chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol however, was persistent for 48hours; in conjunction I experienced significant body aches, migraines, diarrhea, chills, and fatigue. Fever broke by Sunday morning however continuance of body aches and fatigue lasted through the weekend.
No adverse event; Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 1805018) for COVID-19 prophylaxis.     It was unknown that patient had any acute illness or any chronic or long-standing health conditions.    On 20-Mar-2021 at 9:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Dec-2021 at 10:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Dec-2021 at 10:19 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had first dose on 20-Mar-2021 and patient had second dose on 08-Dec-2021.).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704639 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704639:Bivalent Dose
Metalic sensation in tongue and back of throat. Onset within 5 minutes. Did not worsen, gradually improved, about 50% better within 30 minutes. No tongue or lip swelling. Breathing normally. The patient describes feeling a similar sensation after her first vaccination that lasted for about 1 hour and then resolved.
severe chest tightness, pain, and shortness of breath lasting 6 weeks this has gradually improved over time but did not occur in conjunction with any other illness or respirator condition.
Patient verbalized that it's her 1st dose and received Moderna covid-19 vaccine during visit. After vaccination. patient verbalized speaking with an oncologist and receive confirmation to receive Moderna covid-19 vaccine as the 3rd dose despite completing the Pfizer covid-19 vaccine series last January 2021. Patient stayed for the duration of the observation period and declined experiencing any allergic or adverse effects before leaving.
rhinitis and shortness of breath with cough around 18 hours post vaccination. Now at 48 hours post vaccination doing much better with mild cough.
-Blacked out in the shower - did not fully lose consciousness, but everything went black. Took a few seconds for vision to come back (7/17).  -Arm pain - right arm was numb/tingly all the way down the arm into the fingers (7/17).  -Leg pain - right leg was achy and radiated down the entire leg into the foot (7/18). -Rash - rash developed on right arm on day 7 (7/24).  Rash was itchy on the first day and did not go away until two days later.
COVID Breakthrough Case  Moderna Dose 1 2/17/21 (024M20A) Moderna Dose 2 3/17/21 (007B21A) COVID Positive 9/24/21  9/27/21: The patient presents with Stroke alert.  Onset: 09/27/2021  and 09/27/2021 16:40:00 .  Location: generalized. Context: Patient is a 58 year old male that presents to the ED via EMS from EMCC with AMS, right sided weakness, slurry speech that began at 16:40. Patient also tested positive for Covid-19 on Friday, 9/24. Patient had a stroke in August with left sided weakness. .  Timing: sudden. Character: moderate.  Associated Symptoms: moderate.  9/29/21: Patient is a 58-year-old male who presented on 09/27/2021 with chief complaint of altered mental status and slurred speech and right-sided weakness.  In the ED, patient was positive for COVID-19 but had no respiratory symptoms or hypoxia or evidence of pneumonia on chest x-ray.  Patient was not a candidate for tPA.  He did receive an MRI that was positive for several new tiny acute infarcts in the left frontal lobe.  CTA head and neck were unremarkable.  Echocardiogram was performed.  This was unremarkable as well.  Neurology evaluated the patient and recommended following up in regards to his previous cardiac event monitor has his recurrent strokes may be cardioembolic in nature.  Continue dual anti-platelet therapy and high-intensity statin until he follows up as an outpatient.  There was also some concern from Neurology the patient potentially had a seizure at time of arrival as his dose of Keppra was recently decreased from 500 mg p.o. b.i.d. to 250 mg in the morning and 500 mg in the afternoon.  They therefore placed patient back on his previous dose of Keppra 500 mg p.o. b.i.d..
About 4 hours  after receiving vaccine my eyes were burning and throat was sore   Soon after  my eyes were blood shot red and pus coming out.    I sat down & said to my wife, I don't feel well and I passed out and fell on floor!    Scared the crap out of my poor grandchildren  who were at the dinner table with mom. dad, gram and poppop (me).    Amblance came and rushed me to hospital.
