chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt already on Amoxocillin & albuterol from late April visit; pt recvd vax 6MAY93 @ city clinic & 7MAY93 9AM had sz & fever @ home; came to clinic for tx; stiff, flexion; jaw open, tight; eyes up;
Pt presented on 10/06/2020 for evaluation of left arm pain to deltoid and bicep s/p IM injection received 09/20/20 in same clinic.  Pt with full range of motion and no neurological or peripheral vascular deficits.  No redness or swelling and injection site, no evidence of infection or trauma.  Pt reports frequent carrying toddler in left arm,  Encouraged rest to extremity with applications of cold/heat for comfort, compression, and NSAIDs as needed. With plan to follow up.  Unable to reach patient at present time.
Covid symptoms reappeared and I retested positive for; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid symptoms reappeared and I retested positive for) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Type 2 diabetes mellitus.   On 22-Apr-2022 at 3:45 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 04-May-2022 at 7:00 PM, the patient experienced COVID-19 (Covid symptoms reappeared and I retested positive for). At the time of the report, COVID-19 (Covid symptoms reappeared and I retested positive for) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment drug were reported.  COMPANY COMMENT: This is a spontaneous case concerning a 47 -years-old male patient, with no relevant medical history, who experienced unexpected non serious EVENT OF covid-19, which occurred 12 days after fourth dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 4- may-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 47 -years-old male patient, with no relevant medical history, who experienced unexpected non serious EVENT OF covid-19, which occurred 12 days after fourth dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 4- may-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient called complaining of a red, swollen and itchy arm that began the next day after vaccination.
Numb lips within 15 min, along with chills, headache and nausea. Followed by sore throat and runny nose.  I had  taken Benadryl and Prednisone before hand because had all above symptoms with first Pfizer shot (EJ1685). The following days I had severe headaches with nausea and dizziness and lethargy as well as diarrhea. Four days later  after the shot on the 1/15 I experienced fluid accumulation in the lungs followed by burning sensation on the tongue, numb lips, and a sensation of swelling in the inner lining of the throat. With Benadryl symptoms subsided.
Hot, red, swollen, painful area near injection site. Lasted 4 days. Patient recovered fully.
Neurologist has diagnosed post vaccine and CFS; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHRONIC FATIGUE SYNDROME (Neurologist has diagnosed post vaccine and CFS) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000050A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHRONIC FATIGUE SYNDROME (Neurologist has diagnosed post vaccine and CFS) (seriousness criterion disability). At the time of the report, CHRONIC FATIGUE SYNDROME (Neurologist has diagnosed post vaccine and CFS) outcome was unknown.            Concomitant product use was not provided by the reporter.  Since receiving vaccination the patient took ill on 12-Feb-2022 and has not been able to work.  The patient was a fit and healthy 41-year-old who worked full-time in construction and was a part-time goalkeeping coach, with no under lying issues. He was running 15k the week he received Moderna vaccine.  Neurologist has diagnosed post vaccine and CFS but he had so many other health issues at the time of report and was using a wheelchair.   The patient rolled up his sleeve and supposedly did the right thing and no-one wants to take responsibility for his horrific health problems (at least 26 different symptoms).  Treatment information was not provided. Company comment This is a spontaneous case concerning a 41-year-old healthy and fit male patient, with no medical history reported, who experienced the serious (disability) AESI of Chronic fatigue syndrome, which occurred 1 day after a dose of mRNA-1273. The patient worked full-time in construction and was a part-time goalkeeping coach, with no underlying issues. He was even running 15km the week he received Moderna vaccine. The patient started feeling ill 1 day after the vaccine and later on, the Neurologist has diagnosed chronic fatigue syndrome, but he also had so many other health issues, at least 26 different symptoms, and was using a wheelchair. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a 64 year old female patient with no drug reactions or allergies. On 04-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route unspecified) at a pharmacy. No concomitant medications were reported. On 04-NOV-2012, her injection site became swollen, red and soar to the touch. The patient did nor seek any medication attention. No treatment was provided. No laboratory diagnostic tests were performed. At the time of report, all the events had subsided with the exception of the redness. The relatedness for all the events was unknown for ZOSTAVAX. Additional information is no expected.
