chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm hurt; arm hurt right away and then hurt for 2 years at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL3249) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Catheter", start date: 2020 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Jan2021, outcome "unknown", described as "arm hurt"; VACCINATION SITE PAIN (non-serious) with onset 23Jan2021, outcome "unknown", described as "arm hurt right away and then hurt for 2 years at injection site".  Additional Information: The caller reported that right after her husband received the first dose of the primary series of the vaccine his arm hurt right away at the injection site and continued to hurt for 2 years. The arm pain began immediately after the vaccines on 23Jan2021 and verified that this pain continued for 2 years.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300069251 Same patient/vaccine, different dose/event;
I was falling asleep when suddenly my heart became "erratic". My heart would suddenly race and just as suddenly stop, with severe palpitations. This feeling that my heart was beating out of time, or would race, or would then be practically undetectable (I would check my pulse sometimes and it was very weak-feeling) was very scary. It kept me up most of the night, I called an ambulance who decided not to take me to the emergency room, as I thought I was having a heart attack at the time and they said I wasn't.. Severe symptoms like this continued for about 2 more days, while more subtle symptoms such as chest tightness persisted for 3 weeks to a month at least. Palpitations continue(d) to occur but less severely and more rarely. Even now, months out, occasional palpitations and chest tightness seems to occur. During the first week(s), on top of the tightness and palpitations, there were a number of other symptoms, some or many of which are hard to describe. One such symptom was that I was looking at my phone and something of thump, almost like a heartbeat, occurred but it was felt throughout my whole body. Very difficult to describe. I would "visually dissociate". Again, very difficult to describe this symptom. A sudden tightness of my neck and jaw would occur and sometimes persist for up to an hour. All of these symptoms other than the chest tightness and palpitations seem for the most part to have gone away. But there is now an anxiety-inducing awareness of my heart that I seem to bear nearly constantly.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and Agency. As per recommendation from agency, affected dose should be repeated. Pt was notified and all questions answered. Pt no showed for 9/15/21 appt, attempted to contact to reschedule f/u appt.
Rheumatoid arthritis flare up; Swollen lymph nodes, the lymph nodes in his right armpit swelled up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No reported medical history.  Concurrent medical conditions included Chronic lymphocytic leukemia in 2018. Concomitant products included LISINOPRIL for Blood pressure abnormal.   In January 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes, the lymph nodes in his right armpit swelled up). On 17-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On 18-Mar-2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes, the lymph nodes in his right armpit swelled up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood count: 3000 (High) White count was up 3000 and 3000 (Inconclusive) White count had gone down 3000 after few weeks..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.    This case was linked to MOD-2021-113371 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Beginning of September 2022, began to have ringing in the ears.  Middle of September ringing in ears became worse, started to have fire shooting pains between shoulder blades.  In October began to have bone pain (random), one day arm would hurt, next day her leg would hurt, etc.   Continues to have ringing in ears and fire shooting pains between shoulder blades and down spine.
late Friday PM 17OCT97 T102.8, sl swelling & redness lt pt started taking 2 advil q 4hr sat AM, temp cont 102;pt exp swelling & redness lt arm;
6/17/10 TDAP/MMR LEFT ARM AND TWINRIX R ARM MIDMORNING. NOTED SWELLING, HURTING, BOTH ARMS.  HOT/COLD COMPRESSES. IBUPROFEN.  CAME TO CLINIC 6/22/10 NURSE NOTES EDEMA BOTH ARMS JUST ABOVE ELBOWS.  BRUISED AREA ON R ARM ABOVE ELBOW.  WARMTH R ARM.  TAKE BENADRYL IF NO IMPROVEMENT.  WILL GO TO DR OFFICE 6/23/10.  ALSO COMPLAINED OF HEADACHE, WEAKNESS, LOSS OF APPETITE, STILL HAS BANDAID MARKS ON ARMS.
Very heavy bleeding and a long and painful period for 2 weeks afterwards. Intense cramps.
This spontaneous report was received from a registered nurse and refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
High fever:105 Lymphadenopathy in neck Chills Diarrhea  Shoulder pain
Patient presented to the ED and was subsequently hospitalized for atypical chest pain, abnormal stress test, atrial fibrillation within 6 weeks of receiving COVID vaccination.
This spontaneous case reported by a consumer, describes the occurrence of inflammation (inflammation in legs), muscle spasms (cramping in shins), myalgia (achy muscles/muscle pain) and arthralgia (joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included blood pressure and stroke issues. On Mar 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inflammation (inflammation in legs), muscle spasms (cramping in shins), myalgia (achy muscles/muscle pain) and arthralgia (joint pain). At the time of the report, inflammation (inflammation in legs), muscle spasms (cramping in shins), myalgia (achy muscles/muscle pain) and arthralgia (joint pain): not resolved. Concomitant medications included unspecified blood pressure and stroke medication. Patient's symptoms started 5-6 months after the second shot. Patient went to the neurologist who did an MRI of his back. Neurologist recommended the patient to go to the rheumatology and have a biopsy of his leg muscle. Patient received unspecified cream for treatment.
