chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; muscle aches /pain; lethargy; dizziness,lightheaded; joint pain; nausea; GI upset; other vaccine same date vaccine date=19Dec2020; This is a spontaneous report from a contactable consumer (patient). This 50-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Unknown, at single dose on 19Dec2020 08:30 AM on left arm at Hospital for COVID-19 immunisation. There was no medical history. The patient had no COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included clonazepam (KLONOPIN) which was received within 2 weeks of vaccination.  Other vaccine was received on the same date on 19Dec2020. The patient experienced headache, muscle aches /pain, lethargy, dizziness, lightheaded, joint pain, nausea, GI (Gastrointestinal) upset on 20Dec2020 06:00. No treatment was received for all events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sore arm; Trouble sleeping; This spontaneous case was received on 07-Oct-2020 from a pharmacist via Health Authority (reference number: SEQW20-03135) and concerned a 57-year old, female patient.  The patient's medical history and concomitant medications were not provided.  On 24-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 276576 and expiration date 30-Jun-2021.  On an unspecified date in 2020, after receiving Flucelvax QIV, the patient experienced sore arm, and had trouble with sleeping. The patient took Tylenol (paracetamol) and ibuprofen as treatment medications.   At the time of initial reporting on 07-Oct-2020, the patient had not recovered from events of 'pain in arm' and 'sleep difficult'. As reported, the patient was not improving.   The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 57-year-old, female patient, was vaccinated with Flucelvax QIV vaccine. On an unspecified date in 2020, after receiving Flucelvax QIV, the patient experienced pain in extremity and insomnia. The patient's medical history and concomitant medications were not provided. Causality is assessed as possibly related for pain in extremity and unlikely related for insomnia. (defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 57-year-old, female patient, was vaccinated with Flucelvax QIV vaccine. On an unspecified date in 2020, after receiving Flucelvax QIV, the patient experienced pain in extremity and insomnia. The patient's medical history and concomitant medications were not provided. Causality is assessed as possibly related for pain in extremity and unlikely related for insomnia. (defaults to "related" in the safety database for reporting purposes)
2/11/2021 Per Healthcare worker.  Day after pt received 1st Covid vaccine went to ER for hives on face and abd pain.  Also reported HA and body aches. Discharged from ER with unspecified stomach pains.  Pt is nonverbal.  Information obtained from Healthcare worker.  As of 2/22/2021 patient is doing fine and having no s/s.  Asked Healthcare worker to provide  a statement from physician or PCP as to whether pt should receive the second dose of the Covid vaccine. RN
A healthcare professional reported that a 4 year old child received an injection of the Flu Shield 2000-2001 formula on 12/8/00. The following day, the child died. No further information was available at the date of this report.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
rash at injection site; arm felt funny; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) and LIMB DISCOMFORT (arm felt funny) in a 3-week-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and LIMB DISCOMFORT (arm felt funny). At the time of the report, VACCINATION SITE RASH (rash at injection site) and LIMB DISCOMFORT (arm felt funny) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pos allergic reaction anthrax shot (1wk); 1. lump in / on skin: right arm most likely from anthrax vaccine. Supportive care with NSAIDS, Benadryl, heat and cold compresses. She should not receive further anthrax vaccine in future. She was instructed to initiate VAERS form.
Swollen and burning in my Neck; I can't swallow very well; Swollen and burning in my Neck; I can't swallow very well; White patch on tongue and green patches on tonsils; Fatigue; White patch on tongue and green patches on tonsils/ Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Swollen lymph nodes; Loss of voice; Ear pain; Knee pain; Itchiness all over; Sickness; Pain in my body; Dizziness; Nose are clogged; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 02Apr2021 10:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.On an unspecified date the patient mentioned everything changed in her body; she had white patch on tongue and green patches on the tonsils ever since she had the first shot. She suddenly felt something like swollen to her neck and burning in her neck. She started to feel like her neck. She can't swallow very well, and she checked in mirror, she saw that it was swollen that's why she can't swallow which she never experienced before. Neck swollen up, supposedly the lymph node swollen because her voice changed. She was itching all over and she felt sickness and fatigued. She also reported Pain in her body, loss of voice, ear pain, knee pain and dizziness. She went to couple of doctors for this but nobody could help her and she don't know what to do. She was still experiencing side effects of the vaccine and felt like she had some type of bread piece chopped in her mouth and then her nose was clogged and she was great before she took the vaccine. Now she also feels pain on her tonsils, heaviness on her tonsils and sometimes when she talk to her family over on the phone whenever her tonsils hurts more and more and she felt heaviness on them and pain was like somebody is digging into my tonsils with a knife to cut off. She already got her second dose but she was experiencing crazy side effects of it after the first one and second one. She was still experiencing it although her first shot was taken on 02Apr2021 at 10:00 and my second on 05May2021 at 10:18. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was given adjuvant without antigen. Pharmacist readministered full vaccine on the opposite (left) arm on the same day.
Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 25 months old male patient who received a 0.25 mL expired dose of FLUZONE QUADRIVALENT lot UI889AA, expiry date: 30-Jun-2018, via intramuscular route in the left thigh on 20-Aug-2018 inadvertently. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Immunization administered - child sitting in chair with mom at side. Approx. 10 min. passed and then finger stick hgb. done. Child uncomfortable with this procedure. Approx. 5 min. passed - child decided to go to bathroom. Upon entering bathroom child fell against wall and passed out. Dr. at side immediately - LOC for only seconds. Elevated gest B/P 100/58 - popsicle given. Released with mom after 20 min. observation.
Inection site pain muscle joint pain headache  fatigue chills, fever pain when lifting arm chest pain
tired; become very cold, especially hands and feet; Hyperhidrosis in feet; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th January 2022, the patient received the 2nd dose of Shingles vaccine. On 28th January 2022, 1 days after receiving Shingles vaccine, the patient experienced tiredness, cold hands & feet and hyperhidrosis. On an unknown date, the outcome of the tiredness, cold hands & feet and hyperhidrosis were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, cold hands & feet and hyperhidrosis to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingles vaccine and next day experienced tiredness and cold all day. The patient noted that, his/her feet sweat a small amount in socks which were pretty heavy, it was not noticed that. Fast forward to day of reporting, it appeared to be hyperhidrosis in feet. It had gotten progressively worse since 27th January 2022. Additionally, the patient still had periods when he/she suddenly become very cold, especially hands and feet. The feet were partially because they were now damp most of the time (as of this week). The patient wanted to know if anyone else had reported such a side effect and if so was there any idea how long it lasts. Consent to follow up was requested. Note- there was discrepant information reported for sweating of feet as it is noticed on next day but in narrative it also mentioned that, hyperhidrosis was worsened since vaccination. For now, time to onset (TTO)captured as 1 day based on the narrative.
The headache from hell. Hurts to move my eyes. To lift my head off the pillow. To cough. To sneeze. To bend over. Feel like my chest has a little pressure, like when you feel you are going to throw up. The pain is like a million ice picks being stabbed into my head. I used to have migraines 20 years ago. This is worse. I have taken two Aleve, two Advil, Tylenol w caffeine. Dr called in Foirecet but I haven?t picked it up because I waited over an hour for it yesterday and it wasn?t ready. I finally rubbed a rx ortho cream I have from a torn ligament on my forehead. It has gabapentin, pain killer and steroid in it. At least today I can raise my eyebrows but all the rest is still occurring. It scares me more so the chest discomfort than the headache even though the headache is awful. But I have had fluid around my heart before and I just had an echocardiogram done due to my heart skipping beats. Echo showed three valves with regurgitation. I keep sighing because I feel like I can?t get that last bit of satisfying breath. But the head pain is awful.
3 hours after  vaccine was given in the right arm employee developed opposite arm numbness. entire arm no dermatome pattern.  Later in evening she developed Left facial numbness .feeling /touch  Sensation and function are normal but feel as it the areas have fallen asleep. arm has resolved and face is improving.
On April 28, (morning after the second dose) I woke up with fever, chills, & body aches; which I was prepared for. I didn't take any medicine--I just "toughed it out.  On April 29th, the aforementioned symptoms continued, and the lymph nodes in my left armpit were swollen and sore.  By April 29th, the fever & chills subsided. By April 30th the body aches were waning. The swollen and sore lymph nodes continued. By May 1, I started to develop hives on the left side of my face and neck. By May 3, the swollen sore lymph nodes had subsided, but the hives were in my hairline, across my torso, groin and legs. This is absolutely miserable. The hives are itchy, painful, and weeping.
