chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red indurated area at the injection site with some itching; red indurated area at the injection site with some itching; red indurated area at the injection site with some itching; Soreness at the injection site; A spontaneous report was received from a Nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some soreness at the injection site and a red indurated area at the injection site with some itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29-Dec-2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.  Upon receiving the vaccine, the patient experienced some soreness at the injection site and after 8 days, 06-Jan-2021 she continued to experience a red indurated area at the injection the injection site with some itching.   Treatment for the events was not reported.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, soreness at the injection site and indurated area at the injection site with some itching, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient called 11-30 to report pain at time of injection and now 2 days later a red spot lower on arm that the injection site.
fever 103,5 F during 5 days, weakness, low oxygen blood level, headache, chest pain, diarrhoea  headache still continue after one week after the jab
Arm has swollen up; Rash that is on my arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose number unknown via an unspecified route of administration, on 17Jun2021 as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient reported, She was at work. Her arm has swollen up. It has swollen up bad. She was concerned about the rash that is on her arm on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Onset 11/9/04 of left leg numbness/weakness. As of 11/10/04, right and left leg numb and weak. Eventual sensory level negative. Hospitalized and diagnosed with transverse myelitis. Seen by neurologist. Receiving high dose medications. Slightly better; not recovered yet. Discharge Summary received on 1/12/2005 states edema, anxiety, and sleeplessness. Medical Record received on 1/12/2005 states dizziness. 60 Day Follow Up: continues to have lower extremity weakness and neuropathic pain.
t103 orally from onset to 24 hrs later w/APAP; then temp to 100 until 48 hrs later & temp to 103.8 orally; called MD & advised to give APAP q 2-3 hrs & give warm bath; some coughing;
Patient was admitted to hospital with "meningitis-like" symptoms.  MD later confirmed diagnosis of Cellulitis, Myolitis and Muscle Rigidity resulting from vaccinations.
pt reports she developed a headache and dizziness while eating dinner this evening - reports she had a syncopal episode   Patient is a 46-year-old female who was brought in by EMS after witnessed syncopal episode tonight.  States did get her 1st COVID vaccination today around noon was fine then sitting at the dinner table when started to feel hot with a headache went to the ground down for an unknown amount of.  Per family.  Though no reported shaking or seizure activity.  Patient now with generalized headache and some mild dizziness.  No nausea vomiting no numbness weakness or tingling.
10 minutes after receiving the vaccine patient complained of feeling sweaty and dizzy.  She had mild tachycardia. She had no nausea, vomiting or diarrhea. She had no shortness of breath, or wheezing.
1. Severe non-stop Migraine from next day 3/19/21 at 8am until waking up on 3/22/21 at 6am. Now I just have a slight headache 2. Pain at injection site for 3 days (red and swollen lump)- This has subsided 3. Tightness and pain in left neck (same side as injection)- This has subsided 4. My period was supposed to end on Saturday 3/20/22, but I am bleeding more heavily and this is unusual for me so I wonder if it is related to the vaccine somehow. Still bleeding as of today 3/22 Note: I treated the symptoms with ibuprophen and tylenol.
After vaccination patient had arm pain that was constant and achy in nature starting around 7PM the night of the vaccination. She also reports flu-like symptoms: muscle pain, nausea, chills, fever, etc. These flu-like symptoms persisted for 2 days. She was able to resolve the arm pain and fever by taking acetaminophen.
pt recv vax 22MAY98 & that noc had 2 shaking spells;had 2 each day for the next 3 days;25MAY98 vomited & eyes rolled back & shook;
I had a breakthrough case of Covid-19 I had the following symptoms: sore throat fatigue nausea cough postnasal drip fever.
Plaque psoriasis; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (Plaque psoriasis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis.    No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis). At the time of the report, PSORIASIS (Plaque psoriasis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No treatment information provided. Concomitant drugs are not reported.
