chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very bad random itching; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 12:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis, allergy to penicillin and sulfonamide. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (VITAMIN D) and calcium supplement (MANUFACTURER UNKNOWN) both for an unknown indications on unknown dates and unknown if ongoing. The patient previously received denosumab (PROLIA) for osteoporosis, last shot was in Nov2020. Also the patient previously received amoxicillin (MANUFACTURER UNKNOWN), mefenamic acid (ADVIL), ibuprofen (MOTRIN) and naproxen sodium (ALEVE) all for an unknown indications on an unknown dates and experienced drug allergy. On 05Apr2021 at 15:00, the patient experienced very bad random itching without rash, like someone was poking randomly around her body (eye lid, scalp, thigh, arm, etc), with a pin, while it did not hurt but was itchy, the patient constantly wanted to scratch those different places. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of adverse event which included treatment with ALLEGRA. The clinical outcome of the event very bad random itching was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever of 101F, fatigue, body aches and chills, body pain, headache, stomach ache  Fluids, vitamins
About a week after the vaccine, I noticed a red ring on my upper arm, 2-3 inches in diameter, around my vaccine injection site. The next morning it is hot to the touch and has started to itch.
This report is concerning a 9 week old female pt who on 9/19/01 was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Secondary suspect therapy included an IV 160mg per 1 dose of ceftriaxone sodium (Rocephin), a dose of poliovirus vaccine. On 9/19/01, in the morning, post vax, the pt returned home from the pediatrician and vomited. At approx. 16:50, the pt was taken to the ER. She had a fever of 102.6F; pulse was 178 and respirations were 40. It was reported that sepsis was to be ruled out. At approx. 21:00, the pt commenced ceftriaxone sodium (Rocephin) 160mg IV reconstituted with 1 ml of dextrose (D5W) placed into a 500cc bag of dextrose (+) sodium chloride (D5 & 1/3NS) for 1 dose. This was administered through a Soluset. 5 minutes following the administration of Rocephin, the pt turned gray and was relocated to the resuscitation table. The pt went into a generalized tonic seizure and the body stiffened. The pt was treated with O2 (oxygen). The seizure resolved and the pt's color returned to normal. The pt was admitted to the hospital and was changed to another unspecified antibiotic. It was reported that the medical charts stated a working dx of sepsis, seizure and febrile illness. On 9/20/01, the pt remained hospitalized. This was originally reported by a pharmacist. No further information is available. F/U states: Information from a pharmacist indicated that the pt recovered and was discharged from the hospital on 9/26/01. The pharmacist indicated that the pt's serious adverse events were considered life-threatening. Further information has been requested. F/U states: the pt was admitted to the hospital on 9/19/01.
Dizziness, Myalgia, Congestion, pain @ injection site. Narrative:
About two weeks after I've had hives under my arm pits. Same arm as the shot was admitted.  Nothing new has changed in diet, soap, etc. Very itchy almost like a rash. Has now moved to both arm put area.
From mailed correspondence received at a manufacturer on 4/11/02, it was reported that a 41 y.o. female donor who was involved with the rabies program at a medical facility. This donor received 4 out of the 5 scheduled rabies shots during enrollment in the rabies program in October 01. She was dropped from the program when she failed to show up for the scheduled 5th immunization. In March 02, she was presented as a normal source plasma donor, and was deferred at the time due to arthritis medications she was taking. On 3/5/02, she was questioning if the Imovax Rabies vaccine that was received in October 01 has precipitated this arthritis episode.
PT RECIEVED A MODERNA VACCINE ON 3/25/21 .  AFTER VACCINATION WHEN ENTERING VACCINE IN GRITS, DISCOVERED PT RECEIVED A 1ST DOSE OF PFIZER ON 3/3/21
sleepy; Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (sleepy) and COVID-19 (Covid) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (Covid). On an unknown date, the patient experienced SOMNOLENCE (sleepy). At the time of the report, SOMNOLENCE (sleepy) and COVID-19 (Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medications were provided. It was reported that patient felt very sleepy after receiving the vaccine. No treatment medications were provided.   Reporter did not allow further contact
Warm to touch, raised, red, hard area. Behavior changed-lethargic,  Seen today by Dr no temperture noted.
