chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medication information was provided.  No treatment medication were provided.  The reporter's causality for COVID-19 event with Humira was reported as no reasonable possibility.  It was unknown if patient was enrolled in COVID-19 vaccine Trial.  Company comment: This spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The event was resolving. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The event was resolving. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient developed 3 hives on her forehead, which is considered a severe allergic reaction after vaccination. She also developed a red throat that wasn't present before the vaccination.
Left thigh with immediate site reaction with 4 inch by 1 1/2 inch erythematous area with 2 inch induration: No respiratory symptoms. Given BENADRYL checked back in 20 mins. No induration erythema 2 inches by 2 inches, no pain.
Arm swollen at site of injection, significantly - mid humorous to top of shoulder with pain, warmth, redness onset less than 12 hours post administration.
This is a spontaneous report from a non-contactable consumer communicated to a Pfizer sales representative. A 60-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient had an allergic reaction to pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date. The patient was in the hospital for pneumococcal pneumonia on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse concerning a patient who in January 2006, was vaccinated with the first dose of GARDASIL vaccine (lot#, dose and route not reported). On 04-JUN-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (lot# dose and route not reported). No adverse events were reported. No other information was available. Additional information has been requested.
Made aware on 2/27/23, that there was an extra diluent vial in the State Menveo box that did not have the counter part with it, the powder vial.  Unable to narrow down who received the incorrect diluent  (received list of 4 patient's that got that particular lot number), so all are being asked to revaccinate.
5/17/01 at 09:00, right thigh has "red splotches" with "some" edema. Cold compresses applied by mom the afternoon of 5/16/01. Child also "guarding" right leg. 5/18/01, phoned mom, red color gone, small knot in right leg/thigh area. Afebrile both days with crying (high-pitched). Tylenol was recommended on 5/16/01.
very Sore neck; hard to sleep; Nausea; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3; Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 22Apr2022, outcome "unknown"; CHILLS (non-serious) with onset 22Apr2022, outcome "unknown"; INSOMNIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "hard to sleep"; NECK PAIN (non-serious) with onset 22Apr2022, outcome "unknown", described as "very Sore neck".  Additional Information: Caller was a 80 year old female who received the second booster dose on 14Apr2022 and has experienced some symptoms such as very Sore neck, hard to sleep, Nausea and chills every once in a while which started on 22Apr2022 and she would like to know if its too late to develop side effects from the vaccine this long after getting the booster dose. The patient has no fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was helping husband make breakfast in morning (one day post-vaccine) and suffered a moment of unconsciousness resulting in the patient hitting her face and fracturing her jaw in 2 places. She was taken to the emergency department where she received stitches and prescriptions for an antibiotic and pain medication. The hospital could not find any other root cause of the fall and the only new factor in the patient's life was the vaccine. Hospital is unsure if this is what caused it but cannot rule it out.
Per note Patient was seen in the office yesterday for a WCC and received immunizations.. Father states the patient is cranky this morning and had red dots all over his back and there are dots starting to appear on his chest. spoke to mom as unable to reach dad. she states that patient was with her last night and she did not see the rash. she "assumes" it started this am. dad sent her a picture and looks like it is white dots surrounded by redness. she doesn't think he has a fever or any other sx's other than being "grumpy" and crying a lot. discussed possible se from the vaccines. can monitor for now and if develops difficulty breathing then would need to go the ED. if develops fever, new sx's, worsening rash then she is to c/b. can give him benadryl 12.5mg/5ml ( cautioned may cause sedation but in some children can make them hyper). also cool baths w/ aveno, or oatmeal or baking soda. tylenol/advil for discomfort. mom states understanding and agreement
I experienced a fever of 102 for 7 days. I also had chills, swollen glands and experienced fatigue for a long time. It took about a month or my energy to come back.
Initial misuse report received from a healthcare professional on 04 November 2013. The patient had received ACT HIB that was reconstituted with sterile water and administered. The nurse reported that no clinical data on the use of other diluents than what was licensed with the vaccine. It was the opinion of our medical director that use of sterile water or 0.9% normal saline (NS) might lead to dissociation of the protein-polysaccharide conjugate. In the absence of clinical data showing that normal immunogenicity was retained using diluents, we cannot support this practice. Act HIB was an inactivated vaccine so can be repeated at earliest opportunity. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Within 5 minutes patient developed hive near injection site, on left subcut arm, upper. Pt was given 12.5 mg = 5 mL BENARDRYL, childrens.
