chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of "Bleeding", "Gastrointestinal bleeding" was not recovered, of "headache" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.
Itchy, raised, pink rash 1-1 1/2" in diameter.
interfere with daily activites for 2 days; body aches/ pain for a week; general malaise; This case was reported by a physician via sales rep and described the occurrence of activities of daily living impaired in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced activities of daily living impaired, general body pain and malaise. On an unknown date, the outcome of the activities of daily living impaired, general body pain and malaise were recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired, general body pain and malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's comments: The patient reported that she had general malaise, body aches and pain for a week after the vaccination. It was not debilitating but strong enough to interfere with daily activities for the first two days. The reporter consented to follow-up.
pt has infantile spasms was taking ACTH gel it was a inject type shot; had a Cat Scan & eye was tested has vision delay, speech delay; has glass now; pt had an ear infect now on new med Tegrotol for spasm;
My son fell asleep roughly an hour after the shot and slept 13 hrs (he normally sleeps 10). Had a fever the following evening and the left arm (site of the shot) is swollen, hard and red. He is also irritable. This has actually happened to him on at least 5 other occasions after getting a vaccine but I never bother to report anything since I view these symptoms as rather mild. So this time I decided to report them, that's all.
This is a sample VAERS submission for a group of patients who received potentially ineffective vaccine due to a batch being stored under inappropriate storage conditions. Per consultation with CDC a single form  will be submitted and a spreadsheet containing pertinent information for all affected patients will be submitted. These were not Adverse Events, but potential administration errors.
The patient experience syncope after administration of the vaccine.  The patient was given juice and resolved.  The patient was released on their own accord.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-OCT-2012, the patient was inoculated with ZOSTAVAX at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 10-FEB-2015, the patient was treated a physician office for the onset of rash, which was diagnosed as shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Employee received Covid vqaccine, approx. 10 minutes later employee c/o dizziness b/p 178/90 Hr 64 02 sat 97%.  Employuee states he is currently being treated by  PCP for HTN.  offered to call RRT and or transport to ED for  evaluation. Employee refused. Recently started new b/p medication prior to leaving observation area employee reports dizziness resolved.  b/p 161/93 HR 68 02 sat 97%.  Employee to follow up with primary care physician
I had a slight reaction in my left upper arm; red; Some swelling; hot to the touch; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a slight reaction in my left upper arm), ERYTHEMA (red), SWELLING (Some swelling), FEELING HOT (hot to the touch) and PRURITUS (itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a slight reaction in my left upper arm), ERYTHEMA (red), SWELLING (Some swelling), FEELING HOT (hot to the touch) and PRURITUS (itchy). At the time of the report, VACCINATION COMPLICATION (I had a slight reaction in my left upper arm), SWELLING (Some swelling) and FEELING HOT (hot to the touch) outcome was unknown, ERYTHEMA (red) had not resolved and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first dose of vaccine almost one month ago. Patient had reactions for about 1-2 weeks. No concomitant treatment information were provided. No treatment information were provided.
Nausea, vomiting, diarrhea, arm pain, tiredness. symptoms started 5 hours after injection and lasted 12 hours.
No additional AE's reported; She states that a patient had already received 2 doses of MMRlI, 1 at 15 months and 1 at 4 years old but she was given a 3rd dose of MMRlI instead of the required VARIVAX/Misuse of MMRlI; was given MMRII insted of the requiered VARIVAX/Misuse MMRII; was given MMRII insted of the requiered VARIVAX/Missed dose of VARIVAX; This spontaneous report was received from an office manager, concerning an 18-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  The patient was vaccinated on an approximately unspecified date in 2004 (reported as at 15-month-old) and in 2007 (reported as at 4-year-old) with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Then, on 23-JUN-2021, the patient was vaccinated with a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, recombinant human albumin (rHA) (M-M-R II) (extra dose administered) lot number S039310 (which had been verified to be a valid lot number, upon internal validation) and expiration date 04-DEC-2021 as prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported), instead of a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (interchange of vaccine products and product dose omission issue). No adverse events were reported.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator- 16Dec2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator- 16Dec2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator- 16Dec2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Date the vial was initially stored in the refrigerator was approximately 26-Dec-2021 and the vial did not undergo any temperature excursions. Treatment information was not provided.
Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not reported. Between 06-APR-2014 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported. No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot number or dates of vaccination.  Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates, and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVASX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 20-APR-2015, a female patient of unknown age received (Oka/Merck) VARIVAX (lot number K021936, expiration date 10-NOV-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015 no vaccines were left from the event. Additional information has been requested.
pt recv vax 25NOV97 & devel red raised welts on face, neck, & behind the ears;pt was afeb;on the morning of 26NOV97 pt exp swelling around eyes & lips swelling;c/o lips felt funny;referred to ER tx w/DPH;dx poss rxn;
pt recv vax 27MAY97 & 2 days later pt exp a localized rxn;
8 x 19 cm marked erythema (L) anterior thigh warm to touch.
The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe. The vaccine was administered to the patient after the recommended beyond-use time.