As someone with severe narcolepsy and cataplexy, it is difficult for me to maintain a high quality of life due to falling asleep or even falling down at inappropriate times and, unfortunately, due to significant side effects, I cannot take medication currently prescribed for it.  I had EXTREME improvement in symptoms in the two weeks following my first vaccine (it's too soon to tell what effect yesterday's dose may have), I was speaking to a physician at the vaccine hub yesterday who strongly suggested contacting you to possibly help find a treatment in the future.
58 yo female, BMI 41, PMHx of diabetes and HTN, admitted for COVID-19 pneumonia, tachycardia, L parotid tenderness and swelling and possible volume depletion on 1/14/2021.  CT of chest from 1/14/21 reveals scattered groundglass opacities (B).  COVID treated with supportive care, parotiditis treated with vancomycin.  Patient discharged to home on 1/19/2021.
Bone aches; Body aches; Felt tired; Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night), BONE PAIN (Bone aches), MYALGIA (Body aches) and FATIGUE (Felt tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Reflux gastritis.    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 POOR QUALITY SLEEP (Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night). On 06-Mar-2021, the patient experienced BONE PAIN (Bone aches), MYALGIA (Body aches) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at a dose of 1 dosage form. On 07-Mar-2021, BONE PAIN (Bone aches) and FATIGUE (Felt tired) had resolved. At the time of the report, POOR QUALITY SLEEP (Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unspecified high blood pressure medication and  reflux medication.
Pt felt nauseated, went to bathroom, then woke up and found herself on floor. Mother came to pharmacy to inform me. Pt looked pale upon waking.
Pt recv vax in 11/98; 1 day post vax pt exp urticaria x 3 day
One of the first one was severe tremoring and had to go to the ER, Chills, and expressive aphasia. At the time those were the ones that presented the most.
Onset erythema, tenderness, swelling (R) deltoid day after injection. Tx- cold compresses, OTC ADVIL.
NAUSEA, FEVER, HEADACHE, FATIGUE  FOR  APPROXIMATELY 20 HOURS AFTER FIRST VACCINE.
Narrative:  62 yo male who presented to the ED 15 days after receiving 2nd COVID vaccine with complaints of rash to bilateral arms, groin and trunk for x1 week. Pt denied any new detergents, soaps or contact with the environment. There was no oral swelling, SOB, or wheezing upon evaluation. Patient reported that he had taken Benadryl with no relief. He denied prior allergic reactions. No fever, chills, headache, neck pain, chest or abdominal pain, N/V/D or GI or GU complaints upon evaluation. Patient was discharged with Benadryl, pepcid, prednisone and an epi-pen. He was instructed to keep a diary of all food intake, creams, detergets etc inorder to track the cause of the allergic reaction. ED provider assessed that mild allergic reaction should not become serious as it had been already going on for 1 week without progression, albeit comfortable symptoms.
Patient received the vaccine at only 6 months of life when it is indicated for ages 12 months & older.
localized swelling, redness, pain @ vax site beginning w/in 24 hrs eventually h/a & nausea & temp 101
"extreme fatigue" that continues and itchy rash that comes and goes. Sometimes itches with no rash.
cramping or pain under his right chest/ little crampy underneath his right chest; muscle cramp under his lower chest/ muscle cramp under the right chest; arthritis has flared really bad; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 18Oct2021 (batch/lot number was not reported) at the age of 56 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concurrent conditions included high blood pressure and "sugar" (captured as "diabetes), both from an unknown date; and arthritis in left arm from Jul2021 and ongoing. Concomitant medications included amlodipine (AMLODIPINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), nebivolol hydrochloride (BYSTOLIC), dextropropoxyphene hydrochloride, paracetamol (DI-GESIC), and empagliflozin (JARDIANCE), indications and therapy dates for all were not reported. Patient did not receive other vaccinations (4 weeks prior). The patient received the Pfizer vaccine yesterday (18Oct2021), about 10 o'clock and had some side effects. The side effects were cramping or pain under his right chest, every once in a while, not consistent. It is little crampy underneath his right chest since an unspecified date. Patient further reported that he had muscle cramp under his lower chest and that's all the side effect he has right now. It just started with muscle cramp under the right chest. Patient took Aleve, Aspirin as treatment for the events. It was also reported that patient had arthritis in his left arm, and since vaccine the arthritis has flared really bad on 21Oct2021. No investigation assessments were provided. The patient has not recovered from the event "arthritis has flared really bad." Outcome of the other events was unknown.  The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.
