chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medications reported by investigator   This case was linked to MOD-2021-049404 (Patient Link).
Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031B21a) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown.            No treatment information was provided.  No concomitant medication was reported.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Client received COVID 19 Pfizer vaccine on 03/09/2021 and 04/01/2021. She tested positive for COVID 19 on 06/11/2021.
Tested positive for COVID-19; Tested positive for COVID-19; Dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 14:15 (Lot number: EW0196) at the age of 25 years as dose 3 (booster), single, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021 14:15, outcome "unknown", described as "Dose received: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: Nasal Swab; (06Jan2022) positive, notes: Nasal Swab; (03Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had no known allergies, no other vaccine in 4 weeks and no other medications in 2 weeks. The patient had no covid prior vaccination and was tested post vaccination.
Patient received x 2 Pfizer doses 1st dose 3/9/2021 and 2nd dose 03/30/2021 . No booster dose yet. On 11/21/21 arrived to ED with shortness of breath, cough and fever  Patient is a 73-year-old man who presents to the ED via EMS for evaluation of fever with associated cough and shortness of breath.   Patient reports the symptoms began approximately week ago.   Patient states he spoke with his primary physician about his symptoms and was prescribed unspecified antibiotic which patient reports he used as directed.  Additionally patient reports he had outpatient COVID testing which was negative.  Patient reports over the course the last week he feels his symptoms have progressively worsened.  He reports that he feels very generally weak and that he becomes very short of breath with only minimal exertion.  EMS reports that during transport to the ED patient was noted to have a room air pulse oximetry of 93% and so they started him on oxygen by nasal cannula, at baseline patient is not on oxygen.  Patient denies having any recent chest pain, leg pain or edema, abdominal pain, nausea vomiting, diarrhea, flank pain, dysuria frequency urgency, skin rash, or any other complaints at this time.
Moody, oppositional, just not feeling well, fever, runny nose. 09/28/2010 was covered with spots. Mom suspicioned chicken pox.  Taken to doctor in PM and diagnosis confirmed.
Patient presented to pharmacy at 9am on 10/03/2019 to report arm tenderness, redness, swelling, warmness below and interior of right upper arm. Pharmacist on duty on 10/03/2019 informed patient to be seen by physician. Pharmacist on duty called physicians office to inform of patients side effects. Nurse stated she would put it in the chart.
01/02/2022  History of Present Illness  The patient presents with 60-year-old female with past medical history of multiple sclerosis comes to ED with chief complaint of malaise, cough, chills, nausea, vomiting that started last week.  Patient states her son at home has similar complaints and is positive for COVID.  Patient denies difficulty breathing or chest pain.  Patient denies any other complaints at this time..
Day after vaccine arm was sore, red & slightly swollen then it all went completely away. Exactly 1 week after vaccination the vaccination site became red, itchy & swollen & had a big lump. Today 1/12 is day 7 of this reaction. Although it is starting to improve.
Mom sent a portal e mail message on 03/01/2022 at 7:15am: this message is being sent.  the paperwork for (they/them pronoun) meningitis shot said to contact you if they get ringing in ears.  it started yesterday afternoon.  over the weekend, they also had fever, sensitive skin and headache.
the nt of receiving vaccine , patient became confused.  next morning somewhat unresponsive & could not walk admitted to hospital from 10-14-23 to 10-20-23   Unable to walk this whole time.MRI, Blood 7 Urine cultures, EEG Spinal tap, Doppler of Carotids done  nothing Found Drs surmise it was inflammatory reaction in the brain, poss due to flu shot  To rehab on 10-20-23  unable to walk or do anything for himself for a few days. then up in chair, trying to walk but need assistance of 2 people for bathroom use  & continuing to work with Pt, OT & speech therapy  beginning 0n 11-8-23 beginning became more independent in walking . on 11-23 strarting walking more & better  not as confused as in hospital & first 10 days of care, but still confused on & off
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE PERICARDITIS, UNSPECIFIED
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 14-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 864 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a female consumer who on 24 Nov 2006 "one week ago" was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently the patient experienced bruising at injection site and a low grade fever. No medical attention was sought. No diagnostic laboratory studies were performed. The patient's bruising at injection site and low grade fever persisted. No product quality complaint was involved. Additional information is expected.
