chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report  was received from a consumer concerning a 63-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced feeling extremely dizzy, headache, soreness of the arm and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of events, the patient received their dose of mRNA-1273 (Batch Number: 026126A) for prophylaxis of COVID-19 infection.   On 01-Jan-2021, the patient experienced feeling extremely dizzy, headache, soreness of the arm and fatigue.  No treatment information was provided  Action taken with mRNA-1273 in response to the events feeling extremely dizzy, headache, soreness of the arm and fatigue was not reported.  The outcome of the events feeling extremely dizzy, headache, soreness of the arm and fatigue was not reported.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded. Headache and fatigue. are consistent with the known safety profile of mRNA-1273.
The patient received a vaccine that is meant and tested for 18 yrs and older. the patient is 12 yrs old. no adverse effect noted by the patient.
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of Varivax. Subsequently the patient developed a brain tumor. There was no product quality complaint involved. No further information was available. Additional information is not expected. Upon interval review the patient's brain tumor was determined to be an other important medical event. The patient's sibling (WAES # 0703USA01528) had the same experience after vaccination with Varivax.
Administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 range (Inconclusive) Antibodies numbers were in the range of 800-900.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided  Patient did not report any adverse events or symptoms
Pt also received the PPD skin test. minutes after shot almost fainted, had nausea, pale wouldn;'t see, like black out. Sat down on chair mother talking to pt to prevent fainting, pt was sweating. symptoms lasted for 5 minutes, until 7:30 pm still felt weak.
Client had a syncope event four minutes after vaccine administration. Client was standing during syncope event , fell to the floor and hit his head. Client lost consciousness for four to five seconds. Client became responsive and able to answer question .  PA-C evaluated client and ordered 911 call. Client was transported to Medical Center  Emergency Room for evaluation. Client was released the same day with instruction to follow up with pediatrician. Client was seen by PA-C on 7-16-19 and ordered an encephalogram.
At first, I felt nauseous but I know that it's standard, but nausea kept getting worse by the hour to the point where I would spit up about 2-3 times a day and my appetite would decrease, and it would make my throat burn. I also had a tender shot arm in both arms, but my right arm was in the most pain. I also experienced body aches that are so painful that I also have nerve pinching all over my body. I've also been dealing feeling so light-headed that I nearly pass out when moving around too much. I have also been dealing with a migraine that rated 7-9/10 on the pain scale. I had thought the symptoms would go away at least by Sunday but they only worsened. So then I needed to wait until Monday morning until I was able to reach my neurologist and Primary Care doctor. I have seen my primary care physician and was prescribed Ondansetron ODT for the nausea and Pepcid to help with Acid Reflux. Now I'm dealing with the body aches and migraines still.
On the evening of 8/27/23 patient noticed some soreness and swelling near vaccination site. Over the next few days the swelling and a red, hot to the touch, outline moved downward almost to the wrist. Patient had body aches and fatigue but no fever. During the visit patient was tested for the flu and the result was negative.
Extreme swelling, itching, redness, hot; fever body aches, headache (2 weeks) shingles, nausea. (Pharmacy stated that 58% of patients have same "Rare" adverse effects but Merck considers "rare" or "uncommon") if I would have known (as many have online) I would have considered more carefully.
12/30 - Arm soreness directly after injection; flu symptoms started about 3 hours after injection (99.5 temperature, headache, body ache, low energy and chills). 12/31 - 7am 101.1 fever; worsening of all above symptoms plus nausea; 8/10 headache; symptoms persisted through the afternoon and started to resolve in PM 1/1 - all symptoms resolved and temperature 97.4
Severe pain coming and going around the liver area at 10:00 AM. This subsided after about 10 minutes.   Burning stomach pain starting in upper stomach and traveling to lower stomach around 2:00 PM and lasting at least 2 hours.
Patient diagnoses on 9/24/04 with possible varicella. Counseling given re: outbreaks, lenght of outbreak etc. 20 tiny vesicles with red base.
The day after my second Moderna vaccine, my heart raced all day. It felt like it was skipping which made me occasionally cough. My resting heart rate is normally 74 bpm. That day, despite resting on the couch all day, my heart rate was in the fat burn zone for 11 hours and 39 minutes. My heart rate was over 100 bpm for most of the day. My heart rate got up to 128 bpm.
tinnitus of the (mostly) left ear. initial side affects included headache, vertigo and severe chills
hives, redness, warmth, itching on arms, legs, back of hands, palms, neck, scalp, entire back, travels, not all areas at one time. Went to the ED last night when it was covering my back. I had taken 3 Benadryl from 4pm on 3-9-21 through 0230 on 3-10-21. Narrative:  Other Relevant History:
pt recvd vax 2FEB93; that evening spiked high fever & had high pitched screaming; exam 3FEB93 was nl x/diaper rash; t99.8 ax; fever gone by 9PM-11PM 3FEB93 w/o rx;
Extreme fatigue for 1 week. Followed by severe shoulder joint pain in right arm (opposite side of shot) for 1 week. Then severe shoulder joint pain in left arm (shot side). Unable to raise my arms. ***Note: I had a second adverse reaction after second shot 04/20/2021, in left arm shoulder joint, very severe pain for 2+ weeks. Non-responsive to NSAIDs. Required Tramadol, Bentyl and Baclofen pain meds to sleep.