Nurse gave expired vaccine. BEXSERO expired 9/30/17 gave it 10/2/17 - called manufacturer - got guidelines and info. No action required.
pt called a few days after receiving vaccines stating that she was experiencing a lot of pain on both arms. rph on duty advised her to take some advil/Tylenol/aleve to see if that helped, and if not, contact doctor. pt stated that the pain in the right arm (shingrix arm) went away, but the pain in the left arm (fluzone HD and prevnar arm) did not get better, so she contacted the doctor. doctor told the pt that whoever administered the vaccine may have hit the tendon and that may be the reason why she's experiencing extended period of pain/discomfort. pt called pharmacy 11/24/20 because her doctor advised her to call the pharmacy to let them know what's going on.
19OCT95 exam WNL-gave vax that PM devel fever, which cont inc to 103 ax;21OCT had brief generalized tonic-clonic sz;T104.9R on arrival in ER;exam WNL;CBC, lytes, glucose, CXR neg; LP not done;u/a not done;rash 24OCT-classic roseola rash
Missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Followup received on 26-MAY-2021 and No new information
This spontaneous report was received from a registered nurse and refers to a currently 7 months old patient of unknown gender. On an unknown date in 2015, the patient was vaccinated with improperly stored PEDVAXHIB of lot # K008878 with expiry date 23-MAR-2017 (via the correct route as per the prescribing information). On 25-FEB-2015, the vaccine was improperly exposed to 21.72F for 40 minutes for 1 cycle. There were no known adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt started with erythematous area on on lower medial left leg, right above the ankle on Monday afternoon after receiving vaccines.  Pt became non-weight bearing on Thursday.
Pt given varicella and DTAP on 3/22/04. That evening fever 101F. Parents alternated Tylenol and Motrin every 2 hrs. 3/23 at 3:15 temp was 106F rectal. Mom gave Motrin then sought attention. At clinic on 3/23 temp was 103.8F. Pt had rhinorrhea but no meningeal signs. No other signs of illness. Continued Motrin and Tylenol every 2 hrs (alternatiing. On 3/24/04 at recheck temp was 97.7, playful, had diarrhea that am--no physical signs of illness.
I started to get a splitting headache and my nose started running out of nowhere. For a couple of days before that I felt really sore and I did not think it was anything. I had chills that evening. The next day I had complete exhaustion and I had no sense of taste or smell. It has been five days and I still can't taste or smell. It feels like I have a bad flu. I feel really tired and achy and as the day goes on I feel more congested. I did a rapid test at home and it was positive. On the third day I had a PCR test and it was positive.
weakness in hand; tingling in hand; This case was reported by a consumer and described the occurrence of hands weakness of in a 63-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th December 2022, the patient received Shingles vaccine. On 7th December 2022, less than a day after receiving Shingles vaccine, the patient experienced hands weakness of and tingling of extremity. On an unknown date, the outcome of the hands weakness of was not recovered/not resolved and the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the hands weakness of and tingling of extremity to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 15th December 2022. Reporter's Comment:  This report was submitted via the online reporting system.  Expiry Date of Shingles vaccine was unknown. Weakness and tingling in hand were the symptoms and it was not treated. The reporter consented to follow up.
Several hours after injection and continuing  up to 3 days after the injection: Severe flu-like symptoms like high fever (103), body aches and pains, weakness, dizziness, chills, arm soreness, lymph nodes swelling under the left arm (injection site), itching of the injection site. Approximately 17 days after injection, I had a heavy period after not having a period for over a year.
Pt received immunizations 8/10/10. 8/11/10 pt came to office with reaction to Varicella #2 Lg welt, red, swelling 44mm x >50mm at site where shot was given, pt was advised by PA - who looked at it to take BENADRYL, use cold packs, if it gets worse to call.
Case number PHEH2011US04546, is an initial spontaneous report received from a nurse on 15 Sep 2011: This report refers to 31-year-old female patient. She received first dose of pre-exposure series RABAVERT (batch number 466011A) on 28 Apr 2011 and second dose (batch number 466011A) on 28 May 2011. She did not receive third dose. On an unspecified date in Jul 2011, she began to experienced fatigue, chest and neck pain and high white blood cell count. She also stopped taking birth control pills. Chest X-ray revealed no abnormality. The reporter stated that, investigation was going at time of this report that whether or not patient has any kind of infection. Outcome of the events was ongoing.
My daughter woke up throwing up a lot (and she has never thrown up before, ever).  The next day she had high fever for 3 days.  That resulted in an ear infection on her right ear, and then with a ruptured eardrum on her left ear.  She took antibiotics for 10 days.  4 days after the antibiotic was done, she got a high fever again, all weekend (still happening). She hasn't been this sick before getting the MMR vaccine.  She also developed a rash after the first episode.
March 25, 2022 I started taking medication for a fungus on my big toe. About 3 weeks after that I developed a rash on my chest and shoulders and now has spread over my whole body. I stopped taking the medication 5 weeks after it was prescribed to me. I still have the rash and I have been to the dermatologist to get a different medication to help get rid of the rash. I have seen a podiatrist as well to help with the rash.
