chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner regarding children (patients) of unknown demographics. On an unknown date the patients were vaccinated with M-M-R II injection (lot number and dosing regimen unspecified). No concomitant medications were reported. On an unknown date the nurse practitioner reported that the children may have been vaccinated with improperly M-M-R II vaccine. No adverse effects reported. There was no product quality complaint involved. The outcome of th medication error was unknown. Additional information has been requested.
Received injection in the afternoon, about 1 am ( got up try go to the bathroom) fainted hit head came too fainted again, husband got me to bed monitered me. Calmy, white, pulse 60 o2 93  husband monitered me  a couple hrs until pulse was back up, he called clinic they thought it was my bloodsugar, checked in the morning it was 63.   For a month to 2  I had spells where I thought I was going to faint and chest hurt.  Had blood work done, monocytes little high 15.1 The fainting spells are finally getting much better.
On the day after vaccination, on September 26th, experienced a sore throat. On the 27th, experienced a runny nose and chest pain, as well as chills and fatigue.
After the shot that day had a sore arm where both YF and Hep A were given; extended up into her neck. No fever. Two days after the shot she noticed some hives located between her shoulder blades which have since changed locations in different areas on her trunk or arms. Has been taking Benadryl. Today c/o her chest getting tight, a little dizzy. Her grandmother was taking her to the ER for treatment at the time of the call by her aunt and mother to the HD.
Day after the vax PT woke up "out of it", vomiting, head ache, short term memory loss. When he went to ER he was diagnosed with TGA/ Transient global amnesia
pt recv vax 1OCT97 & approx 4hr p/vax pt exp rhinitis, nausea, achiness & indigestion;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 02-FEB-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
Pain in arms; Felt totally wiped out; Fever; Chills; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arms), FEELING ABNORMAL (Felt totally wiped out), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) in a 58-year-old female patient who received mRNA-1273 (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arms), FEELING ABNORMAL (Felt totally wiped out), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Pain in arms), FEELING ABNORMAL (Felt totally wiped out), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain) and NAUSEA (Nausea) outcome was unknown.            No treatment information was provided.
Swelling and redness on the injection with severe pain radiating toward the left side of neck to left lower arm. Left axillary lymphadenopathy.
pt recv vax;an ELISA test revealed that pt failed to seroconvert;another test in 13dec95 was 0.07 EU;
On 6/17/21 patient was brought to the hospital by ambulance with what had appeared to be signs of a stroke. Numbness is extremeties  slurred speech and when brought to e.r. stroke was ruled out.  He was not able to move legs and this continued up his body.  He was eventually intabated all test run on him came back negative. He was in ICU for 3 1/2 weeks where he remained til he got his trachea and was stable to move to the next step down in the hospital.  An is now in rehab slowly getting some strength back and started to be able to speak being weened off the ventilator.  Recover is going to be a long road
For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after my vaccination, my left armpit started feeling sore. This has continued to today where I have left armpit swelling and what feels to be a swollen, hardened lymph node in my armpit. It feels like a hardened lump that is not fixed and is tender when I palpate it. On visual inspection, I can tell that my left armpit is more swollen than my right armpit (which is normal). It hurts to have my arm at my side and it hurts to lay on my left side at night when I am sleeping.
the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot # 1660704, expiration date 20-MAR-2021 (exact dose was not reported) for prophylaxis. The vaccine was stored in a temperature of 12.1 degrees Celsius for 16 hours and 11 minutes. There was no previous temperature excursion. The digital data logger was involved.