Fine pinpoint rash appeared from head to foot in 3 days, post vax. She has been fussy since vaccination. Rash is all disappeared within 5 days. Sister had 1 day of fever during the same period.
pt devel fever 30NOV96 p/vax on 22NOV96;pt devel a rash over most of body;pt also had muscle aches, joint pain, stiffness & swelling of hands;the hives had the appearance of sunburn from the neck down;inc WBC;serum sickness vs viral URI;
8 hours after vaccine, the chills started. Violent, body shaking chills. It sounded like woody woodpecker when my teeth were chattering against my mouth guard. Then the fever came in. 17 hours after the vaccine, my fever is still at 101.  Did not sleep much. Woke up with severe headache and muscle pain. Drank a gallon of water yesterday and 32 oz in the middle of the night. Despite that, I?m still thirsty.
Pt who received Pneumovax 23 IV instead of SQ; This spontaneous report as received from a physician referring to a 47-year-old patient, gender was not provided.The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.       On 21-APR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (dose, frequency, strength, lot number, and expiry date were not reported). The vaccine was administered intravenous instead of subcutaneous (incorrect route of product administration).    The outcome of incorrect route of product administration was unknown. No other issues were reported.
Other than fatigue, no adverse events noted immediately post injection.  Since 2/24/21, have experienced  intermittent chills and fever (max 101.4 degrees), dry cough and lightheadedness.  Do have seasonal allergies and have been using OTC fluticazone and Zyzel as well as Tylanol for fever control.  Will be seeing rheumatologist on 3/31/21.
Patient received vaccine @ 1315. At approx 1325 patient showed signs of seizure activity and possible anaph. Patient was laid down flat At 1335 patient was given Epi in (L) thigh and 911 was called. Ambulance showed up at 1345 and patient was taken to hospital. Epi lot# 0FM498 Exp. 05/2022
Received MENACTRA in left deltoid 7/5/11 red & tender at site on 7/6. Increased in size, seen in our office 7/7/11. Treated with BENADRYL and cold compresses, resolved in 72 hours.
Dizzy; Dull Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 09:10 (Lot number: EW0175) at the age of 82 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN taken for thyroid disorder (ongoing); LOVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Single; 13:15 PM; Batch/Lot No.: ER8732; Anatomical Location: Left Arm, Vaccination site, administration date: 31Mar2021, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Dizzy"; HEADACHE (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Dull Headache".  Additional information: She reported that she got 2 shots and called for the last one shot. She got her shot Friday morning and on Saturday morning when she got out of bed she was dizzy and had to hold onto the bed so she wouldn't fall down. She got up in the night and she was still dizzy. She said that it has been going on since Saturday. She also had a dull headache during the daytime and asked if this was normal. She said that the dizziness only happens when she gets out of bed after she has been laying down. Dull headache was not continuous, it kind of comes and goes during the daytime and the dizziness began in the morning. She got up in the night to go to bathroom, also in the morning when she got up, she been dizzy ever since. She experienced dull headache on Saturday night. Headache was not getting worse, it was still just kind of ongoing. The reporter stated that only medications she took was for her thyroid and cholesterol and that she did not think it had anything to do with this and has been taking levothyroxine and lovastatin for years. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as no. The patient never had a vaccine that she knows of in her whole life and if she did have a vaccine, it was when she was little. Additional vaccines administered on same date of the Pfizer Suspect was reported as no. Prior Vaccinations (within 4 weeks) was reported as no. The reporter denied being sick at the time of vaccination. NDC number and expiry date of COVID 19 vaccination was unknown.  No follow-up attempts are possible. No further information is expected.
