chrisvoncsefalvay/vaers-outcomes huggingface dataset:
missed her 2nd dose of Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose of Moderna COVID 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose of Moderna COVID 19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose of Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Patient is a 88 y.o. female who presents today with episode of rectal bleeding. She woke up around 2am to use the restroom and noted bright red blood per rectum. Associated with mild left lower quadrant crampy pain. She had 2 episodes at home and then presented to the ED. While in the ED she had additional bright red bleeding with clots. This was associated with lightheadedness and syncopal episode while on the commode. A brief episode of CPR was performed due to unresponsiveness and she revived. Her vital signs stabilized. Significant lab finding included lactic acid 3.0, Hgb drop from 13 to 10. . She was resuscitated with 2 units of PRBC emergently and sent for a CTA abdomen and pelvis which showed no acute GI hemorrhage, mild inflammatory finding suspect colitis vs diverticulitis. Discussed with GI and it was advised patient transfer for evaluation of scope. Patient has had previous episode of bright red rectal bleeding, first was about 5 years ago presumed due to diverticular bleeding and was hospitalized in 2017. She had colonoscopy at that time that showed diverticulitis in sigmoid colon. No intervention needed at this time. She had a second episode of rectal bleeding about 1 year ago. She wa not hospitalized at that time. She was referred to a general surgeon at that time for EGD/colonoscopy which she declined at that time (11/2020).
Pt recv vax on 3/17/97; on 12/15/97 pt exp decreased appetite, dx=hepatocellular carcinoma; tx=system chemotherapy, chemo-embolizations, liver transplant- 8/98; lung metastases; Annual follow-up dated 10/9/00 states that the pt died on 6/18/00. She experienced spine metastases. She suffered kidney failure. The cancer also returned to her new liver and shedied at the age of 17 1/2.
Patient was told and documented as receiving Jansen vaccine but was given Moderna vaccine in error.  Patient was called and no ADRs noted immediately after vaccination.
Blood Clot in Lung, Diagnosed 4/14/21, given Eliquis -Shortness of Breath started 4/11/21 Leg swelling below knee in both legs, given lasix
Hib powder component was inadvertently mixed with normal saline instead of DTAP-IPV diluent provided in the PENTACEL box. Inquiry was sent to CDC, and it was recommended to give PENTACEL vaccine again as the dose given would not count.
I had gone to the Dr. 6 months after the vaccine Went to the ER was told my BP was high 148/99. I started monitoring my blood pressure at home. I had another episode of HBP and went to Urgent Care. Was prescribed Hypertension medication which I am not taking at this time.
received Ipol at 2 months 4 months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 16 years old male patient who received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect IPV (VERO) vaccine (formulation, dose, route, batch number and expiry date unknown ) in unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the patient developed a non-serious event received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event  (inappropriate schedule of product administration) (unknown latency) following the administration of IPV (VERO).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event ).  At time of reporting, the outcome was Unknown for the event received Ipol at 2 months 4months and early at 6 months and earlier than 4 at 3 years 4 months with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient felt fine the day of and day following vaccination. 8 or 9 days after receiving the shot, however, her arm felt warm and itchy, and hurt somewhat. She now has a clearly demarcated, erythematous, swollen rash covering most of her anterior upper arm, which is warm to the touch. The affected area has grown in size over the last 24 hours. She is afebrile, with normal vital signs. No cervical, axillary, or epitrochlear lymphadenopathy.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX on 06-AUG-2015. This was one of several reports received from the same reporter. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Pain in neck and left shoulder initially responsive to ibuprofen/heat/cold. Progressed to increased pain, profound weakness in left arm, numbness tingling in both arms, numn tight belt around upper abdomen, loss of ability to feel urge to stool, lower extremity weakness, loss of reflexes. hospital stay, 5 day IVIG infusion for atypical Guillain Barre. Home now with continued weakness and neuropathies.