Client arrived at site to receive second dose, upon assessment client notify vaccinator that upon  waking up the next morning noticed that lips was swollen and had hive all around her body. she didn't notice them before she want to bed. she said it went away couple of days after. She was not given the vaccine instead resources about her contacting pcp was given to her.
pt nasal congestion & large amounts of loose stools; not sleeping well;high pitched cry, vomit, diarrhea;became lethargic, spitting up,uncomfortable;only tolerating small sips of water;sleeping on/off moan when awake;
Initial sensory problems in upper extremities and head/face, progressed to weakness and fasciculations, and ultimately involved lower extremities as well as tinnitus and frequent dizziness.
Headache; Chills; Lethargic; Almost sleeping for 24 hours because he was so tired; Almost sleeping for 24 hours because he was so tired; He was warm; Rash in the chest area; This is a spontaneous report from contactable healthcare professional via a Pfizer Vaccine Sales Representative. A 17-year-old male patient received first dose of meningococcal group b rlp2086 (TRUMENBA), intramuscular on 04Aug2020 at 0.5 mL for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received Flu and tDap vaccines and the patient did develop other reactions to the Flu and tDap vaccines that they have documented, it was noted in his file from when he was 11 years old. It was reported that patient got the meningococcal group b rlp2086 vaccine on 04Aug2020 and he developed side effects within the hour, patient had a headache, chills, was lethargic, he was almost sleeping for 24 hours because he was so tired, he was warm, but had no fever. They just talked the mom who was going ballistic. A lot of the side effects have gone down, but he has since developed a rash in the chest area in Aug2020. He is coming back to the office to follow up on the side effects and the rash he developed. The patient's mother was going ballistic and did not hear the fact that they were trying to rule out Covid because the family just got back from a state. The reporter said that had they known that, they would not have given the patient the vaccine and would have waited 14 days before allowing him to come back to the office. The patient is stable, but except for the side effect of the rash. The outcome of the event rash in the chest area was not recovered while the outcome of the other events was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial unsolicited report received from a physician on 30 November 2015. This case involves a 63-years-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI496AB, expiry date: 30 June 2016, dose, dose in series were not reported and site of administration was unknown) intramuscularly on 23 October 2015. The patient's illness at time of vaccination was unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergic to penicillin (PCN), Erythromycin, Percocet and had hypertension (HTN), Gastro esophageal reflux disorder (GERD). Concomitant medications were not reported. On 24 October 2015, one day following the vaccination, the patient had developed occular hyperemia with bloodshot eyes, tearing, drainage and swelling around the eyes with a sore throat. The patient had previously received many doses of FLUZONE QIV. The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The patient had not recovered from all the events. List of documents held by sender: none. Follow-up information received from a physician on 21 January 2016. It was reported that the patient received 0.5 ml dose of FLUZONE QIV in left deltoid.
Pregnant patient calling to be added to the pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient calling to be added to the pregnancy registry) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism in June 2020.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-May-2021. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient calling to be added to the pregnancy registry). On 23-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient calling to be added to the pregnancy registry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Internal review on 28JUN2021 resulted in updates to pregnancy details.
High Fevers, Nausea and Vomiting, Severe pain at injection site, Syncope, dizziness, abdominal pain, patchy hair loss. Lasted for 72 hours.
Chronic inflammatory demyelinating neuropathy attack.  1/19/09 Reviewed hospital d/c summary for 1/8-1/12/2008. FINAL DX: chronic inflammatory demyelinating polyradiculopathy. Records reveal patient experienced recurrence of pain, weakness of right leg, low back pain, difficulty sleeping.  Tx w/IVIG x 5 days w/improvement.  D/c to home with on continued pain management w/neuro outpatient f/u.  1/8/09 Reviewed PCP medical records for 7/22/08-10/24/08 FINAL DX: recurrent chronic inflammatory demyelinating polyradiculopathy Records reveal patient experienced right hip pain, arthritis, constipation, insomnia, hyperesthesia of skin & dx w/herpes zoster, tx w/antiviral meds. 7/22/08 record indicates pt recently released from hosp s/p chronic demyelinating polyradiculopathy.  Continued to have pain, difficulty walking, gait disturbance, depression & falling down at that time.    12/2/08 Reviewed hospital medical records of 10/16-10/19/2006. FINAL DX: chronic inflammatory demyelinating polyradiculopathy Records reveal patient experienced recurrent pain & weakness left leg beginning 9/2006.  Admitted for IVIG x 4 days.  Improved & d/c to home.  10/27/06 GI consult done for normocytic normochromic anemia & colonoscopy.
09/05, local reaction, 09/06 local reaction (1.2/4") 09/06 local reaction 2 1/2" x 2 1/2" with tender, hard & hot.
