chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a Female subject, who had been receiving Nasal QLAIV (INTRANASAL). Concomitant medications included HEPATITIS A VACCINE and TYPHOID VACCINE. FLUMIST (INTRANASAL) started on 19-Feb-2015. It was reported that the patient was unintentionally administered expired FLUMIST which started on 19-Feb-2015. The outcome of the event of UNINTENTIONAL ADMINISTRATION OF EXPIRED PRODUCT is unknown. The report was considered to be non-serious. The reporter considered that the event of unintentional administration of expired product was not related to QLAIV. The company physician considered that the event of unintentional administration of expired product was not related to QLAIV.
vaccination site pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
rom Providers On: A child was given COVID vaccine and had left the clinic area. Patient/family did not wait full 15 minutes. The mother noticed unilateral periorbital swelling and came back upstairs with the child and went to registration to report this. We administered Diphenhydramine but we discovered that we do not have any Famotidine or Cimetidine. We ended up calling the ED, administering Epinephrine per their guidance and awaited EMS transport. Was transported to ED.   From ED: Got Pfizer COVID vaccine at today. About 15 minutes afterward developed swelling of right eye and whole body itchiness. Was given benadryl about 30-45 min after vaccine dose for these symptoms. She was then observed. Epi given at about 1753 and she was subsequently brought to ED by EMS for further management. No breathing issues. No swelling of lips, tongue, mouth. No rash noted on body. No vomiting. She is otherwise healthy. Takes no medications. No food allergies or other known allergies. No recent fevers, rhinorrhea, cough, abdominal pain, dysuria, diarrhea. Currently feeling well. Did get lidocaine under arm prior to vaccine injection. Family wondering if she could have touched the lidocaine and then touched her thigh. Had eye redness and itchiness with swelling initially.
No ADR, timing ERROR, 2nd dose given 61 days after 1st Narrative: No ADR, Timing ERROR, 2nd dose given 61 days after 1st.
5 days after shot while riding my bike I appeared to lose consciousness and crashed.  (note I had pretty severe fever and body aches 14 hours after injection)
Information has been received from a physician and a nurse concerning an approximately 17 year old female who on 05-JAN-2008 and 12-MAR-2008 was vaccinated with her first and second doses, respectively, of GARDASIL (Lot # 655327/1287U and 0515X). The patient experienced shortness of breath after her first and second doses of GARDASIL. Subsequently the patient recovered from the events. The reporting physician did not think the reactions were vaccine-related, especially since the patient did not mention the reactions after they happened and came into the office to let the doctor know she would not be getting the third dose. Additional information has been requested.
This is too report that the VSafe info was NOT an AE.  My son seemed fine the day of his second vaccine dose.  Had a cough that evening.  He woke up around 3am with a really bad croup-y cough, so we took him to the ER where he got a rapid PCR covid test that was positive.  So all the VSafe follow-up info (fever, tired, etc) was because he had covid, and most likely not an AE to the vaccine.
Information has been received from a licensed practical nurse concerning a 6 yr old female with no allergies or medical history who on 03Dec01 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 28Feb06, the pt experienced seven to eight little spots, one was blistered, itching, and an oral temp of 100. Unspecified medical attention was sought and she was treated with acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl). No diagnostic lab tests were performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from the nurse who reported that the patient woke up the morning of 28-FEB-2006 with a low grade fever of 100 degrees and a low (7-8) pox on the arms and abdomen that were itchy. She was exposed to chicken pox at school the previous week. The patient recovered on an unspecified date.