Patient accidentally received the Daptacel vaccine instead of the Adacel vaccine with no adverse event.; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00561685).  This case involves an 11 years old female patient who accidentally received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5743AA and expiration date: 06-Jun-2022) via unknown route at an unknown administration site (wrong product administered) for prophylactic vaccination on 09-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter states that when she went to get the Adacel vaccine, the Adacel and Daptacel boxes were next to each other and the boxes were the same size. Because of this, she accidentally grabbed the wrong box.   At the time of reporting, the patient experienced no specific adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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.
Blotchy; Covid arm; Arm is tender to the touch; Vaccination site pruritus; Vaccination site rash; Vaccination site swelling; diarrhea; stomach upset; Felt tired; Ache/pain; Sluggishness; Arm very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache/pain), SLUGGISHNESS (Sluggishness), PAIN IN EXTREMITY (Arm very sore), RASH MACULAR (Blotchy) and VACCINATION SITE REACTION (Covid arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS, Diabetes, Blood pressure high and Cholesterol blood excessive.   On 24-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) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Ache/pain) and SLUGGISHNESS (Sluggishness). 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm very sore) and FATIGUE (Felt tired). On an unknown date, the patient experienced RASH MACULAR (Blotchy), VACCINATION SITE REACTION (Covid arm), TENDERNESS (Arm is tender to the touch), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE SWELLING (Vaccination site swelling), DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (stomach upset). At the time of the report, PAIN (Ache/pain), SLUGGISHNESS (Sluggishness), PAIN IN EXTREMITY (Arm very sore), RASH MACULAR (Blotchy), VACCINATION SITE REACTION (Covid arm), TENDERNESS (Arm is tender to the touch), VACCINATION SITE PRURITUS (Vaccination site pruritus), FATIGUE (Felt tired), VACCINATION SITE SWELLING (Vaccination site swelling), DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (stomach upset) outcome was unknown and VACCINATION SITE RASH (Vaccination site rash) was resolving. Not Provided          Concomitant medication included diabetes, high blood pressure, high cholesterol, and thyroid medications.  Treatment information included tylenol, ice, and hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-061364 (Patient Link).
LEFT KNEE INFLAMATION, FEVER CIPRO 500MG  TWICE DAILY  PREDNISONE 10 MG DAILY FOR 5 DAYS ETODOLAC 500MG TWICE DAILY
Stiff neck; This spontaneous case, initially received on 29-Aug-2018 and reported by other healthcare professional, concerns a 48-year-old adult female patient.  The patient's medical history was not available. The patient's concomitant medication included Venlafaxine for an unknown indication.  On 27-Aug-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF36105 (as reported) and expiry date: 07-May-2019] for active immunization against influenza disease caused by influenza virus subtypes A and type B. The reported batch number (YF36105), did not match Seqirus batch numbers, however, because the reporter named Seqirus product Afluria Quadrivalent' as the suspect vaccine, this report had been conservatively entered as a Seqirus case.  On 28-Aug-2018 (reported as yesterday), 1 day after vaccination, the patient woke up with a stiff neck. On 29-Aug-2018 (reported as today), the patient's neck was still stiff with no improvement and the patient was scheduled for a visit with her doctor.  At the time of this report, the patient had not recovered from the event.  The reporter assessed this case as non-serious.  Follow-up report received from pharmacist on 11-Oct-2018: The reporter confirmed the dose of suspect product as 0.5 ml, route of administration as intramuscular and anatomical location as deltoid. The secondary reporter was added. The narrative amended accordingly.; Reporter's Comments: A 48-year-old female patient developed neck stiffness, 1 day after vaccination with suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event as related due to plausible temporal relationship between the event and suspect vaccine.
Disequilibrium in the late evening. Unable to stand or move without assistance the next morning due to extreme dizziness, accompanied by diarrhea. Extreme vertigo lasted for a full day. Lingering balance issues for about a week.
