chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness stopped after a day or 2 at the arm but it went to chest; Soreness stopped after a day or 2 at the arm; Patient's left shoulder was sore next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest), PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose). On an unknown date, the patient experienced CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose) outcome was unknown and PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the concomitant medicines for the patient included unspecified diabetes medications and unspecified blood pressure medications.   This case was linked to MOD-2021-220610 (Patient Link).
Pt states that she was experiencing anxiety and tongue tingling on her way out of the clinic. Had patient wait in clinic another 15 min and took her vitals. B/P- 130/80, P-72, R-20, SPO2-98% room air.
patient was given an undiluted dose of the pediatric pfizer vaccine. so far patient has shown no signs or symptoms of an adverse reaction. will continue to monitor patient.
pt recvd vax & exp nausea, general weakness, pain at inject site & lightheadness; pt continue to feel very weak;
Severe feelings of malaise, weakness, and muscle ache. Red rash about the size of an orange developed around injection site, extended in days following all the way to elbow. After a week reported that the rash was still present, very faint now and about the size of a half-dollar. Side effects developed the night of the injection. Wife missed day and 1/2 of work her symptoms were so bad. Called her primary care doctor the following day after the injection and she took ibuprofen which helped with the muscle pain.
Fever, chills, body aches, severe headache.  Lasted 24 hours.
Pt recvd vax & 6 to 8 hrs later devel croup & stridor which required Decadron & DPH; pt is highly allergic to many things esp eggs so cause of sx not clear;
Rotarix lyohpilized powder lot G973H with diluents of lot M4AR7; Rotarix lyohpilized powder lot G973H with diluents of lot M4AR7; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) (batch number G973H, expiry date unknown) and (batch number M4AR7, expiry date unknown) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the patients received dose of Rotarix lyohpilized powder lot G973H with the diluents of lot M4AR7(mismatched diluent/powder lot numbers), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further information reported. The reporter consented to follow-up.
Elevated heart rate, elevated blood pressure, headache, nausea, increased joint pain in right shoulder rotator cuff and joint pain in both Achilles tendon?s, Temperature of 101.5
Initial misuse report received from a healthcare professional on 12 June 2013. A patient had received an 'outdated' dose of MENACTRA. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Intense headache that began 2 hours after injection. Lasted until I went to sleep. Three Advil liquid gel caps and one extra strength Tylenol helped ease the symptoms. 12/29 I felt like I had flu symptoms (slightly dizzy, body aches, diarrhea, upset stomach, left arm pain. 12/30 I felt back to normal.
Restlessness and tiredness 8 hours after. Intense Chills 12 hours after injection with 5 minutes of uncontrollable shaking. Then still chills and insomnia. Fever that persisted over the next 36 hours. Responded well to Ibuprofen 400mg for 4.5 hours until symptoms returned. Began alternating with Acetominophen 650mg for better effect. Fever was highest (recorded) at 102.2 F 29 hours after injection. Woke up 40 hours from vaccine after a night of sleep and with reduced fever. Still going up and down a bit off any medication. Last reading 46 hours from vaccine 100.6, but two hours earlier was 99.4. I?ve also had nausea, exhaustion, and tiredness. Also cold symptoms which may be related to the slight cold I had the morning of the vaccination that I didn?t think was anything to worry about - my kid is in daycare and I feel like this for a large part of the winter! Thanks
Arthralgia, Fever, Pain, redness L shoulder, Fatigue Narrative:
Flare up; A spontaneous report  was received from a consumer concerning her daughter, a 41-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history included rheumatoid arthritis and migraine. Products known to have been used by the patient, within two weeks prior to the event, included steroid injections, antibiotics and medications for rheumatoid arthritis and migraine (not specified).  On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the pregnant patient had a flare up of her condition which is a medically significant event.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was not reported.; 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.
Localized swelling and tenderness persisted. Now, 2 months later, induration and tenderness continue.
