chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Medium, Systemic: Unable to Sleep-Medium
This spontaneous report as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of VARIVAX (Merck) (lot number L004651, expiration date 11-FEB-2017; lot number L025208, expiration date 07-JUL-2017) (dose and route not reported) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient came to pharmacy 6/6/19 around 7pm to pick up a copy of her flu shot form b/c she said she's still have pain from the vaccine and her md told her it was given incorrectly.  The patient states she always has a reaction to vaccines.  So when her arm first was very red and hurt she didn't think anything of it b/c this always happens to her. The patient states that it appeared to be like a "red strip" from the back to the front of her left shoulder. Today she is feeling joint pain in the area. Patient states received vaccine 9.22.18 and followed up with her PCP office about 3 weeks after the shot. She said after her first follow up she saw staff at the PCP office about 2 weeks later. After seeing staff she went back one more time to see Dr. who order xrays and she recommended to see an orthopedic doctor. She went to see Dr. around Jan 2019. The orthopedic doctor did a cortisone injection in her left shoulder and was recommended to do therapy. She states he told her that the flu shot was given in the incorret area and he could see that on a MRI she had after visiting him in Jan 2019. She plans to go for a follow up with the Dr b/c she's still stating she has pain now (joint pain and pain from the back top of her shoulder to the front top of her shoulder). She just saw Dr, her PCP, last week, who's in the same office as orthopedic Dr. and staff. The patient states that her md says she now has another nodule forming at her shoulder area and the Dr is thinking she has a torn rotator cuff from the shot. Again the patient wants to see the orthopedic doctor one more then and then follow up again with her PCP to see if they are on the same page with these findings.  The patient reports still feeling pain in her arm. She states she feels it in her joints mostly when she's moving.
About 12 hrs after the vaccine was administered, I became extremely fatigued (about 6 a.m. on 5/30/18). As the morning progressed, I became more fatigued, the muscles of my extremities began to ache, then I developed chills. I felt miserable. During the lunch break, I had the staff check a quick flu test on me, I was negative. (I am a pediatrician and did not want to expose my pts if I had the flu). I then read the CDC site & figured the Sx were due to the SHINGRIX. I took ibuprofen & acetaminophen. About an hour later, I started sweating (x ~30 minutes). Later I felt better intermittently. By 11:00 p.m, I only had mild fatigue. The entire next day (05/31/2018), I just felt mild to moderate fatigue. On 06/01/2018, I felt mild fatigue.
shortness of breath; low grade fever; feeling cold/feeling chilly; This case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine).   On 27th October 2019, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix and an unknown time after receiving Flu vaccine, Albuterol and Advair, the patient experienced shortness of breath, low grade fever and feeling cold. The patient was treated with salbutamol sulphate (Albuterol), fluticasone propionate, salmeterol xinafoate (Advair), paracetamol (Tylenol) and ibuprofen (Advil). On 15th December 2019, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the shortness of breath and low grade fever were recovered/resolved.   It was unknown if the reporter considered the shortness of breath, low grade fever and feeling cold to be related to Shingrix.  Additional case details were reported as follows: The patient received her 1st dose of Shingrix and developed the feeling of a low grade fever, feeling chilly or cold all the time, and shortness of breath. The patient consented to follow up.
Patient rec'd vaccine and within 5 minutes began feeling hot & itchy.  Patient had generalized rash mostly on left cheek, back, and chest.  Red & raised.  Patient was taken to the ED - vitals were stable, patient was given Benadryl PO and Prednisone 60 mg PO.  Pt was observed for a couple of hours and then released.