TOOK FOUR UNREFRIGERATED DOSES; A spontaneous case report was received from a caregiver on 25-Feb-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201902-000150 (PVX2019-502; wife) and PVX201902-000151 (PVX2019-503, husband) were created and cross-linked in the database.  This case report describes a male consumer who "took four unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day; lot no: 3003240) for typhoid fever prophylaxis.  It was reported that the consumer did not refrigerate Vivotif for two weeks and later took all the doses. The first dose was taken on 17-Feb-2019 and the last was on 23-Feb-2019.  The action taken with Vivotif with respect to event "took four unrefrigerated doses" was not applicable.  The clinical outcome of the event "took four unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000150:
deep red bruise directly behind my left lower rib/ the bruise was mildly painful to the touch; 3days after the second injection I developed a fever of 101.; blood pressure and blood sugars are not as well controlled; blood pressure and blood sugars are not as well controlled; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 26Mar2021 at 15:45 (at the age of 58-years-old) in left arm as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, covid-19, hypertension, allergy to Tamiflu and mushrooms all from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included metformin hydrochloride (METFORMIN ER); glimepiride (GLIMEPIRIDE) and Irbursar all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Batch/Lot number: unknown) on 05Mar2021 at 16:15 (at the age of 58-years-old) in left arm for covid-19 immunization. On 29Mar2021, 3days after the second injection the patient developed fever of 101. He took a dose of Tylenol and it went away. One week after the second dose on 05Apr2021 at 13:30, she noticed a deep red bruise directly behind her left lower rib, it was about 5 cm. She called her doctor and went in the following week to see the MD. She was told to watch the bruise and call back if it did not subside. The following week the bruise began to dissipate. The bruise was mildly painful to the touch and she had not suffered any injuries causing the bruise. Since the vaccination, her blood pressure and blood sugar were not as well controlled. She had been switched to amlodipine 7.5mg. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood glucose and blood pressure measurement: not as well controlled on an unknown date in 2021, body temperature: 101 on 29Mar2021. The outcome of the event bruise was recovered in Apr2021 and all other events were resolved in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 10 minutes after administration of DTaP, IPV and PCV 7, she developed petechiae and hives. No respiratory or other distress. Relieved by Benadryl. Petechiae were the unusual event.
Patient experienced extended dizziness and vision disturbance post vaccination, with symptoms improving at around 32hrs. Patient also had c/o headache at around 48hrs post vaccination, which was improved at 52 hrs.
I had a fever over 100.0 and body ache. I had a cough for about 5 days. The doctor did not prescribe me any medication.  My symptoms occurred after a meeting; where ever one had all 4 shots. After 7 days I was okay.
About 12 hours after receiving the vaccine, began shivering uncontrollably. Shivered for 5 hours. Then, vomited several times. After nausea, began feeling better. Then, a week later began noticing ringing in ears. Ringing has developed and progressively gotten worse. Had ears checked and suspect side effect of Shingrix.  Until this vaccine, have never had a side effect. Did fine with 1st shot and receive flu shot every year.
Myalgia, Fever, CoughWheeze, golf ball sized lump at injection site, unable to life arm Narrative:
Pt presented to our office to Establish Care w/ the provider on 6/28/21.  On exam there was noted Thyroid Enlargement.  Pt was then sent for lab and US.  On pt's physical that was noted to be done on 2/10/21 at another facility, she had nothing wrong with her thyroid.
burning and itchy vagina-treated for UTI although test was negative,also treated for yeast infection and is still present, headaches, blurred vision, back pain on right side-kidney ultrasound negative, swollen lymph nodes in groin painful and bruised size of golfballs
The pain & soreness that many people including myself experience the day after returned about 5 or 6 weeks later after feeling perfectly fine for over a month. Since I first started experiencing the discomfort it has progressively gotten worse - this week especially. I am unable to put much weight on the arm or move it in certain directions. I tried massaging the sore area last night and it seemed to irritate it more. I have been periodically keeping ice on it the past few days. I took some ibuprofen last night to try to ease the pain. as well. The ice packs seem to help a little, but the pain is still there when I move my arm  in certain directions.
Large area of redness to injection site. Tender to touch, cough, sore neck, pain in arm and right thigh.   PCP MR received revealing a 61 yr old in for check up.  Pneumovax given and 2 days later pt. c/o that she was having headaches, neck aches, non-productive cough and sinus drainage. Also c/o throbbing pain in the right arm where vax. was given, as well as numbness and pain in the right thigh, fever, chills, aches. Sent to ER by PCP for labs and IV antibiotics for r/o cellulitis/abcsess.   Hospital record received revealing a 3 day admission for reaction, status post pneumococcal vaccine. Cellulitis vs. allergic reaction.  PE revealed a 5 cm. area of well-circumscribed erythema c/w cellulitis. Tx'd with vancomycin IV and d/c'd home on doxycycline. Discharge Diagnosis: Cellulitis. F/U 2 1/2 weeks post vax: Small area (1.5cm) of induration remains, dramatically improved.
