chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment information was reported.   Reporter did not allow further contact
Enlarged lymph node under right arm; Causes sharp pains at times and sore; Causes arm to go numb sometimes; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via intramuscular route of administration in the left arm on 22Jan2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via intramuscular route of administration in the left arm on 23Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as not applicable. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021, a week after the vaccine, the patient experienced enlarged lymph node under right arm which had not gone away at the time of this report. The enlarged lymph node caused sharp pains at times and sore and also caused the patient's arm to go numb sometimes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with antibiotics and ultrasound. On an unknown date, the patient underwent Ultrasound and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events enlarged lymph node under right arm, caused sharp pains at times and sore and caused arm to go numb sometimes was not recovered at the time of this report.
crying 1-7PM, TID 4PM p/inject p/8PM; lethargy fever broke 3AM; slept until 130PM; active & alert now;
Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; This spontaneous report was received from a lawyer and the consumer referring to a 51-year-old female patient  the patient concomitant medications included asthma, depression, blood triglycerides increased, diabetes mellitus, gastrooesophageal reflux disease, restless legs syndrome, hypertension, blood cholesterol increased, blood cholesterol and hypersensitivity. The patient's medical history included varicella and tobacco user. Concomitant therapies included fish oil, calcium, cetirizine hydrochloride, mometasone furoate(ASMANEX), fluoxetine hydrochloride(PROZAC), omeprazole(PRILOSEC), salbutamol sulfate, atorvastatin calcium and losartan.      In 2003,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (strength, dose, anatomical site of administration, lot number and expiration date were not provided), the patient was revaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  in 2005, 2015, 2016 and 06-OCT-2021 (inappropriate schedule of product administration).  This is one of 2 same patient reports.; Sender's Comments:  US-009507513-2202USA004321:
administration post excursion (with no reported adverse event); products were exposed to a temperature of 17 degrees Fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event); Initial information was received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient of influenza quadrival a-b vaccine [Fluzone QIV] products were exposed to a temperature of 17 degrees fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event) and administration post excursion (with no reported adverse event).  It was reported that unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination(Immunization). There will be no information available on batch number for this case.  On 13-Oct-2023 the patient reported that products were exposed to a temperature of 17 degrees fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event) (product storage error) (unknown latency) following the administration of influenza quadrival a-b vaccine. On an unknown date the patient reported that administration post excursion (with no reported adverse event) (poor quality product administered) (latency: same day).  Reportedly "Caller stated the cause of the excursions were from the refrigerator temperatures dropping. He did not provide any other specifics. Notified the caller that the extended stability information does not cover an excursion of this length and/or temperature, and the dispensing of the products is no longer supported. After we notified the caller that any exposure below freezing would make the products not viable for use, he stated one of the vaccines had been administered, and asked what to do regarding that. Only pt information the caller could provide us with at the time was that they were a male pt. "  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event products were exposed to a temperature of 17 degrees fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event) and was Unknown for the event administration post excursion (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Swelling to right deltoid. Lymphadenopathy to Rt. axilla and Rt. neck - cervical lymph node.