"really itchy"; large red ring rash; Left arm became sore,tender and burning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS ("really itchy"), VACCINATION SITE PAIN (Left arm became sore,tender and burning) and VACCINATION SITE ERYTHEMA (large red ring rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) and Hypertension. Previously administered products included for an unreported indication: shingles vaccine and FLU. Concurrent medical conditions included Diabetes. Concomitant products included METOPROLOL, INDAPAMIDE, LOSARTAN, FAMOTIDINE and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication, FISH OIL.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Left arm became sore,tender and burning). On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS ("really itchy") and VACCINATION SITE ERYTHEMA (large red ring rash). At the time of the report, VACCINATION SITE PRURITUS ("really itchy"), VACCINATION SITE PAIN (Left arm became sore,tender and burning) and VACCINATION SITE ERYTHEMA (large red ring rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information include cold compress
2MAY97 fever, irritable, sleepiness, vomit, weakness; seen in ER given ATB for ear infect;6MAY97 slept all day;7MAY97 mom noticed lt leg was weak;seen by MD said that leg would get better 27MAY97 saw MD for 4mo check, MD had x-ray done;
Patient who was diagnosed with COVID-19 two days ago and started Paxlovid today; Patient who was diagnosed with COVID-19 two days ago and started Paxlovid today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep disorder" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN taken for sleep disorder; CBD OIL taken for sleep disorder; VITAMINS NOS. No prior vaccination within 4 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "not recovered" and all described as "Patient who was diagnosed with COVID-19 two days ago and started Paxlovid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive; Weight: (unspecified date) 190, notes: I weigh about 190, I guess. 185. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The caller is a 65-year-old male patient who was diagnosed with COVID-19 two days ago and started Paxlovid today. He asks if there is any interaction between tart cherry juice which he states is an anti-gal medicine and Paxlovid. The caller mentioned he had the two primary doses of the Pfizer Biontech COVID-19 vaccine but not the boosters. The caller asks if there is any interaction between alcohol and Paxlovid. Consumer stated he had 2 of the vaccines and he only had the very first dose of Paxlovid today. Consumer stated, "I also have question for you too after you get through. Can I ask you a quick question? I am thinking that this particular anti viral Paxlovid may also help eliminate some other chronic viral things like I had going on in my ears or my urinary tract (Further clarification was unknown if patient had such conditions like that over the call) something like that. Do you have any information does that possibly happening?" When probed if patient is experiencing any problem with Paxlovid: Consumer stated, "Not yet, I have only had the first dose. I was expecting to have some stuff with it, you know." About concomitant medication, consumer stated, "No other medication, just vitamin. I take Melatonin at night if that matters and I take CBD oil to go sleep at night it helps with my sleep, at night. I take those thing to sleep at night." About lot number, consumer stated, "The last number on my vaccination card? You want the vaccination number? It was 18Jan2022, FJ56 I think 82 (Further LOT# was not alphabetically clarified over the call)." About expiration date, consumer stated, "Ok, 18Feb2022. That is the date I got it, think, I do not think that is the expiration date. It is the day I got it."  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
This spontaneous report was received from a 60-year-old female patient regarding herself. Current conditions included rosacea and high blood pressure. Patient was allergic to penicillin, morphine and unspecified antibiotics, patient experienced a rash due to these drugs. On 19-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) dose and route not reported. Concomitant medications included: spironolactone for rosacea (reported as roseasea) and high blood pressure. On 18-AUG-2012 patient underwent tuberculosis (TB) skin test, results were unknown. Patient explained that approximately on 21-SEP-2012 (reported as 2 days later) she developed a large bruise on the back of her arm that was very feverish and painful, like being shot with a paint ball. She explained that the bruise lasted 3-4 days approximately till an unknown date in September 2012 and healed on its own. She explained that on 10-SEP-2012 she underwent STD (Sexually transmitted diseases) testing and showed positive antibodies for herpes 2. She explained that she had no other effects other than the abnormal test results and the initial bruising. No treatment was given for the events. Herpes Simplex Zoster (HSZ) 2 testing had been conducted within a full blood panel. New testing will be taken on 09-NOV-2012 or 10-NOV-2012. Medical attention was sought for the events. Additional information has been requested.
Knee pain -> after vaccination started one wk after vaccine and has not improved. Today is 11/9/10.
Patient complained of very sore left arm, extreme weakness, dizziness, difficulty breathing and generalized tingling.  Arm soreness developed a few hours after vaccination.  Other symptoms began 12 hours later.  Required no treatment.  Contacted 9/20/2007 and said was much improved.  Contacted  9/21/2007 and stated felt "great"
While the olfactory sensations decreased, she reports an intermittent "burning plastic, burning rubber smell."
Within 6 hours, I had localized pain in my arm around the injection site (resolved within 48 hours) and a severe migraine headache with nausea. I continued to have migraines on and off for the next several days along with moderate fatigue.
Tested COVID positive; Sore throat like burning in his throat up to his jaw area; Weakness; Fever; Headaches; Muscle aches; Chills; Fatigue; Nausea without vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Headaches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting). On 13-Feb-2021, the patient experienced COVID-19 (Tested COVID positive). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PHENOL (CHLORASEPTIC) at a dose of Sprays and Lozenges; PSEUDOEPHEDRINE at an unspecified dose and frequency and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of Augementin Antibiotic. At the time of the report, COVID-19 (Tested COVID positive), OROPHARYNGEAL PAIN (Sore throat like burning in his throat up to his jaw area), ASTHENIA (Weakness), PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea without vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive. On 13-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive to the covid-19 virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medications also included nasal sprays.
No additional adverse event reported; The patient was administered PROQUAD and VARIVAX the same time instead of MMR II and VARIVAX; The patient was administered PROQUAD and VARIVAX the same time instead of MMR II and VARIVAX; This initial spontaneous report was received from a nurse concerning a 13-year-old male patient.  The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.   On 26-AUG-2023, the patient was vaccinated with an unspecified dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, Lot #, expiry date, and route of administration were not provided) and at the same time (overdose) he was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, both administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse events were reported.