After leaving site (while driving), my tongue became very heavy and almost difficult to swallow. After approximately 20 minutes, it passed. At the same time my right arm (opposite the injection arm) began to have muscle spasms which too passed. A wave of cold spread throughout my body and immediately my anxiety began to skyrocket (untriggered). None of these symptoms occurred after 1st dose.  Insomnia the night of both the 1st and 2nd doses.   Nearly 2.5 weeks after 2nd dose, dizziness is a daily occurrence followed by symptoms of vertigo (at times wakes me up at night). Fatigue has intensified.
Patient presents to Emergency Dept with sudden onset of palpitations and "lump in my throat" that started approximately 5 mins after receiving Covid vaccine. Denies SOB. Denies chest pain. Afebrile. No focal neuro deficits.
Pt waited 15 min. Came back after attempting to get into car.  RN stated that patient reported left arm "electric" feeling down arm briefly after arm, then dissipated. Pt did not report this to an RN. Pt trying to get into car, and reported new onset left let weakness. She came back up to the clinic. RN did neuro check, left leg/foot weakness noted compared to right and possible foot drop also noted. Pt advised to go to ER, initially refused. Then changed mined and then went to ER. According to ER nurse, patient checked in then decided to leave without treatment.
This spontaneous report was received from a pharmacist refers to a multiple concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were "possibly" vaccinated with improperly stored doses of GARDASIL, lot# K007828 and expiration date 02-MAR-2017, lot # L039066 and expiration date 19-MAR-2017 and lot# L035105 and expiration date 14-MAY-2017 as reported (dose, route of administration and anatomical location were not reported). There were no concomitant medication provided. The GARDASIL vaccines were exposure to 34F for 295.75 hours. There was no previous excursion and no data logger issue. No adverse effects reported. No product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
41 yo Female developed numbness and tingling in the tongue and mouth about 15 minutes after receiving 1st dose of Moderna vaccine.  She reported a history of anaphylaxis to shellfish in the past and was being observed for 30 minutes.  Member was brought over to care area to be monitored closer.  After about 10 minutes, she reported progression of her symptoms with itchy throat and worsening tongue tingling.  Exam and vitals remained normal.  Based on her history and progression, team was concerned for early anaphylaxis.  She was given an epipen shot and within 5 minutes all symptoms had resolved.
fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 at 09:30AM (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension .The patient also reported allergy to shellfish. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient's concomitant medications included Cozaar (MANUFACRURER UNKNOWN), vitamin B12 (MANUFACRURER UNKNOWN), vitamin D (MANUFACRURER UNKNOWN) all for unknown indication from unknown dates and unknown if its ongoing. On 14Mar2021 (Day 5), the patient started to feel fatigue but on 16Mar2021 (day 7), it was so intense that prevented him to do habitual physical activity. The patient who was an athlete, preparing for a triathlon, was not able to finish a 4-mile run, which was very simple to his fitness level. The patient was treated for the event fatigue with Advil (MANUFACRURER UNKNOWN). The clinical outcome of the event fatigue was not recovered. No follow up attempts are possible. No further information is expected.