Flu; Initial information received on 17-Nov-2020 regarding this unsolicited valid non-serious social media case from a consumer (patient) via Social media.  This case involved a patient with unknown demographics who experienced flu (Influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (Influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient had flu two years in a row.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Patient had no history of vaccines. Mom stated she had never been vaccinated. Patient stared sneezing immediately following injection of 3rd vaccine - order 1 Pediarix, 2 MMRII, 3 Varivax. I was concerned about reaction, told mom to call doctor if it did not resolve. After patient left, I called a local doctor to inquire about rxn. He had never heard/experienced such rxn but advised me to tell mom to dose pt with Benadryl. Employee called mom who stated the patient had started wheezing. Advised her to go straight to emergency room. Followed up with phone call to mom who stated pt received IV steroids, benadryl and epipen. She stated the patient does not have a doctor. I gave her recommendations and told her I may be able to get her seen by the doctor I called for advice if she is unable to locate one.
Soreness of spine down middle of the back; Vaccine had expired; Soreness on both arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had expired), LIMB DISCOMFORT (Soreness on both arm) and SPINAL PAIN (Soreness of spine down middle of the back) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) and LIMB DISCOMFORT (Soreness on both arm). On an unknown date, the patient experienced SPINAL PAIN (Soreness of spine down middle of the back). The patient was treated with NAPROXEN SODIUM (ALEVE) (oral) from 17-Feb-2021 to 18-Feb-2021 at a dose of 200 mg. On 17-Feb-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had expired) had resolved. On 20-Feb-2021, LIMB DISCOMFORT (Soreness on both arm) and SPINAL PAIN (Soreness of spine down middle of the back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-015145, MOD-2021-075421, MOD-2021-075452, MOD-2021-075507 (Patient Link).
Pt turned pale, fainted; 920AM BP 74/54, P72; 930AM BP 78/54, P72;
Few minutes after shots, patient had a brief syncopal episode lasting 30-45 seconds; complete recovery.
Patient is too young to get Moderna, she should have received Pfizer as her first dose.
Break out of hives all over body. Treatments of itch relief cream and allergy medicine.
Not so itchy/in the arms it was where it itched the most (the blisters)/most itchy in the palms/most itchy beneath her feet; In the arms it was where it itched the most (the blisters)/it was like blisters/blisters got pain-tender/it was like blisters; Blisters got pain-tender/it was like blisters; rash in arms/rash in thighs/rash in front trunk (the worst)/rash in back/rash in scalp/rash in back of the neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH, PRURITUS, BLISTER, and PAIN in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced RASH. On an unknown date, the patient experienced PRURITUS, BLISTER, PAIN, and RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
Dermatographia. Vaccine was given on Dec 11, first time rash appeared was on Dec 23rd, rash would appear in different places on torso, neck and arms daily. Responds to antihistamines. On Jan 13th, Dr gave diagnosis of dermatographia, recommended xyzal daily through the end of January, then to try to taper off of xyzal and see if the rash has subsided.
pt recv vax & exp angioedema, hives & diff breathing;MD also noted had done a skin test w/vax;
faint, sandpaper like rash devel on rt flank/axilla 5-7 days p/vax, in rt deltoid; no tx neede
PATIENT ARM HAD SWELL UP WITH A HEATED KNOT IN HER ARM AND DIDN'T GO DOWN UNTIL ABOUT TWO WEEKS LATER.
Pain, bleeding immediately after injection. swelling, redness and warmth afterward. one month later patient is still having pain in the arm at the injection site.
PT GIVEN HIGH DOSE FLU VACCINE IN ERROR, PT REPORTED NO SIDE EFFECTS ASIDE FROM SORE ARM. DENIED ANY FURTHER QUESTIONS OR CONCERNS AT THIS TIME
Fever, chills, and aches after 13 hours. Headache and chills and weakness after 24 hours
Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures; Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053022A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Bivalent vaccines stored in freezer because thermometer was not a Digital data logger and not able to upload temperatures).    No concomitant medications were reported. HCP stated that the vaccines were stored in the freezer, they keep a log of temperatures morning and evening, have had no prior or current temperature excursions, no alarm and no power outages. Treatment information was not provided.  This case contains information for the 14 of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-687867 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687867:Master
81 yo M with PMH of AFIB, OSA, anemia 2/2 CKD, CKD stage 3,  DM 2, macular degeneration age related, CAD (IDC 2016), COPD, PVO, OA,  H TN, HLD, and hx etoh abuse. Recieved COVID-19 bivalent booster (Moderna)  on 10/28/2022. Reports pain to shoulder that lasted 3 days (this is unclear as RN  had documented giving vaccine to buttocks - unable to clarify actual location of  administration). Reports n/v, "heart racing," and "HTN with SBP in 150s." Patient  self-reported all these sx and stated they started on the night of 10/28/2022 and  subsided on 11/01/2022.