Approximately 48 hours after my 1st dose I experienced the following symptoms: I lost hair from my scalp and several different locations. My head was really itchy and I had a lot of hair falling out of my head. I went to the doctor and she diagnosed me having Alopecia and they applied steroids in my scalp as treatment - it was an ongoing condition for me until I had my 2nd dose vaccination (Moderna) the hair fall has gotten so much worse. It took me 3-4 rounds of steroids treatment until I have recovered. Up to this day I still experience  the same symptom but in a different part of my head and still continue to receive the steroid treatment.
itchiness arm, back,side and leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchiness arm, back,side and leg) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concomitant products included METHYLPREDNISOLONE for Itching.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PRURITUS (itchiness arm, back,side and leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LORATADINE (24 HOUR ALLERGY REMEDY) at a dose of 5 ml twice a day. At the time of the report, PRURITUS (itchiness arm, back,side and leg) had not resolved. Not Provided      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.   Concomitant medication included Blood Pressure medication. Patient reported that on prior to receiving the vaccine he experience itching on his arm, back, side and legs that could have come from poison ivy or oak which his health care provider prescribed Methylprednisolone which he took 21 pills during a 5 days. After the 5 days on the Methylprednisolone and receiving the vaccine the patient reported still experiencing the itchiness. Patient reported that his health care provider was going to be prescribing him "hydroxine" tablet soon.
Shoulder to elbow are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Shoulder to elbow are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rotator cuff injury (The patient reports that she had injury at rotator cuff in 2015. and re-injured while shoveling or doing any hard work.).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Shoulder to elbow are swollen). At the time of the report, PERIPHERAL SWELLING (Shoulder to elbow are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore arm; This is a spontaneous report from a contactable consumer (patient, reported for self).   A 59-years-old (non pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 21Jan2021 09:15 (At the age of 59-years-old) as single dose, for COVID-19 immunisation. Medical history included diabetes mellitus from an unspecified date and unknown if ongoing. The patient did not have known allergies. The patient did not have other vaccine in four weeks. The patient did not have COVID prior vaccination. Other medications in two weeks, yes.  On 22Jan2021 22:00, the patient experienced sore arm. The patient was not tested for COVID post vaccination. No treatment was given for the event. The outcome of the event was recovered.  The information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sudden tinnitus March 13 left ear pain countinous slight fluid from left ear. Higher slightly erratic BP on App irregular heart bears higher then normal BPM high 90s normally 60s mar 15 still persists.
1/11/18 Patient came in said arm is still sore and has a lump at injection site. Also is painful when he lifts his arm-affecting range of motion.
Mother states the child developed a fever a few hours after the immunizations were given.  She started "vomiting uncontrollably" around 2:00 AM on 9/24/2013 and her fever reached approximately 103 degrees F.  Advil was given but the fever did not respond.  Mother also reports that there are blisters on the child's lips.  Food and beverages are not tolerated well at this time.
start getting stiff painful joints; start getting stiff painful joints; difficulty walking and moving; difficulty walking and moving; low energy; headaches; nausea; loss of appetite; This is a spontaneous report from a contactable consumer(patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: El0142 and expiry date was not reported) via an unspecified route of administration into the left arm, at the age of 54-year-old, on 28Jan2021, as dose 2, single for covid-19 immunization. Medical history includes arthritis, vitamin D deficiency, and tested positive for COVID-19 infection, all from an unknown date. The patient had known allergies. The patient was not pregnant at the time of report. Concomitant medication within 2 weeks of vaccination included paracetamol (TYLENOL A) as needed.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers: Fl0140 and expiry dates were not reported) via an unspecified route of administration into the left arm, at the age of 54-year-old, on 07Jan2021, as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021, the patient experienced stiff and painful joints, difficulty walking and moving, low energy, headaches, nausea, and loss of appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. On 07Sep2021, nasal swab test was conducted and had negative result. The patient received treatment in response to the events which included prednisone, sulfasalazine, duloxetine, pregabalin, b12 and tylenol extra strength. The outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Noted black coloration (like dirt or oil) of knuckles & fingernails of both hands, could not be washed off.  Felt "tight chest", anxious in afternoon & evening.  Black coloration lasted 48 hours, no treatment sought.  On 11/7/07, 5 days post vaccine administration, patient reports feeling "worse than ever" - sore throat, joint pain (especially neck & shoulders).  Taking ibuprofen regularly.  On 11/8/07, 6 days post vaccine, patient reports symptoms no better; aching all over; shoulders & neck very painful.  Fever last night 100 degrees.  Encouraged to see Dr. - will do so on 11/9/07 if not feeling better.
