chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed more severe arthritis pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (developed more severe arthritis pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Drug allergy (Sulfa).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (developed more severe arthritis pain) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (developed more severe arthritis pain) had not resolved. Not Provided          Patient states she received 1st COVID vaccine 10 weeks ago, and 2nd COVID vaccine 6 weeks ago.   Treatment information was not provided.  Company comment: 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.; Sender'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.
RN administered dose of Synagis and dose of Fluzone (0.25 cc) 1st time for Fluzone, had Synagis one month prior and was fine, no reaction. Within 5 minutes after giving injections, infant presented with hives widespread, blotchy distribution, respiratory system unaffected and no SOB or dyspnea or wheeze. Evaluated by MD. Per MD gave infant 1/2 tsp Benadryl po at that time. MD sent infant to ER for observation.
I received the second dose of the Pfizer vaccine at approximately 11:30am on 3/31/21, and at 2pm that same afternoon experienced a severe episode of vertigo.  The experienced symptoms of horizontal spinning, nausea and vomiting and extreme fatigue.  This lasted 3 hours. On Tuesday April 6, one week later, in the morning at 8am, I was stricken by a second, somewhat milder attack of vertigo.  Symptoms were horizontal spinning, nausea and fatigue. The episode lasted 2 hours. On Thursday afternoon April 22 beginning at 1pm, I experienced a 3rd episode of vertigo with horizontal spinning, nausea and fatigue. The episode lasted 3 hours.  I have hearing loss in my left ear and have had tinnitus with that hearing loss, but
Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error.
covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history and concomitant medications were provided.  No treatment information provided
Started to break out with lesions on 3/7/02. "Covered with pox" as stated by mother by 3/9/02. Visit to MD on 3/11/02 and 3/12/02. Lesions dried enough by 3/22/02 to return to pre-school. Sister (DOB 5/12/93) received varicella vaccine on 11/2/95 and broke out with lesions on 3/14/02. Mother felt it was from exposure to her brother.
Approximately 12 hours after the event, I had throat swelling, chills, sweats, temperature of 102.5, headache, muscle soreness, dizziness, lightheadedness. Onset was over the course of about 1 hour. I had previously taken part in the double-blinded Astrazeneca in COVID-19 trials (meaning I did not know I was vaccinated) in November 2019, so the nurse told me that the response could really be from anything: partly due to some interaction between the vaccines, allergy, and/or already producing antibodies. I was unblinded and told I was given the Astrazeneca vaccine. Interestingly, I had none of these responses to just the Astrazeneca vaccines, just a bit of soreness after the first one. I have never had such a strong response, and I believe this is the highest my temperature has ever been, and my lymph nodes are still swollen. I am much better now; however, even last night and this morning, I was feeling unwell.
Red, itchy, swollen injection site on left arm and its extending on arm- treated as a Cellulitis; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Red, itchy, swollen injection site on left arm and its extending on arm- treated as a Cellulitis) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029 K 20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer, Osteoporosis, Drug allergy (Norco), Drug allergy (Tramadol) and Drug allergy (Sulfa). Concomitant products included FENTANYL for Pain, OMEPRAZOLE, LISINOPRIL, ROSUVASTATIN and CARVEDILOL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (Red, itchy, swollen injection site on left arm and its extending on arm- treated as a Cellulitis). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Cellulitis, at an unspecified dose and frequency and CEPHALEXIN [CEFALEXIN] for Cellulitis, at an unspecified dose and frequency. In February 2021, VACCINATION SITE CELLULITIS (Red, itchy, swollen injection site on left arm and its extending on arm- treated as a Cellulitis) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: NNI-Autoreply email with OOO On 22-Apr-2021: Follow up added patient demographics, medical history, vaccine information, concomitant therapy, event outcome, treatment information.
About 2 wks post vaccine my husband started to develop dyspnea which appeared at that time on exertion (walking & exercise). Probably took another week to get into the doctor but I do not remember for sure.  Dr. Diagnosed him with exertional asthma. He was put on inhalers and a medication.  I do not know what medication.  He seemed to be getting worse and was put on a more potent inhaler with cortisone and took an OTC supplement called NAC which he bought at a healthfood store.  Then on May 19 at 7;45am we were sitting on the sofa having morning  coffee.  I noticed he was  having what looked like a  worse breathing episode. I asked if I should call 911.  He said, "No, this will pass." So I said I was going to take a Pulse/Oximeter reading because I brought that and an AED from our surgery center which we had just closed and retired in 2019.  His O2 was 100% w 62 pulse.  That looked good to me. I layed down the Pulse/Oximeter and  about a minute or two he had a cardia arrest! I called 911, pulled him on the floor and started CPR while talking with the EMS all the while. I stopped for a minute to put on the AED.  I told EMS I am going to defibrillate , he has not pulse!  The AED did not go off.  I continued CPR, then the EMS came and started CPR and tried defibrillation but theirs did not go off. The EMS told me he was in a PEA (pulseless electrical activity) where he had not heartbeat but still had electrical activity in his body so the the debribrillators  read it as a rythymn that was not amenable to defibrillation..   Now I found out the threat of blod clots and feel that is what he had!
