chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within hours after receiving the flu shot I started to have soreness and bruising around the injection sight that lasted for almost 10 days. Within 48 hours I had a high fever, chills, muscle aches accompanied with joint pain, weakness and dizziness. At around 3 days after the flu shot I had hives, a bright red rash all along my arms, which was then followed by severe chest pains, shortness of breathe and heart palpitations.  In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Day after kinrix pt developed swelling , redness over the entire rt arm, no swelling in the forearm, no fever. Cool compress, Ibuprofen given . Seen in office on 9/30/21, at phone followup on 10/1/21 father reported symptoms decreasing, 10/7/21 followup call almost back to normal.
This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to ROTATEQ. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Has large lump - tennis ball size at site of injection. Site red, hot and itchy.
I had a bowel obstruction.  It is due to scar tissue.  They had to do surgery to fix the bowel obstruction and remove the tissue.  I was in the hospital for 5 days.  They did blood work and CT scans on me.
Patient reports he had the first dose of the COVID Pfizer vaccine on 6/14/21. On 6/16/21 he woke up with a headache and blurry vision. He reports he had a daily headache for 3.5 months after the vaccine  and he continues to have intermittent headaches (2-4 headaches per week).  Patient reports the headache occurs on the front and sides. For the  first3.5 months after the vaccine nothing relieved the pain. He reports he tried hydrocodone, sumatriptan and extra strength Excedrin for migraines. He reports now the extra strength Excedrin for migraines relieves his intermittent headaches. Prior to the vaccine he would get about 2 headaches per year . Patient reports he also has had a sore at the injection site since he received the vaccine.
I started to get headaches and my blood pressure was elevated. I just monitor it for a couple days and my blood pressure was still elevated. I started blood pressure medication in June.
Severe Headache, body aches, chills, nausea, weakness in legs, lack of balance, fell multiple times, brain fog, vision issues, extreme fatigue, lack of energy, no energy, lack of desire to exercise. This lasted for 6 weeks. Had CT head scan and blood work. Doctor not sure of cause and problem. Currently taking a prednisone to see if my condition improves.
History per mother: child was seen on 05/14 for 18mth wcc and states pt received shots that day (Hep A on right leg of concern, DTaP on left). On the day of the app pt would complain when touching. The day after the app pt began to "walk a bit funny". Yesterday area began to become red, was a bit swollen and was very hot. Temp Monday 101, Tuesday less than 100 F. MD assessment 5/18: No fever. Some mild tenderness in area. Only calor. No puss from injection site. No trauma. Patient eating normally. Child has not limped today. Walking funny on Tuesday. Rash on Wednesday, photo shown with significantly more redness ~2 times as big. Diagnosis: Rash at application site (R21). Patient Plan: Child with rash that developed 2 days after Hep A placed on right medial thigh, child had only 1 day of fever on initial day, but child currently afebrile and having improvement of rash without any medication today to ~50% original size from yesterday. Provided child with 2.5 mL of Benadryl now. Will schedule Cetirizine and PRN Children's Benadryl until rash resolves. No need for antibiotics at this time, will follow up tomorrow for repeat evaluation while monitoring off antibiotics.
Initial and follow up information has been received, from a physician and a healthcare professional, concerning a 19 year old white female patient, with no previous pregnancies and a history of an abnormal pap (indicating human papilloma virus, atypical squamous cell of undetermined significance and a low grade squamous intraepithelial lesion; date unspecified), who on 21-NOV-2006, was vaccinated with the first dose of Gardasil (Lot #653650/0702F), and on 22-JAN-2007 with the second dose of Gardasil (Lot #654540/1161F). On 22-MAY-2007, the patient took a pregnancy test in the doctor's office which was positive. The patient was unsure of the date of her LMP. No problems were reported. Follow up information from the healthcare professional indicated the patient "had decided to terminate the pregnancy," although the reason for the decision was not specified, and the date for the procedure was left blank; it was not confirmed that the procedure had actually been completed.  Upon internal review, decided to terminate the pregnancy was determined to be serious as an other important medical event. Additional information has been requested.
