chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at injection site; Patient took off his bandage and some of the skin came off with the bandage; Irritation at the injection site; Burning sensation at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE EXFOLIATION (Patient took off his bandage and some of the skin came off with the bandage), VACCINATION SITE IRRITATION (Irritation at the injection site) and VACCINATION SITE PAIN (Burning sensation at the injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Burning sensation at the injection site). On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE EXFOLIATION (Patient took off his bandage and some of the skin came off with the bandage) and VACCINATION SITE IRRITATION (Irritation at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE EXFOLIATION (Patient took off his bandage and some of the skin came off with the bandage), VACCINATION SITE IRRITATION (Irritation at the injection site) and VACCINATION SITE PAIN (Burning sensation at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided
1-day post-vaccination,  injection site swollen, raised circle about 1.5 inches in diameter, warm to touch. No past reactions to other vaccines.
CHEST PAIN STARTED RIGHT AFTER SECOND DOSE, BUT I ASSUMED IT WAS ENDOMETRIOSIS RELATED (MY CHRONIC CONDITION). PAIN GOT WORSE AND ON 6/07 IT WAS ADVISED I GO TO AN URGENT CARE. AFTER EVALUATION THERE, I WAS REFERRED TO THE ER. MY D-DIMER LEVELS WERE EXTREMLY HIGH.
Left neck lymph node going to explode; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot Number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included spontaneous coronary artery dissection (SCAD), thyroid and pseudocholinesterase deficiency. The patient has known allergy to  PCN (penicillin), sulfa, Macrobid, Neosporin and cat gut stitches. Concomitant medications included acetylsalicylic acid (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), fluconazole (DIFLUCAN), vitamin D (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Mar2021, same day of vaccination, 45 minutes after jab in left arm, the patient experienced left neck lymph node going to explode. It felt hot and cold concurrently or like something was piercing it. She experienced super odd never before felt sensation and it subsided after about 3 days but again 2 weeks later the patient was still aware of it. It did not hurt but definitely did not feel 100% normal. It was never swollen (like they would have been normally swell a little when she would get a cold or something but it didn't even do that). Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left neck lymph node going to explode was recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
PATIENT HAD PFIZER COVID-19 DOSES, Dose 1 date: 12/23/2020,  Dose 2 date: 01/13/2021. PATIENT TESTED POSITIVE TO COVID.
no adverse event; vaccine leaked out of patient's arm; while administering PNEUMOVAX 23 by intramuscular injection to the patient, some of the vaccine liquid leaked out out of the patient's arm resulting in possible partial dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's concurrent condition, pertinent medical history and concomitant medications were not provided. On 27-JAN-2020, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose # and schedule were not reported) lot #S006777 expiration date 20-NOV-2020 via intramuscular route for prophylaxis, while administering the vaccine some of the vaccine liquid came out of the patient's arm (injection site extravasation) resulted in possible partial dose (incorrect dose administered). No addition adverse effect information provided (No adverse event). The outcome of the event injection site extravasation was not reported. The causality assessment was not provided.
Red induration around injection site 15-20 cm in size. Happened within hours of immunization given.
20 minutes after receiving injections of HEP A, MENACTRA, ADACEL, & FLUMIST became pale, light headed, Loc.
Hives at site of injection about size of half-dollar. Hives resolved after a few hours then came back to site of injection, only smaller and lasted a few hours. No symptoms since.
Information has been received from a registered nurse concerning a 24-month-old female with no history of drug reactions or allergies no pre-existing medical conditions who on 19-MAY-2005 was vaccinated subcutaneously in the left deltoid with a 0.5 ml dose of Varivax (Lot # 649270/0987P). Concomitant therapy included brompheniramine maleate/pseudoephedrine DM (DIMETAPP); it was also indicated that there were no concomitant medications at the time of vaccination. There was no illness at the time of vaccination. On 24-MAY-2006, the patient experienced an upper respiratory infection; on 04-JUN-2006 (also reported as 03-JUN-2006) she experienced varicella rash with a total of 15 to 20 pink, papulo-vesicular lesions on both forearms and two on her face. There were no additional symptoms. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. There were no adverse events following prior vaccinations. No additional information is expected.