Site became hot, hard, red, & gradually increased in size. Pharmacist said use BENADRYL which did not help. Went to Dr. on 4/30/2012 & ordered Clindamycin 300mg 4xday x10days.
PATIENT DID NOT QUALIFY FOR A 3RD DOSE, BUT HAD NO ADVERSE REACTIONS.
ACHES; CHILLS; FATIGUE; HEADACHE; FEVERISH; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, fatigue, headache, and feverish on 25-MAR-2021. This report was non-serious.
10 minutes after receiving vaccine in L deltoid arm, pt felt warm in chest and L arm itching itching of L arm then became ?. Developing a few hives on neck. Benadryl PO given with resolution of most symptoms.
pain where injections was given; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had the injection yesterday (unspecified date in Jan2021) and saw that one of side effects is pain where injections was given, which is the only side effect he has had. The outcome of event was unknown.  Information on Lot/Batch number has been requested.
Information has been received from a medical assistant concerning a female who in August 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). In November 2007, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). On 03-SEP-2008, "today", the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
At Hepatitis A outreach box of Hepatitis A pediatric dose put in cooler instead of adult dose. Used vial of pediatric instead of adult. Revaccinated on 11-2-18 with Hep A Vaqta R018775, 2019Aug09.
Initially, flush and some minor sensitivity response (feeling like I was getting sick) In the evening, about 8 hours post injection, Fever, chills, cold shakes and muscle spasms Next day: headache, fever, muscle spasms - couldn?t lift head off pillow and had to sleep until the following morning ? except for the most incredible muscle spasms. Spasms continued 3rd day? large muscles, small muscles ? legs, abdomen, fingers, toes, back.
Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarrhea
Extreme headache within one hour,  by evening body aches,  fever 100  (Sat 2/27) (Sun 2/28)  Body aches, shivering and excessive cold,  fever 102,  fatigue and severe headache.  Later the same day sweating and again fever 101,  extreme headache.  (Mon 3/1)  sweating, fatigue, no fever,  headache.  By (Tues 3/2 ) all symptoms except fatigue were gone.
Patient called and said she got rash, warm to touch on injecting site and fever on 6/9/21 and went to Urgent care and Dr told her she has infection on injection site and prescribed Bactrim DS.
Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100.  As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers.  BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.
mixed 2 vials of adjuvant together / antigen was not mixed. This mistake was caught before administering to the patient; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) (batch number 9zj25, expiry date 23rd January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error. On an unknown date, the outcome of the intercepted product preparation error was unknown.  Additional details were provided as follows: The reporter was the pharmacy manager. The age at vaccination was not reported. The reporter notify that her pharmacist colleague had accidentally mixed 2 vials of adjuvant together, instead of 1 vial of adjuvant and 1 vial of antigen. In this mixture, antigen was not mixed, which led to intercepted product preparation error. This mistake was caught before administering to the patient. No patient involvement. The reporter provided an email address and a fax number to the pharmacy. The reporter did not consent to follow up as no patient involvement.
Information has been received from a registered nurse (R.N.) concerning a 15-year-old white male with no pre-existing allergies, birth defects or medical conditions, who on 29-AUG-2005 was vaccinated with a dose of Varivax (lot# 648943/0893P). There was no concomitant medication and no illness at the time of vaccination. On 10-OCT-2006 the patient experienced exact same itchy rash as his sister who had a confirmed case of varicella. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered as of 22-OCT-2006. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: Approximately 15 minutes after receiving Pfizer-BioNTech COVID-19 vaccine patient complained of dizziness, nausea, and headache. Vomited once but remained awake and alert. No rash, no evidence of respiratory distress or respiratory compromise, and no loss of consciousness. Patient was transported to the emergency department where vital signs were blood pressure: 114/71 mmHg, heart rate 96 beats per minute, temperature 36.6 degrees Celsius, respiratory rate 20 breaths per minute, and oxygen saturation 97% on room air.  Lungs were clear to auscultation bilaterally without wheezing. One dose each of intravenous (IV) diphenhydramine 25 mg, oral ibuprofen 600 mg, and IV ondansetron 4 mg were administered. Patient's symptoms resolved and no new symptoms developed. Patient was discharged from the emergency department to home approximately two and a half hours after receiving the medication. On follow-up telephone encounter the next morning at 10:44 am patient reports improvement and only symptom is a slight headache controlled with acetaminophen. Patient denies shortness of breath, angioedema, or other concerns.