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th June 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: It was unknown if the consumer had previous cases of shingles or had received the ZOSTAVAX vaccine. Concomitant medications included unknown medication. At 14:30 hours, the patient received SHINGRIX in the left deltoid. On Monday, 18th June 2018, the patient went to her physician and was diagnosed with a mild case of Shingles. It was reported that the pharmacist was made aware of the event by a phone call from the consumer on Monday also. The pharmacist noted the physician was baffled that SHINGRIX would cause the case, but noted it was a milder case probably because of the vaccine.
COVID vaccine] treatment under Emergency Use Authorization(EUA): patient experienced shortness of breath and chest pain the day following the vaccine. The patient was hospitalized and received a stent. Unable to rule out vaccine playing a role, so it is being reported.
1 day after vaccination, pt developed erythema, swelling, pain, induration and small bruise at site of vaccine on left deltoid. Seen  by PNP 2 days after vaccination, about 70 x 50 mm area of blanchable erythema. Pain improved, allowed palpation without complaint. Moving arm and using normally. Induration already improving her guardian
This spontaneous report was received from a nurse practitioner and refers to a 4 year old male patient. The patient's concurrent conditions included develop mental delay and his concomitant medications included DTAP-IPV, PREVENAR 13 and Enders-Edmonston (+) Jeryl Lynn (+) (Wistar RA 27/3) M-M-R II. No information was provided regarding the patient's medical history, drug reactions, allergies or concomitant medications. On 31-JAN-2012, the patient was vaccinated in the left thigh with second dose of Oka/Merck VARIVAX subcutaneously, lot Number reported as 1285X, expiration date on 10-SEP-2010 for prophylaxis (strength was not reported). An unspecified system in the office flagged that as the Oka/Merck VARIVAX was already expired when it was administered, but she was not sure if the expiration date was correct. It was also reported an error during preparation and administration of Oka/Merck VARIVAX and it was unknown if drug treatment for the experience was required. There were no adverse symptoms reported.
Child has red arm, swollen and hot, no much pain at this temp. Moving L limb without problem no other complaints at this time.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAY-2016 the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml (lot # L003856, expiration date 02-FEB-2017, therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine were refrigerator (R)/ freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
3 weeks after flu vaccine admitted to the Medical Center Emergency Dept with symptoms consistent with Guillain Barre syndrome. Neurological consult felt consistent with GBS. Treated with 5 days IVIG, transfered to accute rehab on 11/5/19
Mother states pt. vomited clear liquid, says afebrile, no diarrhea, has good appetite, eats but continues to gag but nothing comes up. Plans to see MD - will call post visit- MD dx flu and gastroenteritis.
Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
For the entire day of 4/10/2021 I experienced fatigue, nausea, dizziness, sensitive skin, headache and left arm soreness. Now on 4/11/2021 I feel completely fine, except my arm still hurts a little.
Extreme fatigue, and body weakness every day a few days after the first dose. Nausea and loss of appetite. Feeling faint and cold sweaty feet. As of this week my throat feels swollen and it's harder to swallow and when talking I feel pressure in left ear
Information has been received from a female patient who on an unspecified date was vaccinated with a dose of MMR II (dose and Lot # not reported). It was reported that when she was  2 year old she had a seizure after vaccination with MMR II. No outcome was reported. Upon internal review, seizure was determined to be an other important medical event. No further information is available.
This spontaneous report as received from a pharmacist refers to a 43 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were reported as none. On 12-AUG-2015 the patient was vaccinated with RECOMBIVAX HB (Lot # K020218 exp. date 24-OCT-2016) (dose, frequency and route were not provided) and PNEUMOVAX 23 (Lot # reported as L012215 exp. date 13-JAN-2017) (dose, frequency and route were not provided) on the same arm (unspecified as to which arm). The patient then, sought medical attention and called the pharmacy 30 minutes after receiving both vaccines to report that her hand and wrist (unspecified as to which arm and wrist) hurt while moving her arm. The pharmacist advised the patient to take ibuprofen (dose and frequency unspecified) for pain control. No labs diagnostics studies were performed. No product quality complaint was involved. The outcome of pain in extremity and arthralgia was unknown. The pharmacist did not assess the causal relationship between RECOMBIVX HB, PNEUMOVAX 23 and the events. Additional information has been requested.
Pt woke this a.m. with red hard area where MMR/Hep A were given.
Like a week after  so it was probably around the 14th of March, 2021 I was having  problems with my right hip mostly.  I don't remember when I called my doctor to report about my hip bothering  me but three weeks after my knee started to hurt. I don't have the date but I started going to chiropractor every Monday and Thursday.
Severe Headache, dizziness, panic, entire body was aching and hot.  Body aches lasting for days, nightmares and other vivid dreams, night sweats and general fatigue and dizziness.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Student got the H1N1 vaccine in one arm at 8:57. Was told he would need a second dose and got back in line at 9:01. Nurse did not realize he was already vaccinated until she went to sign form.