This spontaneous report was received from a medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2014 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of GARDASIL (lot #, expiration date, dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT reports immediate severe left shoulder pain at time of injection that has progressively worsened. No change in ROM, no erythema, no warmth, no swelling.
Patient exposed to COVID-19 from roommate. Diagnosis confirmed 12/2/2021. On O2 NC. 12/4 placed on bipap. 12/6 intubated and placed on assist control vent. 12/8 during hemodialysis patient coded. She responded to ACLS protocols; however, family elected to remove her from life support and she expired with family present.
Vaccine was administered to a patient that did not meet the criteria. She is not pregnant and is 58 years old. She is not 60 years or older.
pt recv one 10 mcg dose; several hr p/ developed rash on head, shoulders, upper chest and arms; resolve in 3 days
Tingling left shoulder; Pain  left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling left shoulder) and ARTHRALGIA (Pain  left shoulder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PARAESTHESIA (Tingling left shoulder) and ARTHRALGIA (Pain  left shoulder). At the time of the report, PARAESTHESIA (Tingling left shoulder) and ARTHRALGIA (Pain  left shoulder) outcome was unknown.            Patient advised he visited his PCF and was being referred to a Neurologist.   No concomitant medication listed.  No treatment information provided.   This case was linked to MOD-2021-313197 (Patient Link).
Severe exacerbation of anxiety, increase in hyperactivity, distractibility and mood swings. Deterioration of handwriting and fine motor skills.
Patient is seeing a doctor for the symptoms of hyperthyroidism, pulse greater than 200 and extreme brain fog.
Ball palsy/ left facial drooping Narrative:  Patient received COVID-19 vaccine on 01/20/21 and presented to ED on 01/23/21 with left sided facial dropping which appeared approximately at 22:00 on 01/22/21. Patient denied fever, cough, nausea/vomiting, and visual changes. Provider consulted with Infectious Diseases and Neurology for recommendations. Per neurology recommendations, patient was discharged with prednisone and acyclovir.
Information has been received from a consumer concerning a 65 year old female who on 12-DEC-2007 was vaccinated with ZOSTAVAX.  Concomitant therapy included paroxetine HC1 (PAXIL), clonidine and "nerve pills."  The consumer reported that "in the past she has experienced swelling of her arm and pain from receiving a tetanus shot."  On 12-DEC-2007 the patient developed itchiness and swelling.  The patient did not seek medical attention.  No further information is available.
0930:  Sudden onset of dizziness and nausea.  Immediate evaluation by onsite EMS and NP.  VS@ 0932:  148/69; p 76; O2 Sat 98% on RA. Offered water and a cereal snack - nausea subsided. VS 10:07:  BP 136/56; p 77; R 18. Sat 98%. Discharged home at 10:10 with resolution of s/s.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) on 24-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced a "cherry red" spot near the injection site. The outcome was unknown at the time of report. The patient had contacted pharmacist for medical attention. Additional information is not expected.
Patient came in on 10/1/2020 saying he has a large, itchy rash on front and back of torso. No other common symptoms of allergic reaction were present (e.g. no shortness of breath or swelling of throat). He took a benadryl and bought some hydrocortisone cream and was instructed to let us know if anything more happens and to call 911 if severe symptoms occur. This patient did get his flu shot a few days before on 9/26 and was told he can get the three shots mentioned above after a few weeks. He came back early and another pharmacist gave the 3 shots on the 29th. Getting so many vaccines in a short amount of time could have contributed to the reaction.
PENTACEL IMMUNIZATION GIVEN INCORRECTLY (TWO VIAL INJECTION) - THE PENTACEL IS A RECONSTITUTED INJECTION WITH IMMUNIZATION IN BOTH THE LIQUID VIAL AND THE DRY VIAL.  IN THIS INSTANCE, ONLY THE LIQUID BLUE VIAL (POLIO AND D-TAP)WAS GIVEN. SANOFI (MANUFACTURER) WAS NOTIFIED AND THEY HAVE SENT OUT A SPECIAL LIQUID TO RECONSTITUE THE DRY GREEN VIAL FOR ADMINISTRATION TO THE PATIENT.  PATEINT'S MOTHER WAS NOTIFIED AND WILL RETURN NEXT WEEK FOR THE SECOND PART OF THE IMMUNIZATION.  NO ADVERSE SIDE EFFECTS HAVE BEEN REPORTED.  ONLY TREATMENT GIVEN WAS THE OTHER HALF OF THE IMMUNIZATION.  WE WERE INSTRUCTED BY THE AGENCY TO REPORT THIS OCCURANCE.  AGENCY AND SANOFI HAVE INSTRUCTED US THROUGHOUT THIS PROCESS. CORRECTIVE ACTION HAS BEEN TAKEN. PROPER TRAINING WAS GIVEN.