chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle aches and pain; Headaches; Chills; Muscle aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Muscle aches and pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle aches and pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Muscle aches and pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle aches and pain). At the time of the report, PAIN (Muscle aches and pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle aches and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
DIZZINESS, LIGHTHEADED, PALPITATION. PALPITATIONS STARTED OFF MILD AND SPORADIC AND OVER TIME BECAME MORE OFTEN AND MORE SEVERE. ON 4/15/2022 PALPITATIONS GOT SO BAD THAT SHE WENT HOME EARLY AND WENT TO HOSPITAL THE NEXT DAY 4/16/2022. THE HOSPITAL DIAGNOSED HER WITH PAC'S AND PVC'S SECONDARY TO INFLAMMATION FROM BOOSTER VACCINE. SHE WAS GIVEN FLUID BOLUS, MAGNESIUM, AND POTASSIUM IN HOSPITAL. SHE HAS APPOINTMENT WITH CARDIOLOGIST ON 4/20/2022.
2-3 days after injection pt had redness size of two quarters around LA injection site swelling of left arm pt, took Motrin 800mg 1-2 times all day for three days, site was also itchy. Started to resolve on the 1st Dec. Also had pain in left hand. Pain and swelling resolved 12/02. Redness still there. On 12/6/02 pt only reported itching around LA inj site.
Covid-19 rebound after Paxlovid treatment; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 05Jun2021 as dose 2, single (Lot number: EW0153), in left arm, on 09Dec2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 03May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Nsaid's, reaction(s): "Known allergies: NSAID's". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (Aug2022) and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered", described as "Covid-19 rebound after Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2022) Positive, notes: iHealth COVID-19 Antigen Rapid Test; (17Aug2022) Negative, notes: RT-CTR COVID-19 Antigen Test; (27Aug2022) Positive, notes: COVID-19 Antigen Rapid Test:. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.Clinical course:Covid-19 rebound after Paxlovid treatment and 14-day quarantine (fully vaccinated/2x boosted).
got the first one and had a allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had an allergic reaction. The patient stated that he/ she cannot get the second one.  The patient also enquired about how protected he/ she was.
is not sure if he received his Fluzone HD QD with no adverse event/.They do not have any record whether he has received it this year; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves an 88 years old male patient who did received his shingles shot but was not sure if he received his INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]  (lot number and expiry date: Unknown) via unknown route in unknown administration site for prophylactic vaccination (product dose omission issue).  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event product dose omission issue.  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information about batch number was reported for the case.
Severe soreness in upper arm preventing full range of movement, headache severe, fever, lower back pain, hip pain, right leg pain nausea. 48 hours, still dealing with some of it.
No adverse effects noted, report being filed on advise of physician advisor that pt mistakenly thought he was to get two shots like last year and came to office two times and recieved vaccination twice.
Patient with no history of anaphylaxis had immediate lip swelling post vaccine, which resolved with 50 mg oral benadryl administered by EMS standing by. No transportation to hospital needed.
she then got a rash on the injection arm that was about 2-2.5in big; fatigue; heart beat went up a little bit; Fever; 5in long 3in across rash on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she then got a rash on the injection arm that was about 2-2.5in big), FATIGUE (fatigue), TACHYCARDIA (heart beat went up a little bit), PYREXIA (Fever) and VACCINATION SITE RASH (5in long 3in across rash on the injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, 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 VACCINATION SITE RASH (she then got a rash on the injection arm that was about 2-2.5in big), FATIGUE (fatigue), TACHYCARDIA (heart beat went up a little bit), PYREXIA (Fever) and VACCINATION SITE RASH (5in long 3in across rash on the injection arm). At the time of the report, VACCINATION SITE RASH (she then got a rash on the injection arm that was about 2-2.5in big), FATIGUE (fatigue), TACHYCARDIA (heart beat went up a little bit), PYREXIA (Fever) and VACCINATION SITE RASH (5in long 3in across rash on the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-059389 (Patient Link).   Reporter did not allow further contact
This case was reported by a consumer and described the occurrence of unable to walk in a 86-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Albuterol, amlodipine, Aspirin, Furosemide, gabapentin, Levothyroxine, MUCINEX, SOLOSTAR Insulin, COLACE, dorzolamide eye drops, hydralazine, ophthalmologicals (Eye Drop), metolazone, metoprolol, repaglinide and ATIVAN. On 7th June 2018, the patient received the 1st dose of SHINGRIX(intramuscular). On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced unable to walk, tremor and speech disorder. On 18th June 2018, the patient experienced fall. On an unknown date, the outcome of the unable to walk, speech disorder and fall were unknown and the outcome of the tremor was not recovered/not resolved. It was unknown if the reporter considered the unable to walk, tremor, speech disorder and fall to be related to SHINGRIX. Additional details were received as follows: The concomitant medications also included ELIQUIS and DILATIN. The patient reported that she received SHINGRIX on the right arm. The concomitant medications also included ELIQUIS and DILATIN. On the next day, the patient experienced tremors and they were bad enough that she was not able to walk around and it was difficult for her to talk. The patient was in hospice and was prior to receiving SHINGRIX. The patient had spoken with her hospice physician and he did not know a way to treat the tremors. The patient thought that the tremors were getting better, but before the date of reporting the patient fell because of the tremors and was taken to the Emergency Room (ER) to make sure that she was not injured. On the same day, the patient was sent home.
