chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stage 0 after having breast biopsy; Vaccination site pain/left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER IN SITU (Stage 0 after having breast biopsy) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BREAST CANCER IN SITU (Stage 0 after having breast biopsy) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Vaccination site pain/left arm soreness). At the time of the report, BREAST CANCER IN SITU (Stage 0 after having breast biopsy) had not resolved and VACCINATION SITE PAIN (Vaccination site pain/left arm soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy breast: stage 0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs were not Reported. On unknown dates, the patient experienced Stage 0 after having breast biopsy and left arm soreness after Moderna vaccination.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns an elderly female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Breast cancer in situ on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient underwent breast biopsy with result reported as stage 0.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Breast cancer in situ on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient underwent breast biopsy with result reported as stage 0.  No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient was given the first dose of shingrix on 8/23/19.  patient presented to patient first complaining of numbness and pain on the left side of her face, neck, and shoulder on 9/7/19.  On 9/8/19 the husband came into the pharmacy and stated that patient first says she has shingles and she most likely got it from the shot 2 weeks ago.  Her husband also stated she is developing a rash on her lip today.
patient was unresponsive for 2 minutes after vaccination. Reaction occurred 10 minutes after injection. Reports feeling sleepy. Difficult to arouse. Team alert was initiated. Patient's vital sign 100/55. HR 61. O2 99%. Patient then woke up and reports that he feel fine. Denies sob, chest discomfort, or difficulty breathing. He was sent to ED for further evaluation due to low BP.
Eye pressure, blurry vision.  Severe muscle aches,  joint & body pain. Uncontrollable shaking. Terrible cold chills. Low grade fever. Extremely foggy brain. Extreme weakness. Above symptoms lasted for 36 hours. 5 days post vac still having cold chills fatigue sleeping all the time and brain fog.
Pt has a red mark on her arm which is inflammed and painful. Pt will monitor and let dr know if does not change or becomes more painful.
covid test date=31Dec2021; covid test result=Positive; covid test date=31Dec2021; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 18:30 (Lot number: ER2613) at the age of 56 years as dose 2, single and administered in arm right, administration date 18Mar2021 18:30 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. Relevant medical history included: "latex" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "covid test date=31Dec2021; covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab.
Hives on chest, shoulders and stomach.  Went to Urgent Care on 5/2/21.  Was prescribed Triamcinolone Acetonide Ointment USP, 0.1% for the itching and told to take Zyrtec.  Older out brakes are fading but still itch but new ones appeared this morning.
polyneuropathy in hands and lips; This case was reported by a consumer via call center representative and described the occurrence of polyneuropathy in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles (had a prior history of Shingles with a case reported in 2020).   In March 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On an unknown date, the patient received COVID-19 VACCINE. On an unknown date, several weeks after receiving Shingrix, the patient experienced polyneuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the polyneuropathy was not recovered/not resolved.   It was unknown if the reporter considered the polyneuropathy to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. Around March 2021, the patient completed her 2 dose Shingrix series.  She reported that a few weeks after her second dose of the Shingrix vaccine received on unknown arm, that she began to develop polyneuropathy in her hands and her lips that was currently still unresolved.  She stated that she was unsure if the Shingrix had caused this reaction but that her physician told her that it could be possible.  The patient stated that she had also received a Covid vaccine within a few months of the Shingrix but did not get it concurrently with the Shingrix.  It was unknown if the reporter considered the polyneuropathy to be related to Covid vaccine. The patient could not provide lot number, expiration date, exact date of vaccines, or route or site of administration. The reporter gave consent to contact health care professional. The reporter consented to follow up. Note: Clarification was raised but as no start date for Covid vaccine was mentioned and reported that received within few months of Shingrix (unclear after 1st or 2nd dose) Covid vaccine received so both vaccines coded as suspect.
Received the shot at 10;45  about 6 hours later the arm swelled a little then a rash  rash has lasted for 2 weeks  This is the first Moderna shot
fainted: pt had been administered & as nurse turned to apply bandage pt sagged to the floor;brief LOC;pallor;initial BP post event 90/50 lying flat;
Developed VARICELLA Disease (chicken pox) Pox to left arm, stomach & legs.  rest, fluids, TYLENOL.
prolonged menstrual cycle; got her period two weeks early and she is still bleeding; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She would like to know whether 'their' side effect, prolonged menstrual cycle (unknown date), is related to the COVID vaccine. The patient received vaccine on 21Apr2021. The next day (on 22Apr2021), the patient got her period two weeks early and she is still bleeding. She says she has seen multiple reports of women online with the same experience as hers. Saw a healthcare professional but they were not concerned. The outcome of the event prolonged menstrual cycle was unknown, while other event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Missed 2nd dose\did not receive the 2nd dose in recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose\did not receive the 2nd dose in recommended time frame) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose\did not receive the 2nd dose in recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose\did not receive the 2nd dose in recommended time frame) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking Birth control pills as concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: follow up document received on 11-AUG-2021 contains start date of the suspect updated.