Severe headache; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot  number: EL1284), via an unspecified route of administration, on 28Dec2020 (at the age of 68-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced severe headache and nauseous on 28Dec2020. The clinical course was reported as: After the first dose, the patient had severe headache within couple hours and then continuing to the next day. He felt really nauseous and then on the second day for another 24 hours.  Therapeutic measures were taken as a result of the events, which included ibuprofen (MANUFACTURER UNKNOWN) 1000 mg. The clinical outcome of severe headache and nauseous was unknown.
Patient who received Prevnar 13 instead of Pneumovax 23; This spontaneous report was received from a nurse concerning  a 58 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) (wrong product administered).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (16Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 09Oct2023 to 14Oct2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335978 same reporter/patient with different drug/AE;
Tingling sensations; Rash on back of left leg after first moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot). At the time of the report, PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.
L/arm sore where shot was given (up to 5 weeks after vaccine was given).
Pt experienced a syncopal episode with approximately 5 sec passed out.  EMTs responded and checked BS = 79.  Laid supine for approximately 10 minutes prior to moving back to his car. Monitored for 30 minutes and released Given phone number to schedule the second dose there as a supine injection. NO medical history, on no medications but prior history of passing out with injections
Myalgia, Arthralgia, flushed, itchy, felt like i had a sunburn, puffy eyes Narrative:
No additional AE.; PEDVAX HIB and ROTATEQ administred after temperature excursion.; This spontaneous report has been received from a nurse and refers to a patient of unknown gender and age.The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 25-JUL-2022, the patient was vaccinated with improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number: W004502, which was determined to be valid, with an expiration date on 10-OCT-2023), and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number: U039951, which was determined to be valid, with an expiration date on 22-JUN-2024). Both were administered as prophylaxis (strengths, doses, routes of administration, and anatomical sites of injection were not reported).   Administered doses were stored at a temperature of 23.8 degrees Celsius (C) during a time frame of 9 hours and 45 minutes (improper storage of product in use). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Fever for 10 hour Headache for 20hour+ Muscle pain for 20hour+
Mother reported that on 9/3 in am, child was noted to have redness,warmth and swelling to left leg. Swelling from knee to groin. Hands were also red and swollen with blisters on fingers. Per hx, pt also had fever x 24 hours. Hands peeling over  next 2-3 days.
Patient states after 15 minutes he left facility and it felt like "throat was very tight. Secondly I just felt off mentally. dazed, confused. I drove myself to the store, felt bad there, came home and didn't want to fool around with this so I drove myself to the emergency room. The only thing gave me was a Benadryl injection and steroid injection. My heart rate and blood pressure - none of that was elevated. "
Within a few hours the right side of my face became numb and tingling and I noticed I had some drooling on the right side of my mouth. Around my right eye was numb and tingling very severely and I noticed a droop on the right side of my mouth as well as my right eye.
Received the first shot on 05/19/21 around 7:00pm. Noticed side effects on 5/20/21 around 9:00am. Severe itching redness, welts. Started taking antihistamine on 5/21/21. The problem still persist after taking antihistamine for a week. Went to the Urgent Care on  05/29/21. The Nurse Practitioner prescribed Methylprednisolone tablets and cream. I have taken day 1 dose and still no relief. I now regret taking the shot.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 18th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient stated that she always reponded to the shots by experiencing a sore arm within 24 to 48 hours after vaccination. The sore arm experienced by the patient lasted for 3 to 4 days for SHINGRIX, it was about a week. This case was linked with US2018GSK182226 case reported by the same reporter.
Incomplete course of vaccination; administered Shingrix to a 43 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number 9K4T4, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had two cases of shingles in last 18 months, before vaccination).   On 30th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 30th March 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced off label use. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the off label use and incomplete course of vaccination were unknown.  Additional details were provided as follows: It was reported that the patient didn't have a prescription for Shingrix. The patient was not immunocompromised but has had two cases of shingles in last 18 months and received Shingrix vaccine at the age of 43 year.  This was caught when she presented for a second dose. At the time of report it was unknown if the patient received 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
Information was received on 10-MAR-2017 from a pharmacist regarding a male and female patient (age not provided) (this case refers to the female patient- see MARRS # 1703USA010583 for male patient case). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the patient received a dose of ZOSTAVAX for prophylaxis (dose, duration, and lot number not specified). On an unknown date, six months later, the patient received another dose of ZOSTAVAX (dose, duration, and lot number not specified). No adverse effects were reported. No other information was available. Additional information has been requested. Sender's Comments: US-009507513-1703USA010583.