p/vax pt exp uncontrolled shaking (no fever) which lasted thirty minutes & no fever;pt recovered;
On and off waves of dizziness (not extreme, but noticeable)  - occurred about 5 minutes after receiving the vaccine  - lasted for about 10 minutes  Itchy, red, puffy finger (right middle finger)  - occurred about 10 minutes after receiving the vaccine  - itchiness lasted about 5-10 minutes, redness lasted longer  Tingly/numb face  - occurred about 20 minutes after receiving the vaccine  - lasted only a few minutes  Slight nausea  - occurred about an hour after receiving the vaccine and was more of an inconvenience than real pain, I did not vomit  Fatigue  - extremely tired at the end of the day  Injection site pain  - pain began about 2 hours after receiving the vaccine and became worse throughout the day  - by about 5:00 PM I was unable to move my arm or put any amount of weight on it  - pain began subsiding significantly the next morning and only feels like a bruise now (3 days after vaccine)
swelling lymph node on the neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling lymph node on the neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History Information was reported.    On 08-Feb-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling lymph node on the neck). At the time of the report, LYMPHADENOPATHY (swelling lymph node on the neck) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling lymph node on the neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History Information was reported.    On 08-Feb-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling lymph node on the neck). At the time of the report, LYMPHADENOPATHY (swelling lymph node on the neck) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
PT FELT FAINT, DIZZY, VISUAL DISTURBANCES, RINGING IN EAR
1/22 Friday- 0800-vaccination received; after about 10 minutes during observation period I felt my heart pounding which lasted for about another 5minutes; discharged from the vaccination site. About early afternoon, my hands felt warm , face warm and lips dry, heart rate was 100, temperature was 99 , right arm very painful. Temperature runs between 98.8-99.4 ,pulse around 80-90's on  Saturday and Sunday. I took extra strength Tylenol every 6-8hrs which helped relieve some pain and fever(tried Advil but this did not help with the arm pain.) Monday morning 1/25/21 woke up and noticed arm pain gone. Temperature was 98.6-98.8 the whole day.  No further symptoms like above felt ( so far)
I had COVID arm on Feb 11 itching, swelling, rash and hot to the touch saw my doctor and treated with antihistamines, Benadryl and ice for hives per doctor instruction. On Feb 18 I had COVID arm again the same thing happen except with out the itching saw my doctor again and the treatment was the same.
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
pt received Zostavax-2 days later had back pain. Three days after back pain started, pt went to ER secondary to pain-given muscle relaxer and steroids-no help. The next day noted rash-pain continued. Then saw me
Received vaccine on 11/02/2006.  On 11/09/2006 Mother reports 3 episodes of eyes rolling back, mouth and lips shaking, irregular breathing, lasting approximately five seconds.  Infant slept after each episode, but appeared normal afterwards.
Office Visit  5/4/2022 MD   Family Medicine Long term current use of opiate analgesic +8 more   Dx Chronic Pain   Reason for Visit   Result QuickNote MD (Physician) ? ? Family Medicine    Overall has reassuring labs; does have elevation to A1c but is actually improved over 9 months ago; also has CRP (inflammatory marker) in normal range, normal thyroid, liver and kidney function and his BNP is also in the normal range (a marker of heart stress) so it appears the new swelling is NOT related to his heart, thankfully. It will be good to have this baseline going forward.  Emailed result to patient. Call if questions.       Progress Notes MD (Physician) ? ? Family Medicine    Patient ID:  Patient is a 61 y.o. male.   CC:   Chief Complaint Patient presents with ? Chronic Pain      ASSESSMENT AND PLAN:        ICD-10-CM ICD-9-CM   1. Long term current use of opiate analgesic  Z79.891 V58.69     reviewed how he's been using these to help with post op pain and also his activities through the day; sometimes will take in the night 2. S/P total left hip arthroplasty  Z96.642 V43.64     has been wanting to wean off medications; now still using about the same issue 3. Panlobular emphysema    J43.1 492.8     using oxygen; feeling of fatigue 4. Bilateral leg edema  R60.0 782.3   with Differential       Comprehensive Metabolic Panel 5. Fatigue after COVID-19 vaccination  R53.83 780.79     T50.B95A E949.6   6. Screening PSA (prostate specific antigen)  Z12.5 V76.44 PSA, Screen 7. DOE (dyspnea on exertion)  R06.00 786.09 TSH, Reflex Free T4       NT-PRO BNP 8. Elevated blood sugar  R73.9 790.29 Hemoglobin A1C   Ensure "Long term (current) use of opiate analgesic" ICD-10 Z79.891 is on the problem list. Pain consult required for MEDD>120;     Chronic pain issues are, mostly being controlled by the current treatment regimen. There have not been concerns or red flags for improper use/abuse of medications. The patient has been consistently compliant with his pain contract requirements.    o The patient's ongoing expectations of chronic pain treatment were reviewed o The patient's ongoing  functional goals were reviewed.                     His goal by next visit is:  Continue to heal from his surgery                   He feels likelihood of achieving this goal is fair to good o Medications: no change o Will continue on 84/28 days at this time
A non-serious, spontaneous report of administration to Asthmatic was received from a physician concerning a 41-year-old female patient. Medical history included asthma. On 08-Oct-2010, the patient received FLUMIST before disclosure to the physician that she had a history of asthma. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 09-Nov-2010 and incorporated into the narrative: The patient did not experience any late occurring adverse events.