Exacerbation of asthma; Throat swelling after taking the 1st dose of Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Exacerbation of asthma) and PHARYNGEAL SWELLING (Throat swelling after taking the 1st dose of Moderna Covid vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma.    No Medical History information was reported.   In February 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling after taking the 1st dose of Moderna Covid vaccine). On an unknown date, the patient experienced ASTHMA (Exacerbation of asthma). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat swelling, at an unspecified dose and frequency. On 02-Dec-2021, PHARYNGEAL SWELLING (Throat swelling after taking the 1st dose of Moderna Covid vaccine) had resolved. At the time of the report, ASTHMA (Exacerbation of asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. On 22-SEP-2021 the patient gone to the emergency room for treatment of an asthma exacerbation while she was off the medication (asthma) following the first dose intake. Currently patient was on a steroid taper and had just ended nebulization treatments for asthma. Patient took Diphenhydramine hydrochloride (Benadryl) for 2 days to treat throat swelling.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
15cmX15cm area of erythema and slight swelling to (R) upper arm no pain, no fever, no other symptoms
Rebound case caller had pneumonia multiple times; Rebound case caller had pneumonia multiple times; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "Rebound case caller had pneumonia multiple times".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Only liquid portion given; Only liquid portion given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, [the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion given) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 The pharmacist reported that he sent 2 vials of Shingrix vaccine to a nursing home to be administered to a patient, but nurse gave only the liquid portion to the patient without mixing it. No additional information was provided. The reporter consented to follow up. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient failed to mention that her first Covid vaccine was Pfizer on 01/23 and knowingly received the Moderna vaccine on 02/13.
Patient presented after falling on February 5 with injury to her scalp.  She apparently also fell on 2/4/21.  Family was uncertain as to whether patient loss consciousness.  According to family, patient has been weak over the last day or 2 with no other complaints aside from some diarrhea. EMS was notified PM Feb 5, and the patient was found to have atrial fibrillation with elevated heart rate to the 160s and hypoxic to the low 80% range on room air. She had a low-grade temperature and elevated respiratory rate according to EMS.  Evaluation in the ED demonstrated bilateral chest infiltrates on chest x-ray (right greater than left), elevated heart rate with atrial fibrillation, and back pain. Imaging demonstrated a T11 compression fracture (possibly new), elevated pro-calcitonin (2.80 ng/mL) and elevated troponin (1.45 ng/mL). Her venous blood gas showed mild hypoxemia (7.39/25/41/33/57), and head CT did not show acute changes and her cervical CT was negative for fracture. Pelvic x-ray did not show fracture. She was covid positive.  Admitted for acute hypoxemic respiratory failure and severe sepsis secondary to COVID-19 pneumonia and acute metabolic encephalopathy.  Received 3 days of remdesivir and 4 days of IV dexamethasone.  Also ceftriaxone was given 4 days for possible UTI.  Goal of care switched to inpatient hospice on 2/8/21.
blind; got her first dose on 15Jul2201 and was supposed to have her second dose on 25Aug2021 but she never made it; The initial case was missing the following minimum criteria: medical information only. Upon receipt of follow-up information on 08Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on 15Jul2021 (Lot Number: FD8448; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunization.  Medical history included ongoing lupus from an unknown date. The patient's concomitant medications were not reported. The patient got her first dose on 15Jul2201 and was supposed to have her second dose on 25Aug2021 but she never made it. The patient then applied for a job and she is supposed to get both shots, she wanted to know if she should just go to the same place that she got her first one, or what should she do. During the call the patient was reading information from the card and stated that she needs a flashlight because she is blind. The outcome of the event was unknown.
Distal Blistering to the immunization site, Erythema in the upper left arm, visible swelling and striation that were ascending up the arm noted.
Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, extreme fatigue.  Lasted for 30 hrs. Fatigue remained another 24hrs. Felt like bad cold or mild flu. I treated with over the counter medication after my physician said that was appropriate.  Still worth getting the vaccine! I?m thankful I could receive it.
This spontaneous report as received from a nurse refers to an 8 months 18 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATTEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Diagnosed with Atrial Fibilulation. No family history of this, but may be suspected or related to Pfizer Covid vaccine, as that is the only medication or biologic that is new. Relationship or causality has yet to be identified, however after receiving 2 doses of the Pfizer Covid vaccine dated February 3rd, 2021 (1st dose), February 24th, 2021 (2nd dose) and booster October 26, 2021.
arm is hot; swollen arm; arm is red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm is red) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm is red). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reported.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with GARDASIL (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion (incorrect product storage) on 01-DEC-2014. No adverse effect (no adverse event) have been reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. This is one of the several reports from the same reporter. Additional information has been reuqested.
Got very sick from the last one 8 yrs ago; Initial information received on 07-Jan-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who got very sick from the last one 8 yrs ago while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date  unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got very sick from the last one 8 yrs ago" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got very sick from the last one 8 yrs ago).  At time of reporting, the outcome was Unknown for the event got very sick from the last one 8 yrs ago.
Redness, itchy. Claims the vaccine was given too low on the arm. Stated the previous vaccine was given too high.