Initial and follow-up information has been received from a certified nurse midwife, for the Pregnancy Registry for GARDASIL, concerning a 22 year old female with inherited bilateral sensoneural hearing loss and a history of vaginal bacterial infections, alcohol abuse and urinary tract infections, and no known drug allergies, who on 23-APR-2008 was vaccinated intramuscularly in the right arm with a 0.5 ml first dose of GARDASIL (Lot# 659964/1978U) while pregnant. There was no adverse event post vaccination. Other medications included prenatal vitamins (unspecified). Prior to the vaccination, the patient was administered a urine and blood test to test for pregnancy. The urine test result was unclear. The blood test result came back with a positive result the next day (LMP = 17-Mar-2008). Results are pending for an ultrasound and CF screen performed on an unspecified date. Unspecified medical attention was sought in the office. The patient's outcome is unknown. Follow-up information was received. Other medications included prenatal vitamins, started on 05-MAY-2008, 1 tablet daily for pregnancy. Complication during pregnancy included fetal vascular thrombosis. On 25-NOV-2008, more than 35 weeks from LMP, the patient experienced fetal death/still birth. The products of conception were examined. The fetus was normal. Upon internal review, fetal death/still birth was determined to be an other important medical event. No further information is available.
The winter following her Gardasil series the patient developed significant Raynaud's Disease. Bloodwork included a + ANA and + RNP antibodies and low white count. So far she has not developed symptoms of SLE or mixed connective tissue disease, apart from general aching, but ANA has been elevated as high as 1:1280 speckled. THere is no family history of autoimmune disorders. Her Raynaud's symptoms continue to be very significant and she is on daily Procardia XL 30 mg, year round. 11/13/09 Medical/lab/ vax records received. OV 10/20/08 DX: Reynaud's syndrome.  PE WNL.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race, ethnicity. The patient's height, and weight were not reported. No past medical history. Concurrent conditions were reported from spouse as "physical issues" (captured as physical disability). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  After receiving the vaccine, the patient go COVID (captured as suspected COVID-19 Infection), felt mild symptoms along with suspected clinical vaccination failure (dose number in series 1). The outcome of the suspected clinical vaccination failure and suspected covid-19 infection were unknown (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported.   After receiving booster patient did not experienced any adverse events and stated as good (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208740. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed a manufacturing related root cause could not be identified, based on the regulatory authority evaluation/investigation performed.; Sender's Comments: V0: 20211256561-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient's wife called, said patient is shaking uncontrollably, cold to the touch, and is sick to the stomach. She also reported he was achy all over. Patient and his wife both received the vaccine a couple hours before and she is feeling fine. I recommended ibuprofen for the achiness. Pt also reported headache - which he normally doesn't get.
Severe stomack pain. 2 days. Went to the Urgent Care and was sent to the ER for exrays. Nothing found, No explaination. Following up on 4/15.
Approximately 3 day after Moderna Vaccine was given on 5/14/21, patient states she started experiencing itching around both eyes with some swelling and redness.  She stated she went to both her eye Dr. and regular PCP and they tried several different things but it was only relieved by a steroid treatment.  She stated that when she had completed the steroid that the itching and redness started to come back.
No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002495: US-009507513-2104USA002492: US-009507513-2104USA002491: US-009507513-2104USA002490: US-009507513-2104USA002494:
pt recvd vax & began to exp fever,vertigo,nausea;then had episodes of passing out once a wk for the first month,then once a month;addl exp neuralgia & myalgia;has been evaluated @ med ctr & still exp vertigo,weakness,numbness
pt had small bruise; red & sl swollen; Sat AM swollen & red about 2-3"; chills; no temp; erthema 55x75mm; broken & intermittent on rt vastus lateralus; no temp or c/o itching;
After receiving the 1st dose of the vaccine 3/11/2021 I had existing health problems of back, shoulder and knee pain, but after the vaccine I had more flare ups and then when I had the 2nd dose of the vaccine, everything that hurt was hurting real bad the day after and it has not let up.
Intermittent chest pain. Very sharp and shooting. Intermittent racing pulse when at rest. Events are completely random and not identified or brought on by any factors. Was hospitalized; Intermittent chest pain. Very sharp and shooting. Intermittent racing pulse when at rest. Events are completely random and not identified or brought on by any factors. Was hospitalized; This is a spontaneous report from a contactable nurse (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 (Batch/Lot number was not reported) (at age of 36 years) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history was none. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on unknown date (Batch/Lot number unknown) for COVID-19 immunisation. Vaccine facility type was in workplace clinic. The patient experienced intermittent chest pain, very sharp and shooting, intermittent racing pulse when at rest on 31Mar2021. Events were completely random and not identified or brought on by any factors. Patient was hospitalized. Covid was tested post vaccination (unknown results), covid test type post vaccination was no. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered. It was unknown if treatment was used for events.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events "intermittent chest pain, very sharp and shooting, intermittent racing pulse when at rest" with BNT162b2 can not be completely excluded in this patient that is relatively young and has no reported known illnesses.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.