Mild case of shingles two weeks after the shots; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced mild case of shingles two weeks after the shot. The follow-up would not possible as no contact details were available. For 2nd dose refer case US2021AMR209336, reported by the same reporter for the same patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR209336:Same reporter.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 mo old F-developed fussiness, bulging fontanelle, 6th nerve palsy within hours of vaccine-PENTACEL, ROTATEQ, PREVNAR. Symptoms lasted 6 days.
c/o headache shortly after receiving Covid vaccine b/p 158/87 HR 81 Pulse ox 98% monitored ee, states feeling better nor headache upon leaving clinic.  b/p121/74, HR 78 02 sat 98%
patient received 2nd dose only 14 days after 1st dose (no symptoms or issues at this point) vaccine was administered outside of normal timeframe
Facial nerve pain/neuralgia.  This started five days after vaccine.  Face pain, stiffness, increased muscle twitching (the twitching had almost completely resolved), tingling across face into nose. Treating with anti-inflammatory medications. This is slowly improving but not resolved.
The vaccine given in her left arm just after we opened at 9 am, but the patient called later in the afternoon to let the pharmacy know she might be having an allergic reaction.  I asked what exactly she was experiencing and she mentioned having swelling in her arm from the injection site down to her elbow and seemed to be getting worse.  She also mentioned itching and discomfort in the arm due to the swelling.  I mentioned she could put ice on it to help the swelling  and Benadryl but she said due to her condition she could not take Benadryl.  For the pain, I mentioned to take Tylenol and if the swelling got any worse or lasted another day to go to the ER or urgent care for extra relief.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Facial/lip swelling (felt not observed externally) and tingling. Better after benadryl. Follow up called in 4 hours
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 1:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 1:51 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Feb-2021 at 1:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Vial was stored on cooler 2 , on 14-FEB-2021, Excursion duration At  9 AM 32, 10 AM 32, 11 AM 32, 12 AM 39, 1PM 37, 2 PM 35, 3 PM 35 and 4 PM 36   On 21-MAR-2021, Excursion time was 9 AM, temp was 34 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 16-MAR-2021. Vaccine BUD date was 15-APR-2021.  Vial was stored on cooler 1 , on 21-MAR-2021, Excursion duration At  9 AM 34, 10 AM 32, 11 AM 34, 12 AM 43, 1PM 40, 2 PM 40, 3 PM 41 and 4 PM 41.   It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Attending Physician: MD Date of Admission: 9/2/2022, Hospital Day: 5 Date of Discharge: 9/6/2022  PRESENTING PROBLEM: Thrombocytopenia COVID-19 virus infection ITP secondary to infection   HOSPITAL COURSE: 57-year-old man otherwise healthy here with recent COVID and now critical thrombocytopenia likened to ITP.  He was initially started on prednisone 50 mg q.day then 40 mg q.day.  Hematology has evaluated the patient and switch him to Decadron and IVIG with platelets improving.  He will complete a 4 day course of Decadron (script sent to his choice pharmacy).  He was discharged home in stable and improving condition. CBC in 3-5 days with his PCP advised and recommend cessation of NSAIDs while in this acute period to protect his platelets. He does have steroid induced leukocytosis and no other infectious symptoms. This should improve with cessation of steroids.
Loss of taste and metallic taste when I eat. Started a day and a half after vaccine and gets worse every day. I am 12 days after the vaccine and either I can?t taste something or it tastes metallic. Smell is off also.
Vaccine administered Tues 7/2/04. c/o mod. local reaction plus HA, Nausea, diarrhea, myalgias and arthralgias
This spontaneous report was received from a health care worker regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported, lot # K018181, expiration date 04-JAN-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information is not expected as there is no permission to contact the physician.
excessive menstrual bleeding for 5 days. This is medically unusual as I have not had ANY period in 5 years, as I have been in menopause since 41 years old; cramps; heavy period; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 23Apr2021 13:15 (Lot Number: ew0175) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included CVID, hypothyroid and asthma from an unknown date and unknown if ongoing. Concomitant medications included immunoglobulin human normal (CUTAQUIG), montelukast sodium (SINGULAIR) and thyroid (ARMOUR THYROID); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, via unspecified route in the left arm on 30Mar2021 04:45 as 1ST DOSE, SINGLE (lot number: er8733) for COVID-19 immunization at 46 years old. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. The 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. The patient stated that on 11May2021 12:00, "I got a very heavy period, cramps for three days, excessive menstrual bleeding for 5 days. This is medically unusual as I have not had ANY period in 5 years, as I have been in menopause since 41 years old." The outcome of the events was not recovered. No treatment was given to the patient for the events.  Follow up attempts are needed. Further information has been requested.
Approx. 6 hours after vaccine I became dizzy, with rapid heartbeat and chattering teeth. Major symptoms passed 2 hours after occurance. Fatigue persisted throughout.
Information has been received from a physician concerning an adult patient who was vaccinated with a dose of Varivax. Two weeks later the patient experienced varicella with more than 100 lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Positive test for Covid 19  one and one half month after receiving the second dose. Right eye has sty or what seems to be a cold in the eye. Pain in Right Shoulder and all down right arm. Pain is severe and wakes her up at night. This is well over one month of having the vaccine. No other incident or exercise could cause this pain.