Off balance feeling, right eyelid twitching, tingling in hands, tingling in feet, numbness in hands and feet, burning sensations in skin, headaches, neck ache, muscle twitches in body.
Acute onset of vomiting and foul smelling diarrhea; onset of lower bilateral extremity myalgia and heaviness.
Fatigue - I was unable to work that day. I was so tired. Pain - in my arm to the point that when I moved my arm I felt like I was going to pass out - it hurt that bad. I felt nauseous like I would vomit. I didn't vomit. Had a headache on day two (I have been having headaches since I had COVID in July 2020). I took Tylenol for that severe headache and that helped and it was just that one day that it was severe.  The worst, was my heart - increased heart rate - anything I did just was difficult on my heart. My heart - was having a hard time - standing, brushing my teeth - was exhausting for my body. That type of exhaustion went on for five days. I was able to feel better by day 11. But my heartrate is still poor. Depending upon what I did - 10 to 30 beats over my normal - just normal work. 40 beats over when I'm attempting a more intense exercise. A slight jog puts my heartrate to 180. My heart rate still hasn't subsided yet - it is still above average above post COVID ( I had COVID in July of 2020). My heart rate was still at an elevated rate post COVID but worse after the vaccine. I have chest pressure now - like someone sitting on my chest - that started day two after the vaccine. Even when I'm resting, I have chest pressure - it comes and goes and there seems to be no pattern as to why. Didn't have a doctor visit this second time yet. I treated with Tylenol for the pain at the injection site and for that headache and then I just rested my body.
client signed up for Pfizer vaccine. At Vaccine station she was asked if she was getting Janssen, She said yes. Janssen administered. When vaccinator looked at label says she received Pfizer.  At this instance she was asked again what dose she was looking for and she say Pfizer.
Mother of child (MOC) reported swollen (R) thigh, 2.5 inches of redness. Child didn't complain of pain or itching. Pt was brought to hospital for eval & tx.
Three days after second injection I broke out in rash with intense itching, burning, pain and swelling in the genital area.Problem so severe that I could not sleep, walk or sit without symptoms worsening. OBGYN could not identify (Other than UGH thats awful) Testing for herpies, and bacterial/yeast infection all negative. Research show that this was likely Genital Psoriasis flair. I have no history of psoriasis. Treated with numerous OTC medications and later steroid cream . 9 weeks later it is 90% resolved, but still red and sore.
dehydrated; heavy breathing; fever; This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (dehydrated), DYSPNOEA (heavy breathing) and PYREXIA (fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031N21A and 008C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced DEHYDRATION (dehydrated), DYSPNOEA (heavy breathing) and PYREXIA (fever). At the time of the report, DEHYDRATION (dehydrated), DYSPNOEA (heavy breathing) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 103.5 High.         Patient was very dehydrated even after having 2 bottles of water and a Gatorade. patient had heavy breathing but no trouble with breathing. He was concerned and wanted to know if he should go to the ER.  No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Child developed mild case of chickenpox with small vesicles and many (about 50) ? lesions-junk papules.
This spontaneous report was received from the registered nurse refers to patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patients were inadvertently administered with improperly stored, PEDVAXHIB lot # L002866 exp: 10-NOV-2017 (dose, route, therapy type not reported). No adverse effects reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
phone call from pts mother stating that during the noc pt had run fever of 103 which mom was able to bring down w/APAP & cool bath & light clothing;this AM pts fever was sl above 102 & pt was subdued & was on the couch;cont w/APAP
This spontaneous report as received from the patients mother, concerning her child of unknown age and gender. On an unknown date the patient ws vaccinated with a dose of M-M-R II (lot E, dose, and route not reported). Concomitant therapy was not reported. The reporter stated that on an unknown date her child had serious side effects after receiving M-M-R II. The patient had severe hives and shortness of breath. On an unknown date the patient had to be taken to the emergency room (ER). The outcome of severe hives and shortness of breath was unknown.  This is one of several reports received from the same reporter: MARRS 1407USSA000434 and 1407USA000509. Additional formation is not expected.
