chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILL; TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced chill, and tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chill, and tired. This report was non-serious.
Patient had a breakthrough infection. Positive COVID test on 1/28/2022. Patient passed away on 3/12/2022.
Lymph nodes in mouth are swollen; Swelling from left ear down to upper part of arm and it was kind of hard to hear; Lymph nodes in neck swelled up horrible; Arm sore 1 hr later; 3 hours later lungs cleared and have not coughed since. I have been coughing for 5-7 years; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Mar-2021 and was forwarded to Moderna on 21-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore 1 hr later), EAR SWELLING (Swelling from left ear down to upper part of arm and it was kind of hard to hear), COUGH DECREASED (3 hours later lungs cleared and have not coughed since. I have been coughing for 5-7 years), LYMPHADENOPATHY (Lymph nodes in neck swelled up horrible) and LYMPHADENOPATHY (Lymph nodes in mouth are swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore 1 hr later) and COUGH DECREASED (3 hours later lungs cleared and have not coughed since. I have been coughing for 5-7 years). On 17-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in neck swelled up horrible). On 18-Mar-2021, the patient experienced EAR SWELLING (Swelling from left ear down to upper part of arm and it was kind of hard to hear). On 19-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in mouth are swollen). At the time of the report, PAIN IN EXTREMITY (Arm sore 1 hr later), EAR SWELLING (Swelling from left ear down to upper part of arm and it was kind of hard to hear), COUGH DECREASED (3 hours later lungs cleared and have not coughed since. I have been coughing for 5-7 years), LYMPHADENOPATHY (Lymph nodes in neck swelled up horrible) and LYMPHADENOPATHY (Lymph nodes in mouth are swollen) outcome was unknown. Not Provided          Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.    This case was linked to MOD-2021-116896 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: follow up was received on 09-May-2021: Consumer's HCP retired last year and 2 dose information provided.
Pt recvd vax 1FEB93 & exp peripheral neuropathy & numbness & tingling in hands & feet 1 mo later;
Vaccine was expired for the beyond use date. BUD was 2/17/23. Vaccine was still in vaccine fridge. Expired vaccine inadvertently pulled from stock and administered on 2/25/23.
Fatigue and GI upset (nausea, emesis, watery brown diarrhea)
-Pain in the injection site; nausea; low fever and diarrhea (started within 24 hours of injection) Resolved within a week; except diarrhea which still happening on an irregular basis.  -Tingling sensation in my feet (started within 1st week after injection). Still happening on an irregular basis. -Decreased feeling in my thighs (outer area) (started within 1st week after injection). Still happening on an irregular basis. -Tingling and numbness in my hands (mostly fingers) (started within 1st week after injection). Still happening on an irregular basis. -Pressure in both ears and forehead (sometimes accompanied with ringing) (started within 24 hours of injection) Still happening on an irregular basis. -Fast Heartbeat (started within 5 minutes after injection) Still happening on an irregular basis. -Dizziness accompanied with a cold feeling rush thru my brain  (started within 5 minutes after injection) Cold feeling rush thru my brain resolved within 4 weeks after injection. Dizziness still happening on an irregular basis.  -Chest pressure (started within 24 hours of injection) Still happening on an irregular basis. -Leg Swelling (started within 1st week after injection). Still happening on an irregular basis. -Blurred Vision (started within 1st week after injection). Still happening on a regular basis.
sore arm for 3 days,  chills, fever of 101.7, headache, and nausea beginning at 12 hours after vaccination and lasting for 24 hours
When Patient originally got the shot on 10/06/17 he had a fever which lasted 2 days and numbness and weakness in his arm, to the point where he could not lift his arm. Some range of motion has returned, but he is not 100% better yet. Patient stated he felt the immunizer went too high on the shoulder. The patient is going to Dr. tomorrow on 10/16/17 to seek medical treatment.
1st 2 days was lethargic and muscles pains a month later it was sharp chest pains for several weeks - diagnosed with pericardial effusion.