Patient received the vaccination and per the mother's account "seemed tense when he got the shot". The patient started to walk to the waiting area after receiving the vaccine when he dropped to his knees and reported feeling dizzy. Our physician observers noticed the patient was also sweating and quickly moved him to a stretcher to recover. After a short time of observation (30 min +), the patient was feeling well and sitting up eating and drinking water. According to our physician observers, the patient never lost consciousness and was not injured.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 01-JUN-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -3.0 Celsius Degrees for 1172 hours, -1.11 Celsius Degrees for 80 hours, 15 Celsius Degrees for 56 hours, 8.33 Celsius Degrees for 416 hours, 8.88 Celsius Degrees for 24 hours, 9.44 Celsius Degrees for 168 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Pt. reported back to the HD front window after waiting 15 minutes post vaccination and leaving the HD. He reported that after he was finished with his 15 waiting period he was about to leave and he had a stinging sensation in the middle of his chest. Pt. denies any shortness of breath or any other symptoms. Pt. BP was taken at 10:09 and was 144/88 and again 5 minutes later and it was 137/ 85. Pulse was regular at 61 BPM. Pt. wife came to HD and stayed with husband while he was observed for another 20 minutes. Pt. reported that stinging pain was gone but he was just worried because he had never had a pain like that before. Denies any problems with first Moderna Covid-19 Vaccine EUA. Pt. was advised to contact primary care provider for further evaluation and follow up for his stinging chest pains. Pt left health deparment with wife unassisted and no distress on 03/01/2021 at 10:25 AM.
Vacs given 12-31-10. Developed large blotchy rash with raised border at (B) buttocks (B) UE (B) ant thigh/perineum.  Eryth. Multiforme-like on 1-11-11. No other sx.
Anaphlaxis Saturday, April 17th Day of Vaccination: under 5 minutes - lips tingle, injection site incredibly itchy within 10 minutes, itching spread across back, hives/rash appeared, face became beet red, confusion, throat began to swell Alerted EMT at 5 minute mark, taken to triage,  Transported to Hospital by ambulance, treated for anaphylaxis- given steroid injection (left thigh) and benedryl (right arm) Post-ER treatment - benedryl   Continued Allergic Reaction Rash continued and got worse, returned to primary care doctor on April 27th  Red rash protruded down arm and across back, throat swelled, thought to lymph-nodes swelling Primary care physician proscribed prednisone - 7 day course to stop allergic reaction   ER doctor and primary care doctor recommended no second dose
Rash on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her right arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Breast Surgery on left side and removed lymph nodes and left arm swollen arm.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rash on her right arm). At the time of the report, RASH (Rash on her right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-028582 (Patient Link).
I gave birth to a stillborn two weeks after receiving the H1N1 vaccine. I was 25 weeks pregnant and there were no birth defects.
Patient presented to office 24 hours after receiving MMR and Varivax with swollen hands and feet and macular, lacy rash on face, arms and legs.  Sibling reacted "violently" to Benadryl.  No other treatment.  Also seen 5 days later with viral pharyngitis and viral rash, diarrhea and cough.  Treated with Nystatin cream to diaper rash.
Soreness at injection site, fever, chills, achy joints and muscles, skin became itchy all over body, tiredness, headache, loss of appetite for 2 days. Flu -like symptoms, achy joints and muscles, and soreness at injection site continues on and off.  Lump on injection site lasted for 3 days. I have not contacted my doctor as of yet.
Patient's blood pressure dropped to 60/40 with a pulse of 50 initially, then she was given Benadryl 25mg  ie 1 tab with half a glass of water, she rested for a few minutes and we checked her blood pressure a second time which read 70/49 with a pulse of 55. We offered the Patient EpiPen and to call 911, but she refused. However, we provided the Patient an EpiPen 0.3mg to take home and instructed Patient's father on how to use it.  We confirmed with Patient that her breathing was fine, she had no difficulty in breathing. Patient was fine when they left to go home.
bad sore throat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program . A female patient of an unspecified age (69 (units not reported)) received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, 4 days later after the 1st dose she experienced a very bad sore throat on an unspecified date in 2021. Stated she received her first dose of the Pfizer covid vaccine on 28Jan2021 and she was scheduled for the second 2nd dose this Thursday. Her doctor prescribed her prednisone to be started today. Caller wanted to know if she can take the prednisone are there any interactions with covid vaccine. The outcome of event was unknown.