Chills; Fever of 104 degrees F; Muscle pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever of 104 degrees F), MYALGIA (Muscle pain) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included METFORMIN, METOPROLOL, CYANOCOBALAMIN (VITAMIN B-12), LISINOPRIL, HYDROCHLOROTHIAZIDE, TIOTROPIUM, METHOCARBAMOL, SIMVASTATIN, PREGABALIN, MELATONIN, PANTOPRAZOLE, DULOXETINE, FERROUS GLUCONATE, MAGNESIUM OXIDE, VITAMIN D [VITAMIN D NOS] and TIOTROPIUM BROMIDE (SPIRIVA) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 104 degrees F) and MYALGIA (Muscle pain). On 06-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, MYALGIA (Muscle pain) and CHILLS (Chills) had resolved. On 08-Mar-2021, PYREXIA (Fever of 104 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 104 (High) Fever.     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.
Patient called pharmacy at 6:07 pm. She said she just wanted to know she had an adverse rxn. The injection site became itchy and started to swell about 1 hour later. After the has it became more itchy and swollen. When she called I told patient to take BENADRYL and hold cold cloth to site. Will give follow up call 10/24/13 in A.M. Called patient again at 10:47 AM, swelling has gone down considerable but still a little warm, Patient said she will be fine.
Swollen lymph nodes in armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 09May2021 at 09:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 10May2021 at 07:00, the patient experienced swollen lymph nodes in armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of event swollen lymph nodes in armpit was resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Fever  chills Narrative:  chills, fever; recovered  Other Relative History:
Severe arm pain day of injection where I was unable to move it for 2 days following, then it would reoccur for the next 2 weeks when shoveling or raking. Also, left eyelid twitch approximately 20x a day, started day after injection and continues to happen over 3 weeks later.  And lastly,  left breast pain that is sharp that is now,  over 3 weeks later now dissipating but still there.
SYRINGE ADMINISTERED OUTSIDE SYRINGE TEMPERATURE REQUIREMENTS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced syringe administered outside syringe temperature requirements. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of syringe administered outside syringe temperature requirements was not reported. This report was non-serious.
Narrative: COVID infection following COVID vaccine series 01/06, Moderna, dose #1 02/02, Moderna, dose #2 08/09 COVID swab, result: :detected 08/05 pt cc: cough, headache, rhinorrhea, fatigue, myalgias, dyspnea, exposure: unknown 08/06-08/13 pt symptoms continue clinically resolved
Had covid; Had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid".  Clinical course: My whole family is vaccinated w/all 3, my son has had covid 2 times, my other son and husband had both had it Had covid twice. Had covid twice. 1st time was not bad, 2nd time was worse and prescribed Paxlovid after 3rd shot ,I had frozen shoulder, went to therapy and still have  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chest Congestion/Bronchitis lasting 5 wks treated with antibiotic. 2 wks after onset of above symptoms. Experienced dizziness, tingling/pins and needles sensation in base of neck. Severe pain in upper back between shoulder blades and lower back sending prickling sensation down lower extremities.  Treatment: Xray of neck. Rx Voltaren 75mg BID for inflammation. Awaiting MRI presently. Beginning of January. Onset of gastrointestinal problems including: Nausea, severe cramping, diarrhea, dizziness. Treatment: Upper Quadrant left and right Ultra sound-Normal, Labs: Comprehensive panel-Normal, CBC-normal, Amalyse/Lypase-normal, Stool Culture-Normal.