Patient had a fever of 102.7, staring, her eyes not moving, seizure, limp, crying, fussy. I called doctor  after hour phone number and was told to go to the ER. My husband and I took our baby to the ER. At the ER she was given tylenol which brought her fever down 101.6 rectal. She was still very lethargic the ER doctor gave us the option of keeping her in the hospital or taking her home. We took her home as the doctor thought she would be fine at home. We were instructed to give Tylenol every 4 hrs prn.  Her fever would come back after about 4 hours and I would have to give Tylenol again. She was very fussy, cried and her fever lasted about 7 days.
Developed flu-like syndrome. Given Azithiamycam X-ray. Developed mild "walking pneumonia" which resolved. No SARS or Legionella evaluation done.
This spontaneous case initially received on 28-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Drug history includes MMR (reaction: night-sweats, rigors, bone aches and body weakness). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: On an unknown date, the patient received MMR. Dosage regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Adverse reactions/events and outcomes: On an unknown date, the patient experienced night-sweats, rigors, bone aches and body weakness for over a month (outcome: not reported). The patient reported having a similar reaction as a child to MMR vaccine. Reporter comments: The healthcare professional considered all events non-serious.
Swelling, warmth, redness, induration, pain, itching increasing on 02/11/2021 and 02/12/2021, no improvement since, tightness overnight 02/14/2021
.50 cent size local reaction at injection erythema, sl. raised, pruritic.
Temp to 100.2; Mild fussiness/restlnessness. Decreased appetite.
bluish dots like a bruise under the skin/red marks on top of hand and blue marks under skin; weird skin reaction to palms of hands; palms were real red; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot and expiry were not reported), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. Relevant medical history, concomitant medications and investigation assessment were not provided. The patient received her first COVID vaccine dose on 29Jan2021 and had a weird skin reaction to the palms of hands. Assuming it started a few hours after getting the vaccine (on 29Jan2021), had red marks on top of hand and blue marks under skin/bluish dots like a bruise under the skin. The patient stated, "it looked like a viral rash like a kid would get but with a blue tint to it". Took a hot shower and the palms were real red and after it calmed down everything was back to normal. As soon as it cooled down (her hands), within the hour everything was back to normal, it was really weird. Wanted to know if this has been reported or the first time Pfizer has heard this. The patient was concerned if she should get the second vaccine or not. The outcome of the event palmar erythema was recovered in Jan2021 while for the remaining events was unknown.  Information on the lot/batch number has been requested.
Aching; Hurting on the joints; Not feeling well; Body soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), ARTHRALGIA (Hurting on the joints), MALAISE (Not feeling well) and ARTHRALGIA (Body soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Aching), ARTHRALGIA (Hurting on the joints), MALAISE (Not feeling well) and ARTHRALGIA (Body soreness). At the time of the report, PAIN (Aching), ARTHRALGIA (Hurting on the joints), MALAISE (Not feeling well) and ARTHRALGIA (Body soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included None
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 40 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
PT PRESENTED TO ER WITH NEUROPOTHY AND LEG WEAKNESS.WEAKNESS WAS BILATERAL, SYMMETRICAL, AND DEEP TENDON REFLEXES WERE ABSENT. FELT TO BE GUILLAIN-BARRE SYNDROME. PT WAS STARTED ON IVIG.
