chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have not menstruated since receiving the Moderna booster. I took an at home pregnancy test in early February and tested negative. Based on symptoms e.g. cramps, I think I am about to finally get my period soon.
38 year old male, received typhoid injection around noon on 9 Sep 04.  He had soreness at the injection site shortly after receiving the injection.  Approximately seven hours later he was running and noticed pruritus on chest, posterior neck, bilateral shoulders and legs.  When he finished his run, he noticed that intensely pruritic "hives" were present on his upper lip, behind his ears, on posterior neck, bilateral shoulders, chest and legs.  Within 5  10 minutes the hives had spread across his body.  His palms and soles itched but did not have any lesions.  He took two Benadryl approximately one hour after noticing the hives.  The intense pruritus lasted for about 45 minutes after taking the Benadryl.  The lesions faded overnight.  Doctor saw him on 10 Sep 04.  At that time, he had some residual, faint lesions on his chest and left ear.  He never experienced any difficulty breathing or swallowing.  He has not had any recurrence of the lesions or pruritus.
This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), DIZZINESS (Dizziness- I couldn't drive), HEADACHE (Headache), PYREXIA (Mild fever) and PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Mild fever). On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness I couldn't drive). On 06-Jul-2021, the patient experienced MIGRAINE (Migraine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine). At the time of the report, MIGRAINE (Migraine), DIZZINESS (Dizziness I couldn't drive), HEADACHE (Headache) and PYREXIA (Mild fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received the 1st & only dose of the Moderna Covid-19 vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Magnetic resonance imaging: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PATIENT NOTICED 2 BULGED MUSCLES NEAR THE SITE OF VACCINATION A FEW DAYS AFTER. IT IS NOT OBVIOUS FROM FRONTAL VIEW BUT ON SIDE VIEW ONE BULGE IS ON TOP LEFT SHOULDER AND ANOTHER ONE A THE BACK OF THE ARM. HE EXPERIENCES NO PAIN, NO SWELLING NOR REDNESS AT SITE. PATIENT TO TO SEE HIS PCP ON 8/9/2019 TO ASSESS  WHAT MAY BE THE CAUSE OF BULGES MUSCLES. DR ORDERED ULTRASOUND SCAN.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information contained updated outcome.
On August 29, I woke up with a fever of 107. I went to get tested on the following Monday, August 2 and got results that I tested positive for COVID on August 4th. I was congested, couldn't breathe through my nose, had a loss of taste and fever. Congestion was the worst and made me call the doctor for medication. I felt bad for a couple of days, and on Saturday, I started feeling better.
First dose of rotavirus vaccine administered over age 14 weeks and 6 days.  Safety data not available in this age group.
Patient was accidentally given two doses of Hepatitis B vaccine on 8/10/23 (Pediarix and HepB). On 8/14/23, mom stated pt had no concernings symptoms or atypical behavior after receiving vaccines and was doing well.
pt c/o not feeling well while in car w/wife;EMS was called when arrived pt was in cardiac arrest;attempts to revive failed was transported to hosp ER states COD listed on ER record as cardiac arrest;
my left hand, and at times my right hand, would completely hurt; my left hand, and at times my right hand, would completely hurt, get random red spots/left leg and my right foot became red; I have trouble lifting things; This is a spontaneous report from a contactable consumer. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Right on 28May2021 (at the age of 37 year) as dose 2, single for COVID-19 immunisation. Medical history included none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was unknown if Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EW0182), dose 1 via an unspecified route of administration in Arm left 07May2021 for COVID-19 immunisation and experienced pain in my left eye. On 08Jun2021, consumer reported that about a month later, consumer left hand, and at times right hand, would completely hurt, get random red spots, and veins would be very visible. This was still happening. Except now, its gravitated to my left leg and my right foot became red for no reason. My left hand feels like destroyed a nerve and have trouble lifting things with it. This has been ongoing a month after my final vaccine. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. It was reported that no therapeutic measures were taken for the events experienced. The patient was hospitalized for all events for 1 days. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Had 2 seizures; her Enbrel misfired and did not inject; her Enbrel misfired and did not inject; This is a spontaneous report from a contactable consumer, based on information received by Pfizer.  