Narrative:  Timing error, 2nd COVID-19 vaccine dose given too soon 15 days after first dose.
Body aches; Exhaustion; pain in arm; Extremely thirsty; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches), FATIGUE (Exhaustion), PAIN IN EXTREMITY (pain in arm) and THIRST (Extremely thirsty) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches), FATIGUE (Exhaustion), PAIN IN EXTREMITY (pain in arm) and THIRST (Extremely thirsty). At the time of the report, MYALGIA (Body aches), FATIGUE (Exhaustion), PAIN IN EXTREMITY (pain in arm) and THIRST (Extremely thirsty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment was reported by the patient.  The patient reported that the symptoms were there for 48 hours.   This case was linked to US-MODERNATX, INC.-MOD-2021-101758 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101758:
10:05 am - Rash chest, back, arms, legs. 10:10 am BENADRYL 25 mg po. 10:20 am No improvement. Epinephrine .3cc sc (1:1000). Sent home on BENADRYL 25 mg every 6-8 hr prn.
50 yo female presents to clinic on August27, 2018 with concern for possible reaction to vaccines. Patient received MMR, varicella, hepatitis B and Td Vaccine on August 20, 2018. Patient reports some warmth and redness on left upper arm but right upper arm was normal. Denies of any fever, increase pain or swelling, weaknesses. Notes: local rxn, non-infected. Ice, NSAID as directed prn. RTC in few days if inc redness, pain o/o proportion. Afebrile, vss. immunizations education material provided.
Patient experienced swelling and redness to the right upper arm 5 days after vaccination with Tdap.  Erythema measured 12cm X 14cm on the right upper arm.  Very hot to touch.  Temp- 98.6.  C/O malaise and lethargy yesterday.
Developed shaking and chills, sweating, fatigue. He had received the Typhim vaccine on 11/9/2010.
End of January 2021 Continued fatigue after vaccine, Shortness of Breath, April went to doctor, with shortness of breath, chest pain, back pain, May went to doctor with continued shortness of breath, fatigue, unable to complete some daily task, August 4 ER with Shortness of Breath, low Pulse Ox.
Need to return an injection with a floater/ floater in the suspension/ Floater identified; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow up information on 11Sep2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FW6029, Expiration Date: Sep2023) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT DEPOSIT (non-serious), outcome "unknown", described as "Need to return an injection with a floater/ floater in the suspension/ Floater identified". Additional information: Vaccine was seen to have a floater in the suspension. Was not presented to a patient or given. The medication error occurred, when the product was prepared. The error was noticed and intercepted before the product was supplied to the patient.  The reporter considered "need to return an injection with a floater/ floater in the suspension/ floater identified" not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "need to return an injection with a floater/ floater in the suspension/ floater identified" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  Follow-up attempts are completed. No further information is expected.
received Dose 3 of GARDASIL 9 too early; This spontaneous report was received from a medical assistant and refers to an 18 year old male patient.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, route of administration, lot# and expiration date were unknown).         It was reported that the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) too early, so the office considered the dose to be invalid. The office brought the patient back to receive an additional dose at a later unknown date.
Itchiness within 15 minutes of injection. Arm soreness within 15 minutes of injection. Full body hives within 12 hours of injection.
Patient walked to waiting room after vaccines administered, began to feel lightheaded, then fainted. Child unconscious for less than one minute. Patients vitals monitored, then moved to exam room, and continued to be monitored for more than 20 minutes. Child steadily improved from time of incident. Child released to mothers care.
Fever 100.4F orally after waking that morning. Chills and sweats in the middle of the night. Fever symptoms started at maybe 1:00-2:00 am and lasted until 1:00-2:00 pm that day. Muscular stiffness/discomfort. General un-well feeling, fogginess, fatigue. Mild flu or cold like feelings. Contacted the clinic first thing after they opened at about 8:00 am, fearing Covid-19/ Was instructed to monitor myself and advised to call if conditions worsened, but was advised that it was most likely a reaction to the vaccine. General un-well feeling persisted for 3 days, but never worsened.