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of VAQTA lot # M003618, expiration date 18-NOV-2017, lot # L031196, expiration date 05-FEB-2017 and lot # M021124, expiration date 02-FEB-2018 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Near syncope - some chest pain & dizziness nausea.  2nd episode  19th/8/09 (same SX). 9/3/09-records recived-date of service 8/25/09-2 episodes of basically near syncope, chest pain and nausea associated with it-dizziness and lightheadedness. First occurred on 8/19/09. Heart beat felt rapid. Second episode on same day. General sense of fatigue which is longstanding.C/O back pain in office day vaccines administered.
chills, strong shivering, fever that night  Next day, fever, body aches, headache, fatigue, took tylenol through day  Night, symptoms reduced and give by next morning
incorrect pfizer covid 19 vaccine administered - should have been pfizer covid 19 bivalent vaccine
Muscle and joint aches, Low grade fever, general not feeling well. These symptoms lasted approximately 36 hours.
My son received the Prevnar vaccine and the next day the lymph nodes in his neck were red and swollen, he was very tired and fussy. The following day, when he woke up from his nap, he was inconsolable, crying nonstop. He then proceeded to display seizure like activity and I called 911. He was taken by ambulance to the ER trama unit where he was diagnosed with cellulitis and lymphangitis and was treated with IV antibiotics. We were only home for a couple hours before he began to scream uncontrollably again and he was exhibiting seizure like activity. Called 911 again and was rushed to the ER trama unit again. There we waited to be transferred to another hospital where we ultimately spent the next 10 days fighting for my sons life. He was given every test under the sun including a spinal tap, many echocardiograms, an EEG, countless different IV sites, among others. He was seen by a neurologist, a cardiologist, an infectious disease doctor, all the resident doctors, and many others all with no answers. Finally, the infectious disease doctor diagnosed him with A-Typical Kawasaki Disease even though he did not show any signs of that disease. I asked every doctor if this could be related to the vaccine he was given the day before, all to be told a resounding no. He was treated with IVIG treatment and began to improve. After being released he has seen his cardiologist multiple times, his infectious disease doctor multiple times, along with his pediatrician. We have since changed pediatricians because of the knowledge we have gained about the dangers of vaccines. My son will have to get his heart monitored for the rest of his life due to this vaccine injury.
Symptoms similar to what I actually had Covid last year. Reflux, constant nausea, fatigue, occasional headaches
our fridge being out of range on 12/02/22 for one hour; No adverse event; patient vaccinated with Moderna vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour).    No concomitant medications were provided by the reporter.  HCP reported that 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09-Dec-2022 and 9 patients were vaccinated on 16-Dec-2022. Excursion happened on 02-Dec-2022 during 1 hour and minimum temperature reached was 1.2 A degree C.   No adverse events were reported.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-695843 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Follow-up received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695843:Same reporter
Vaccine given about 1024. At 1032 presented with generalized itchiness and macular rash on extremities. BENADRYL 50mg IM given in R deltoid. HR/RR normal, lungs clear. 1045 itchiness spreading to face, no airway involvement, no improvement in symptoms. 1055 EMS arrives to transport patient to local hospital for continued monitoring. Vital signs normal, lungs clear, patient alert/oriented.
Patient was given covid -19 vaccine 6 days earlier the minimum vaccination period. pt waited after vaccination 20 mins without any complications. patient was examined by two health care providers. Providers cleared patient to go home and to go to the nearest emergency room if any symptoms present.
1420: Vaccine administered. 1425: Reported right arm numbness distal from injection site. Circulation intact. ROM intact.  1452: Complains right arm numbness, right hand cooler to touch than left. 1500:  Complains of right arm numbness- temp 97.0 Resp 16 HR- 67 BP- 130/85 1515: Reports somewhat improvement of numbness. Temp- 97.2 Pulse- 78 Resp- 16 BP- 124/86 1530: Reports somewhat improvement of numbness. Temp- 97.5 Pulse- 70 Resp- 18 BP- 114/79 1545: Reports right arm still tingling no more or less than previously reported. Temp- 97.1 Pulse- 74 Resp- 17 BP- 116/79
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PT NOTICED BLISTER & PUS UPON REMOVAL OF BAND AID, OVER 12 HOURS AFTER VACCINE ADMINISTRATION. PT COMPARED IT TO A "CHEMICAL BURN." BLISTER & PUS RESOLVED AFTER A COUPLE DAYS, BUT RASH IS STILL ONGOING. LESION IS LOCALIZED TO AREA WHERE IMMUNIZER PINCHED MUSCLE TO LOCATE OPTIMAL VACCINATION SITE & WHERE BAND AID WAS ATTACHED. AS OF TODAY, DAY #4, SYMPTOMS HAVE NOT COMPLETELY RESOLVED.