Patient developed severe muscle pain in right arm, and applied ice. It has lasted for 2 days, and we discussed pain relievers that would help and application of ice and heat. It is likely a direct result of having 2 vaccinations in the same arm (patient requested both due to injury to left arm). Patient experienced sweating, "shakes," and flu-like symptoms day of vaccination that has lasted for 2 days. Likely adverse reaction to vaccine due to immune response. Discussed following up with a physician if symptoms persist. Patient has developed a productive cough on day of vaccination that has lasted 2 days. Possible adverse reaction or coincidental infection. Discussed following up with a physician if symptoms do not improve.
Information has been received from a physician concerning a 65 year old female patient who on 22-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, (route not reported) (lot number 667995/1150Z Exp. date 04-MAR-2012). On approximately 22-MAR-2011, the patient experienced tenderness of the left arm, nausea and fever of 103.8. The patient sought unspecified medical attention. It was noted that the patient improved "after therapy was stopped". At the time of the report the patient was recovering. Follow up information has been received from a health professional concerning the 65 year old female patient with not acute chronic hypertension, diabetes mellitus, sickle cell trait, elevated cholesterol, osteoarthritis and allergy to DEMEROL with nausea, vomiting and heart rate, who on 27-OCT-2004, was vaccinated with the first dose of PNEUMOVAX 23 (route, expiration date and lot number not reported). On 22-MAR-2011, was vaccinated with a second dose of PNEUMOVAX 23, 0.5 ml, IM, in the left deltoid (lot number 667995/1150Z Exp. date 04-MAR-2012). Concomitant therapy included lisinopril (MSD), CRESTOR, MAXZIDE, HUMALOG and HUMULIN. On 23-MAR-2011 the patient woke with tenderness at injection site. Had fever to 103.8 and nausea. She returned for recheck on 25-MAR-2011, the patient was found afebrile and nausea was resolved. On exam the left arm was found with erythema, swelling and warmth. No laboratories were performed. At the time of the report the outcome of the patient with erythema in the left arm, swelling and warmth were not reported. The patient was advised with cool compresses to site and for pain and fever, the patient was advised to take TYLENOL and ADVIL, PRN. Additional information has been requested.
Rash, UrticariaPruritus, EMPLOYEE STATES ITCHING AND RASH DEVELOPED ON 12/25/20 ON LT BUTTOCK WHICH HAS CONTINUED UNTIL NOW; NO FOLLOW-UP;
Sunday morning 2/14/21 - Mild Diarrhea from 4 AM till noon, and middle of mild to moderate chest pain when inhaling for a couple of hours and then it went away.
Information has been received from a physician for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with a medical history of vaccine exposure to pregnancy (WAES #0901USA01198) who on 11-DEC-2008 was vaccinated with one dose of GARDASIL (lot # 660391/0063X) IM in her deltoid. After the vaccine exposure to the initial pregnancy, the patient transferred from the physician's care another location. The physician reported that according to social workers at this agency, the patient delivered on 17-DEC-2009, which was three months early from her due date. The date of LMP was determined to be in June 2009 and EDD was approximately 17-MAR-2010. The physician thought this pregnancy was a different pregnancy from the initial one reported given the dating conflict. The physician added that the mother tested positive for marijuana at that time, and that "there were a lot of other things going on" with this young mother. The physician did not have information on the health and outcome of the baby. Upon internal review, premature labour was considered to be an other important medical event. The baby's experience has been captured in WAES #1001USA02981B1. No further information is available.
I noticed I was having difficulty writing with my right hand, it was small and shaky. I was having trouble, thinking and organizing my thoughts internally, I felt like my words were garbled. Later that day, I had trouble typing. The symptoms started around 11AM in the morning and seemed to resolve by 7PM. I called my doctor the next day and she told me to go to the emergency room to get checked out. Once I was there, they ran a CAT scan and MRI. They found that I had, had and acute lacunar. I was kept in the observation area of the emergency room for 36-48 hours. Upon discharge I was given ELIQUIS and LIPITOR. I do not feel any residual effects.
Tinnitus developed in both ears after COVID vaccine (1st dose). Loud persistent high pitched ringing making it difficult to sleep or concentrate. For example, I need to use a loud floor fan to drown out the ringing at night.
Large red and itchy circle around the injection site , a week after the injection. Lasted around 48 hours.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown.            No concomitant medication details were provided. Treatment details included Tylenol(paracetamol) and caffeine.
This spontaneous report as received from a pharmacist via a representative refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX. No concomitant medications were reported. On an unknown date, the patient developed a shingles looking rash on their arm, post vaccination. The outcome of developed a shingles looking rash on their arm was unknown. The rash extended for 7 days duration. No other information provided. Patient sought medical attention by contacting pharmacy. Causality assessment was not provided by reporter. Additional information is not expected.
Headache, chills, sore muscles, severe stomach pains, nausea, rash (like prickly heat) very flu like symptoms. Unable to to eat for about 36 hours, could tolerate ice chips only. Four days later finally feeling better, but arm is still sore.
Extremely high fever (102), chills, extreme fatigue, nausea.  Began on Friday and subsided on Sunday, January 9