Pt was given Tdap instead of a Dtap. Which he still was not due for. Pt recieved a pediarix on 4/19/23 and it had not dropped into system before his next appointment on 4/28/23 so when the system was pulled it appeared pt was still due for a Dtap.  Pt did not have any reactions from the second dose.
04/02/2021 @ 7:30pm - chills lasting all night 04/02/2021 @ 9:45pm - fever of 104.3. Fever bounced between 103.1 and 104.3.  04/03/2021 @ 8am - extreme fatigue with my head feeling like it is being pumped and blurry vision with each pump. Lasted 2 days. Fatigue lasted 6 days. Would go away if i layed down. It wouls start back up when i sat up. Sore arm at injection site for 1 wk. Left leg pain most of the day.  04/04/2021 @ 7am - woke up with hives covering the inside of my mouth. Weakness and head pulsing all day but no vision issues.  04/05/2021 @ 7am - woke up with swollen mouth(gums and lips) Went to urgent care. Swelling was on and off all day including the hives  04/06/2021 @ 1:15pm - headache back of my head.
April 2, 2021, severe chest pain after exercise (hiking uphill).  It passed and I ignored it. April 3, same. April 4, same, except that pain persisted.  Sleeping was uncomfortable April 5, severe chest pain most of the day, unable to stand upright.  Unable to get comfortable in bed.  Went to hospital emergency room just before midnight April 5/6, ER diagnosed pulmonary emboli.  No obvious cause, though family history (both parents) of stroke.  Prescribed apixaban. Subsequent followup with hematologist and PCP confirmed diagnosis and treatment with apixaban. No lingering symptoms.
Patient c/o fevers, myalgias, arthralgias 9 days following smallpox vaccination.  On 10th day, pt developed purpuric macular rash on bilat lower ext (L>R).  Pt c/o painful burning sx where rash worst on left medial ankle.  Pt with robust take on left arm with viral cellulitis apparent and tender axillary lymph nodes on left side.  No mucosal lesions.  UA and CBC wnl.  Chemistries/LFTs wnl.  Pt will be followed closely for what appears to be L.E. vasculitis, r/o progression to HSP.  Pt started on Indocin and Atarax.  F/U in AM.
Lower back pain, cramping, abdominal pain, body ache, headache. Pt's mom gave her ADVIL 0630-0700 and she slept. Had MCV and HPV yesterday, went to school and was OK. In the middle of the night had HA, body aches, stomach cramps. Sweat a little while sleeping which is not abnormal per mom. Has slept most of day. HA is gone now, lower back pain now is now moved to mid-back, a bit of body aches. OK to touch chin to chest. She is getting better per mom. No fever.
No additional AE reported.; MMR II underwent a temperature excursion and was administered; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rHA, lot # S025155, expiration date 13-AUG-2021 (strength, dose and route of administration were not provided) for prophylaxis. Administered dose of vaccines experienced the temperature excursion of 50 degrees Fahrenheit (F) for 1 hour and 46 minutes. Data logger was involved. There were no previous excursions reported. No adverse symptoms were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2007USA012014: US-009507513-2007USA012054: US-009507513-2007USA012060: US-009507513-2007USA012061: US-009507513-2007USA012124: US-009507513-2008USA000314: US-009507513-2008USA000326: US-009507513-2008USA000367: US-009507513-2008USA000370: US-009507513-2008USA000372:
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a health care provider, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a physician for shingles (herpes zoster). On an unknown date, pt was hospitalized due to the event. As a direct and proximate result of pt used of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES 7/16/22-7/19/22
Within hours swelling, red, hot @ IM injection site Deltoid m. origin, lasting 1 wk, Tx Amox caps & Bacitracin topical ointmt. Severe loss of muscle strength 2wks post injection. Deep pain unable to raise arm, open car door, lift canned goods currently.