I had very difficult time in trying to walk or stand up; I could not re-talk or I could not re-walk; my motor functions were disabled; Fear that I am not going to live; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The re-porter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol. Concomitant medication(s) included: AMLODIPINE; ESCITALOPRAM; FINASTERIDE; LISINOPRIL; SENNA [SENNA ALEXANDRINA LEAF]; TAMSULOSIN; OMEPRAZOLE.  The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "I had very difficult time in trying to walk or stand up; I could not re-talk or I could not re-walk"; MOTOR DYSFUNCTION (non-serious), outcome "unknown", described as "my motor functions were disabled"; FEAR OF DEATH (non-serious), outcome "unknown", described as "Fear that I am not going to live". The event "i had very difficult time in trying to walk or stand up; i could not re-talk or i could not re-walk" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had an adverse reaction serious enough to put me in emergency. Patient just brought it out yesterday. Patient has been transported by ambulance to the hospital and it was 8 months out when patient had the current side-effect which was serious now and thought it was going to take patient's life." Patient just got out of an ER and they check all over. Patient had very difficult time in trying to walk or stand up. It was like motor functions were disabled. Patient thought was going to pass out like at the floor and could not re-talk or could not re-walk. Patient was scheduled or an ERI and an MRI and Patient had to cancel that because couldn't walk or anything so and had fluid like symptoms all over. This was the extremes of all, patient was at 'carness' as far as the severity." Patient had extensive lab work an ER Yesterday which they tested and they were way possible and they told nothing of the ordinary they had blood test in all system found nothing at out of the all and Blood tests and Urine analysis and all they found nothing wrong." (Further clarification unknown. Prior Vaccination (Within four weeks) was None. Patient just like to be updated to as far as patient was unable to know that nobody had the any reaction for that it was an eight months and then woke up one day and couldn't probably navigated all they wanted to administrate to ER and so had some very severe reaction one to this time that fear that patient was not going to live that was the summation then. Patient have been requested to know if anybody had a reaction eight months out?"   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.   On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: wnl (normal) WNL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-391981 (Patient Link)
Day of -light headed approx 1/2 hr after vaccine lasting a few hours, anxious, palpitations Next day, tired, headache, feeling like "coming down with something" Fri:  headache, sore throat, chills, runny nose, sinus congestion Sat: COVID PCR test, same symptoms with cough Sun: Negative Covid result, same symptoms, headache worse
Red spot all over arm. Localized allergic reaction, hives and itching. Nausea day after immunization. Patient took 4 doses of BENADRYL 25 mg. Cleared up to a great extent.
pt recv vax 12JUN95 & 7APR96 pt broke out w/chickenpox;pt presented to MD on 18APR96 & was covered w/bumps which were mostly dried up by then;the reporting MD felt this case was severe, & that there was a problem w/this particular lot;
approx 15min p/inject pt rt eye started swelling; rt perioorbital edema;
It was reported that a pt (5 of 5) received a Fluzone SV '00 - '0 vaccination. Reportedly sometime after the vaccination the pt developed a local reaction of redness and warmth. No specifics provided, further information is requested.
"Muscle ache and pain of (R) arm. Joint pain down to the bone; traveling to forearm - down to the top outside forearm. Started getting worse 11/5. No problems for a couple of days after getting shot. Pharmacist friend told me to take Naproxen."
Given an expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given an expired dose of the Moderna COVID19 vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given an expired dose of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given an expired dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.  Dose was administered after 30-day Use By Date or after manufacturer date of expiry. Date the vial was initially stored in the refrigerator was reported as 16 Mar 2022. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains significant information Patient details were added. On 04-Apr-2022: Follow up received contains no new information
Bulge developed on clavicle (left) , continues to swell larger and cause pain to the left arm/shoulder/neck region. This is after BOTH shots.
Information has been received from a registered nurse concerning a 19 year old black male with a past medical history of hernia repair who on 27-SEP-1996 was vaccinated with the first dose of RECOMBIVAX HB 0.5 ml. On 26-OCT-1996, was vaccinated with second dose of RECOMBIVAX HB 0.5 ml. On 28-NOV-1998 the patient was vaccinated with the third dose of RECOMBIVAX HB 0.5ml. Concomitant therapy included ALLEGRA. Subsequently on 18-JUN-2007, when the patient was tested for college admission for hepatitis B immunity (Hepatitis B surface antibody), the patient showed no immunity to hepatitis B virus. The lot numbers of the initial vaccinations are not available. The patient did not seek medical attention. No product quality complaint was involved. The patient was revaccinated on 03-JUL-2007 with RECOMBIVAX HB 1.0 ml IM. On 03-AUG-2007, the patient was again revaccinated with RECOMBIVAX HB 0.5 ml IM (also reported as an adult dose). Anti-HBs titer will be done in the future. Additional information has been requested.
