chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense migraine:  12 hours after injection -Tylenol 1000 mg - it would decreased in intensity but never went away with Tylenol sore arm chills fever 100.1 while taking Tylenol ; it lasted 12 hours All symptoms went away after 32 hours
Noon next day increased heart rate over 100bpm,; then extreme swelling and pain underarm, so much swelling I could not lay my arm next to my body.; then extreme swelling and pain underarm,; This is a spontaneous report from a contactable consumer, the patient. This 49-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0161) via unspecified route in the left arm on 20Apr2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Patient had no medical history. Patient had known allergy to Codein. Patient did not have COVID prior to vaccination. No other vaccines were received in four weeks prior to COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via unspecified route on 30Mar2021 at 15:15 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Concomitant medication included ibuprofen. On 21Apr2021 at 12:00 (Noon next day), patient experienced increased heart rate over 100bpm, then extreme swelling and pain underarm, so much swelling she could not lay her arm next to her body. Pain was unrelieved with pain meds. Pain has subsided, swelling not yet. No treatment was received for the events increased heart rate over 100 bpm and swelling. The outcome of swelling was not recovered, while of other events was recovering. Patient was not tested for COVID post vaccination.
Right lymph node under collar bone is swollen, hard, and tender.  Muscles on top of right thigh are painful to touch (feels like a very deep bruise).
Difficulty taking a deep breath. Also had wheezing for approximately 2-3 hours. Overall body aches and burning eyes.
Fever, headach, body aches, fatigue, red itchey rash at the vaccine site appeared on 10/31/2021
Patient was given 2 doses in one day, no symptoms developed, no symptoms as of yet (spoke with patient today)
pt recv vax 2DEC96 & fever 104-105 following day & saw MD 5DEC96 & was treated w/Ibuprofen & ATB x 10 days for ear infect;MD also gave 2" inj in office;
muscle spasms in left arm (site of injection) that have been consistent since vaccination   Chest pain occasionally grouped with muscle spasms
Develped a lump in right armpit area on Saturday afternoon.  Lump is about the size of a tennis ball, soft to the touch, painful if pushed on.  Visited doctor on Monday at his request.  Started an antibiotic on Tuesday, 11/30/21.
Lymph node tenderness of left side of the neck and left armpit, redness with warmth at the vaccine injection site of left deltoid
The initial case was missing the following minimum criteria: the suspect product and event were not reported or specified. Upon receipt of follow-up information on 06Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program, by contactable consumer and a contactable physician. A 68-year-old male patient of an unspecified race/ethnicity received PREVNAR 13 (Lot# N16562, Exp Oct2017), intramuscular at single dose in the upper arm on 26Sep2016 08:47 AM for immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing pulmonary fibrosis, ongoing pulmonary embolism, ongoing cardiac failure, ongoing neuropathy peripheral. Concomitant medication included FLUZONE (Lot# U1682AC) intramuscular in the upper arm on 26Sep2016 for immunization, metoprolol at 50 mg 1x/day, prednisone oral 10 mg 1x/day for COPD, pulmonary fibrosis. On 26Sep2016, the patient experienced (SOB) shortness of breath, fever, increased hypoxia, myalgias that required hospitalization. The final outcome of the events was unknown. The patient was hospitalized for the events from 26Sep2016 to 28Sep2016. The patient underwent lab tests and procedures which included Chest X-ray showed bilateral interstitial thickening and no acute pneumonia (Sep2016). Therapeutic measures were taken as a result of (SOB) shortness of breath. Hospital Course: The patient was admitted with increased hypoxia (oxygen saturationin the 60's; usually in the mid 80's on room air) with aching (myalgias). He had received a Prevnar 13 injection earlier on the day of admission. He denied worse cough or colored phlegm. He had a history of prior pulmonary emboli but had refused anticoagulation in the past. On coming to the ER he was started on 02 at 6 liters/minute with improvement in the oxygenation. Chest X-ray showed bilateral interstitial thickening and no acute pneumonia. He was started on IV steroids and antibiotics in the ER. He felt much better by the 2nd hospital day without fever and his O2 needs were back to baseline with oxygen saturation of 96%. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The Company however considers the presence of underlying/pre-existing conditions an important confounder in the independent assessment of the causal relationship. 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.
Patient is 30 weeks pregnant. Her EDD is 4/17/19. She is a G2P0.
PATIENT REPORTS AFTER THE VACCINATION DATE, TWO DAYS LATER SHE NOTICE RASH AND REDNESS AREA  ON HER ARM BELOW THE INJECTION SITE ABOUT 3 INCHES BELOW. THE AREA IS RED, ITCHING , A LITTLE HOT AND TENDER. WE RECOMENDED SHE NEEDS TO USE COLD COMPRESSION AND TAKE BENADRYL FOR NOW THEN REPORT TO HER PCP IF THE ADVERSE REACTION STILL NOT GETTING ANY BETTER
An 18-year-old female patient experienced an injection site reaction after receiving an intramuscular right deltoid injection of ADACEL (lot number C2730AA) and an intramuscular left deltoid injection of Menactra (lot number U2138AA). The patient receive both vaccinations on 14 June 2007, and the site of the ADACEL injection subsequently became black and blue, red, and warm, with a "large lump". Medical history included asthma, environmental allergies, and an amoxicillin allergy; the patient was not ill at the time of the vaccination. Concomitant medications included LEXAPRO, AVEON, and CLARITIN. The event had not yet resolved.
