chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Both arms hurt for a couple days after the shots; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021. The most recent information was received on 23-Jul-2021 and was forwarded to Moderna on 24-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Both arms hurt for a couple days after the shots) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003b21a and 041b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Both arms hurt for a couple days after the shots). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Both arms hurt for a couple days after the shots) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       The concomitant medications were not provided.   This case was linked to MOD-2021-090542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added patient information which includes height, weight, race and ethnicity. Added Treatment information which includes Ibuprofen. Updated outcome of the event.
Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced hair loss two weeks after vaccination. Medical attention was sought. Additional information has been requested.
Subsequent to receiving one dose of rubella virus vaccine live (second generation) the pt experienced migratory arthropathy and cervical bilateral adenopathy. She sought unspecified medical attention and was treated with Ceftin. The pt completed the course of treatment. No further information is available.
Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Face felt tight, first vaccine.; Mouth and nose dry, first vaccine.; Mouth and nose dry, first vaccine.; Sore arm, first vaccine.; This is a spontaneous report received from a contactable consumer(patient). A 73-year-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 73-years-old, via an unspecified route of administration, administered in Arm Left (in the back of the arm) on 20Jan2021 (maybe at 11:10 am) (Lot Number: EL3246; Expiration Date: Apr2021) as single dose for covid-19 immunisation. Medical history included ongoing Postural vertigo maybe 10 years ago for a day. No family medical history relevant to AE. The patient's concomitant medications were not reported. Patient got the Shingles vaccine years ago and the next day, she had a sore arm and tingles, up and down her arm. She didn't feel food for 7 days and felt achy. It was the first Shingles shot. No prior Vaccinations (within 4 weeks). The patient experienced blood and clots came out of nose and mouth on 21Jan2021 (the same time that she woke up) with outcome of recovered on 21Jan2021. She blew her nose and leaned over and noticed a drop of blood on the rug and grabbed a Kleenex. She blew her nose, easy, and all of a sudden blood and clots came out of her nose and mouth. It lasted for about 8 minutes. Sore arm on 20Jan2021 (started in the evening) with outcome of recovered on 21Jan2021. Face felt tight on 21Jan2021 (around 8:30 or 9:00 am) with outcome of recovered on 21Jan2021. Mouth and nose dry on 21Jan2021 (in the morning) with outcome of recovered on 21Jan2021.
pt recv vax late morning;by evening had rash all over w/diff breathing;mom gave breathing treatment a/going to MD said MD ordered DPH & said no more HBV;
Patient called on 5/4/21 to report what they described as "severe right hip pain" that radiates from the hip to the knee. This started on 5/2/21 and has had minimal improvement. The patient said that the pain would radiate down to their ankle when lying down. The patient said that on 5/4, the pain was still severe but only noticeable when moving. Patient stated that they are able to take a shower and do normal activities without as much pain. Patient stated "I would not be comfortable saying that it has improved since Sunday, but it is not getting worse." Patient stated that they would follow up with their primary doctor by the end of the week if no improvement. Patient stated that they have a history of spinal stenosis and sciatic nerve pain for the past 10 years. They have received treatment for it but have not had any issues with sciatic nerve pain recently.
pt recvd vax 27OCT93; pt exp constant aching  in the arm of inject & arm felt heavy; pt was treated w/Motrin but sx cont;
This spontaneous prospective pregnancy report was received from a consumer refers to her daughter of unknown age. On 04-OCT-2013 the patient was vaccinated with 0.5 milliliter (ml) (reported as standard dose) dose 1, GARDASIL (lot # and expiration date not reported) intramuscularly. Patient was currently 5 weeks pregnant with Last Menstrual Period of 20-SEP-2013 and Estimated Delivery Date of 27-JUN-2014. Initial exposure to GARDASIL was at 2 weeks. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: pt insisted to get up to go to bathroom and got dizzy and fell on her way to bathroom hit the chin face down on the floor
Muscle soreness at inner portion of upper left arm (not at injection site) with red welt like circles warm to the touch. No symptoms.
This spontaneous report as received from a Registered Nurse refers to a 22 month old male patient. On 27-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006158, expiration date 30-AUG-2013, dose, indication, route not reported) instead of PROQUAD. No adverse effects reported. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant information received.
The vaccine is by Johnson and Johnson.  There was no lot number.  Side effects are absolutely no energy.  I just want to sleep all day.  My head has pressure.
Age under the requirement for EUA (<18 years of age).  No other adverse symptoms noted.
PATIENT'S SPOUSE REPORTS PATIENT WAS ADMITTED TO HOSPITAL ON 031421 FOR SEVERE SEPSIS WITH ACUTE ORGAN DYSFUNCTION, ACUTE METABOLIC ENCEPHALOPATHY, BILATERAL PNEUMONIA AND ACUTE HYPOXEMIC RESPIRATORY FAILURE THEN PASSED AWAY ON 3/27/21.
