chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; nausea; tiredness; joint aches; swollen lymph nodes; feeling unwell; Headaches; Injection site swelling; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 18:00 (Lot number: FD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "ARB's allergy" (unspecified if ongoing), notes: known allergies: ARB's. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: ER8733, administration time: 10:00 AM, dose number: 1, vaccine location: Right arm), administration date: 27Mar2021, for COVID-19 Immunisation. The following information was reported: PYREXIA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "tiredness"; ARTHRALGIA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "swollen lymph nodes"; MALAISE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "feeling unwell"; HEADACHE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Headaches"; VACCINATION SITE SWELLING (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Injection site pain".  Additional information: Other medical history: Lupus. This was patients (booster) vaccine. Previously fully vaccinated. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient called on 10/19/17 regarding her arm getting a lump and its getting bigger. She came in pharmacy and I looked at her arm and it does look infected. Advised her to go to a doctor and she called back later and said her doctor gave her some BENADRYL and antibiotics and that her doctor said the shot went into the fat tissue instead the muscle. She is okay overall.
On 12-19-06, my boy/girl twins rec'd the MMR, HIB, Hep B and Varicella vaccinations. The twins should not have had the shots since they were both recovering from colds but the Dr. never told us that. My husband & I refused the MMR shot several times while in the office but we were intimidated by the Dr. & his staff to give it. My daughter immediately developed flu-like symptoms, a full body rash including her vaginal and anal areas, and she lost ALL of her [full head] hair over the next 4 days. She lost speech and communication including up to 15 words she had learned. She became catatonic & non-responsive to verbal & physical cues. Daughter was referred to several Dermatologists (for hair loss) & an Immunologist/Allergist. Dr. concurred with other Dr. diagnosis of Hypogammaglobulinemia for daughter. Daughter's blood work with Dr. showed weak Immuno development including very low counts of fighter B & T cells. Daughter has only shown improvement in strengthening her Immune System after seeing a Holistic Dr. starting in June 2007. This Dr. has placed her on a wheat-free, gluten-free, dairy-free diet including holistic vitamins & probiotics. To this day, daughter continues to break out in body rashes, has continual anal & vaginal rashes & her hair has not yet grown back fully. Daughter is developing physically, in speech & cognitive learning at the normal level for her age. She has met all of her major milestones. She is still under the care of her Holistic Physician to continue to build her Immune System.  5/22/08 MR received from PCP from birth to 2/5/08. Infant presented for 12mon WCC on 12/19/2006 with Assessment:  12mon healthy baby girl who is thriving very well. Developmentally appropriate for age.  No parental concerns. 8-10 word vocab. PE WNL. Vax given. Returned 12/29/06 with c/o hair loss x 2 weeks. DX:  alopecia areata.  Referred to derm. Seen again 12/30/06 with c/o rashes of the head and neck.  DX:  Skin rashes, positive, allergic vs viral rashes. 15 mon WCC 3/20/07 with Assessment R OM. WCC.  No parental concerns. 3-6 word vocab. 1/21/2010 Patient's immune system is still rebuilding. She continues to see a holistic doctor on a monthly basis when she eats certain foods (Gluto, corn, some dairy, sugar) she still breaks out in a body rash. Her vaginal/anal rash has stoll not end gone away. Most of her hair has grown back except her left eyebrow. She is still slightly delayed in overall cognition and learning but not t the degree that she needs therapy. Patient easily gets cold and flu and is prone to illness as her immune system was compromised by her vaccinations.  Seen 7/24/07 with c/o rash all over. DX: Roseola. OV 8/30/07 Eczema resolving. Assessment: Hypogammaglobulinemia for eval. Immunology Eval 8/16/07 for alopecia, eczema, and bumps on the face/trunk. Mother reports "catatonic state", unlikely r/t vaccines.  PE WNL except for alopecia of head.   DX:  Likely transient hypogammaglobulinemia of infancy 2 yr WCC. Developmentally, speaking in 2 word sentences. No parental, social or school concerns. Assessment:  Well child exam.  Alopecia
Patient received first dose of moderna vaccine on 05/01/21 at Complete Health Partners. Patient received second dose of moderna vaccine on 05/22/21 at Complete Health Partners. Patient received second dose 7 days earlier than recommended 28 days after first shot. Patient waited required 15 mins after injection and did not have an adverse reaction. Called and notified CDC. Stated that patient did not need another dose. Sent email with CDC info on vaccine to clinic manager. Clinic Manager called patient, apologized and  informed of situation. Relayed information that CDC had stated. Sent email with CDC information to patient.