Immediate Side Effects: Fainting after injection Nausea Dizziness Lethargy Malaise Extreme arm pain Extreme neck pain Confusion  Side Effects that evening and over the next 1-2 weeks: Fever Dizziness Brain fog Confusion Chills Nausea Hot flashes Severe Arm pain Severe Neck pain Stiff neck Severe headache causing nausea Heart palpitations Fast Heartbeat Strong Heartbeat Heavy chest Difficulty breathing Pain in the right leg Dehabilitating fatigue impacting my ability to function and work  Ongoing Side Effects 4 months out: Inconsistent fatigue Chest and throat sensations/pressure Occasional chest pains stabbing and then gone Palpitations at night (irregular and inconsistent) Thyroid TSH number doubled Hashimoto's Autoimmune Disease Confirmed (Immune system damaged) Thinning hair Depression/Despair Mood dysregulation  Treatment: Teledoc Appointment Urgent Care  Cardiologist Referral Primary Care Doctor Monitoring   Outcome: Autoimmune Disease  Immune System Damaged Thyroid Inflammation/Damage  I am set to retest in 4 months
LEFT ARM IS SORE, RED AND SWOLLEN.  PATIENT IS ALSO TIRED AND WEAK AND HAVING TROUBLE WITH FULL RANGE OF MOTIONS OF LEFT ARM.
Sensitivity to light; Tenderness in lymph nodes in neck and groin; Dizziness; Soreness in arm; Fatigue; Mild headache; A spontaneous report, was received from a nurse practitioner (patient), concerning herself, a 61-years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, sensitivity to light (photophobia), soreness in arm (pain in extremity), fatigue, mild headache (headache), and tenderness in lymph nodes in neck and groin (lymph node pain).   The patient's medical history was not provided. Concomitant medication reported included venlafaxine hydrochloride and sertraline for depression.  On 30 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number: 039K20A), intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient experienced soreness in her arm, dizziness, fatigue and a mild headache. These symptoms improved over the next two days. Then on day four after the vaccine, on 03 Jan 2021, the patient experienced a bad headache, sensitivity to light and tenderness in lymph nodes in neck and groin. Treatment for the events included acetaminophen, plenty of water and rest. As of 04 Jan 2021, the patient reported that she was feeling better and has less headache, lingering fatigue and no longer in need of pain-relieving medicine.   Action taken with second dose of mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, dizziness, sensitivity to light, soreness in arm, fatigue, mild headache, and tenderness in lymph nodes in neck and groin were resolving at the time of this report.; 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.  Further information has been requested.
mouth very sore; tongue discolored; headache; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (mouth very sore), TONGUE DISCOLOURATION (tongue discolored) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced ORAL PAIN (mouth very sore) and TONGUE DISCOLOURATION (tongue discolored). On 25-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, ORAL PAIN (mouth very sore) and TONGUE DISCOLOURATION (tongue discolored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
titer test for varicella and MMR and the results were low; titer test for varicella and MMR and the results were low; titer test for varicella and MMR and the results were low; titer test for varicella and MMR and the results were low; This spontaneous report was received from an office manager concerning to a 21-year-old male patient.   The patient medical history, current condition, previous drug reactions or allergies, and concomitant therapies was not reported.  On an unspecified date,in the past when he was younger,the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, both administered as prophylaxis (dose, strength, vaccination scheme frequency, route of administration, anatomical site of application, lot # and expiration date were not provided).  On unknown date in 2022 (also reported as "sometime in the past 6 weeks"), the patient did the titer test for varicella and measles, mumps, and rubella (MMR) and the results were low(antibody test negative, measles antibody negative, mumps antibody test negative, rubella antibody negative).  The outcome of the events antibody test negative, measles antibody negative, mumps antibody test negative and rubella antibody negative; and the causal relationship between the above-mentioned events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) were not provided
Sore arm; Hard arm; Hot arm; Felt sick; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included covid 19 vaccine (received covid shots on an unknown date). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, induration, extremities hot feeling of and sickness. On an unknown date, the outcome of the pain in arm, induration and extremities hot feeling of were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the pain in arm, induration, extremities hot feeling of and sickness to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she had numerous autoimmune diseases and the Covid shots did the same thing. After receiving Shingles vaccine, the patient experienced hard, hot sore arm and also felt sick for a few days. The patient's doctor said he/she need to keep massaging the area to disperse the medicines. The follow-up would not possible as no contact details were available.