Information has been received from a consumer concerning her son a 7 year old male with asthma and no known allergies who in October 1999, was vaccinated SC with a 0.5 mL dose of Varivax. Concomitant therapy included montelukast sodium. On 17-MAY-2006 the patient developed mild case of chickenpox. Unspecified medical attention was sought. No laboratory tests were performed. At the time of the report the patient was improving. There was no product quality complaint involved. Additional information has been requested.
A vaccinator was vaccinating a client, and some fluid leaked out at injection site.; A vaccinator was vaccinating a client, and some fluid leaked out at injection site.; blood trickle down the arms; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 24 year-old male patient received bnt162b2 (COMIRNATY), administered in arm, administration date 08Feb2022 (Lot number: 33030BD, Expiration Date: 31May2022) at the age of 24 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), VACCINATION SITE EXTRAVASATION (non-serious) all with onset 08Feb2022, outcome "unknown" and all described as "A vaccinator was vaccinating a client, and some fluid leaked out at injection site."; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 08Feb2022, outcome "unknown", described as "blood trickle down the arms".  Additional information: Reporter is a Physician Assistant, working at a vaccination site. A vaccinator was vaccinating a client, and some fluid leaked out at injection site. Unsure how much of the vaccine was actually administered. Asking that should we give another dose immediately. Patient was administered today (at the time of report, that is 08Feb2022). Physician assistant confirmed that not the entire dose of the purple cap Pfizer BioNTech covid-19 Vaccine has been administered to a patient. They estimate it to be about half or 3/4 of the dose only administered, after she pulled the needle out there is little bit of fluid and little bit of blood trickle down the arms. Reporter don't know how much actually got in but MA (further not clarified) told me after she pulled the needle out there is little bit of fluid and little bit of blood trickle down the arms. Reporter was thinking it was at least half the dose if not more actually got in, but just can't be sure and didn't see it.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities and updated event from injection site leaking to vaccination site extravasation.
Throat all of a sudden started feeling like when I eat walnuts-tingling and coughing and the sense of closing or swelling. Took Benadryl for the evening. Woke up and only slightly better but throat felt like it was spasming. Called cdc, called doctor, called urgent care-ended up going to ER. Gave me steroids and Pepcid and Benadryl to help with reaction.  Tuesday-still have slight spasms and slight weazing like when my asthma kicks up.
patient got the vaccine and less than a minute later he slumped in his chair, his color was yellow HR was 38 BPM, emergency department were called he stayed unconscious for around 1 minute, patient claims that he has had anything to eat since breakfast and he claims that this has happened on his first dose, the ED waited till he is better and he walked to his parent car and went home according to mom
Nausea, vomiting. Diarrhea, Fever over 100 degrees Beginning 5:30 am day following vaccine. Seriously ill for around 8 hours. Treated with Motrin, rest
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with M-M-R II (lot # M007277 with expiration date 09-SEP-2018, lot # M029230 with expiration date 08-JUN-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677:  US-009507513-1707USA006507: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676:
tested positive for Covid-19; muscle ache; shortness of BREATH; This case was reported by a nurse via licensee and described the occurrence of coronavirus test positive in a 21-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 9th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 21st November 2020, 12 days after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device and an unknown time after receiving RabAvert, the patient experienced muscle pain and shortness of breath. On 22nd November 2020, the patient experienced coronavirus test positive. On an unknown date, the outcome of the coronavirus test positive, muscle pain and shortness of breath were unknown.   It was unknown if the reporter considered the coronavirus test positive, muscle pain and shortness of breath to be related to RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient getting pre-exposure immunization with Rabavert tested positive for COVID-19.  The patient had the 1st dose of Rabavert on 2nd November 2020. The patient started presenting symptoms muscle ache and shortness of breath last Saturday (21st November 2020) and tested positive for COVID-19 on 22nd November 2020. Next dose was scheduled for Saturday. The patient must now need to remain isolated, quarantined. The reporter asked if they postpone the dose meant for day 28 or if there was a problem or what happens if they vaccine a few days later
mom states, pt became very pale & t102.6 to 103 R around 1 to 2PM on 24SEP93;
Hospitalized (02.27.2022-03.02.2022); COVID-19 positive (02.27.2022); Fully vaccinated plus booster  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 2/27/2022 Discharge Date: 03/02/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia COVID-19   HOSPITAL COURSE: Patient is an 86-year-old male presenting to the emergency department on 02/27/2022 with chief complaint of shortness of breath and weight gain.  In the emergency department, patient tested positive for COVID-19 his chest x-ray showing increased bibasilar infiltrates.  Patient also had evidence of hypoxia and was placed on 2 L nasal cannula.  For patient was started on Decadron.  No remdesivir was given secondary to length of symptoms.  Patient was able to be weaned to room air during the day but did qualify for nocturnal oxygen 2 L nasal cannula upon discharge.  Patient did present with chronic suprapubic catheter which was replaced prior to discharge.  Patient improved during his hospital stay and was deemed stable for discharge and agreeable to treatment plan