I received the Moderna #1 vaccine on 4/30/21 (lot 048B21A) at the same store as the #2 vaccine on 5/28/21 (lot 014C21A).  I keep track of my monthly menstrual cycles and they were normal and regular prior to the vaccines.  My last regular cycle before the vaccines began 5/7.    After the 2nd vaccine on 5/28, I began having menstrual cramps on 5/31 which was about a week early and menses started on 6/3.  This was a long cycle as I was still spotting daily through 6/16.  Beginning on 6/27 and for about 2.5 weeks I had severe hot flashes on a daily basis and many times each day.  In July I only had one day of light spotting on 7/12 and two days of mild cramping 7/13-14.  I had no menses in July.  On 8/4- 8/6 I had some light spotting and menses began 8/9 through-8/13 (short).  There was a gap of about 8 weeks between menses.  I also had no menstrual cycle at all in September.  I had some random days of cramping on 10/8, 10/12 and 10/16.  Menses started again on 10/22 through 10/30.  There was an 11 week gap between menses this time.  My cycles started occurring regularly monthly again after this point and had start dates of 11/14, 12/10, 1/7 and 2/3.
Pt complained about dizziness aftfr the shot was given she said the dizziness went away after about 5 minutes
1/6/2020 irritability, refusing to walk, crying, food refusal, disturbed sleep, insomnia, irritability  1/7/2020 lethargic, food refusal, refusing to walk, crying, dropping eyes, irritability fever from 98.9 F at 1:10pm to 102.2F at 1:46pm.  Treated with Motrin 5.5ml of 100mg/5ml at 845am Treated with Tylenol 5ml of 160mg/5ml at 2:10pm Pediatrician visit 1/7/2020 at 345pm fever was 100.4 Rapid Flu negative Negative for URI symptoms and negative for ear infections
Engorged lymph node in armpit of arm received vaccination. Node was the size of a baseball for 4 days.  Mild Flu like symptoms during sleep hours night following vaccine
Extremely swollen lymph node right axillae approximately 30 hours post injection. (Size of a grapefruit).  Painful to touch. Treating with warm compresses, Tylenol/ Ibuprofen as needed.  Highest temperature within 24 hours of receiving the vaccine 101.3....temp has returned to normal.
Patient seemed slightly apprehensive, but stable after 20 minute observation period following immunization with COVID19 vaccine at 6:55. Patient requested to leave the store to check her blood sugar in her car, but shortly returned after (approximately 5 minutes), feeling stuffy and reporting that she was experiencing shortness of breath/difficulty breathing to the front store manager. Patient appeared diaphoretic, tearful, and having trouble breathing. PharmD felt for patient's pulse; felt thready and hard to palpate. PharmD administered epinephrine 0.3 mg via Epic-Pen into patient's left thigh, laterally, at 6:03 pm. Patient still appeared unwell, though conscious and breathing - pulse was difficult to palpate. 911 dialed and EMTs arrived within 3 minutes and took patient to the nearest hospital. Patient's family was present and sharing medical history with EMTs.
Injection site painful for 72 hours.  After six days injection site became swollen, red, and itchy.  Area of rash has well defined margins and  measure 3.5 inches by 4 inches.  Rash persists after 9 days.
vertigo; Felt Drunk; Groggy; Tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), FEELING DRUNK (Felt Drunk), SOMNOLENCE (Groggy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021321A and 036A2A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced VERTIGO (vertigo), FEELING DRUNK (Felt Drunk), SOMNOLENCE (Groggy) and FATIGUE (Tired). On 04-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VERTIGO (vertigo), FEELING DRUNK (Felt Drunk), SOMNOLENCE (Groggy) and FATIGUE (Tired) outcome was unknown.            Concomitant medication information was not reported.  Treatment medication information was not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076256.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 21-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). Additional information has been requested.