Central chest pain (started two days after vaccine, admitted to the Hospital on day three after vaccine), nausea, vomiting, shortness of breath.
EXTREME body aches, chills, pounding head ache,  heavy vaginal bleeding for 3 days and I was 2weeks before the start of mensis,  still unkown long term effects
After second dose of vaccine, about 10 minutes or less of vaccination, I had flushed redness in my arm, itching, and hives from my neck on the left side, down to my wrist.  The symptoms resolved on their own within 10 minutes.
I woke up during night after vaccine, and couldn't move on my whole right side of body. Extreme pain in joints and muscles. My chest was in the same pain. The next morning it got better but still have symptoms. Aching and tingling in legs and aching in shoulders.
Swelling at the injection site; soreness at the injection site; Tiredness; Headaches; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site pain, tiredness and headache. On an unknown date, the outcome of the injection site swelling, injection site pain, tiredness and headache were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, tiredness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The caller was a patient.   The caller stated that she experienced tiredness, headaches, swelling and soreness at the injection site for which adverse event was reported. The reporter did not consent to follow-up. No additional details were provided by the caller.
expired dose of ACTHIB was administered with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who reported expired dose of HIB (PRP/T) vaccine [ACT-HIB] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received a 0.5ml dose (dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UJ646AAA and expiry: 05-Mar-2023 via intramuscular route in the left thigh for immunization.  On 07-Mar-2023, the patient developed a non-serious event expired dose of ACTHIB was administered with no reported adverse event (expired product administered) (same day) following the administration of HIB (PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of ACTHIB was administered with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
The vaccine was given on 10/20/2018. Pt states her Left arm started hurting about 3 hours after and with a red swollen circle going around the injection site. The vaccine was injected subq of the left arm. The red circle begin to get larger and is not going under the pt arm near her armpit.
Pt vaccinated with DTP experienced screaming > 4 hrs, listless & floppy, no cyanosis, no S2.
Facial swelling on Saturday evening with itching on face and inside throat. Slight pain on right jaw
A family of 4, (2 adults with their 2 children) came to Covid vaccine clinic today, 11/19/21, to be vaccinated. They were in the pediatric wing with the vaccinator, all in one room. One parent was a flu only, the kids were the 5-11 covid dose and a flu vaccine The other parent was to be a 12+ covid vaccine and a flu shot. This 'other' parent was given the pediatric dose of the covid vaccine instead of the adult (12+) dosage. It was not realized and then confirmed by its charting and documentation, until after they left the room. The patient and family were not made aware of this at this time.
8PM immed redness around inj site;820PM face/neck red, swollen, itching;835PM itching /redness, inc body from waist;856PM dec eye swelling;
The child was receiving a catch up vaccination schedule. RN reviewed the forecast and removed the vaccine from storage for administration. MA prepared and administered the dose. While the dose of Kinrix is age appropriate for the child it did not meet the minimum spacing interval for a DTaP catch up schedule of 6 months from dose #3 to dose #4.  The error was caught immediately after administration. The parent was assured while the dose was early is should not harm the child but may not count as valid and that the next dose is due in 6 months. The parent left abruptly and went to the clinic where she was seen by Dr. who contacted this clinic and was informed of the nature of the error.  Upon research the DTaP dose is valid and the child will need another dose of Kinrix in 6 months to complete her series (dose #5 of DTaP and valid dose #4 of IPV). Physician notified by email of the dose being valid and messages left by phone for mom who is not returning calls.
Information has been received from a physician concerning a 21 year old female who on 29-OCT-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X), IM, left deltoid.  Concomitant therapy included SEASONALE-BARR.  On 29-OCT-2008 within 12 hours post vaccination, the patient experienced swelling and redness at the injection site, a rash that was painful to the touch, the area felt hot and felt like a little ball or nodule at the injection site.  At time of the reporting, the patient had not recovered.  No medical attention was sought.  Additional information has been requested.