During monitoring period post Pfizer COVID-19 vaccine, pt states she has mild tongue swelling and tongue numbness. VS: 123/72, Given Benadryl 25mg by mouth. Patient was transferred to: home
PLATELETS DECREASED; This spontaneous report received from a consumer concerned of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune deficiency.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Laboratory test was recommended by her doctor due to her autoimmune deficiency.  On an unspecified date, the patient did quarterly blood test for platelet count which showed poor platelets numbers (platelets decreased), however retest was performed for possible test error and poor numbers. Retest showed the worse results and doctor requested patient to proceed to an emergency room. Patient was hospitalized (date unspecified) for a week with hourly blood test to daily test. Patient was discharged from hospital at the end of week with weekly test checks. Laboratory data (dates unspecified) included: Platelet count as Low/Poor numbers and platelet count second test showed worse result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from platelets decreased. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210411605-covid-19 vaccine ad26.cov2.s-platelets decreased. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY
pt recv 2 doses of vax on 29JUN95 & 27JUL95 & 14AUG96 lab eval revealed that the pt failed to seroconvert w/a titer of 0.05;
Cellulitis in the arm i received the shot; pain in my arm where i received the shot; This is a spontaneous report from a contactable other hcp. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EL1284), dose 1, via an unspecified route of administration on 30Dec2020 (at the age of 37-years-old) as a single dose for covid-19 immunisation. Medical history included was reported as none and the patient reported no known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other medications were received within 2 weeks of the vaccination. On 15Jan2021, the patient reported he started having pain in his arm where he received the shot. He went to the doctor and was diagnosed with cellulitis in the arm he received the shot. Therapeutic measures taken included unspecified antibiotics. Clinical outcome of the events cellulitis and pain in the arm he received the shot was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of cellulitis and pain in arm due to temporal relationship.  There is limited information provided in this report. This case will be reassessed once additional information is available.  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.
TEMPERATURE EXCURSION, vaccine was stored in the Freezer longer than the recommended manufacture time frame.
Pt recvd 1st dose of vax w/o incident; Pt recvd 2nd dose of vax & c/o severe burning when inject administered & for hrs p/administration; in the morning following the 2nd dose, awoke w/stiff neck, soreness @ inject site, aching all over;
Dizzy, nauseated, shaking, difficulty breathing apporx.  1-2 hours after receiving vaccine.  Taken by ambulanc to Heartland ER.  Symptoms had subsided by the time they reached the ER.
This spontaneous report as received from the patient's mother refers to her son, a 6 months old male patient. The patient was vaccinated with a dose of VAQTA (Lot # not reported). Concomitant medications included PEDIARIX and PEDVAX HIB. In February 2004, while on the vaccine the patient experienced vomiting, diarrhea and had a slight body shake. His hair also became dry. He still had dry hair at the time of report. His eyes were dry and red at the time of report. He was a picky eater. His motor skills had also been affected. The patient sought for medical attention by visiting the doctor. The outcome was reported as not recovered. Additional information is not expected.
brain bleed; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program support. This is the first report of 2 reports, for the first dose.  A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, administered in left upper bicep on 26Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation.  Medical history included ongoing diabetes and the patient had it for 10 years or so and was diet controlled, his blood sugars was good. And ongoing supraventricular tachycardia (SVT) for about 4 years and was medication control. And patient was an amputee from an accident many years ago. Concomitant medications included ongoing carvedilol (COREG) taken for SVT.  It was reported that the patient had a brain bleed after the first dose that might be but probably wasn't related to the vaccine. Event outcomes was unknown.  No follow-up attempts needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021596614 same reporter/patient/drug, different event/dose.
Perimyocarditis - Chest pain, shortness of breath  Elevated troponin to 12. TTE EF mildly reduced to 45-50%.  Ketorolac, colchicine - Improved over 3 days. Troponin down to 1.2. Echo modestly improved by discharge to 50-55%.
needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose; body aches; headache; lethargic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose), MYALGIA (body aches) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LETHARGY (lethargic), MYALGIA (body aches) and HEADACHE (headache). On 19-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose). On 19-Apr-2021, PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose) had resolved. At the time of the report, LETHARGY (lethargic), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.     No treatment information was provided. No relevant concomitant medications reported.
high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas.  My arm flet like it had a fever at injection sight.  I was pale in face.