All of a sudden felt every bone in my body hurting; Hurt to move; Painful to just get out of bed to use the restroom; Flu like symptoms; Had absolutely no energy at all; All of a sudden felt every joint in my body hurting; Entire body aches for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ASTHENIA (Had absolutely no energy at all) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu-like symptoms (Patient had flu-like symptoms in her life.). Concurrent medical conditions included Allergy to NSAIDs (Allergy to Aspirin), Allergy to NSAIDs (Allergy to Ibuprofen), Anxiety, Vitamin deficiency, Migraine and Sleep disorder. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and LORAZEPAM (ATIVAN) for Anxiety, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, MIRTAZAPINE (REMERON) for Sleepiness, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Had absolutely no energy at all), ARTHRALGIA (All of a sudden felt every joint in my body hurting) and MYALGIA (Entire body aches for 4 days). On 17-Apr-2021, BONE PAIN (All of a sudden felt every bone in my body hurting), MOBILITY DECREASED (Hurt to move), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Painful to just get out of bed to use the restroom), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Had absolutely no energy at all), ARTHRALGIA (All of a sudden felt every joint in my body hurting) and MYALGIA (Entire body aches for 4 days) had resolved.            The patient never had diagnosed with or tested positive for COVID. Patient had no acute or chronic illness at the time of vaccination. It was reported that with the second vaccination patient was fine until that evening. Patient just wanted to sleep and not to move and on the fourth day all the events started getting better then all of a sudden it just went away as if nothing had ever happened. No treatment medications were reported.   This case was linked to MOD-2022-520457, MOD-2022-452688 (Patient Link).
nonstop buzzing and ringing in the left ears since the second dose. Began the day after the injection and the buzzing has persisted.
when they gave her the Pfizer Covid Vaccine shot that day, it bled.; pain, it started at the injection site; pain in her hand, and arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 84 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), 1 day after the suspect product(s) administration, outcome "unknown", described as "when they gave her the Pfizer Covid Vaccine shot that day, it bled."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain, it started at the injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her hand, and arm".  Additional information: The patient reported that when they gave her the Pfizer Covid Vaccine shot that day, it bled. And the nurse apparently told her that she's never had that bleed before but she's developed pain her arm and it started at the injection site but now it run and travelled to her hand and she said that it was very painful and she wanted to know if that could be a side effect of the vaccination. She added she did not know if it was from that or not (the vaccine), but it was very painful down into her hand.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Began symptoms of a period the next day after previously finishing my period 4 days prior to shot: spotting, cramping and flow enough for a tampon.
Mother brought child into office with fever of 105.3F (ax). Child was alert but very irritable. Mom had given Tylenol at home without relief. Motrin elixir was given in office with relief. Temperature went down to 100.7F (ax) after 40 minutes, post Motrin dose given.
No addtional AE; Inbound call from HBP who stated VAQTA was inadvertently administered after a supported temp excursion. No additional AE details or PQC.         ?    Names of vaccines involved (including lot/exp) VAQTA W017819 12/27/2023        ?    Temperature; This spontaneous report as received from an unspecified reporter, mentioned as HPB concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  09-JAN-2023, the patient was vaccinated inadvertently with a dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe, lot # W017819, expiration date: 27-DEC-2023 for prophylaxis, after supported temperature excursion (Product storage error). No additional adverse events  or PQC were reported.  The administered dose of the vaccine experienced a temperature of 35.2degress Fahrenheit for 9 hours with no previous temperature excursion.
This spontaneous report was received from a register nurse concerning an approximately 70 year old female patient (reported in her 70's). Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, expiration date and route were not reported) dose reported as 1 injection. Co-suspect and concomitant therapies were not reported. The register nurse reported that on an unknown date, the patient developed shingles along her hairline after being administered the ZOSTAVAX vaccine. At the time of the report the outcome was unknown. Additional information has been requested.
Site of injection became red, sore, swollen. Swelling eventually involved entire upper arm. Skin became crusted. Client did not see doctor, she used ice packs on arm. Condition lasted 5 days.
Kinrix administered to 2-year-old twins, Kinrix is licensed and recommended only for children ages 4 through 6 years. Immediate Actions Taken or Suggestions for Improvement: -Reviewed CDC recommendations - Kinrix is only licensed for use as the fifth dose of the DTaP vaccine series and the fourth dose of the IPV series in children age 4 through 6 years. CDC has provided this guidance for when Kinrix is given off-label:Kinrix given to a child younger than 4 years as DTaP and IPV doses 1, 2, or 3: Count as valid if all minimum intervals met