Tested positive for Covid-19 Runny Nose  Headache  Sneezing  Congestion  Shortness of Breath
April through May: Electrical jolts in both lower legs and heaviness, tingling sensation in left arm, tingling sensation in head, tingling sensation on left side of face, numbness and tingling sensation on left side of the tongue  June to present-continuing to have tingling sensation on the left side of face, numbness and tingling sensation on the left side of the tongue, occasionally tingling in the head, occasional numbness in the left calf down to the foot, occasional weakness in hands and functions, especially the left hand (unable to grip and hold objects), weakness in the left arm
Information has been received from a 32 year old female medical assistant concerning herself who on 11-OCT-2007 was preparing a pre-filled syringe to vaccination a patient with GARDASIL vaccine (yeast) (lot #653650/0640F). On 11-OCT-2007 the pre-filled syringe leaked onto medical assistant's hand. She washed her hands with soap and water but experienced slight burning on her hand with no redness. It was noted that the adverse experience persisted. It was also noted that another employee helping at this time was also splashed in the left eye with the solution (reported in WAES #0710USA03432). No further details were provided. Additional information has been requested.
Hives on his chest, back and arms.Given benadryl.  Shot was given my Health Department.  Do not have manufacturer or lot number.
swelling in my L armpit, lump 2x2 inches, looks like a lipoma
This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a 60-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2020). Concomitant products included Levothyroxine and NEXIUM. On 3rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd March 2018, immediately after receiving SHINGRIX, the patient experienced back pain, light headedness, fatigue, heartbeats increased, abnormal breathing, fever, flushing and panic attack. On 4th March 2018, the patient experienced sleep excessive. On 4th March 2018, the outcome of the fever was recovered/resolved. In March 2018, the outcome of the back pain, light headedness, fatigue, heartbeats increased, abnormal breathing and flushing were recovered/resolved. On an unknown date, the outcome of the panic attack and sleep excessive were unknown. It was unknown if the reporter considered the back pain, light headedness, fatigue, heartbeats increased, abnormal breathing, fever, flushing, panic attack and sleep excessive to be related to SHINGRIX. Additional information was reported as follows: On 3rd March 2018 at 18:30, the patient received SHINGRIX, in right arm. Immediately after vaccination with SHINGRIX, the patient experienced intense pain which was extended behind her back and toward neck. The patient also experienced fatigued, dizziness, light-headed immediately after vaccination and she became flushed. After a couple of minutes patient's color returned to normal and heartbeat was rapid and breathing didn't seem right. The reporter asked the patient if she was having difficulty breathing and the patient responded that she didn't know, just that her breathing felt off. The patient stayed seated for 15 min. after the vaccination, then stood up for about 1 min., then sat for an additional 10 minutes. The patient commented that it felt like she was having panic attack. As the time was gone, the patient was feeling better and she went home after about 30 min. On next day the patient came and developed a low fever, about 100 F in the night, but it had resolved by the next day. The pain also continued through the night, but did resolve. The patient slept most of the next day (4th March 2018) and was trying to decide if she was going to get the next shot.
Pt reported feeling light headed, clammy and pale. Placed in semifowler's position, given a bottle of water to drink and felt better. VSS and within acceptable parameters.
About 3 weeks after vaccine administered got rash all over trunk and face not vesicular in nature, just slightly raised, afebrile.
This non-serious medically confirmed spontaneous report (initial receipt 19-JAN-2015) concerns a 60 year-old female patient who had AFLURIA last year (2013) without any issues. On 11-OCT-2014, the patient received intramuscular AFLURIA (batch number 10049221B). It was unknown which arm AFLURIA was injected as per the patient's medical chart. On an unspecified date in OCT-2014, the patient experienced arm pain and visited an urgent care centre for the arm pain. The patient was treated with cephalexin and hydrocortisone cream. On 10-DEC-2014, the patient visited the family medical practice and complained of arm pain which was only at the injection site, not both arms. The patient described she had difficulty lifting her arm and this is the fist time she had issues with AFLURIA. The patient also had swelling, redness and discomfort. The outcome was not yet recovered. Reporter's comments: The reporter was not aware of the patient's past medical history of arm injuries or if patient received multiple injections on 11-OCT-2014. The reporter assessed the events as related to AFLURIA.