30 yo (at time of 1st anthrax vaccine) male received anthrax vaccines on 7 Nov 2015 and 17 Feb 2016. Patient reports receipt of 3rd anthrax vaccine, but third dose not reflected in vaccine history. (Because of interval of 2 vaccines given (interval just > 3 months), assume these were anthrax #1 and #2; 3rd anthrax vaccine should have been given no earlier than 17 Jul 2016, but patient does not recall receipt of vaccine around this time.) Within one hour of receiving his first anthrax vaccine, patient noted a sharp, pressure-type pain across his forehead, on the top of his head and behind his eyes. Pain intensity was about 5/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Activity, especially "working out", made the pain worse. Pain was associated with increased sensitivity to light. No nausea and vomiting, visual changes, or changes in mental status. Patient increased his fluid intake and rested and headache resolved after a few hours. However, over the next 2 days, he experienced recurrence of similar headaches. He did not self-treat or seek evaluation. After receipt of his 2nd and 3rd anthrax vaccines, patient experienced similar headaches accompanied by photophobia within hours of vaccine receipt. Pain intensity was increased (6-8/10) with subsequent vaccine receipt. Patient did not seek evaluation or self-treat headaches, other than increasing fluids and avoiding physical activity. Headaches intermittently continued for several weeks following patient's 2nd anthrax vaccine, and after his 3rd anthrax vaccine, headaches continued intermittently for almost 2 months. Patient has no history of chronic headaches and has not experienced any headaches over the past several months. In addition to experiencing headaches after receipt of anthrax vaccine, patient also reports experiencing redness, warmth, tenderness, and swelling surrounding his anthrax vaccination sites within 24 hours of vaccine receipt. After his first anthrax vaccine the affected area was about the diameter of a 12-ounce soda can and symptoms resolved after a few days. After his subsequent anthrax vaccines, the affected area extended from near his shoulder almost to his elbow and resolved after about a week. He did not experience any numbness and tingling or weakness of the affected upper extremity. He also denied dyspnea, hives, nasal discharge, facial swelling, dysphagia, N/V and lightheadedness. Following his 2nd and 3rd anthrax vaccines, he recalls experiencing mild body aches and fatigue lasting 2-3 days. Patient was feeling well on day of vaccine receipt and is unable to identify any other possible factors contributing to development of symptoms. He reports a negative health history, and was not taking routine medication at the time of vaccine receipt. Patient has no allergies to medications, foods, latex, and insect stings. He denies history other vaccine adverse events. He received IIV in Sep 2016, without adverse events.
I am experiencing chronic fatigue. Within minutes after receiving the shot, I had to go home and lie down. I thought that the interaction between the vaccine, anesthesia from the Cataract surgery, and sinus/allergies could have caused that fatigue. But, it continues. I know it's not a life threatening matter, but I am exhausted and wonder if it is from the vaccine. I have sensitivities to medication and can hardly take any type of prescription medicine without have adverse effects.  I am eating well, was tested for COVID prior to each surgery (negative), but am exhausted. I had to have a cardiogram and other tests prior to the surgery, and all was okay. Just not certain if anything can be done to alleviate this fatigue, and I am due for the next shot on the 27th of April
HE CAME HOME FROM SCHOOL LAID DOWN AND COULD GET UP ONCE HE WOKE UP.  HE WAS PARALYZED FROM THE NECK DOWN.
diaphoresis,chills,dizzy,nausea,arm soreness and became erythematous.
red, raised wheal 1inch by 1.5inch w/in 24hr of vax @ inj site lt deltoid;
Muscle ache, fever, chills, nausea, fatigue, sore arm.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient briefly fainted post vaccination, was accompanied by mother, immunizing pharmacist assisted with care, provided ice pack for head, laid patient on back with feet elevated, patient returned to conciousness, after returning to seated position patient complained of nausea so we returned patient to laying on back feet elevated.  Patient was observed by immunizing pharmacist and mother prior to leaving under own ability.  BP 123/81 HR 87 at 555pm, injection was at 517pm.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient still experiencing deep ache at injection site for the last 2 months, experienced within first few days. Since event had been stable, not better nor worse. The vaccine was not administered at their facility, no information regarding patient not vaccine available. The healthcare professional reported local GlaxoSmithKline representative was informed of the adverse event. The reporter did not give consent to follow up.
pt recv vax 02NOV94 & following day parent exp vomiting & diarrhea for 3-4 hr, myalgias & arthralgia; pt recovered; pt had no event;