Patient was given the half dose of 0.25 ml rather than the full 0.5ml dose
Immunization was given on 10/21.  Symptoms started out as a sore arm, within 2 days patient could not lift arm.  Visited Doctor office a few days later, after using ibuprofen and salonpas.  Dr took x-ray of arm and shoulder with no findings.  Patient has a return appt later.  She said symptoms are letting up as of today (november 8).
Within 5 min of vaccine administration customer close her eye and she passed  out. Mother started talking to her and try to wake her up. blow air with papers on her face gave cold water to drink. In few min Customer opened her eye and started talking had some water . Mother wanted to call emergency, customer was constantly refusing to call . ED. After five min customer closed her eye again for few min and open her eyes and started talking. EMS people came and took over.  Customer indicated that she has phobia and allergic reaction to the needle. Customer came prepared with her mother.
Pt developed sudden-onset of severe left-sided chest pain with heavy pressure, shortness of breath and diaphoresis; pt collapsed and had a period of unresponsiveness lasting approximately 10 minutes. EMS was called and noted significant ectopy as well as frequent NSVT on ECG. Pt was transported to the Emergency Department and subsequently admitted for observation.
Systemic: Bell's Palsy-Mild, Systemic: Confusion-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Approximately 5 minutes after receiving the Pfizer covid vaccine, the patient's mother reported that the patient was having a reaction the vaccine. Upon examination, the patient was sweating profusely, complained of feeling numbness/tingling in her hands and appeared severly disoriented. After approximately 30 minutes she felt well enough to be transported to urgent care to be examined. Several hours later that day, the patient returned to the pharmacy with no issue.
Numbness, tingling left hand, sharp pain left shoulder, weakness left arm. Within two weeks progressed to pain in joint/elbow left arm. Month later it progressed to the inability to bend, flex, or straighten arm without excruciating pain, unable to lift objects with left hand without assistance of right hand. Left arm remains weak, with occasional numbness/tingling to hand & fingertips.
Chills; Fever; Vomiting like "20 times"; Severe stomach ache like sharp pain; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for covid-19 immunization at the age of 13-year-old. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for covid-19 immunization.The reported stated that the patient got a worse side effect. On the night of vaccination, the patient experienced side effects of chills, fever and at 4:00, had started vomiting like 20 times and had severe stomach ache like sharp pain. The reporter went to the pediatrician of her son but that did not help and the pediatrician told this symptom is not a COVID vaccine (as reported). The reporter stated that the patient never got sick before and that her son was feeling better at the time of this report. The outcome of the events was recovered. Therapeutics measures were taken for events chills and fever and included acetaminophen (TYLENOL) and ibuprofen (ADVIL).  Information on lot/batch number was requested.
Patient reported via phone call that she woke up this morning with a whole body rash. Rash was not open or itchy but seem to be more pronounced on the areas over the respiratory track as stated by the patient. Patient was unsure if the rash was related to the vaccine or just a heat  rash.
I will give you the vaccine information when you take me seriously. You deal with me. All the drs and 'professionals'are dismissing all these symptoms from people. They were told to lie.