chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Really bad case of cellulitis; The lymph nodes in her legs blew up really bad; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in arm right on 03Feb2021 (at the age of 73-years-old) at mid day (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021) as DOSE 1, SINGLE for covid-19 immunization. Vaccination facility type was hospital and vaccine was not administered at other facility. Medical history included ongoing lymphoedema and cellulitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccines included Flu vaccine years ago, and last Flu vaccine on 15Dec2020 taken for immunization and had a cold (she tried to get good sleep, 8 hours of sleep at night and to eat well and take care of herself when was getting her vaccines), Shingrix vaccine in Aug2020 and Oct2020 taken for immunization and reaction was not reported, if any. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine: Vaccine Name: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: Vaccine Name: None. She's calling about the Covid 19 vaccine. She reports she does have multiple medical problems. Patient reported after she received her Covid 19 vaccines she had a really bad case of cellulitis and the lymph nodes in her legs blew up really bad. The problem started with the first Covid 19 vaccine. She did get an antibiotic from her doctor but she doesn't remember what the name of it is and she did not remember what day she went to see the doctor. Maybe sometime in Mar2021 or Apr2021. She didn't make the connection with the Covid 19 vaccine until she saw that other people were reporting it. She did have a history of Lymphedema and cellulitis but her legs have never blown up like that. Her legs did get better but the swelling came and go. She was using Ace bandages on her legs. The events resulted in Physician Office Visit and not resulted in Emergency Room visit. Therapeutic measures were taken in response to the events. Investigation assessment/ relevant tests were none. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Narrative:  See "Other Relevant History" in Section 6 above Symptoms:  ElevatedLiverEnzymes & death, pneumonia, afib Treatment:
Patient received vaccine on 11/10/2020.  Side effect reported by patient on 01/12/2021.  Patient showed pharmacist that arm could not be lifted (full range of motion not seen).  Patient states a throbbing feeling.  Recommended visit to PCP to be assessed.
Patient Received her booster dose Pfizer vaccine (LOT#: FL3209) at 1527 on 1/16/22. Patient alerted EMT's at 1549 that she felt short of breath, cool and clammy and felt her "heart fluttering" a little after getting vaccine for about 5 minutes. Patient alerted EMT's after most symptoms had subsided. Patient stated that she felt weak. Patient was moved to anti-gravity chair. EMT took patients vital signs at 1549. BP: 124/76, HR: 99, O2: 99%. RN arrived on scene at 1551. Patient stated that she felt weak, no SOB, no irritation in the throat. Patient stated this has happened in the past as far as her heart fluttering. Patient has seen PCP about this issue back in July 2021. EKG was taken and patient states everything is normal. EMT retook patients vital signs at 1557. BP: 122/73, HR: 86, O2: 100%. Patient stated she is feeling better and all symptoms have subsided. EMT retook patients vital signs at 1611. BP: 120/74, HR:76, O2: 100%. Patient reports no new symptoms. EMT reassessed and retook patients vital signs at 1622. BP: 118/74, HR: 76, O2: 100%. Patient did not report any new symptoms. RN educated patient on side effects of COVID vaccine and when to seek help from EMS. RN also recommended that patient go see PCP once again for her heart fluttering issue. Patient verbalized understanding. Patient completed her 30 minute observation and left vaccination site with a steady gait with her aunt at 1623.
THIS FACILITY IS NOT THE FACILITY AT WHICH THE VACCINE WAS GIVEN.  PATIENT WAS SEEN FOR PAIN IN HER ARM ON 03/06/2023 FOR PAIN IN THE RIGHT ARM AT THE SITE OF PREVIOUS COVID VACCINATION GIVEN 04/2021.  SHE HAD INCREASED WARMTH TO TOUCH AND SORENESS AT THE TIME OF THE VACCINATION WHICH RESOLVED BUT THE SATE REMAINED DISCOLORED (HYPERPIGMENTED) AND IN THE PAST 2 WEEKS SHE HAS STARTED TO HAVE SORENESS, ITCHING AND INCREASED WARMTH TO TOUCH AT THE VACCINATION SITE.  SHE ALSO HAD THE SAME VACCINATION IN THE LEFT ARM WHICH HAS NO SIGNS OF REACTION OR DISCOLORATION.