Patient stated that shot was higher then normal and hurt very badly going in. She had left the Band-Aid on to show me and it was pretty high on the shoulder but I assured her that it of course was still in the deltoid muscle. She said that when she got home that day that she could not lift her arm and it hurt so badly that she could not lift it for the following 4 days. After that she said that she had a sharp pain in her arm and shoulder that kept her awake at night for the next 13 days. She finally reported sleeping through the night on day 14 after taking Ibuprofen and resting the arm through the entire day. She also reported muscle spasms in the bicep a few days after injection.
Information has been received from a physician concerning a 69 year old female who on 21-JAN-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX (lot number 659150/1384U).  On 22-JAN-2009, the as next day after vaccination the patient experienced stiffness on her arm, blood clot and bruises on her arm.  Physician noted that the arm where the patient had the reaction is not the injection site where she received PNEUMOVAX.  The patient recovered from the events on an unknown date.  The patient sought medical attention by calling the office.  Follow-up information was received from a physician concerning the 69 year old female patient with no pertinent medical history and no known allergies/drug reactions who on 21JAN-2009 received the dose of PNEUMOVAX (lot number 659150/1384U) intramuscularly into her left deltoid.  The physician reported that on 22-JAN-2009, the patient described feeling tightness, heaviness in arm and subsequently went on to difficulty moving the arm and had decreased range of motion for 1-2 weeks.  On 23-JAN-2009, two days after vaccination, the patient also developed ecchymosis and hematoma in antecubical fossa.  The physician described all the adverse events as self limiting.  At the time of the report, the patient had recovered.  No relevant diagnostic tests and laboratory data were performed.  There was no illness at time of vaccination.  No further information is available.
No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 15-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009891:
Amenorrhea - Lost Period - No bleeding  Have not had a period since 02/28/2021 I was vaccinated on 04/01/2021 and was supposed to start my period on 04/03/2021. It never came. I am not pregnant. I am currently in birthcontrol and have never missed a period.  I am unsure if the vaccine affects birthcontrol or fertility or how long it will cause amenorrhea. I was told to ?wait another month and see what happens.? This was not caused by stress, diet change, weight gain, pregnancy, etc. The only thing that changed in my life was the vaccine.  You need to investigate this association with blood clotting in women of childbearing age.
Upon arising, very light headed, nearly fainted.  Vertigo-like symptoms upon movement and Poor appetite both continue until this report (>5 hours.)
Rec'd on 9/21/2020.  Called on 9/24 with complaints of bump and tendersness at injection site.  Saw Dr. who dx cellulitis and ordered antibiotics FROM CHART Cellulitis of other specified site  (primary encounter diagnosis) Plan: sulfamethoxazole-trimethoprim (BACTRIM DS)        800-160 mg per tablet   Patient with a profound inflammatory response to her immunizations, and potentially beginning cellulitis given tracking toward axilla. She is stable and not in any distress today with normal vital signs. Will begin Bactrim x 7 days. Patient was counseled regarding proper use and potential side effects of medication. They were advised to call with any problems. Advised cool compresses. Drew line around red area. Advised with any redness that extends outside of border, worse pain, fever, rigors, she needs to go to the ER right away. Otherwise, will see back as scheduled. The patient is agreeable with the plan.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's husband). A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history included pneumonia (hospitalized with pneumonia several times). Concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was hospitalized due to the event. Outcome of the event was unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
3-5 minutes after receiving Pediarix on Left thigh.Entire leg became red/purple per mom- bled  small amt at site. stopped with bandaid -then blotchy/vasculitic rash down entire leg which did not blanch.Child alert,happy,smiling, moving leg. Rash present when patient left.  Will f/u by phone.