I got fatigue a few hours after vaccine and resolved after a nap of 3 hours.  My arm also still has soreness at the injection sight when touch and area around my underarm hurts with movement.
LUMP IN THE CREASE OF ARM; BODY SORENESS; CHILLS; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body soreness. On 28-MAY-2021, the subject experienced chills. On 29-MAY-2021, the subject experienced lump in the crease of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAY-2021, and had not recovered from lump in the crease of arm, and body soreness. This report was non-serious.
slight tingling of my face; muffled hearing; facial flushing; This is a spontaneous report from a non-contactable other health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), single dose via an unspecified route of administration on 16Feb2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient immediately after vaccination experienced slight tingling of my face, muffled hearing, and facial flushing. Patient questioned about who will decide if to get second dose or his doctor. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administration error: Vaccinator diluted 5 to 11-year-old Pfizer with 1.8mL of saline instead of 1.3mL. 0.3mL administered (intramuscular deltoid).
Extreme muscle pain for 48 hours after onset of symptoms, extreme dizziness, extreme headache, nausea
Information has been received from a physician concerning a 11 week old female infant's mother (WAES #0402USA01716) who on 01-Dec-2003 was vaccinated with a 0.5 cc first dose of varicella virus vaccine live (lot #646230/0541N). On 17-Dec-2003 the mother developed a varicella skin rash. On 26-Dec-2003 the patient developed chicken pox and now has permanent scarring mostly on the trunk. The report indicated that the patient recovered. Unspecified medical attention was sought. The patient's mother (WAES 0402USA01716) also developed chicken pox. Additional information has been requested.
Almost 24 hours after my 1st shot, I started to get dizzy and so I laid back on the bed and my heart was pumping so fast, I could not get it to slow down. It got to the point that I thought I was going to faint, but never did. I called my neighbor, rather than calling the rescue squad. Dose 2: directly after the shot--while still in Pharmacy, the dose seemed to go straight to my heart. I could see my shirt moving because my heart rate was so fast/high, It continues daily & feels heavy! Since then, I have had a couple episodes where I thought I was going to faint, once actually fell to the floor. I continue to have heart flutters/racing heart beat and have gone in to see my physician about these symptoms. I was referred to a Cardiac Specialist by Dr. (who since then has retired on 01/14/2022) and I was given medication for anxiety in which I still take daily. I held off on making any appointment with Cardiac Specialist but now that it's been over 6 months. I plan to make that appointment this week because I DO still feel those same symptoms: random Heart flutters during the day, My heart/chest pounds heavily when I lay back flat at night, I am Short of Breathe, have lack of energy & feel exhausted with just about everything I do, I have occasional chest & leg pains (but no swelling), I have had in the past, episodes of fainting or feeling like I was going to faint--most recently was on 05/24/2021, My ears ring almost all day long as well and I struggle with head fog (I'm forgetting simple words and it takes me longer to come up with them & I also forget what I am doing or my train of thought). I have decided to NOT get my Booster shot because of these side effects and will be visiting the Cardiac unit soon. I have Chronic left side shoulder pain that I had prior to my vaccines but the pain has increased by 100%. Could it be possibly MORE inflammation or irritation there? I tested positive for COVID-19 in 10/2021.
This spontaneous report was received from a registered nurse via a company representative refers to a female patient (daughter) of unknown age. On an unknown date in 2006 or 2007, the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported). Since an unknown date in February 2013 she had experienced amenorrhea. The nurse also noted that her daughter was at present in rehab for heroin. Treatment information was unspecified by the reporter. It was unspecified whether any laboratory diagnostic studies were performed. The outcome of amenorrhea was unknown. It was unspecified whether patient sought medical attention for the event. Causality was not reported. Additional information has been requested.
Severe tightness, stiffness, pain, tenderness to upper right arm and radiating to back and neck.  Unable to get range of motion to side with arm during am & pm, muscle strain going on to three weeks after injection.  Symptons worse in pm and am.