This serious spontaneous report was reported on 09/JUN/2021 by a consumer and involves an approximately 66 years old female patient who had two seizures [PT: seizure] and her Enbrel misfired did not inject [PT: accidental exposure to product] while receiving Enbrel with Single Dose Prefilled Autoinjector (lot number: 1125683, expiration date: 30Sep2023). No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis mutilans. The patient's concomitant medications included covid-19 vaccine (batch/lot number unknown). No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, when she took Enbrel before getting covid vaccine she had two seizures and the physician thinks it because she took covid vaccine to close to taking with Enbrel also patient stated that her Enbrel misfired and did not inject. No treatment information was received. The outcome of the events seizure and accidental exposure to product was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the event seizure. The consumer reported that the event seizure was possibly related to Enbrel. The causal relationship between the event accidental exposure to product and Enbrel was not provided by the consumer. The causal relationship between the events seizure, accidental exposure to product and Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Manufacturer Comment: This safety report does not necessarily reflect a conclusion that etanercept, and device, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Covid; Vaccine does not work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid) and VACCINATION FAILURE (Vaccine does not work) in a 4-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (Covid) and VACCINATION FAILURE (Vaccine does not work). At the time of the report, COVID-19 (Covid) and VACCINATION FAILURE (Vaccine does not work) outcome was unknown.            The patient was in 30s.  It was reported that patient not took any medication. No concomitant medications were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706221 (E2B Linked Report).; Reporter's Comments: This spontaneous case concerns a 4-decade-old female patient, with no medical reported who experienced the unexpected events of Covid-19 and vaccination failure approximately 3 months after a dose of  mRNA- 1273 bivalent vaccine. We have no information about primary schedule, events after them and outcome of the event. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706221:Husband case
6 inch diameter erythema around injection area noticed after injection administered. Had pain for 2 days.
New onset diagnosed alopecia Areata within 11 days of vaccine.; 2 large bald patches on the scalp as well as overall thinning; 2 large bald patches on the scalp as well as overall thinning; Fist signs were 6-7 days out; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0150), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jul2021 at 14:00 (Age at vaccination: 17 years) as dose 1, single for covid-19 immunisation. Medical history was reported as None. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not test covid post vaccination. Patient did not had allergies. The patient reported  fist signs were 6-7 days out (hypoaesthesia) on 27Jul2021 and reported new onset diagnosed alopecia areata within 11 days of vaccine, 2 large bald patches on the scalp as well as overall thinning 02Aug2021. Adverse events resulted Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of new onset diagnosed alopecia areata within 11 days of vaccine, 2 large bald patches on the scalp as well as overall thinning, fist signs were 6-7 days out. Steroid injectons in scalp, topical steroid was received as a result of events. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0176), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 at 02:00 PM. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Left upper thigh with 3 cm induration & erythema with visible puncture warmth & pain to touch.
eye twitch, facial numbness. Left eyebrow  lower than right, unable to move. unable to smile. DX w/ Bells Palsy. Treated w/prednisone + valtrex
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (quite sore), vaccination site swelling (swollen) and vaccination site warmth (hot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 018B21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 23, 2021, patient experienced vaccination site pain (quite sore). On Mar 30, 2021, patient experienced vaccination site swelling (swollen) and vaccination site warmth (hot). At the time of the report, vaccination site pain (quite sore), vaccination site swelling (swollen) and vaccination site warmth (hot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
FEVER/FELT FEVERISH; FATIGUE; INJECTION SITE SORENESS; GENERALIZED BODY ACHES; TASTE IN THROAT; NAUSEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included fell on hips, and concurrent conditions included did not consume alcohol, and did not smoke, and other pre-existing medical conditions included there was no any drug abuse or illicit drug usage. The patient experienced eye allergy when treated with azelastine for eye allergy, and transient ischaemic attack when treated with acetylsalicylic acid for transient ischaemic attack.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced generalized body aches. On 07-APR-2021, the subject experienced taste in throat. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced injection site soreness. On 08-APR-2021, the subject experienced fever/felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever/felt feverish, was recovering from nausea, generalized body aches, and taste in throat, and had not recovered from fatigue, and injection site soreness. This report was non-serious.