Modern a COVID-19 Vaccine EUA; RED SKIN AND HOT ARM FROM SHOULDER SHOT TO ELBOW IMMEDIATELY FOR TOTAL  7 Days; Headache 2nd day; Constipated 7 days; UPSET STOMACH FOR 14 days - hard to eat; Swallowing  and coughing up clear mucus from day of shot - still ongoing; Heart palpitations on and off during day.
72 hrs p/vax parents called office & reported pt w/rash & hives on trunk & extremities-also extremely irritable; brought to office & had severe urticaria; brought to office & had severe urticaria rash over extremities & trunk;
On the night when I took the second Moderna shot (5/10), I went to bed early. Throughout the night I felt pain in my right arm and some parts of my body. I felt extremely hurt in my vagina, more likely the urethral orifice area. The hurt feeling was so strong that it felt like something tearing apart my vagina. The next day (5/11), I had a low fever so was lying in bed almost the whole day. The third day after the vaccine shot (5/12), I started bleeding in my vagina (which is not the normal period). I felt something big dropped in my vagina and bleeding. Ever since then, I have experienced frequent urinating, dragging feelings in my belly, burning in the vagina etc.
soreness in right arm extending from vaccination site to wrist. on sat within two hours and continued for 24 hours. headache on Saturday following injection and continued 48+ hours.
Approximately 2 weeks after vaccine, had new onset atrial fibrillation/flutter with rapid heart rate, requiring hospitalization.  Was also mildly hyperthyroid at the time.
Initial report was received from a health care professional on 10 February 2011. An 11 year-old female patient with a history of asthma, eczema, a peanut allergy and environmental allergies had received on 08 February 2011 a first dose intramuscular right deltoid injection of MENACTRA, lot number U3518AA, a first dose intramuscular right deltoid injection of ADACEL, lot number C3489AA, GARDASIL (Merck lot number, route and site of administration not reported) and Hep A (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same day, experienced a Arthus reaction of swelling and redness of the right upper arm down to the elbow. The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included ADVAIR, Albuterol, FLONASE, CLARITIN and an EPIPEN. According to the reporter the patient had a "similar reaction" after she had received an IPOL and MMR vaccine. The patient also had to be revaccinated after having a DTaP vaccine when she was five year old because it was thought that the vaccine had been "unstable" from being too cold. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
I did not have an adverse reaction to the vaccine but I tested positive for Covid 19 on May 30, 2022. I felt symptoms on May 16- with a cough. No fever, headache, not tired or not achy.  Doctor prescribed a steroid and antibiotic. The phlegm I was coughing up was very green. Now it's not as green and not as much as before. I also tested positive for Covid 19 and pneumonia in February 2022.  I had symptoms then as I did this time. I also have bronchitis so what I was experiencing really didn't seem any different than  when I have a flare up.
Large hot, hard red area with significan itching. Returned to pharmacy and purchased Benadryl 25mg. Awoke the next morning with significant muscle aches and joint pain. Returned to bed and slept until 2PM. Felt better by round 6pm.
patient received 2nd moderna vaccine and developed dizziness and fainted for a short period in front of pharmacy. Medical help was called. Patient's blood pressure was low and he was pale, but no serious injury.
Soreness of arm at injection site, fatigue and headache on the first day. Second day, arm was super sore and hard to move around. Pain in the armpit and up the neck, all on left side. Chills and body aches and major headache throughout the entire day and night.  Couldn?t sleep, even with pain meds. Third day was was much better, arm mildly sore but no chills or body aches.  No fever on any day.
States her right arm was not swollen last night, but just sore. States it began to swell today. States abduction of right arm is painful. Noted firm, indurated area right deltoid measuring 6 inches across and 7 inches in length. No increased temperature or redness
Went from walking and living a every day life to paralyzation. At first he complained numbing and tingling in hands and feet for days. Then a week later he could barely walk. In a few days he stop walking.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL (lot # not reported). Subsequently the patient experienced severe headaches. The physician reported that he did not believe that this experience was related to therapy with GARDASIL. The patient sought unspecified medical attention. No further information is available.
Tested positive for COVID on 8/15/2022 and  I was prescribed a course of Paxlovid. However I tested positive for a second time on 8/24/2022 .
Information has been received from a nurse concerning a 79 year old female who on 08-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  On approximately 13-AUG-2007 the patient developed a rash on both legs in her lower extremity area.  As of 22-AUG-2007 the patient was recovering.  Additional information has been requested.