Moderna COVID19 EUA  chest tightness and shortness of breath, covid negative per rapid test, tachycardia and HR in 180s-190s. elevated BP and hypoxic, narrow SVT found through EKG, adenosine ineffective, admitted for pneumonia  later developed chest pain and transferred to Hospital
Patient got the Pneumovax23 in her right arm. Per patient, her arm swelled up from her elbow to her shoulder and turned bright red and was warm to the touch. She also experienced headache, fatigue, and coughing. As of 9/25/19, symptoms are improving.
Red, raised head to toe rash 2-3 hours post Td vaccination with itching.  Complained of a headache on day 2 post-vaccination.  Father gave Benadryl po which decreased itching only.  Went to PCP on 8/26/04.  Rec'd steroid injection and allegra po & prn.  Headache gone.
puffiness about 1hr p/inj;arm ached; 3" x 2" welt across upper arm;redness under arm;next day 2"x6: welt;entire arm very sore;put on Doxycycline;
Patient's and father came for dose 2 of the Pfizer COVID 19 vaccine (5-11 year old.) on 12/1/22. The vaccine was taken out from storage in the refrigerator, diluted and given to patient. When reviewing paperwork, I noticed the manufactured date on the vaccine was 12/2021 meaning the vaccine expired on 11/30/22. I immediately notified the patient's father and called the manufacturer for guidance. Unfortunately, the manufacturer's help line was closed and was advised to call during normal business hours.  I called the manufacturer in the morning the next day 12/2/22 and received guidance. Per the manufacturer, they have done studies on the use of expired vaccinations and while not recommended, the use of the vaccine beyond the extended expiration date can be supported as long as used within 7 days of expiry date and as long as the vials were stored at appropriate storage conditions throughout their entire shelf life. After the call, I notified the patient's father of the manufacturer's guidance. The father reported no adverse side effects at this time. Also consulted father to continue monitoring and reporting any symptoms.
COVID 19 VIRUS TEST POSITIVE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid 19 virus test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 virus test positive was not reported. This report was non-serious. This report was associated with product quality complaint 90000241173.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 04-Nov-2021. Vial did not undergone any temperature excursion. No adverse event was reported.  No treatment medications were reported.
HIGH FEVER AND RASH ONSET WITHIN 24HOURS OF ADMINISTRATION.   ANALGESICS FOR FEVER AND PAIN
This spontaneous report as received from a healthcare worker (medical assistant) refers to a child patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 06-AUG-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) lot # L011079, expiry date 01-OCT-2016 (route of administration and dose not reported). The reporter stated she did not have the medical record at the time of the call. No adverse effects were reported. Additional information has been requested.
a very rare cancer; couldn't walk after 2 weeks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on 06Jun2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: unknown) on an unspecified date at single dose for COVID-19 immunisation. After the second shot on 06Jun2021, the patient couldn't walk after 2 weeks, and was diagnosed with a very rare cancer in Jul2021. The event rare cancer resulted in doctor or other healthcare professional office/clinic visit, death, life-threatening and caused hospitalization. It was unknown whether the patient had been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of rare cancer and couldn't walk. The patient died on 19Aug2021. It was not reported if an autopsy was performed. Reported cause of patient death was cancer. The outcome of event rare cancer was fatal. The outcome of event couldn't walk was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: a very rare cancer
Following second injection on  03/11/2021 with lot A31A21A muscle and joint pain  subsided but never wen away.
Pt recvd vax & devel swollen lymph nodes on rt side of groin following vax; No further details were provided;
sick for one week; Initial information was received on 03-Nov-2021 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional via social media.  This case involves a male patient (age unspecified) who was sick for one week (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date, the patient was sick for one week (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " Same here I will never get the flu shot. My neighbor get the shot and he's sick for one week".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  On an unknown date, the patient recovered from the event.  The reporter did not report causality of event with suspect.  There will be no information available on the batch number for this case.
Red & itchy bumps on toes, right arm from the elbow up, joints on thump & index finger & back of fingers & on fave & neck
Patient presented with strokelike symptoms.  CT angiogram of the head showed artifact and basilar artery occlusion and subsequent increased amount of collateral vessels involving the circle of Willis a lot of collateral flow around the right middle cerebral artery and occlusion of the M2 branch.  Patient subsequently underwent transfemoral cerebral angiogram with selective left vertebral artery injection; superselective catheterization injection basilar artery, right and left posterior cerebral artery, mechanical thrombectomy of 3 separate vessels including basilar artery, left posterior cerebral artery, right posterior cerebral artery; right common femoral angiogram evaluation.