Information has been received from a health professional  concerning an 8 week old patient who on 28-AUG-2006 was vaccinated with an oral dose or rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccine included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (tetanus toxoid and a dose of Hib conj vaccine.  "About two hours post vaccination", on 28-AUG-2006, the patient's parents indicated that the patient was crying excessively. Subsequently, the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  The health professional also reported a second patient that had a similar experience following vaccination with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Additional information has been requested.
bad cramping for 5 days then it stopped; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (bad cramping for 5 days then it stopped) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    The patient's past medical history included No adverse event (no medical history provided).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (bad cramping for 5 days then it stopped). At the time of the report, ABDOMINAL PAIN UPPER (bad cramping for 5 days then it stopped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided. caller refused to provide additional information
Seen by MD 8/7/02. Prescribed antihistamine per guardian. S/S swelling egg-sized lump upper L arm, hot to touch with 102.6 fever. MD prescribed Claritin.
Oct. 2, 2017 - given flu vaccine - within few hours, severe pains started in left hip joint; pain continued to move to knees and ankles and within 24 hrs. severe pain was in every joint on Lt. and Rt. sides below my waist with burning pain in all muscles. Oct. 2nd to 12th - joint pain w/burning muscles too severe to sleep. Doctor office where vaccine was given told me to see my "PCP"! Oct 12th - went to PCP who gave me anti-inflammatory shot, "ketorolac" which gave me relief for 4-5 days! Oct. 19th - pains returned; Oct. 20th "PCP" gave me a second "ketorolac" shot which lasted another 4-5 days. Started on Oct. 25th and has continued as joint pain has started to become less, each day I have been hit w/debilitating flu symptoms" of chills, feeling "feverish" (but no elevation in temp.), headaches, aching, extreme tiredness and nausea! It will stay w/me from a few hours to all day, so I am unable to plan any activities! Nov. 12th - I am starting my 7th week since flu vaccinations and each day I still face some joint pain, flu symptoms, or both in varying degrees!!!
Upper right arm was red and swollen. Treated by doctor and he thought it was allergic reaction. Treating with Benadryl and Cephalexin. Right arm is affected area.
Following the injection, the patient began to experience atrial fibrillation with RVR. The patient was taken by EMS to Medical Center, and was hospitalized on 04/03/2021 The patient was discharged from the hospital on 04/07/2021.
Female 9 years old 4cm red, swollen circle and tender to the touch; Female 9 years old 4cm red, swollen circle and tender to the touch; 4cm red, swollen circle and tender to the touch; 4cm red, swollen circle and tender to the touch; 4cm red, swollen circle and tender to the touch; This is a spontaneous report received from contactable reporter(s) (Physician).  A 9 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Female 9 years old 4cm red, swollen circle and tender to the touch"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "4cm red, swollen circle and tender to the touch".  Additional information: It was reported that event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dizziness, Lightheadedness,Loss of Consciousness,Weakness  "Approximately 10 minutes after receiving first COVID-19 vaccine, patient reported she felt lightheaded. Denies CP, SOB, throat swelling. Denies any hx of severe allergic reaction or anaphylaxis. Reports hx of similar reactions after receiving the flu shot. On initial evaluation: BP 126/69 HR 68 RR 16 O2 sat 97% ORA   After sitting in a wheelchair for approximately 15 minutes she reports symptoms had resolved other than a very mild headache. No signs of anaphylaxis or severe allergy Patient released after monitoring. State she feels comfortable driving home."
This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via route of administration on 02Mar2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose BNT162B2 for Covid-19 Immunisation. A 65-year-old female stated that she had her second dose of the Pfizer Covid-19 vaccine on 02Mar2021 and three weeks later she started having chills that come sporadically, they disappear after a few minutes in Mar2021. The event was reported as non-serious. The outcome of the event was recovered in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Symptoms are generalized itching that didn't require medication. Large local 14cm X 7cm area on left upper arm. Injection site still itches.