18OCT93 1410 mom called pt crying excessivly rt thigh red & swollen;  instructed to come back to office; rt thigh @ site 2x2 round enlarged hot & tender;
Abdominal and back rash - have tried creams to resolve itching and appearance. Still some on my back. Abdomen rash has cleared.   Chest pain, right sided. Pain through jaw and shoulder. Felt as if I pulled a muscle. Slept a few hours and it was gone; had it not been gone when I woke up, I would?ve went to the ER.
4 days after vaccine increased pain in right upper arm. It got progressively worse over the next 3 days. Went to see occupational health, PA did a ROM shoulder exam. I was prescribed ibuprofen and flexeril. Also advise to do ROM exercises and heating pads at home
A physician reported that a 33 month old female with a recent history of ear infection, received her 1st dose of Prevnar on 2/9/01. On 2/10/01, she developed a "mildly" itchy rash that started on her legs as small bumps and spread to her torso and then her face. The rash persisted throughout the week.
Itchy rash at the site of injection - delayed onset (1 week after injection). Ongoing at this time.
Obsessive-compulsive disorder. A mother reported that her child who has a history of OCD trends and tics received his 1st dose of Prevnar on 4/18/01. Soon after vaccination he experienced an exacerbation of his OCD trends and tics.
tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 11:00 (Lot number: ER20013) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing), notes: prior history of SVT's that had resolved. There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: TACHYCARDIA (non-serious) with onset 21Mar2021 07:00, outcome "recovering", described as "tachycardia". Therapeutic measures were taken as a result of tachycardia.  Additional information: No other vaccine in four weeks, No Other medications in two weeks. tachycardia after limited physical exertion within 48 hours of first dose of vaccine. Ae treatment: homeopathic and naturapathic cardiac support. No covid prior vaccination and Patient was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200238071 Same reporter patient, Different AE/dose
It started with the flu, cough, severe muscle pain, nause since Thursday and it remained the same until Saturday when he started with temperature. Went to the hospital for emergencies and they tested him for Covid and it came out negative. He is tired and severe stmach pain. Only paracetamol for treatment, Ibuprofen and medication for nausea.
Patient received the vaccine around 6:30 pm and went to the hospital around 11 pm the same day. Patient called our pharmacy the next day to let us know what happened.
10 minutes after vaccine patient felt dizzy. She was sitting up and talking fine. her breathing  was fine .Rph asked mom if we can do anything  and if we need to call emt. She said call emt. Emt arrived in 10min took vitals  and told rph they will take it from here
Loss of upper field of vision Right eye; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 03Mar2021 16:15 (Lot Number: EN6198) as single dose for covid-19 immunization (age at vaccination: 66 years). Medical history included fibromyalgia, hypothyroid, hyper cholesterol, arthritis, depression, and allergies: Mango, penicillin, sulfa drugs, all from an unknown date. The patient is not pregnant. No Covid prior to vaccination and not tested for Covid post vaccination. Concomitant medications included thyroid (ARMOUR THYROID); fluoxetine hydrochloride (PROZAC); atorvastatin (LIPITOR); celecoxib (CELEBREX); zolpidem; all taken for an unspecified indication, start and stop date were not reported. The patient previously took floxacin and experienced drug allergy. The patient experienced loss of upper field of vision right eye on 03Mar2021 18:30. No treatment given for event. Outcome of the event was unknown.; Sender's Comments: Based on the information provided, and on a close temporal association,  the Company  assessed that a reasonable possibility could not be completely excluded that the reported event Loss of upper field of vision right eye  was related to the PFIZER-BIONTECH COVID-19 VACCINE..
This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 2 of 6 (see case IDs A0952647A, A0952654A-A0952657A for details of the other reports).
2 hours after shot I developed a marijuana high with confusion. This lasted less then 1 hour.
metallic taste; heartburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste"; DYSPEPSIA (non-serious), outcome "unknown", described as "heartburn".  Additional Information: Patient had metallic taste on her mouth for 3 days and a half after the first dose and after the second dose she experienced a stronger metallic taste that lasted a day and heartburn  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) which was also administered to a patie; This spontaneous report was received from a medical assistant referring to a 11-month-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 16-JUN-2023, the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL once via injection in right thigh, lot # W039033 with expiration date 01-OCT-2024, for prophylaxis (strength and route of administration were not reported). It was stated that the vaccines was exposed to a temperature of 49.1 °F for 34 minutes, with two previous excursions at (35.9 °F) for 2 minutes and again at (35.9 °F) for 2 minutes). No adverse effects were reported.
