chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 22-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Tingling and numbness in my left hand, mainly the 4th and 5ths fingers. This occurred about 15 min after the injection. It has persisted until today (01/10/2021). Tingling now is mostly in 5th finger. It is not present all the time. It is worse when I extend my arm at the shoulder.
Dose interval is 44 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval is 44 days) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval is 44 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval is 44 days) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.  No treatment information was provided.
complications since my second Pfizer Covid Vaccination in Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported: VACCINATION COMPLICATION (non-serious) with onset Aug2021, outcome "unknown", described as "complications since my second Pfizer Covid Vaccination in Aug2021". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I'm exposed you know I do the testing at my office at school; Loss of taste; Loss of smell; Sneezing; This is a spontaneous report from a contactable nurse (patient).   This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # not clarified, Expiry Date 30Apr2021) intramuscular at single dose in the deltoid on 08Jan2021 15:00 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified several drugs. On 08Jan2021 22:00, the patient experienced loss of taste, loss of smell, sneezing with outcome of unknown. No treatment required. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Jan2021.   Nurse stated: "I just wanted to know the Covid Vaccine would it have given me that symptoms I mean obviously I'm exposed you know I do the testing at my office at school." When probed for causality, Nurse stated, "No, I don't think it would be from the vaccine, probably you know just exposure."  Information on the lot/batch number has been requested.
pt recv vax 24JUn98 & mom reports noting a rash on infants back, stomach & legs around 130AM then child began inconsolable crying later 25JUN morning that last off & on but no more than 1 to 1 1/2hr;nonstop inconsolable crying began 26JUN;
The patient was in the clinic for his 6 month immunizations. The other nurse taking care of the nurse-only visits was busy at the time, and the mom had stated that she had somewhere to be soon. I had some time, so I helped draw up the vaccines. Since the mom had somewhere to be, the other nurse and I decided to wait until after we gave them to document them in our immunization log (which helps us keep track of our counts as well). I took the PENTACEL vaccine box out of the fridge and grabbed one of the vials from the box. The vial I grabbed happened to be the Hib portion, which is a powder. I didn't see that there was a specific diluent portion of the vaccine (the DTap-IPV part), and reconstituted it with 0.5 mL of the sterile diluent used for other vaccines. The other nurse and I went to administer the vaccines. I administered the "PENTACEL" IM into the left thigh. The patient tolerated it well with no immediate reactions. He left the clinic with his mother. I went back into the med room where we had drawn up the vaccines. I was documenting the immunizations when I realized my mistake. The PENTACEL count number in the log was not matching up with the number of vials. The vials were tipped over in the box, and when I took a better look, I saw that there was also a diluent part of the vaccine. I immediately informed my supervisor of the incident and called the HD and spoke with staff. She informed me that the entire vaccine was invalid, and the patient would have to return for a repeat immunization. Staff stated that this would cause no harm or adverse reactions. I called the mother to inform of the situation. She was understanding of the situation. No harm had been caused. The mother brought the child back for the proper immunization on 8/17/17.
Complained of a "shooting" "tightness" that traveled through left arm, and then localized in chest. Stated chest remained tight.  Narrative:
Received injection at work in one of the clinic, this was the second dose and the next morning I could not move my right arm shoulder was completely locked.  I could only raise my arm to less than a 30 degree angle
Vaginal bleeding; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Sep2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills-low estrogen (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Oct2021 at 12:30, the patient experienced vaginal bleeding. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal bleeding was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 Mar Received second Moderna vaccine. 26 Mar  Noticeable swelling and joint pain/inflammation in right knee. 29 Mar  Saw family physician, referred to orthopedic surgeon and physical therapy. 30 Mar  Received cortisone shot from orthopedic surgeon. 3 Apr Effects of shot worn off, left knee is now inflamed and painful, left hand is also swollen & sore. 4 Apr -14 Apr  Inflammation in both knees worsen, can no longer bear weight, pain is at an 6-7+.  Left hand is sore, but swelling has gone down some.  Nausea noticeable with corresponding loss of weight.  14 Apr  See physical therapist, he recommends going back to physician. 26 Apr  Family physician and I discuss this quick onset of severe RA-like symptoms as coming on immediately following second vaccine.  Pain in both knees is excruciating, 8+.  She puts me on a 6-day regime of methylprednisolone (4MG USP Dose Pak).  Six pound weight loss in three weeks, nausea continues. 28 Apr  Start Dose Pak with good results, follow directions by taking 6 pills first day, 5 pills second, etc. 4 May  No longer taking steroids and both knees are returning to former painful/inflammatory state.  Walking in difficult two more pounds lost due to nausea. Pain returning to previous levels, no improvement.  Being referred to a rheumatologist.
