chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bright red; tightness in the breast; lymphoedema; thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better; Sharp pain in breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Sharp pain in breast), ERYTHEMA (bright red), BREAST DISCOMFORT (tightness in the breast), LYMPHOEDEMA (lymphoedema) and RASH (thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Surgery (lymph nodes removed on the left side 11 years ago). Concomitant products included ROSUVASTATIN for Blood cholesterol abnormal, CALCIUM and VALACICLOVIR for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced BREAST PAIN (Sharp pain in breast) and RASH (thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better). On an unknown date, the patient experienced ERYTHEMA (bright red), BREAST DISCOMFORT (tightness in the breast) and LYMPHOEDEMA (lymphoedema). The patient was treated with DOXYCYCLINE for Infection, at a dose of for 4 to 5 weeks; CEFADROXIL for Infection, at a dose of for 4 to 5 weeks and CORTISONE at a dose of for 4 to 5 weeks. At the time of the report, BREAST PAIN (Sharp pain in breast), ERYTHEMA (bright red) and BREAST DISCOMFORT (tightness in the breast) outcome was unknown and LYMPHOEDEMA (lymphoedema) and RASH (thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data includes biopsy which was fine and sonic gram and a mammogram with unknown results.  Treatment included topical steroid cream from 05-MAY-2021 to 06-APR-2021   This case was linked to MOD-2021-274985.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received contains significant information: Added event and treatment
Headache, Myalgia, Fever,  left axillary Lymphadenopathy, aches, headaches and fever Narrative:
Pfizer COVID vaccine given 6/25/21 and 7/16/21. Patient presented with vertigo 9/3/21. No previous history of vertigo. Unknown if related.  Meclizine, Zofran prescribed, patient will start modified epley maneuver.
100 degrees F temp - 20 days. Left arm red and swollen - 1 week. Nauseous- 2 days. Achy - 2 days.
muscle pain; headache; chills; fever; tiredness; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional who reported for herself. A female patient of an unspecified age received BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on an unspecified date in Jan2021 (reported as "yesterday") for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing headache muscle pain, chills fever and tiredness. She was asking even though she was experiencing these side effects it did or did  not mean she was positive for COVID 19. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
PATIENT HAD EMERGENCY TETANUS VACCINE IN BETWEEN THE FIRST AND SECOND COVID VACCINE
4 hours after the vaccine, my samrt watch recorded that I was in Afib and my heart was fluttering and had weakness in legs. Went to ER, and had an EKG, was referred to my Cardiologist. Cardiologist prescribed ELIQUIS and is going back to have Electrical cardioversion done.
Within 24 hours of getting the vaccine, I started getting dizzy and thought it was vertigo. After a couple of days I start getting dizzy again and started getting shortness of breath, I had high blood pressure 175 over 150.... I was so dizzy I didn't feel comfortable driving for about a month and has affected my work also I missed out on personal events with family and friends.  I then went to the ER where they pumped me with fluids and felt much better they told me I was dehydrated and could go home which I did... 24 hours later thought I got my results and my enzymes were normal when I was at the ER so I wasn't dehydrated.  I then went to see my family doctor and saw him around 6 times over the course of 6 months complaining of these issues.  We did an MRI, EKG, Catscan, and a stress test, and all of those things came back negative everything was fine but I was still having issues.  He did put me on as a last resort verapamil er 180 mg and that has worked for about a year, but now I am slowly having issues again
Patient got Moderna Covid-19 vaccine at about 3:49 pm on Friday 03/12/2021 and she felt dizzy after that.  She sat on the chair at waiting area then about 6 or 7 minutes later she stood up and walked to register counter to tell  associates she did not feel well and she felt on the floor.  Responding team helped her to seat on the chair after asking her if she felt fine.  Responder observed the patient to make sure she is fine.  She said she was fine she was scared of the needle.  She was advised to seat on the chair until she completely feel fine and she should ask someone to pick her up.  Responding team was monitoring her during the time she was seating in the waiting area.  After another about 15 minutes she said she felt fine now and she walked out of store.  Next day (on Saturday), pharmacist called patient to follow up.  Patient said she was fine and she has no issues after she left the pharmacy,
pt recvd DTP/OPV/MR/PPD & then devel a swollen red arm;
Patient was vaccinated beyond use date of 7/6/2022.  No symptoms reported by patient.
Vaccines given 3-26 (am). 3-27 (am) awakens with redness and swelling around eyes. No discharge, sclero white. comes to office-benadryl given (3-28) (3-29) returns to office-swelling increased along with redness-given prednisone script (never filled) continues with benadryl 3-31 (looks normal)
Case number PHEH2013US018949, is an initial spontaneous report received from a medical assistant on 06 Sep 2013: This case refers to an 11 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: A12092), reconstituted with sterile diluent from Merck, intramuscularly on 03 Sep 2013. No adverse reaction was reported following this administration error.