Patient received Pediarix, Hib, Prevnar and Rotateq. Started with gastroenteritis later (vomiting + diarr)- Required 2 ER visits and finally admitted for Bowel Rest  1 week later 6/12/08-records received for DOS 4/27-4/30/08-presented to ED with nonbloody vomiting and diarrhea times 5 days. Two days after vaccination began having loose stools. Decreased oral intake, watery stools. Third visit to ED with dehydration and vomiting. DX:acute gastroenteritis.
At a visit for an unrelated health issue he reported that following his first dose of Anthrax vaccine he developed pain at the injection site and possibly chest pain. He reports that after his second dose he developed pain at the injection site associated with chest pain, shortness of breath that was worse with exertion, nausea, headaches, and insomnia which lasted for several days prior to resolving. After his third dose he reports he again developed pain at the injection site associated with chest pain, shortness of breath with exertion, and fatigue; he reports his symptoms were not as severe with the third dose as with his second. Symptoms resolved spontaneously without treatment and he did not seek care at the time of his adverse reaction(s).
ErythemaMultiform arm soreness, localized swelling Narrative:  arm soreness day of vaccination, localized swelling reported occurring the next day; took Tylenol twice, feels like symptoms are resolving.
Tingly face, minor numbness in left arm (injection side) maybe mouth and tongue numbness too
numbness of lt hand n approx 1hr p/vax;numbness persisted 7 worsened;saw family MD;no specific treatment or medication by 13OCT98 numbness gone;
Fever Left swollen axilla lymph nodes Employee evaluated by PCP for left swollen axilla lymph nodes on 1/11, prescribed Ciprofloxacin 10 day course scheduled for follow up on 1/15/21. Reports decrease in swelling of lymph nodes (1/4 in size) day 4-5 after receiving the COVID vaccine.
Attends college, was sitting at his desk awaiting teacher arrival when he put his head down on his desk.  Seizured Grand Mal.  Taken to ER given fluids, oral depakote and blood taken along with CT scan.  Had vomited 2 times during transport to ER.  Recalls nothing only severe headache and light sensitivity.
pt recv vax 10JUL89 & suffered & cont to suffer, permanent mult & severe bodily, brain & neuro injury, including but not limited to sz disorder, convuls, encephalopathy, mental retardation, hypotonicity, coordination problems, ataxia,lethar
Loss of concentration, dizzy, memory loss, mood swings, night sweats, tinnitus, joint pains, increased BP, low pulse, syncope, staring spells for 5-10 minutes duration, numbness and tingling of left upper and lower extremities, splinter hemorrhages, 75 lb weight loss, rash and swollen glands. Also, had Anthrax vaccines on 10/31/98, 11/9/98, 4/4/99, 11/99 and 6/3/00. Committed suicide. Autopsy report received states pt cause of death as gun shot wound to the head. Death certificate confirms cause of death.
Large circular red circle around left deltoid-sore and itchy. Noticed on second day after vaccination.
Client received 1st dose of Pfizer vaccine on 07/30/21 and received 2nd dose Moderna on 9/20/21.  Monitored client and educated on possible on side effects and adverse reaction.
Itchy throat and slight rash around the neck, face and arm. Benadryl 50mg was given to patient. Patient not reporting nor exhibiting any severe symptoms or adverse reaction.
Left arm swelling 1 day after vaccines 4" x 8" warm pink swollen left upper arm. Patient recovered spontaneously.
or 48 hours, fever 101.3, muscle aches, vomiting, diarrhea, nausea, headache