Itching, hardness, redness, heat around injection site. ?Covid arm? symptoms.  Developed  8 days after injection.
Acute bilateral lower extremity DVT found on venous duplex after reporting new bilateral leg swelling  7-8 days after receiving Janssen COVID-19 vaccine.  No prior history of DVT.  Brain MRA pending at time of report w/ concurrent history of new/moderate/persistent headache.
rashes like hives on body.; Severe itching; swelling; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Apr2021 at 15:00 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 13:00, the patient developed rashes like hives on body, severe itching and swelling. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with tropical cream. The clinical outcome of the events rashes like hives on body, severe itching and swelling was not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a facility nurse via a company representative regarding two patients of unknown age and gender. On an unknown date, the two patients were vaccinated with a dose of PROQUAD (Merck) (lot # J001054, expiry: 28-JUL-2014). On an unknown date, the two patients developed confirmed cases of cellulitis after receiving the PROQUAD vaccine. It was unspecified if the patients sought medical attention. The outcome of cellulitis was unknown. Additional information has been requested.
The morning following immunization, the patient reported to our Triage Phone Line the following sx:  Body aches, chills, pain at injection site, severe headache at base of skull, took temp and was afebrile.  Sx worsened by that evening, gradually lessened over next two days, and were completely resolved by 6/5/18.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, unknown number of vaccinated with M-M-R II (lot #, expiration date, route, frequency and dose were unknown) which had been improperly stored were administered to unspecified number patients. No adverse effects were reported. This one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from healthcare worker refers to a 64 year old male patient. Patient's concurrent conditions, pertinent medical history and drug reactions/allergies were none. On 14-DEC-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L029073, expiration date: 19-APR-2017, dose 0.5ml, subcutaneously. Concomitant medications were not provided. On 14-DEC-2015, the patient experienced pain at the site of injection. On 16-DEC-2015, he developed "redness and warmth" at the injection site. On 17-DEC-2015, the patient returned to the physician's office and sought medical attention. The adverse effects were beginning to subside and so the patient was not given any treatment for the events. (Outcome: recovering). Causality assessment was not provided. There were no product quality complaints involved. Additional information has been requested.
Increased temperature to 104F and seizures x2 (has history of known seizure disorder).
1533 patient became dizzy after walking out of exam room <5 min after receiving vaccines. Patient fell against NNP who then lowered her to ground. Patient was pale, complained of "feeling funny", tachypnic. Calmed patients breathing ambulated back to patient. Room to lay down. WNL vital signs. 1600 patient has no complaint of dizziness; WNL vitals, walked to car.
Faintness followed by sweating, chills, tightness in chest, labored breathing. All symptoms arose within 5 minutes of the dose and subsided within 30-45 minutes. Pharmacy called 911 and EMTs came and said my vitals were good.
someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)).    No concomitant medication was reported.  Reportedly, patient received Moderna for the first dose and then the second dose was given 3 weeks later (instead of at least 4 weeks later).  No treatment information was provided.
45 min after injection face became red and flushed and headache began,  redness left in about 4 hours, headache still remains 24 hours later but mild. joints ache for 24 hours and neck slightly stiff after about 12 hours
2.5 days rash (25 small splatches); 101 temp prior to rash (2 day fever); conjunctivitis.