No adverse event. The vaccine administered on 3/30/22 expired on 3/17/22. Moderna tested the stability if the same lot number and determined that the dose given was still protective against the Covid19 virus.
On 21-Sep-2021, patient experienced Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (On 21-Sep-2021, patient experienced Rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced RASH (On 21-Sep-2021, patient experienced Rash). At the time of the report, RASH (On 21-Sep-2021, patient experienced Rash) 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.   Concomitant products were not provided. Treatment medication were not reported.
Pt experienced a fever and irritability the evening of the vaccine. 3 days later, the pt developed a high fever, febrile seizure. Dx with strep pneumonaie. Treated with IV Rocephin and Augmentin
Pt underwent cardiac cath with PCI and stents on 2/10/15. He came to office on 2/18/15 after discharge. At visit pt. was given PNEUMOVAX and PCV 13. The following morning he had severe chills, fatigue, red, swollen arm radiating to chest, rash over upper arm and dizziness. No fever.
His arm was only sore the same day he received the second dose of the covid vaccine, and the next morning; He slept a lot that night; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX US Support. A 18-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 (at the age of 18-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunisation and had arm was sore and weak for 2 or 3 days. On 11May2021, on the same day of second dose of vaccine, patient arm was sore of the first day and the next morning, then it was fine. He slept a lot that night. He did not have nearly as much symptoms as most people say. He did not have many side effects. Outcome of the event pain in arm was recovered on 12May2021 and for other event was unknown.  Information about lot/batch number has been requested.
Reaction noted on 6/15/01 as an area of swelling, redness and warmth. No treatment was given. The swelling was gone by 6/19/01. Redness (3cm diameter) was still present.
Extreme soreness in left shoulder at site of injection. Pain would possibly be in the 8 category. Very uncomfortable and cannot lift left arm anywhere near shoulder height.
Lower lip swollen, pale, weak, sweating. B/P 116/90, BP 151/91 IV 0-9 Sodium chloride given, 50ml of Benadryl 3mg Epinephrine
for the past 2 years the patient had her right knee prosthesis swell up 10-14 days after a flu shot.  She ended up in surgery for washout each time.  Cultures/Crystals, PCR all negative
Tachycardia, dizziness, flushing, sweating. BPs 163/64 (pulse 120-137), 148/73 (pulse 140-145). Sent to Urgent Care for tachycardia.
Ezema allergicum; No known egg allergy; Previous vaccinations w/Fluzone 2x in'86, 1x in  '87, 1x in"88;
PATIENT CAME INTO PHARMACY FOR PREVNAR VACCINE ON 8/4/2017. SHE WAS TOLERATING WELL WITH THE VACCINE. SHE CALLED PHARMACY ON 8/11/2017  AND REPORTED REDNESS AROUND SITE OF INJECTION AS SIZE OF A DOLLAR COIN. PATIENT SAID SHE HAD NO FEVER BUT A SLIGHT WARMTH AND  AROUND SITE OF INJECTION.
No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted; HCP states that the personadministering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering it; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-AUG-2022, the patient was vaccinated with the second dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 mL (route of administration was not provided) lot #U039951, expiration date: 22-JUN-2024, administered as prophylaxis which was accidentally diluted with 0.5 mL of normal saline (Incorrect dose administered) (Product preparation error). No additional adverse event (AE) information provided.  This is one of several cases received from the same reporter.
One week late menstrual cycle. When cycle began it was painful and excessive bleeding. Tissue, clots, and blood lasted several days. All symptoms were anomalous; have never happened before.
Urticarial rash at site, red, poorly circumscribed, raised and blanching.
Delayed injection site response. 3 inches diameter hard raised red circular lump at injection site that will occasionally be very itchy.
This is a spontaneous report received from a contactable reporter (consumer).  A 5 year-old female patient (not pregnant) received bnt162b2, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: yes child has had allergic episodes in the past but the root cause for her, allergies not identified. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pre Dose Dose Number: 1, prev dose product=COVID 19, prev dose brand=pfizer biontech vaccine, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, prev dose administration_date=Nov2021, prev dose dose number=1), administration date: Nov2021, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 10Dec2021, outcome "recovered", described as "Hives started from abdomen and spread through over a few hours covered all upper body up to her neck"; HYPERSENSITIVITY (non-serious) with onset 10Dec2021, outcome "recovered", described as "The child had the vaccine on 08Dec and allergic reaction started on 10Dec". The events "hives started from abdomen and spread through over a few hours covered all upper body up to her neck" and "the child had the vaccine on 08dec and allergic reaction started on 10dec" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria, hypersensitivity.  Clinical course: the patient had the vaccine on 08Dec2021 and allergic reaction started on 10Dec2021. Hives started from abdomen and spread through over a few hours covered all upper body up to her neck. Hives were not itchy and there was no respiratory difficulty in her breathing. The child has allergic history without any particular root cause defined. Parents took her to ER and ER doctor stated that it may have been allergic reaction to the covid 19 vaccines or anything else she may have ate at home or at school. The doctor gave Zyrtec and child recovered from hives in a few hours. No covid prior vaccination. Not covid tested post vaccination. Patient has had allergic episodes in the past but the root cause for her allergies not identified. No other vaccine in four weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Approx 10  minutes after patient received vaccine, he began to complain of chest pains, dizziness, and blurry vision. His vitals were stable at BP 133/95, HR 90, Pulse ox 97% on room air. His symptoms persisted so 911 was promptly called. Dr. came and assessed patient and he was found to have clear lungs with no abnormal heart sounds. When EMS arrived, his vitals were very similar and still stable. Patient was taken to Hospital. I spoke with him the following day, 4/7/21, and he reported that his labs were all unremarkable and they treated him for a panic attack and he was feeling well by the time he got home.