Happened at the injection site, redness, hard to touch and painful. Patient iced the area. Suggest patient to keep putting cold compress twice a day, take some pain relief medication and keep monitor. If the symptoms get worse, contact PCP.
This spontaneous report was received from a physician via a medical affairs director and refers to a 31 years old female patient. The patient did not have any (at the age of 26 years old) pertinent medical history, concomitant medications, drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and site of administration, lot # and expiration date were not reported) as a human papilloma virus (HPV) vaccination. On an unknown date, the patient visited the physician's office presenting with adenocarcinoma in situ, positive for P-16 from PAP smear for high risk HPV. The physician reported that the patient received an unspecified treatment on an unspecified date. The patient would have follow up PAP smears on unspecified dates. The outcome of the event was reported as recovering. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of adenocarcinoma in situ, positive for P-16 from PAP smear for high risk HPV was considered to be medically significant.
Almost immediately after the vaccine the doctor who was monitoring me approached asking was I feeling ok because he noticed I had starting flushing. I advised my throat was a little itchy but wasn't sure if it was the vaccine or due to my regular allergies acting. I was monitored and started itching really bad. The itching got worse, and my throat irritation got worse so I was given water and monitored and advised to be transported to the ER, but I refused. I was eventually released and advised them I would take Zyrtec and if the symptoms worsened, I would seek care. I took the Zyrtec when I got home, and it did help and stop the symptoms. Various times since the vaccine I have woke up with the itching and burning sensation in my throat and has had to take the Zyrtec daily. If the Zyrtec is missed the symptoms comes back.  On Sat 10/23 I woke up because I couldn't breathe or swallow. I took the Zyrtec, but it didn't work. I used the inhaler, but it took almost 2 hrs. to get relief. So, I saw the doctor yesterday and was prescribed an Epi-Pen and to use it if the symptoms arose again. I was prescribed Claritin and have to take it every morning and the Zyrtec is now no longer used on an as needed basis but has to take it nightly on a daily basis now. If these meds aren't taken daily now the symptoms return. I am also now experiencing persistent hives daily that are very very itchy. A pulmonary function test was performed but everything there looked good.
About 30 min after injection, I felt slight tingling in my face and metallic taste in my mouth. The tingling went away about 15 min later. Metallic taste stayed all day and all day the following day, but went away the next day. Metallic taste however returned on day 6 for one day only. Day 7 my left armpit was very sore all day. Day 8 armpit pain went away but injection site became hot and progressively more pink/red in the site and itchy.
Concerned about getting 2nd vaccine; Fast heart rate; Muscle ache; Fatigue; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), COVID-19 IMMUNISATION (Concerned about getting 2nd vaccine), HEART RATE INCREASED (Fast heart rate), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M024) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Hay fever.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), MYALGIA (Muscle ache) and FATIGUE (Fatigue). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Concerned about getting 2nd vaccine). At the time of the report, DIZZINESS (Dizziness), COVID-19 IMMUNISATION (Concerned about getting 2nd vaccine), HEART RATE INCREASED (Fast heart rate), MYALGIA (Muscle ache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications not provided Treatment information not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Called and reporter declined further follow-up
Patient came in for covid-19 vaccine booster (DOSE 3) as well as for the flu vaccine.  It was missed that the patient was immunocompromised and given the Pfizer Bivalent covid-19 vaccine at 0.3 ml in the left arm.  Upon further investigation, discovered patient was diagnosed with colon cancer after his primary series of 2 doses of moderna vaccine.
10/8/05-10/10/05 cough; 10/11/05 dr. said lungs sound clear; 10/14/05 102 degree fever; 10/15/05 104 degree fever; 10/18/05 Emergency Room; 10/20/05-10/23/05 admitted to hospital for pneumonia; 9/06 asthma ***prior to this vaccine, this child, who was 4 years old and 7 months at the time of the vaccine has NEVER been sick, no cough, no fever, nothing.  8/23/07 Received hospital medical records which reveal patient experienced fever x 1 week.  Seen in ER on 10/18/2005 w/fever, lethargy & dx w/pneumonia.  Put on oral antibiotics & d/c to home.  Continued w/fever, cough, abdominal pain, poor oral intake, lethargy, vomiting & diarrhea.  Admitted 10/20-10/23/05.  Found to have bilateral otitis media, abdomen distended & diffusely tender.  Tx w/IVF, IV antibiotics.  Gradually improved & was d/c to home on continued antibiotics. FINAL DX: LLL pneumonia, bilateral otitis media, ileus. 10/9/07 Received initial pcp records of 11/1/05 which was f/u visit s/p hospitalization for pneumonia.  Patient was to complete antibiotics & get CXR prior to next visit.   No further med records provided. 1/11/2010 Got pneumonia, then because of pneumonia he now has asthma.
Patient presented to ER with left leg swelling, diagnosed with extensive Left leg DVT and extensive bilateral pulmonary emboli