One week after receiving Zostavax, pt. developed Herpes Zoster confirmed by his dermatologist. Treated with Famvir. A consult to his ophthalmologist confirmed that there was no ophthalmic involvement by HZV. The temporal relationship between vaccination and outbreak led me to file this Adverse Reaction Event.
Little light headed; Tire easily; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Little light headed) and FATIGUE (Tire easily) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Little light headed) and FATIGUE (Tire easily). At the time of the report, DIZZINESS (Little light headed) and FATIGUE (Tire easily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. Treatment information was not provided.
Right lower area of thigh red and swollen knot size of dime.  Related to Pneumo vaccine.  Had mom apply warm compress with a steroid cream (topicort).
mom states 1AM on 9APR96 pt began w/vomiting, chills & fever of 105.2 R;took to hosp when arrived t104;MD states sx d/t virus & only tx given APAP;
full-body hives, swelling tongue and throat, difficulty swallowing, severe joint pain,  red and burning skin (full-body)
pt recvd vax; pt exp'd itching in right arm & became swollen & hard; pt exp warmth in right deltoid & became swollen & hard;
expired Daptacel was administered to a 6 month old patient, with no reported adverse event; Initial information received  on 27-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient and it was reported expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered to a 6 month old patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); POLIO VACCINE; and ROTAVIRUS VACCINE all for Prophylactic vaccination.  On 22-JUN-2023, 0.5 mL of expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] Suspension for injection (batch/lot number: C5893AA; expiry date: 21-Jun-2023; frequency: once; strength: standard) was administered to a 6 month old patient intramuscular route in the right thigh for immunization, with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Patient was given his 2nd COVID vaccine and was sitting in our waiting area. Around 5 minutes after he received his vaccine he mentioned that he felt his throat was starting to swell and his throat was hurting. I sat him down to evaluate the situation. He was given 50mg of Benadryl and a bottle of water. He said he was starting to feel better, but we continued to monitor him. He seemed very agitated (sweats/clawing at throat). He then mentioned wanting to go across the street to the hospital because of this throat pain. He requested EMT come to check him out, as I would not let him leave alone at this point. EMT came and took the patient by ambulance to Hospital.
pt recv vax 10NOV04 & 22NOV94 pt devel a gen rash; reporter felt that there was a problem w/this particular lot;
Patient called EMS from for respiratory distress. EMS arrived, noted severe distress and hypoxia. Patient transported to Hospital Emergency Dept. Patient deteriorated to respiratory arrest and cardiac arrest. Per ED note, after 30 minutes of aggressive resuscitation (including approximately 19 minutes in the ED), no ROSC was achieved. Patient expired
Pain in left calf that continued to get worse over 5 days. Dr ordered ultrasound and found DVT. No prescribed blood thinners (xeralto)