vaccine was in refrigerator and administered on 18-Oct-2021; 1 dose administered after vaccine reached Beyond Use Date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) and PRODUCT STORAGE ERROR (vaccine was in refrigerator and administered on 18-Oct-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was in refrigerator and administered on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) and PRODUCT STORAGE ERROR (vaccine was in refrigerator and administered on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No Treatment medications were reported. Beyond Use Date was reported as 09-Oct-2021 and vaccine administered mentioned as 18-Oct-2021
Information has been received from a medical technologist concerning a 43 year old female with a sulfonamide allergy and a history of arthralgias, alcoholism, liver failure and drug reaction to ARTHROTEC who on 22-DEC-2008 was vaccinated with her first dose of PNEUMOVAX (lot number 663012/1163X) Im into her left arm. Concomitant therapy included VICODIN and vitamin supplements. On 23-DEC-2008 the patient was seen by the physician because she had swelling, induration, warmth and erythema at the injection site. The are was 15 x 10 cm. the patient also had satellite areas of induration and erythema. The patient had no fever. The patient was prescribed clindamycin and told to ice the are. On 24-DEC-2008 the patient was doing better. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements if the Center and was released. This is one of several reports received from the same source. Additional information has been requested.
Pfizer dose for 5-11 yrs was given to the patient although he was 12 year 10 months of age.
; This is a spontaneous report from a contactable nurse (patient herself). A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: El1823, expiration date was unknown), via an unspecified route of administration on the right arm on 14Jan2021 at 11:00 at a single dose for COVID-19 immunization. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 26Dec2020. Both doses were administered at the hospital. The patient had no medical history; she had no known allergies. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 15Jan2021 at 12:00, the patient experienced nausea, vomiting, and fever greater than (>) 103 (units unspecified). The patient did not receive any treatment for the events. The patient was not recovered from the events.
This is a 27y.o. female with medical history of PCOS and HTN, COVID detected Sep 3rd. A 27-year-old female presents to the emergency department via private vehicle complaining of Corona virus concern. Patient states she was at a party 3 days ago and then had a friend told her to get tested due to her positive test. Patient has been vaccinated with Moderna. Patient then noticed the next day she had postnasal drip, congestion, a slight cough, and shortness of breath with exertion. The patient has a history of allergies and thinks this might be that. The patient is not complaining of any nausea vomiting, sore throat, abdominal pain, or diarrhea. Patient she has had some fevers and chills but has not had an accurate reading at home. Patient present in 9/12/2021 ED for blurred vision, double vision x 1 day,  She also noticed dizziness and unsteady gait since..  Patient continues to endorse disconjugate gaze with the left eye seeming dysfunction independently of the right.  She is also experiencing blurry vision.   ED course: troponin < 0.01, BMP grossly WNL,  WBC 12.5, Hgb 10.2, Neutrophils 7.9, Plt 499, CT head no acute concerns. EKG sinus, MRI brain /orbit ordered, Neurology consult,
Tested positive for Covid; Tested positive for Covid; Headache; Sore throat; Congestion; Fever; Chills; Loss of voice; Aches; DUPIXENT MY WAY  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2021SA431415 (Sanofi).  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 23Dec2020 (Batch/Lot number: unknown) as dose 1, single, administration date 13Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for immunisation; dupilumab (DUPIXENT), first regimen from 04Sep2020 (Batch/Lot number: unknown) to 04Sep2020 at 2 DF (2 df, 2 injections of unknown dose, unknown route for the initial loading dose on 04sep2020) and second regimen (ongoing) (Batch/Lot number: unknown) at 300 mg (300 mg (qow)) for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 18Dec2021, outcome "not recovered" and all described as "Tested positive for Covid"; HEADACHE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Sore throat"; COUGH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Congestion"; PYREXIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Chills"; APHONIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Loss of voice"; PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (18Dec2021) positive. The action taken for dupilumab was dosage not changed.  Reporter causality: not reported for all the events. Company causality: not reportable for all the events.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.