No additional AE information provided.; HCP states that PROQUAD was administered to a patient on 12/14/2022 after a supported temperature excursion that took place on 12/1/2022; This spontaneous report was received from Medical Assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status rHA (recombinant Human albumin), 0.5 milliliter, lot #W020552, expiration date: 26-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) after a supported temperature excursion (temperature 19.4 Degree Fahrenheit for 50 minutes) that took place on 01-DEC-2022 (product storage error). No additional adverse event information provided. There was no previous temperature excursion.
received around 10 back to back injections against my will, repeatedly told i had no choice to decline despite my philosophical, religious, and health objections. immediately felt extremely weak with ringing in the ears and blurred vision, could barely even walk. experienced onset of constipation, when previously i would go twice a day on average. since have been alternating between diarrhea and constipation for years. the worst immediate symptom was a constant lack of energy, which has persisted to this day. i would get extremely light-headed in exercise and feel like i was going to pass out and have to stop the PT. when i tried to relay my health difficulties after the vaccination incident i would be told to stop making shit up, that i'm a 'pussy' and to 'suck it up' 'be a man' and other sexually derogatory remarks such as 'queer', etc. my pleas went unheard at best, and more often ridiculed and punished for not being able to complete the exercise with even more intense exercise which would cause severe pain in my head, such as working out in a a coat-drying room at ridiculously hot temperatures, being forced to wear every single article of clothing we were issued. since this time, i have been struggling with low energy levels every day, with no relief from even the healthiest diet and lifestyle choices i implement, and have a few weird unexplainable growths which i am unable to get checked out with no health coverage. i also started to experience at the time of the vaccines and continue to experience mild twitching of various muscles as well as finding myself rocking back and forth when my stress levels are high. my ability to concentrate on tasks such as reading and memory retention has significantly decreased since prior to the exposure. my vision still goes blurry from time to time and the ringing in the ears definitely persists. i also have severe joint pain and feel like a feeble eighty year old, robbed of my youth. i clearly remember waking up the night of the vaccines and being paralyzed for several hours, not being able to call out or even move a finger or toe, and seeing everything in a crimson red hue. i feel completely violated, forced to be injected with a gross excess of unknown adulterants, and have become severely socially withdrawn since this time, unable to be around groups of people, even family, without severe physical anxiety issues; shaking, eyes running, heart racing; which has greatly limited my ability to network and find work. i also experience these anxiety symptoms unprovoked when i am just sitting on the couch by myself, but they are a constant when around anyone. when prior to this i was a normal healthy young man with no problems socializing. I even competed in high school athletics only a year or two before this, playing varsity football with none of these fatigue problems or social fear that i do now. i struggle every day to find the strength to continue thru the physical and psychological pain of having my vitality taken from me at such a young age and to find some hope that i may be returned to my prior functionality and zest for living.
Dizziness, light headedness that lasted approx 8 hours. Rested and resolved itself
Pain in shoulder area upon injection. Had discomfort throughout the night. Pain continued till next day then improved. In 2 weeks since injection pain now returning when move arm certain way. Suggested follow up with Primary Care MD.
slight fever, chills, arm soreness, body aches, left shoulder discomfort x days2-3 after 1st dose.  Narrative:
1225 Pt in 15 minute waiting lot after receipt of vaccine above. Nurse responded to vehicle 2 to c/o dizziness BP reading 222/92, P 80, R 20. Gave water and monitored. By 1205 BP down to 149/98. Pt left lot accompanied by wife 1355: Nurse  placed f/u ph call to pt. Was monitored at ER for 2 hours BP returned to normal Denies further concern
PT CAME INTO PHARMACY TO REPORT FEVER LETHARGIC MUSCLE PAIN. SHE HAD LARGE HOT RED CIRCLE RASH ANS ABOVE BRUISE AREA WHICH WAS ALSO HOT TO THE TOUCH.
got the vaccine. Had a fever; got the vaccine / felt horrible; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were unknown.   It was unknown if the reporter considered the fever and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not provided. A year later after shingles the patient received Shingles vaccine and developed fever and felt horrible. The follow-up would not possible as no contact details were available.