Fever on 4-17-09, 7 PM. On 4-18-09 upon awakening had eyes swollen shut, face incl tongue puffy and red, eyes were also red. Facial swelling/redness resolved on 4-19-09 mid-day. Parent measured highest temp as 100.8. Seen in clinic 4-21-08, T 102, sneezing, nasal discharge, sore throat.
Initial unsolicited report received from consumer (patient's parent) on 28 May 2015. A 02-month-old male patient had received a first dose of PENTACEL (batch number, expiration date, dose, route and site of administration were not reported) on 17 February 2015. The patient had medical history of lactose intolerance. The reporter doesn't know (at this point), if it is Ig mediated or secondary effect due to other sensitivity/allergy. Concomitant medication was not reported. On 26 February 2015, nine days after vaccination patient had experienced significant blood appeared in stool. The incident was reported to pediatrician. The pediatrician told that this is not related to vaccination; however, it did started week after he got his first vaccine. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Upon internal review, company assessed the event of significant blood appeared in his stool as serious and important medical event. List of documents held by sender: none.
Patient was very dizzy about 10 minutes after vaccine was administered. She was very weak and was slumping down on the chair. I helped her to the floor. Her blood pressure was low. She was not unconcious and was able to answer my questions. Her husband was in the store and came to help her as well. I gave her water and a protein bar. EMS arrived to take her. She did not want to go at first but agreed to go with them.
feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle aches; This is a spontaneous report from a contactable consumer(patient).A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration on 12Jan2021 16:45 at single dose, left upper arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient had a little bit of muscle aches on 12Jan2021 after the vaccine kind of all day. Other days it came and went. On 19Jan2021 the patient felt icky all day. She got a rash on the front and back of her neck. Rash was also on her chest and a little bit down both arms. She went to a walk-in clinic. Wasn't sure if it would be related to the COVID-19 Vaccine, but was advised to report it.  Events required a visit to walk-in clinic. The outcome of the events was unknown.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-OCT-2015 09:31, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.4 (2 hours and 40 mins) and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Became immediately dizzy, blood pressure shot way up 160/105 was made to sit down at the health department for 30 minutes or so and was so dizzy she could not walk to her vehicle by herself.    My sister had to escort or pretty much carry her out of the health department to put her in the vehicle to take her home.  The Nurse at the health Department told my sister to give her Motrin over the next few days and the dizziness should pass.  She stay in the bed for the next 4 to 5 days with flu like symptoms along with the dizziness but then begin to feel better the next week.    Then she would all of a sudden be hit with waves of dizziness so bad she could not lift her legs to walk and had to be taken to the E/R.
Swelling and pain in arm starting the day after vaccine. Patient insisted vaccines be given in same arm.
Swollen, red, purple bruise, warm to touch/Tylenol given, warm/cool compress
Day 2, I couldn?t lift my left arm. It was extremely tender and painful. Day 3, I broke out in hives (torso, groin and armpits). Still unable to use my arm. Day 4, regained mobility of arm, the injection site was hot, red and tender. One week later, day 7, the red and swollen area had spread up and down my arm, shoulder to elbow. Day 8, it became very itchy. By day 10, visible signs had faded but it remained itchy. It is now day 15, and I have occasional itching sensation.
Ulcerations on the lining of the stomach; Vomiting; Diharrea; This spontaneous case was reported by a patient and describes the occurrence of GASTRIC ULCER (Ulcerations on the lining of the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced GASTRIC ULCER (Ulcerations on the lining of the stomach) (seriousness criterion medically significant), VOMITING (Vomiting) and DIARRHOEA (Diharrea). At the time of the report, GASTRIC ULCER (Ulcerations on the lining of the stomach), VOMITING (Vomiting) and DIARRHOEA (Diharrea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The patient received treatment for unknown indication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.