Exhaustion, starting when I get up in the morning, and lasting throughout the day, even if I take several naps a day. Stomach aches. No treatment has been prescribed yet.
Moderately severe headache with significant fatigue. Headache caused minor nauseating feeling.   Adverse symptoms lasted about 8 hours but wasn't severe enough for emergency medical care.
red rash; soreness last at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PAIN (soreness last at the injection site) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PAIN (soreness last at the injection site). At the time of the report, RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PAIN (soreness last at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Numbness, tingling, entire body. Neuropathy, extreme exacerbation. Face, tongue, hands, painful numbness. Very weak, exhausted, and very dizzy. Also, increased blood pressure and increase of heart PVC's. Symptoms ebb and return. It's been 8 days and still dizzy, weak, and neuropathy is so bad that it feels like I'm slightly paralyzed on the left side of my body.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. And on an unknown date, the patient was hospitalized.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
his penis is swelling up; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL SWELLING (his penis is swelling up) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Edema legs.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GENITAL SWELLING (his penis is swelling up). At the time of the report, GENITAL SWELLING (his penis is swelling up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded.
Pain upon extension (up, out and especially behind) of left arm. Pain is often severe and interferes with sleep. Dressing and turning steering wheel are painful. Also experience frequent numbness from shoulder to fingertips.
Patient came into the office for a routine appointment and I was told by the provider, he was going to be getting Hepatitis A and Hepatitis B injections at checkout. I went and checked his insurance, and went to our fridge that holds private stock injections and found private doses of both Hepatitis A and Hepatitis B injections, grabbed them and the supplies needed for his injection and doubled check to ensure I had the right Patient, Right insurance and gave him both injections. He then checked out and I went back to my desk and charted and documented injections in between patients.    - It was actually a Pediatric dose of both Hepatitis A and B he received. When I was notified about him receiving the pediatric injection, the Vares form was filled out, an incident report was documented, and the patient was informed that at his next appt he would have to come in and get the Adult dose of the injection.
Initial report received from a health care professional on 07 November 2011. This reporter also reported other adverse events which were captured in case number 2011-10824 and 2011-10825. A female patient (age not reported) received an injection (route and site not reported) of ADACEL, sanofi pasteur lot not reported, on 28 August 2007. The patient had no other vaccinations within 4 weeks of the ADACEL. The patient's medical history and concomitant medications were not reported. On 11 October 2011, the patient was diagnosed with pertussis. The patient's blood work for IgG and IgM were positive for pertussis. The patient's sputum smear on 11 October 2011 showed routine respiratory flora. The outcome was not reported. Documents held by sender: None.
flushing; throat swelling; tight chest; blood pressure increased; Pain in arm; This spontaneous case was reported by a pharmacist and describes the occurrence of FLUSHING (flushing), PHARYNGEAL SWELLING (throat swelling), CHEST DISCOMFORT (tight chest), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN IN EXTREMITY (Pain in arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (morphine), Fragrance sensitivity, Allergy to chemicals (generally sensitive skin to dyes), Soap allergy and Allergy to plants (hay).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced FLUSHING (flushing), PHARYNGEAL SWELLING (throat swelling), CHEST DISCOMFORT (tight chest), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, FLUSHING (flushing), PHARYNGEAL SWELLING (throat swelling), CHEST DISCOMFORT (tight chest), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided. No concomitant medication were provided.
Around 6:00 pm on the day of vaccination I started to feel very fatigued and developed body aches - this felt similar to the beginning of developing Covid-19 symptoms. (I had Covid-19 back in November of 2020)   Around 8:00 pm I had developed some head congestion and swollen lymph nodes along with some throat pain and sinus congestion - again feeling very similar to Covid-19 symptoms.   Around 10:00 pm as I was heading to bed the symptoms became  a lot worse, I had pretty intense body aches and started to experience chills as well as a slight fever (around 99.5 in F). At this time the symptoms felt similar to how I had felt during the worst of my previous Covid-19 symptoms, very weak and achy, headache was very bad, and felt very uncomfortable overall.   Around 2:00 am on March 13 I woke up with a fever of 101.8. The previous symptoms had also gotten worse, I was having a hard time getting out of bed because things were very uncomfortable, I drank a lot of water and took some ibuprofen to combat the fever, about an hour after this the fever had come down to about 99.9 and I was able to fall asleep, but before taking the medication I couldn't have fallen asleep because of the discomfort of the aches, chills, and fever.   Throughout the following day I was unable to complete many of my day to day activities without taking a daytime cold and flu medication. With the medication I still felt sick but was able to walk around and complete some simple household chores, this carried through into the evening, when the medication wore off the chills and aches and headache were much worse and I still had a fever around 99-100. That night I was able to sleep with the cold and flu medication taken right before bed.  Upon waking up the next morning (March 14) I still had some congestion, headache, and general discomfort but the worst of the aches were gone and I no longer had a fever, these symptoms continued to diminish throughout the day.   On March 15 and March 16th I have had a slight lingering congestion headache, this also feels really similar to the lingering headache I had upon recovering from Covid-19. It is not debilitating and is continuing to improve. Otherwise I am feeling healthy again and have been able to complete my usual activities and even exercise.   Overall the symptoms felt like a couple days of having Covid-19 again, but recovery was much faster, and it was definitely worth receiving that first dose of the vaccine and getting started with the process of doing my part to reduce community spread.