HAD A C SCAN AND ALL OF A SUDDEN I NOW HAVE SPINAL STENOSIS. YOUR NURSE TOLD ME TO REPORT THIS
Headache, Myalgia, Fever, NauseaVomiting, fatigue, pain at injection site Narrative:  Other Relevant History:
While vaccines were being administered by medical assistant she noted that the patient turned pale and started having mild upper body shaking.  Lasted around 5 seconds.  Patient then started to vomit.  When questioned patient reports that he felt lightheaded and the next thing he noticed was "everyone" in the room.  Patient was taken to a room to lie down.  VS taken and blood sugar.  Blood was drawn as well before vaccines were adminstered.
Information has been received from a registered nurse concerning a 4 year old white female with a history of asthma and no known drug allergies who on 28-APR-2005 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) (lot# 648307/0582P). The illness at the time of vaccination was nasal congestion. On 30-NOV-2007 the patient developed one spot on the left side of her back. It was unknown whether medical attention was sought. No labs or diagnostic studies were performed. Subsequently, the patient recovered. Additional information has been requested.
After administering booster shot of Moderna (0.25ml) came to find out patient had already received 2 doses of Janssen vaccine, a previous does on 11/18/2021 and one the year before in another state (so the first original dose did not show up in our database).   Patient is not experiencing any adverse events that I am aware of but did receive an additional dose.
Chronic Fatigue, Fibromyalgia, PAIN! Everywhere, all the time. Insomnia. Twitching, Autoimmune like issues. These started around the time of my first dose and after my last one......it never stopped.
Fatigue 24-48 hours after injection; Pain at the injection site up to 3 days; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 at 13:00(at the age of 34 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient does not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue 24-48 hours after injection, pain at the injection site up to 3 days on an unspecified date on Jan2021. The patient did not receive any treatment for events. Outcome of all the events were recovered.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Severe soreness to left arm, could not use extremity at all, weakness, headache, severe nausea. Took 800 mg po of Motrin every 8 hrs. Thereafter. Symptoms have continued for more than 24 hrs.
Injection site is sore, raised, swollen/firm and warm to the touch.  He also reports a swollen lymph node in his armpit. He feels the soreness ebbs and flows.
Information has been received from a 72 year old female consumer with Non Hodgkin's Lymphoma, allergy to antibiotics and a history of herpes zoster breakouts who on 07 Oct 2006 was vaccainted SC with one dose of varicella zoster virus vaccine live. Concomitant therapy included PROCRIT, DETROL, NEXIUM, and RESTUSGAN. On 07 Oct 2006 the patient reported that she was itchy all over. She reported that she has a compromised immune system due to cancer treatments. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Numbness, tingling, HA, body aches, shingles vesicles next day
45 minutes after first vaccination, her heart was raising; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (45 minutes after first vaccination, her heart was raising) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced HEART RATE INCREASED (45 minutes after first vaccination, her heart was raising) (seriousness criterion medically significant). At the time of the report, HEART RATE INCREASED (45 minutes after first vaccination, her heart was raising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
little pain; tiny rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain) and RASH (tiny rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Glaucoma. Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes, BIMATOPROST (LUMIGAN) for Glaucoma, EZETIMIBE for Hyperlipidemia, LISINOPRIL for Hypertension.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (little pain) and RASH (tiny rash). At the time of the report, PAIN (little pain) and RASH (tiny rash) had resolved.            Treatment details included, pre-medication with - 100mg vitamin C, 2 diphenhydramine, 2 naproxen and cold zinc suckers.   This case was linked to MOD-2021-040433 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Events for 2nd dose added, product details added, treatment details added. On 26-Apr-2021: Reporter's email address added. On 28-Apr-2021: Additional information recieved, contact details added, patient demographics added, history added, product details added, Concomitant medication added, event outcome updated.
Gradual onset of very mild rash and symptoms gradual improved with IM administration of diphenhydramine 50 mg and oral famotidine 20 mg.  The physician was questioning if the mild rash was from where the patient was scratching secondary to anxiety vs allergic reaction.  Patient was monitored for improvements.