Headache, Myalgia & Fever Narrative: dose 1: chills; fever; ha; joint pain; muscle aches; swollen glands; cramps of legs; dose 2: sore arm day 1-2; day 2-  bodyache;day 3 fever;day 4 chills
Still in treatment. Shortness of breath, chest pain. fast heart rate. heavy persistent coughing to the point of throwing up and cant breathe in between. Hurst my ribs, asthma attacks, moderate to severe post nasal drip that causes me to choke, headaches. This condition usually lasts 3-4 months when I get the flu shot. Reacting the same to covid shot so expecting the same. The Immunologist put me on an Albuterol inhaler, Budesonide and Formoterol inhaler, Spiriva inhaler, and Oral dexamethazone. Cough is tolerable with inhaler but mucus and sinus inflamation is not controled.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
Joint pain in both shoulders, elbows, wrists, fingers, knees, ankles, and feet, as well as muscle soreness. Two days after the first shot on February 15th, the pain in my arms, joints and muscles, was awful. The pain lasted for two days. After yesterday's shot, the soreness and pain came on within 12 hours. So far, the pain is manageable.
Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: 10 minutes after receiving vaccine patient experienced shakiness, tingling, weakness, sweating and appeared pale.  Checked blood pressure initial reading 96/68.  Second BP taken 15 minutes later BP 107/72.  Pulse stable at 68 BPM.  Patient stayed 35min for oberservation and seemed to feel much better when he left.  Water provided to patient.
Pt reported area below injection site swollen, red and a red line down to elbow. Seen on 8/20 no redness or swelling present.
3/8/21 ~ 8:00pm General fatigue along with soreness in arm at injection site 3/9/21 ~ 11:00am started to feel lethargic 3:00 pm Felt like I had fever and asked wife to check temp. Fever of 99.7 behind ear with temporal scan thermometer 4:30pm took 800mg of ibuprofen for the fever which made me feel better and resolved the fever 3/10/21 - continued to feel lethargic, but no fever. Took sick day from work to rest. Took 1000mg acetaminophen which made me feel better. 3/11/21 - felt much better when I woke up and felt good throughout the day. My arm was still sore at the injection site but not as bad. 3/12/21 - I feel completely well, but arm is still slightly tender.
I get like I was having a heart attack, my heart was racing, shortness of breadthe, extreme chest pain.  Describes as potential myocarditis
This was the third shot (booster) in the Moderna series. After about a day, I developed a red, warm rash near injection site that gradually spread further down my arm and swelled greatly. After 3 days, the rash was down to my elbow and around the backside of my arm as well. It was hot and sore. I had a telemedicine consult with a doctor from my insurance plan, and she prescribed me antibiotics as it looked very bad. She also advised that I not get another booster shot.
This case was reported by a nurse via sales rep and described the occurrence of pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (Refer case US2018GSK119885). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and pain in arm. On an unknown date, the outcome of the pain and pain in arm were unknown. It was unknown if the reporter considered the pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced very mild pain noting nothing like symptoms after 1st dose SHINGRIX, except sore arm. The reporter did not give consent for follow up. This case has been linked with case US2018GSK119885 reported by the same reporter for the same patient.
Per patient report - pain, difficulty lifting arm, clicking sound when using affected arm. Visited doctor 11/5, who prescribed pain medication and physical therapy.
Chills, urticaria, dizziness, tachycardia Pt complained of palpitations immediately after vaccination. Dizziness, hives, chills and tremor associated. Hx of Mast-Cell d/o and anaphylaxis to NSAIDs.  No reaction to first dose.  Initial BP 136/93, HR 147, O2 100% RA.  Pt appeared pale, tremor   Patient sent to ED.
Mom messaged at 8:12pm the next day to report area was red, warm to touchc, very itchy.  She described red bumps around area. Spoke to Mom 10/18/2023 she stated all symptoms went away after 2 days.