pt recvd vax & pt devel a knot & redness @ the inject site, & a fever;
Pain on her left breast down near her armpit, which spread around her breast; Arm hurt for 24 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt for 24 hours) and BREAST PAIN (Pain on her left breast down near her armpit, which spread around her breast) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt for 24 hours). On an unknown date, the patient experienced BREAST PAIN (Pain on her left breast down near her armpit, which spread around her breast). On 25-Feb-2021, PAIN IN EXTREMITY (Arm hurt for 24 hours) had resolved. At the time of the report, BREAST PAIN (Pain on her left breast down near her armpit, which spread around her breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a health professional concerning a 37 month old female who on 05May03 was vaccinated with a dose of varicella virus vaccine live. On 21Jun05 the pt developed 10 vesicular lesion on her trunk and legs. No other symptoms were noted. Unspecified medical attention was sought. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
Pain in lower left bicep in first week, experiencing fatigue/tiredness. After 10 days I experienced severe pain at the site of injection, very small red spot appeared around injection site. Pain was so severe, I took one capsule hydrocodone 5-325 TB at 2 AM. The medication did not cure the pain, and I slept less than two hours. I called my nurse practitioner's office, and they offered an appoint late in the morning. And I couldn't wait that long so I drove to urgent care. Prompt care examined and saw no swelling, ruling out possible blood clot. Prompt care did not have ultra sound. They told me to use ice, heat, and pain medication. Extreme pain continued for about three more days, pain medication did very little to help. Unable to speak directly to the Nurse Practitioner on the phone, due to my disability and alexia, communicating online is very difficult without an assistant present. The pain slowly subsided over the next week.
Client verbalized tingling of the lips after receiving the vaccine.  Client evaluated by onsite Sheriff Fire Rescue.  Client released to go home at 11:25 am by Fire Rescue after symptoms resolved.
Fever staying between 105 and 105.9 degrees (orally) for 48 hours without respite, beginning 24 hours after vaccination.  Called administering health department and was advised to contact our pediatrician.  Pediatrician was not concerned, gave no advice, did no follow-up, did not believe this to be vaccine related.
rash on thigh/ rash on arm; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rash on thigh/ rash on arm) in a male 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 RASH (rash on thigh/ rash on arm). At the time of the report, RASH (rash on thigh/ rash on arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-may-2021 contains non-significant information.
Two days after receiving the first Pfizer Covid Vaccine, I am experiencing a rapid heart rate and chest pain. I conducted some research on the topic and learned that there is a link between the vaccine and heart-related issues, such as inflammation. What does the CDC recommend at this point? Will this issue resolve itself or should I go to the hospital?
Initial and follow up information has been received from a physician concerning a 80 years old female patient with diabetes type II, who on an unknown date at private doctor's office/hospital was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included PREDNISONE (manufactured unknown). The physician reported that the patient experienced herpes zoster (shingles) on 17-SEP-2008. On 01-OCT-2007, the patient recovered it, reported that the physician's office does not carry the vaccine but they give the vaccine if brought to them. There were no lab diagnostic studies performed. Additional information has been requested.
lump in arm that went away and returned; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump in arm that went away and returned) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0KTN120A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced AXILLARY MASS (lump in arm that went away and returned). At the time of the report, AXILLARY MASS (lump in arm that went away and returned) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product details were provided Treatment details include Tylenol.
within 5 minutes of vaccination, had facial edema and whole body edema.  received benadryl and transferred to Emergency Dept.  In ED treated with decadron, pepcid, and and benadryl.  Recurrence of symptoms on 3/7/2020 treated with IV solumedrol.
fever, diarrhea on 25APR (father also had flu @ this time); 2MAY & 3MAY temp 102-103, dulling @ ear some;4MAY cough;5MAY gen rash face & trunk & extremities;diarrhea, lethargy;mom is 13wks pregnant
This initial spontaneous case, was received on 08-Oct-2017, from a pharmacist, concerning a 54-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 07-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178302A, expiry date: Apr-2018). It was reported that, the vaccine was given to a 54-year-old patient (explicitly coded as inappropriate age at vaccine administration) and had soreness in the arm (began on an unknown date). The outcome of the event was not reported. The reporter considered the report as non-serious. Follow-up received on 18-Oct-2017: The reporter stated that the patient experienced soreness in the arm since an unknown date. The outcome was not reported. Narrative amended accordingly. Significant case correction received 18-Oct-2017: The event "no adverse event" was deleted.
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  It was reported that the vial was initially stored in refrigerator on 20-Apr-2021.The vial didn't undergone any temperature excursions.  HCP mentioned that there were 14 patients instead of 18 because of some duplicates.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Reporter's Details and Narrative were updated.