4hr p/vax tightening of throat;hoarse dry cough;DPH given;pt is RN & recognized sx;
Narrative:  # Cardiac Arrest, unclear cause, Suspect covid myocarditis or thrombotic event/ami 3/9/2021 05:55 Pt was found apneic. Code blue was called PEA, intubated, TTM after ROSC, no meaningful response after rewarming phase. CT head no acute findings. --trop remained negative, however possibly represent down trend, EKG poss nonspecific ST changes. --Seen by Cardiology with initial impression acute MI. # Acute Hypoxic Respiratory Failure, not POA Pneumonia, presumed superimposed bacterial, not POA, suspect covid related COPD on inhalers (COVID + on admit, however asympt from resp standpoint at that time) (CTA CHEST Negative for PE) IV ABX Vanco and Zosyn # ACUTE KIDNEY INJURY, POA and recurrent post CARdiac arrest, improving # ENCEPHALOPATHY not POA, s/p cardiac arrest Off Sedation No significant improvement in mental function CT HEAD showed no acute changes PATIENT WAS INFECTED WITH COVID AND PASSED AWAY AFTER COMPLICATED COURSE AS NOTED ABOVE. PATIENT TESTED POSITIVE FOR COVID ~9 DAYS AFTER RECIVING FIRST DOSE OF 2-DOSE SERIES OF THE COVID-19 VACCINE. IT IS NOT LIKLEY THAT THE VACCINE CONTRIBUTED TO THIS PATIENTS DEATH.
NECK NUMBNESS; SHOULDER PAIN; NECK PAIN; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced neck numbness. On 12-APR-2021, the subject experienced shoulder pain. On 12-APR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, shoulder pain, and neck numbness. This report was non-serious.
States he has a headache, dizzy. Rested. States he is better - no dizziness. Slight headache.
couldn't move her arm; soreness in the muscle; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization and her arm was sore. The reporter's mother said she couldn't move her arm for a day after receiving the first dose of the Pfizer Covid vaccine on Monday (18Jan2021). She had soreness in the muscle. By the 3rd day after receiving the vaccine, she was feeling fine. Outcome of the events was recovered 21Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
The day after receiving the Covid 3rd dose I woke up w a painful, hard lump that was an inch wide, red in color, extremely painful to touch and extremely itchy.  Warm compresses did not help . Benadryl cream did  not help. It was hard to sleep for 2 nights due to pain and itching.  A week later the itching is gone, redness is less. Still have a painful lump the size of a marble at the site.
No adverse effect; an unspecified number of patients may have been administered an improperly stored doses of MMRII; This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reaction/allergies were unknown. Concomitant therapies included sterile diluent. On an unknown dates, the patients may have been administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) of lot # S005249  with expiry date 20-FEB-2021 (dose, strength, dose number, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccines were exposed to the temperature of 11.73 Celsius for 4 hours and 30 minutes. There was no previous temperature excursion and digital data logger was involved. No adverse effects were reported.   Follow up information was received from physician on 07-NOV-2019.     No vaccine adverse reaction were reported. The only had to recall patients because no data available for temperature excursion. On 23-OCT-2019, during office site visit temperature excursion were noted. 10, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses (Lot # R000550, expiry date: 08-JAN-2020) were stored to 24.08 degree Celsius. Since no data exists were (illegible doc) to revaccinate. No adverse reaction noted.    This is a non-valid case due to lack of patient identifiers.  Follow up information was received from the physician on 08-APR-2020.   This information refers to a 11-year-old male patient. On 18-JUN-2019, the patient was administered with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with Lot number R000550.  This is one of several cases received from the same reporter.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient demographics were obtained.; Sender's Comments:  US-009507513-2004USA002896: US-009507513-2004USA002897: US-009507513-2004USA002898: US-009507513-2004USA002899: US-009507513-2004USA002900: US-009507513-2004USA002901: US-009507513-2004USA002902: US-009507513-2004USA002903: US-009507513-2004USA002904:
Body aches, ice pick headaches, diarrhea, congestion  Able to relieve body aches and headaches with Motrin So far 72 hours but still continuing