This spontaneous report as received from a pharmacist, as part of a marketing research program refers to an over 60 year old male patient (patient's exact age and ethnicity were unknown). On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not provided). The pharmacist reported that 1-2 years after receiving ZOSTAVAX injection the patient experienced shingles. On an unspecified date the patient recovered from shingles. Relatedness between the event of shingles and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
3RD DOSE COVID VACCINE GIVEN 7/11/22, MODERNA #017B22A; pt resides in a SNF, she had a positive COVID test on 9/11/22 and passed away in the SNF
Narrative: Patient tested positive for COVID following completion of Covid vaccine series. 01/12 COVID vaccine dose #1 02/03 COVID vaccine dose #2 04/13 symptoms described as " summer cold, " runny nose, congestion, cough, Covid test positive 04/14 runny nose, new onset cough x1 week, 04/16 feeling much better.
Client presented to the office, "My flu vaccine was administered too high." Left shoulder, arm pain and stiffness upon awakening the following morning, October, 3 2023. Client states, "I initially could not move my arm." Client gained limited range of motion back over the week with slight improvement in pain and stiffness. Client started home exercises after 1 week, applied ice for comfort with minimal improvement. Continues to experience constant pain in left upper arm to elbow, pain will radiate to hand at times. Intermittent tingling of left hand on top and to the fingers.
Mother stated "child started staring into space and eyes were twitching, child would not answer any questions".
Headache, Fever, NauseaVomiting, Chills, body aches (unspecified), scratchy voice, loss of taste, nasal congestion Narrative:
I noticed that a while after the Pfizer booster 1, there was an increase in frequency of tachycardia AND I seemed to notice a-fib occuring daily one to two times. This continued well into January. I notified Dr in November and a cardiac monitor which, of course, showed none of what I had experienced. I did NOT have any adverse arrthymias with the first two doses of the Pfizer Vaccine. It only occurred with the booster. I hesitated to have the second booster and finally after considering the benefits and the risks, I decided to have the 2nd booster but to have the Moderna.  I had consulted Dr via his nurse  and there was no verbal objection. I advised my primary doctor. My thinking was as there were no issues with the first 2 Pfizers, perhaps I developed some sensitivity with the 3rd one. Additionally, my left arm remains sore at times. This also did not occur with the first two doses of the vaccine. The first two doses were given at a vaccination clinic. My memory may be faulty with the dates but I do know that my arm still hurts and I did have an increase in the frequency of tach and had more a-fib episodes than I've had since I had the ablation. Most of the interaction between cardiology was via the portal and phone. I did not present at the office.
Patient behind on immunizations. Received Tdap in 3rd trimester. Later that evening noted pain, redness, swelling at injection site. Increased in size over next 2 days. Redness & induration & warm - 6cm x 6cm
Intense pain but then subsided. Unable to sleep/pain in joint not in muscle. Pain was worse 4 days later upon any movement. Pain w/certain movements - Ibuprofen as recommended by MD. On Monday 10/16/17 had flu injection in my left arm. I have an annual flu injection as part of my work requirements. I have never had a reaction ever. Upon injection I felt intense pain. It then subsided. Later that night I was unable to sleep due to pain in my joint - not my muscle. On Thursday pain was worse. Pain upon any movement. Since then the pain has lessened. I have been able to use my arm but continue to have pain with certain movements. I have been taking Ibuprofen as recommended by MD. Pain is worse at night and I have been unable to sleep well since the injection. Saw Dr. at her office on Tuesday and suggested it was given in her tendon capsule. Recommend ibuprofen.
Staph aureus infection (R) shoulder 23Jul08. Two surgeries 23Jul08 and 5Jan09. Decreased ROM, chronic pain (R) shoulder.