ring around injection site the size of a golf ball, redness, itching, and dizziness while sitting. No treatment for the events was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, arm feeling painful, large red ring around injection site, injection site the size of a golf ball, itching, dizziness while sitting, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
There were no symptoms, patient got a 4th dose of Pfizer Bivalent even though it is not authorized as a booster yet.
30NOV arm swelled, red, hard, sore; 1DEC could not move arm, sl fever 99-100 ax; general malaise, achiness, h/a, dizziness;
Pt presented 10-18-20 covered in hives. upon questioning no other new exposures pt could identify, Counseled signs if severe reaction/breathing issues and got pt benadryl and hydrocortisone cream.
Pain in upper left arm (same arm that received vaccine) has continued for 6 weeks. Started when I got vaccine and has not stopped since. The pain occurs when I move my arm.
I woke up the next morning after the shot  on 5/18/21 with a fever and bad headache. The fever went away within a few hours but the headache has been continuous for the past 24 days straight, including today.  I have had no relief  from varying levels of head pain since the shot. The headache varies  in intensity throughout the day, but has not let up.  In the past I rarely have experienced headaches, maybe a few every year, so having chronic headaches is not typical for me.  Unfortunately, my chronic headaches are a direct result of receiving the first Moderna vaccine.
Delayed menstruation by 7 days, causing severe menstruation pains (cramps) that have never been experienced in any prior menstruation (15 years). Menstruation has also been paired with a migraine (light and noise sensitivity, severe head pain) - I have NEVER experienced a migraine like this before (no history of having migranes).
Patient reports that since 3/4/2020 he has had severe pain in his left upper arm, "where the shot was given."  He currently rates pain "8" out of 10.  He describes it as a "prodding, hammer" pain.  It is constant.  It is not exacerbated by movement.  He is currently taking ibuprofen, which does not help much.  Ice also does not help much.  Paint denies redness or swelling in the arm.  He denies any history of blisters, sores, or any lesions.  He denies any history of pain or problems with that arm prior to 3/2/2020.
Product deemed to be ineffective due to refrigeration issue. Manufacturer contacted. Patient notified and advise for re-administration of the dose. No adverse effects reported.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (She experienced indigestion.), MALAISE (She felt sick.), NASOPHARYNGITIS (She experienced cold.), CHILLS (She experienced chills.) and VOMITING (She experienced vomiting.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DYSPEPSIA (She experienced indigestion.), MALAISE (She felt sick.), NASOPHARYNGITIS (She experienced cold.), CHILLS (She experienced chills.) and VOMITING (She experienced vomiting.). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, DYSPEPSIA (She experienced indigestion.), MALAISE (She felt sick.), NASOPHARYNGITIS (She experienced cold.), CHILLS (She experienced chills.) and VOMITING (She experienced vomiting.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Outcome of the events updated ( from not recovered to recovered)
Bell's palsy, dense right facial hemiparesis now 24 hours without other focal neurologic signs. she did have facial filler injection 10 yrs ago but only around mouth, below site of sx.  after first injection had unusual numbness and itching on right back of neck radiating around to right breast but self resolved within a couple days.
Patient came and received his first COVID-19 vaccination 09/18/2021; when the father brought the child back to get his 2nd dose he revealed that he lied about the patient's DOB at the initial dose. I verified on the database that indeed the patient was born in 2010 and not 2007.
Fri 2/5, developed fever, fatigue and flu symptoms. Sat 2/6 developed sub-clavicular lymph node (golf ball-size) on same arm as injection site. Mon 2/8 developed angioedema of face and neck.
NO IMMEDIATE SYMPTOMS. FEVER/MALAISE/HEADACHE AROUND 16 HOURS AFTER VACCINATION. THEN ERYTHEMA OF LEFT DELTOID WITH LOCAL EDEMA AND TENDERNESS DEVELOPED. SHE REPORTED TENDERNESS ALL THE WAY TO THE ELBOW. THESE SYMPTOMS INCREASED OVER 24-48 HOURS BEFORE MOSTLY RESOLVED BY THE TIME SHE HAD CONTACTED ME - SHE HAD USED ASPIRIN AND TYLENOL AS NEEDED TO CONTROL LOCAL SYMPTOMS.
Severe headaches; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches) and PAIN (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headaches) and PAIN (Body aches). At the time of the report, HEADACHE (Severe headaches) and PAIN (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Child woke up the day after Vericella vaccine with 5 spots that look like chicken pox.
Chills - 12 hours after shot  (lasted 2 hours) Vomiting -12 hours after shot (2 hours) Diarrhea - 12 hours after shot (8 hours) Headache - 12 hours after shot (20 hours) returned next morning for 3 hours Body aches  - 12 hours after shot (48 hours) Swollen lymph nodes - 12 hours after shot (24hours)
First 24 hours sore arm and felt achy and out of it. Thought I was starting to feel myself by Sunday midday but then suddenly on Sunday afternoon almost exactly 48 hours after the shot I started to feel extreme confusion and short term memory loss. My body started shaking, I felt very hot and then very cold (back and forth) and began experiencing shortness of breath. It was all very scary and I ended up in the ER.
Admit for COVID pna dx same day in clinic. Received O2, steroids, vit-c, zinc. No remdesivir due to CKD. Recovered and DC home on RA.