Blister under the tongue; Swelling on the feet; Joint pain; Muscle aches; joint , muscle and head aches; Fever 101.5; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blister under the tongue), PERIPHERAL SWELLING (Swelling on the feet), ARTHRALGIA (Joint pain), MYALGIA (Muscle aches) and HEADACHE (joint , muscle and head aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blister under the tongue), PERIPHERAL SWELLING (Swelling on the feet), ARTHRALGIA (Joint pain), MYALGIA (Muscle aches), HEADACHE (joint , muscle and head aches) and PYREXIA (Fever 101.5). At the time of the report, ORAL MUCOSAL BLISTERING (Blister under the tongue), PERIPHERAL SWELLING (Swelling on the feet), ARTHRALGIA (Joint pain), MYALGIA (Muscle aches), HEADACHE (joint , muscle and head aches) and PYREXIA (Fever 101.5) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Rash started on 9th day post MMR. Rash started on neck and face first and then spread down the rest of the body. Large erythemaotus maculo papular rash. Rash resolved in approx 3 days.
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 55-year-old female patient who received SHINGRIX (batch number LN9TL, expiry date 30th January 2020) for prophylaxis. On 11th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythematous rash and raised rash. On an unknown date, the outcome of the erythematous rash and raised rash were recovered/resolved. The reporter considered the erythematous rash and raised rash to be probably related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) was unsure of vaccine lot number and stated the first letter could be a H. The HCP stated that the patient developed a large red raised rash, size of a dollar bill that lasted a month then not completely gone until a few weeks later.
CLINICAL IMPRESSION 1. Acute respiratory failure with hypoxia  2. COVID-19 virus infection
Pts speech changed within a couple of wks after PCV13 was adm. pts; mtr stated that he began to talk very slowly & have much difficulty getting his words out. (Which was a huge change for him). He became ashamed of it & stopped wanting to talk. Mostly, still has some trouble from time to time.
tentivac was expired for 16 days and was accidentally given to a patient with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an 80 years old female patient where diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was expired for 16 days and was accidentally given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7189AA and expiration date- 30-Sep-2023) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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.
I woke up in the middle of the night with a scratchy throat. By the next morning whole body aches, burning behind the eyes, cough. I called my provider and let them know about my symptoms and that I had COVID-19.  Provider said to keep taking my OTC medications. I will retest for COVID-19 tomorrow 03/09/2023.
This is a spontaneous report from a nurse who reported for himself  A 28-years-old male patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EK5730 in left arm on 28Dec2020 09:00 09:00 at SINGLE DOSE for covid-19 immunisation . Age at vaccination: 28 Years. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine:Medical history included none.  The patient's concomitant medications were not reported.  The patient experienced palpitations on 14Jan2021 11:00 with outcome of not recovered.  Event reported as non serious.The adverse event result in Emergency room/department or urgent care.No treatment received.Prior to vaccination,  the patient was not  diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
Dolor de cabeza fuerte detras del ojo, se cerro el ojo y desplazamiento de mandibula. Se me viro la cara del lado derecho.
First day after had severe headache and than I had GI /upset stomach and diaherra for a week after first shot.   After the 2 shots I had a complete change in menstural cycle for 3 months - days of cycle increased - 1st month and 2nd month 9 days, 3rd month - lasted 14 days.  Called MD and they were not concerned but my period was regular for the last 9 years and than I get the shot and it changed.  Vaccine was the only thing that changed.
Patient received vaccine on 11/15/2017 at 4:50 pm and later on that evening experienced severe soreness, pain, bruising and a fever of 100. Patient husband came in on evening of 11/20/2017 to report incident and show pics.
Within 12 hours of my second Pfizer COVID19 vaccination, my right breast had a 6cm area that was very red.  8 hors after that, the area had grown to approximately 10cm and was a darker, "angry" lookin; Within 12 hours of my second Pfizer COVID19 vaccination, my right breast had a 6cm area that was very red.  8 hors after that, the area had grown to approximately 10cm and was a darker, "angry" lookin; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 53-years-old female patient received BNT162B2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 15:15 (Batch/Lot Number: EW0168) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 53 years). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past medical history included breast cancer from an unknown date and unknown if ongoing (occult primary, 1 lymph node of right axilla, ER-, PR+, HER2+), photon radiation therapy to breast from 12Oct2020 to an unknown date 25th day of radiation treatment.The patient previously received BNT162B2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12May2021 15:30 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunization.Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 03Jun2021 at 02:30 am the patient reported Within 12 hours of her second Pfizer COVID19 vaccination, her right breast had a 6cm area that was very red.  8 hours after that, the area had grown to approximately 10cm and was a darker, angry looking red, with almost purple veining. (This is the same breast that received radiation for cancer. My 25th day of radiation treatment was on October 12, 2020.) she contacted her radiology oncologist and am waiting to hear from her. No treatment was received. The event outcome was not recovered.  Device Date: 03Jun2021  Follow up attempts needed. Further information is expected
Tinnitus in Left ear- started about a week after initial vaccine of SHINGRIX, started seeing Chiropractor 1 month after tinnitus began.