Patient received vaccine and completed 15 minute observation without incidence. Patient went home. Patient's mother-in-law (MIL) was working as a MD today. About 2:15pm, the MIL notified a staff RN in the clinic that her daughter-in-law (patient) was c/o of tachycardia. The patient called her PCP who recommended she use her prescribed epi-pen and go to the ED. The MIL told the staff RN that the patient had a history of allergies and carried an epi-pen. The MIL left the clinic at that time and we have not heard any update from her or the patient. In Item 21, I selected "Emergency Room," but do not know for certain if the patient went to the ED.
Myalgia, Fever, FATIGUE, WEAKNESS, NO APPETITE, INJECTION SITE PAIN Narrative:
patient presented to emergency department on 11/16/21 with weakness and fatigue patient was admitted for further management of acute respiratory failure with hypoxia patient was found to be covid-19 positive on 11/16/21 patient did require treatment for symptoms associated with covid-19 infection. treatment included remdesivir patient was discharged to home on 12/12/21
Began having severe muscle aches followed by dark colored urine. Went to the emergency room and they determined I had rhabdomyolysis.
Tired, weak. Headache. Shivering. Vomiting Stomach pain.  Lasted day of injection into the night. Let up next day except tiredness & weakness.  3rd day was better
redness and swelling on the injection site  Narrative: employee able to return even with the  swelling in her injection site
hearing loss; Ringing in ears; This is a spontaneous report from a contactable other hcp.  A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 13:00 in left arm at single dose for covid-19 immunisation. Facility type vaccine was hospital. No other vaccine in four weeks. Medical history were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies: No known drug allergies (NKDA). Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]), zolpidem tartrate (AMBIEN CR), diazepam (DIAZEPAM) as needed. Historical vaccination included first dose of BNT162B2(lot number: ELO142) on 06Jan2021 01:00 PM in right arm for covid-19 immunisation. The patient experienced ringing in ears and hearing loss that is continually worsening on 29Jan2021 12:00 with outcome of not recovered. AE resulted in doctor or other healthcare professional office/clinic visit. it is unknown whether treatment was received.; Sender's Comments: Considering the plausible temporal association, and lacking any reported alternative explanations, a causative role of BNT162B2 vaccine for the reported worsening of ringing in ears and hearing loss cannot be excluded.   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.
Mom called in on Feb 2 to report redness and swelling at injection site. Redness keeps growing. Slight fever. Redness started the same day as injection.
Pain left side of neck; Feels like a pulled muscle; Can't look to the left; Left shoulder sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain left side of neck), MUSCLE STRAIN (Feels like a pulled muscle), MUSCULOSKELETAL STIFFNESS (Can't look to the left) and ARTHRALGIA (Left shoulder sore) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Pain left side of neck), MUSCLE STRAIN (Feels like a pulled muscle), MUSCULOSKELETAL STIFFNESS (Can't look to the left) and ARTHRALGIA (Left shoulder sore). At the time of the report, NECK PAIN (Pain left side of neck), MUSCLE STRAIN (Feels like a pulled muscle), MUSCULOSKELETAL STIFFNESS (Can't look to the left) and ARTHRALGIA (Left shoulder sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received vaccine on 11/4/21.  Admitted to hospital on 11/12 for with SOB and chest pain.    Provider ruled potential myocarditis.  However,  ECHO noted normal left ventricular systolic function with an estimated ejection fraction of 55 to 60%, normal diastolic function, no wall motion abnormalities.  Patient noted to have no significant vascular abnormalities.  Only sign was slightly elevated troponin.