This spontaneous report as received from a registered nurse refers to unspecified patients. The nurse reported that ZOSTAVAX vaccines were exposed to 25 F for 420 hours, but did not have lot numbers and expiration dates available for evaluation. The nurse stated that she believed that patients may have received ZOSTAVAX (Lot#, dose and route not reported) in the month of July 2013. No adverse effects were reporter. Additional information has been requested.
Right deltoid swelling, tenderness and difficulty moving right arm 48 deg after immunization w/DTaP #5 treated as cellulitis - resolution.
Information has been received from a physician concerning an 8 year old male who on 22 June 1998, was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In November 2005, the patient experienced mild breakthrough chickenpox. The case was so mild that the patient's mother did not report it to the physician's office and the children had no medical attention. Outcome was not reported. No product quality complaint was involved. The patient's sister (WAES #0602USA04816) had a similar experience after vaccination with varicella virus vaccine live (Oka/Merck). Additional information has been requested.
no energy/lack of energy; nausea; vomiting; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy/lack of energy), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). On 10-May-2021, the patient experienced ASTHENIA (no energy/lack of energy). On 09-May-2021, PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, ASTHENIA (no energy/lack of energy), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications include Aleve, TUMS, Pedialyte electrolyte powder.    This case was linked to MOD21-088917 (E2B Linked Report).; Sender's Comments:  MOD21-088917:Same reporter, different patient
24 hours after receiving vaccine, the patient describes severe chill, a large red bump with a width of 3-inch bump in her arm, and it is warm to the touch. The patient presented to the pharmacy 3 days after vaccination. The patient arm was no longer swollen but remains red and warm to the touch. I recommended the patient take Benadryl at bedtime to help with the reactions.
Covid-19 vaccine administrations (Moderna) 3/23/21 lot# 013A21A 4/20/21 lot# 013A21A  Admission to Hospital (5/2/21 ? 5/10/21) for hypertension and acute on chronic back pain requiring ICU admission, hyponatremia thought to be due to SIADH. CT of abdomen done at hospital noting no significant lumbar abnormalities and a plain film of her lumbar spine with no obvious compression fracture. Outside hospital notes do not further outline why she could no longer ambulate. Brain MRI done and negative during that admission. Discharged to a rehab facility for ongoing weakness.  On 5/13/21, patient?s son requested admission to hospital for further evaluation. She states that she feels confused and her legs are very heavy and she can barely move them.  Notably she lives alone in her own home, used to drive, did not use any assistive device to walk, and paid her own bills until 2 weeks ago. The symptoms did occur approximately a week after receiving her last Covid vaccine. Pt also notes around April 1, 2021 having taken an engorged deer tick off her head. 5/14/21 Lyme serology IgM & IgG = negative. Neurology was consulted. She had an MRI of her thoracic and lumbar spine, as well as an LP. She had had an MRI brain at a hospital. Her MRIs did not reveal a source of her weakness and pain. Her CSF revealed albuminocytologic dissociation. Given this finding and the constellation of symptoms and LP findings, it was thought she had Guillain Barre Syndrome, presumably due to her COVID vaccine. She was given IVIG for 5 days. She improved with this.    As above, she had a recent admission for hyponatremia and hypertensive urgency. Here, her blood pressure was somewhat labile, but at times was low. She was started back on amlodipine and carvedilol, but at much lower doses with plan for ongoing monitoring. In terms of her hyponatremia, her salt tabs were stopped, and eventually her fluid restriction was able to be lifted. Her sodium was 136 at discharge.
Pt had fever, nausea, vomiting & stomach ache morning after receiving injections.
After first vaccine about 25 mins after the shot, the tip of my tongue and lips went numb. I had general fatigue the remainder of the day. The day following I was aching, bad headache and pain down my neck, my stomach was upset  along with fatigue. These feelings came and went throughout Sunday 10, Monday 11, and Tuesday 12.  I felt better on Wednesday Jan 13th.  On Sunday January 23rd I started feeling very fatigued, achy and had a fever of 100 F.  This lasted through Monday Jan 24
Dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo). The patient was treated with MECLIZINE [MECLOZINE] for Dizziness and Vertigo, at a dose of 12.5 mg. At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Vertigo) outcome was unknown.            No concomitant medications were reported.  The patient reports the onset of the events occurring some weeks after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains non-significant information, but initial events onset date captured as 2021 and vaccine facility information added hence processed as significant .; Sender's Comments: This case concerns a 63-year-old female patient with no relevant history reported, who experienced the unexpected non serious events of Dizziness and Vertigo. The events started a few weeks after the second dose of Moderna COVID-19 Vaccine. The stop date and outcome of the events are unknown. Rechallenge is not applicable as no additional dosing will be given. The delayed onset of the events remains as a confounder for the case. The benefit-risk relationship of covid-19 vaccine is not affected by this report.