Severe ringing in ears  Shooting nerve  pains all over body at night  Pain in liver area Poor sleep  Diarrhea  All started within week of first dose and continue til now, 2 weeks after second dose
Bright red, thrashing and screaming, fever, large cyst like spots all over her body.
Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L035129, expiration date 14-SEP-2017, lot # M017292, expiration date 07-APR-2018; dose and route were unknown). The vaccines were stored at 7.5 Fahrenheit degree for 2 hours 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After the 2nd dose, around the end of May 26, 2021, I started seeing flashing and different color lights of purple and yellow in the left eye. It was very bad for 1 week. It was flashing so much and distracting and I could not drive.  It did start to improve and I have seen weekly improvements but has not completely resolved.   I went to see a doctor who indicated that something is tugging on the "vitrous humor"  and should  go away.  I am being followed by the eye specialist.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from program. A non-contactable female consumer (patient) of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced tested positive for covid. The patient underwent lab tests which included sars-cov-2 test: positive on an unspecified date. She was asking what would happen if a certain person took the 1st dose of the Pfizer COVID-19 vaccine and tested positive for COVID after. She was asking how long she needs to wait to get the 2nd dose. The outcome of both events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's mother noticed a red rash behind both knees about 2-3 hours after receiving vaccine. Pt's mother states that the rash did not appear to be bothersome to patient. Today, the patient's mother states that the rash is diminishing.
Information has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in October 2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, once, intramuscularly, lot # N014946 with expiration date on 01-FEB-2019 (anatomical location was not reported) for prophylaxis. No adverse effects were reported. It was reported that on 10-OCT-2017, the vaccine had a temperature excursion of 32°Fahrenheit (°F) to 35°F (32F) for 24 hours and later on 12-OCT-2017, the temperature excursion was 32°F to 35°F (34F) for 9.5 hours. The reporter stated that no previous temperature excursions occurred and no digital data logger was involved.
PT RECEIVED YF ON 3/21/13 AROUND 1400 AND LATER THAT EVENING PT NOTICED HIVES; HEADACHE & FEVER ONSET WAS ON 3/22/13.  HIVES HAVE PERSISTED SINCE THURSDAY BUT HEADACHE & FEVER SUBSIDED ON 3/23/13.  "Scattered small pink skin lesions on lateral abdominal wall, left greater than right.  Lesions scattered raised blanching mildly erythematous papules consistent with localized hives on the left & right lateral upper abdominal and lower to mid chest wall."
She and I were both in bed for Thanksgiving; This case was reported by a nurse and described the occurrence of bedridden in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 28th November 2019, 2 days after receiving Shingrix, the patient experienced bedridden. On an unknown date, the outcome of the bedridden was unknown.   It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was in bed. This case was linked with case US2020AMR007083, reported by the same reporter.
Within 2 weeks of vaccine, distal paresthesia, loss of taste, progressive muscle weakness, imbalance, incoordination, delayed thought processing. Progressed to inability to walk without assistance. Multiple diagnostic testing. No treatment. Wait up to 1 year to determine residual effects.