Pt called at 4PM 10-4-14. Say cellulitis type rxn on (L) arm from vaccine. "Size of head of Coke can". Red, hot, swollen in 2 places starting 2" below inj site down to elbow. Says she had fever 10-3-14. No itching or no breathing problems. .She is retired nurse. Told her to apply cool compresses. Couldn't lift arm 10-3-14 morn.
received two doses of FLUBLOK QUADRIVALENT, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency (Reference number- 00869084) and transmitted to Sanofi on 22-Nov-2021.  This case involves a 53 year old female patient who was vaccinated with two doses of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (extra dose administered).  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  She had no other vaccines  On 22-Nov-2021, the patient received first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur via unknown route in unknown administration site for prophylactic vaccination.  On 22-Nov-2021, the patient received 0.5 ml second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur (Suspension for injection, lot number: QFAA2122 and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency same day).  It was reported "Call received from Nurse reporting a patient received two doses of FLUBLOK QUADRIVALENT. Caller reporting both doses were administered today. Caller reporting the patient had a doctors appointment (where she received the first dose of FLUBLOK QUADRIVALENT) and then a flu shot appointment, both at their practice but in separate buildings. The script information contains data from the patient's second dose. Caller with question on what adverse reactions to expect. Caller also with question on what reactions need reporting"  No adverse event was reported.  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.
2/21/20 Client reports upper left arm at injection site very sore, redness size of baseball.  Motion somewhat limited due to pain.  Also red, raised rash to torso, mainly back, and bilateral legs.  Approximately 20 spots.  Itching intense, then subsides.  Also describes Right-sided temporal headache- also comes and goes.  Symptoms began 2weeks following injection.  Client denies fever.  Referred to HealthCare Provider.   3/6/20-Client again phoned- same symptoms exist- subside for 2-3 days at a time, then return.  No change in appearance of rash per client.  Again, referred to Health Care Provider.
Mild headache initially within about 4 hours after injection. 12 hours later, experiencing severe headache, general fatigue, nausea and occasional chills. Took acetaminophen to help lessen symptoms. Symptoms continuing at approximately 17 hours after injection and at the time of this report.
Generalized hives on arms, ears, neck, legs.  Joint pain. Migraines. Early onset menstruation with severe abdominal cramping.
body aches/fatigue for 24  hours followed by generalized abdominal pain, diarrhea without blood, nausea, vomiting, diaphoresis, dizziness.  at evaluation had benign abdominal exam and was clinically stable with normal VS.  symptoms started early morning of  4-11-21, day of medical evaluation 4-15-21
sore arm; swollen arm; red arm; chest hurting on her left side; even her teeth hurt; little bumps she felt with her fingers; redness the size of a dime around the injection site; severe headaches; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm) and CHEST PAIN (chest hurting on her left side) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management and Nerve pain. Concomitant products included GABAPENTIN for Nerve pain, ZOLPIDEM TARTRATE (AMBIEN) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), CHEST PAIN (chest hurting on her left side), TOOTHACHE (even her teeth hurt), VACCINATION SITE MASS (little bumps she felt with her fingers), VACCINATION SITE ERYTHEMA (redness the size of a dime around the injection site) and HEADACHE (severe headaches). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Adverse event, at an unspecified dose and frequency and OXYCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), CHEST PAIN (chest hurting on her left side), TOOTHACHE (even her teeth hurt), VACCINATION SITE MASS (little bumps she felt with her fingers), VACCINATION SITE ERYTHEMA (redness the size of a dime around the injection site) and HEADACHE (severe headaches) outcome was unknown. Not Provided          Other concomitant medications included blood pressure and antacid medications.
pt recv vax 3JUL96 10AM pt started running fever 4JUL96 @ 7PM;5JUL96 had diarrhea-pt thigh red, swollen, tender to touch;pt seen in ER 4JUL96-in for inc temp;MD 19JUL96 for inc temp feels viral no rxn to vax;
70y.o. female with a medical history significant for Extranodal Marginal Zone Bcell Lymphoma, on  rituxan with bendamustine,  and pulmonary sarcoidosis who presented with chief complaint of fall. Acute covid-19 infection. She had chills earlier in week. She was not hypoxic and stable from respiratory standpoint. Chest x-ray was negative for acute findings. She is immune compromised from chemotherapy. Consulted service. Finished 3 day course of remdesivir. She has been vaccinated. She requires extended 20 day isolation protocol due to immune status; this will end on 9-1-2022. She is stable on room air for discharge home.