pt was given the wrong vaccine. pt was to receive Shingrix but instead received menveo. supervisor, provider and patient was notified. no adverse reaction at the time of coversation. documentation was done and no treatment needed. pt was to get this vaccine in the future, it was not what the provider ordered at this time.
pt had edema in left arm with slight warm to touch and erythema from elbow joint (10x5cm) to upper shoulder. Pt is stable today 06JUL04. Left arm swollen larger than right arm.
Patient report teeth chattering, weak muscles, and she fell when she got up in the morning. She said she did not hurt herself. Has also reported headache. She is wondering if she is experiencing severe flu-like symptoms. I will follow up with her on Wednesday 08-29-18.
severe localized rxn @ inj site;size of tennis ball-hot to touch, red, purple, h/a, fever, chills, gen flu sx, nausea, vomiting, could not keep food down;
Patient came in with Epigastric pain and Covid-19 positive. Labs showed elevated d dimer. Day 3 of hospital admission, patients feet became cold and discolored; CTA was done and showed arterial occlusion of right popiteal and left femoral. Patient underwent emergent open thrombectomy.
Really fast heart rate, shortness of breath, chest tightness. Took INDERAL by 10pm felt better. Right now feels achy.
One month after second dose, mild tinnitus (had for seven years previous) became severe and began causing ear pain/headaches.
Fever that was between 102-104 for 12 days straight unbroken (even after medication - Tylenol). Severe night sweats to the point I was being woken up by cramps in my calf (drank 1-2 gallons of water a day because of this). Severe headaches - almost went to the hospital. Was unable to work for almost two weeks.
back pain; This is a spontaneous report from a non-contactable consumer (patient's spouse) from via Medical information team.  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 15Feb2021 as 2nd dose, single and dose 1 via an unspecified route of administration on an unspecified date as 1st dose, for COVID-19 immunization. Consumer reported that her husband received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine today and is having issues with his back. She wants to know if he can take the steroid injection that his doctor prescribed him with for his back pain. She also mentioned that her husband previously took the steroid injection 2 days after his 1st dose, but now they want to be safe. She wants to know how long her husband has to wait before taking the steroid injection after receiving the 2nd dose of the vaccine. The outcome of the event was unknown. The patients' wife wants to know if her husband should receive a 3rd dose of the Pfizer-BioNTech Covid-19 Vaccine since he took a steroid injection after the 1st dose and if there is a test that her husband can take to assess the Pfizer-BioNTech Covid-19 Vaccine's effect on him.   No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
Dry mouth; Gain weight; Dry lips; Dry feet; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), WEIGHT INCREASED (Gain weight), LIP DRY (Dry lips) and DRY SKIN (Dry feet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), WEIGHT INCREASED (Gain weight), LIP DRY (Dry lips) and DRY SKIN (Dry feet). At the time of the report, DRY MOUTH (Dry mouth), WEIGHT INCREASED (Gain weight), LIP DRY (Dry lips) and DRY SKIN (Dry feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and no treatment was reported.
10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    Concomitant medication was not reported. Treatment medication was not reported.  This case was for the 2nd patient out of 10 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant Follow-up appended: Patient details (age group) was added..
Vaccination failure; Shingles outbreak; Bumps that were on back; Painful; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number MX2LT, expiry date unknown) for prophylaxis.   Concurrent medical conditions included parkinson's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On 11th February 2019, the patient received the 2nd dose of Shingrix (intramuscular). In February 2019, not applicable after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced injection site swelling. On 30th September 2019, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown and the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient experienced bumps that were on her back and painful and was later seen by her physician and diagnosed with shingles. The patient was prescribed a course of Acyclovir. The patient experienced swelling at injection site after receiving Shingrix. The reporter consented to follow up. The reporter requested to be copied on any letters sent to her physicians.