Widespread petechiae beginning on 4/9/21, ultimately diagnosed with aplastic anemia, required a bone marrow transplant
gave vaccine way below deltoid; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (gave vaccine way below deltoid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (gave vaccine way below deltoid). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (gave vaccine way below deltoid) outcome was unknown.            Concomitant medication not provided by reporter.  Treatment information not provided by reporter
PREVIOUS HISTORY - SEVERE ALLERGIC/ADVERSE REACTION TO ANTHRAX VACCINE IN JUNE 2004, LOST FEELING IN HANDS, LOST SKIN ON HANDS, SORE LIMBS, FATIGUE. VAERS INVESTIGATION COMPLETED, RECOMMENDATION FOR NO MORE ANTHRAX VACCINATIONS.  EXEMPTION SIGNED BY MEDICAL DIRECTOR. HOSPTIAL WANTED TO DO PATCH TESTING WITH THE ANTHRAX VACCINE, AND MY SQUADRON COMMANDER SAID NO, BECAUSE MY COMMANDER WAS NOT GOING TO RELEASE ME TO BE A MEDICAL "GUINNY PIG." MEDICAL GROUP EXEMPTED ME FROM ANTHRAX WITHOUT FURTHER TESTING.  FURTHERMORE, IT WAS UNKNOWN WHAT FUTURE MEDICAL PROBLEMS I WOULD HAVE ASSOCIATED WITH THE PROBLEMS CAUSED BY ANTHRAX VACCINE. ALSO, IT WAS UNKNOWN WHAT PROBLEMS I WOULD HAVE WITH ANY FUTURE VACCINATIONS OTHER THAN ANTHRAX. WHEN ASKED PRIOR TO DEPLOYING, HOME STATION MEDICAL DOCTOR DID NOT KNOW WHAT AFFECT OTHER VACCINATIONS WOULD HAVE. ON SEPT 26, 2005, I RECEIVED MY FIRST VACCINATION SINCE HAVING THE ANTHRAX VACCINATON.  I RECEIVED A FLU SHOT.  I'VE NEVER HAD ANY PROBLEMS WITH ANY OTHER VACCINATIONS TO INCLUDE THE FLU SHOT PRIOR TO THE ANTHRAX VACCINE INCIDENT.  APPROXIMITELY 15 MINUTES AFTER HAVING THE FLU SHOT, FELT BURNING SENSATION WITH PAIN 7 OUT OF 10, SIMILAR TO ANTHRAX SHOT BURN.  2 HOURS LATER, WENT TO EMEDS, AND DOCTOR COULD NOT EXPLAIN CAUSE. BURNING SENSATION 2 HOURS LATER WAS A 5 OUT OF 10. I HAVE NO FOOD/DRUG ALLERGIES. I INFORMED DOC OF PREVIOUS HISTORY WITH ANTHRAX VACCINATION, AND THE DOCTOR TRIED PURSUADING THAT ANTHRAX WAS SAFE AND DOES NOT CAUSE PROBLEMS WITH OTHER VACCINATIONS. OBVIOUSLY THE DOCTOR WAS NOT LISTENING WHEN I EXPLAINED MY PREVIOUS CASE HISTORY. THE DOCTOR OFFERED BENADRYL AND I DECLINED IT AS I FELT IT WOULD BE OF NO HELP. I BELIEVE THAT MY ANTHRAX VACCINE MESSED UP MY IMMUNE SYSTEM (NO HEALTH TESTS WERE EVER COMPLETED FOR MY EXEMPTION, EVEN THOUGH MEDICAL RECORDS STATE POSSIBLE IMMUNE/NEUROLOGICAL DAMAGE), SEEING HOW THE FLU SHOT WAS A TRIAL AND ERROR SHOT TO SEE WHAT WOULD HAPPEN, THE AFFECTS ARE EVIDENT. ITS NOW 7 HOURS AFTER RECEIVING THE SHOT, AND THE BURNING IS STILL A 5 OUT OF 10. THE EMEDS DOCTOR WANTED ME TO RETURN IF THE CONDITION PERSISTED, AND DID NOT WANT ME TO FILE A VAERS REPORT. I FOUND NO HELP AT EMEDS WHEN I WENT THE FIRST TIME, AND WILL I WILL NOT RETURN TO EMEDS. I INFORMED MY CHAIN OF COMMAND HERE OF MY CASE HISTORY, AND THEY RECOMMENDED I FILE THIS REPORT. MY CHAIN OF COMMAND IS MONITORING ME TO MAKE SURE I DON'T BECOME INCAPACITATED. IT IS EVIDENT FUTURE HEALTH VACCINATIONS ARE DETERIORATING TO MY HEALTH CAUSED BY UNKNOWN HEALTH PROBLEMS ASSOCIATED WITH MY ANTHRAX PROBLEMS. I AM DEPLOYED AND SUPPOSED TO RETURN IN MID JANUARY.  TO CONTACT ME, PLEASE EMAIL AS I CAN CHECK THAT EMAIL FROM ANY COMPUTER.