Tired, slept 24 hours, diarrhea, chills, headache, painful injection site with swelling.
Patient received an expired dose of Pfizer vaccine. Expiration 09/30/2021. Patient did not report any adverse reactions.
This spontaneous report as received from a pharmacy technician concerning a currently 1 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX lot #J009165; expiration date: 24-JUL-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Chills, fever, headache, sore Muscles, right leg sore enough to impede walking
Pt self reported receiving covid vaccines (no vaccine info), and was admitted to inpatient facility with positive covid test
Numbness to injection site approximately 1/2 inch to right of needle entry.  Effected area approximately size of a quarter.  No numbness to other areas of extremity.
I got the vaccine on my left arm and the back of my left knee, it''s slightly swollen; my leg is hurt; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that patient just (2021) got first dose of Pfizer Vaccine and the patient was having a side effect where leg was 'hurt' (incomplete word), left leg (incomplete sentence). The patient got the vaccine on left arm and left leg, 'it's hurting' and the back of left knee, it's slightly swollen. The patient wanted to know if that was something like a blood clot. Outcome of events was unknown.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Gullian-Barre Syndrome (received H1N1 vaccine 3 weeks prior to symptom onset).
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Other medical history: DM depression; "DM" (unspecified if ongoing), notes: Other medical history: DM depression. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No allergies were known of the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300151941 same reporter/patient, different product/AE;
Follow-up report on 2/4/03: History of Present Illness: The PT became ill with a nonspecific illness just before Christmas (appears to be of 2002). This illness is characterized by myalgias, fevers, headaches, and a somewhat productive cough. The PT has taken a variety of nonsteroidal pyretic agents including Advil, also Tylenol and his symptoms persisted. He came to the Emer. dept this morning and was found to have a temp of 103 deg's w/headache and painful neck that was uncomfortable in all directions of motion. While the PT's spinal fluid was being evaluated an add'l dose of dexamethasone 38 mg and vancomycin and Rocephin were administered. Spinal tap turned out to have no elevations of his white cells and a normal glucose and protein. The PT had given a history of a possible small pox immunization as well as possible Anthrax immunization.  Infectious diseases was consulted because of the possibility of a vaccine reaction as well as the consideration of an acute infectious process. The PT has a remarkably negative past medical history. He was once treated for tonsillitis. He has been treated for Helicobacter pylori in the past. He has had a tonsillectomy as a youngster. The PT has some diffuse myalgias w/out localization of any particular joints.
About 2 AM all of the muscles in my arms, legs and torso started twitching.  This continued until about 5 AM, at which time I dozed off.  When I woke up (about 7:30 AM), I noticed that all of the twitching had stopped.  It never returned.
Arm has been with pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter had stated that, the patient he/she had one of the 2 vaccines but his/her arm had been with pain.  The reporter had asked if your arm was hurt or not. Additional supportive information: Follow-up would not possible as no contact details were available.
diarrhea; Severe joint pain in knees; lower back pain kidney area; kidney pain; pain in his thigh muscles and buttocks; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot number: EN6205) via an unspecified route of administration on 10Mar2021 at 02:00 pm on the left arm as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications patient received within 2 weeks of vaccination included : Lisinipril, coreg hydrocodone, Cialis and sertraline. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. On 10Mar2021, at 09 30 pm, the patient experienced severe joint pain in knees, lower back pain and kidney area. The caller also stated that he experienced severe pain in his thigh muscles and buttocks. He had terrible pain in his knees. He also had pain in his kidneys for 4 days. The patient took Meloxicam for inflammation, Hydrocodone for pain and Flexeril for a muscle relaxer. The caller stated that he can deal with his muscle and joint pain but is concern was about the kidney pain and he didnot want kidney failure. The caller stated that he also had diarrhea on the 5th and 6th days. The caller stated that he was scheduled to get the second shot tomorrow. caller has read that the second dose was worst than the first. The caller stated that he doesn't know whether he should get the second dose and his doctor advised him to speak with Pfizer or where he received the first vaccine or to go to the emergency room. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
pt recvd vax & ran a T; apap given; pt had convuls & shake; pt seen by ped;
When I was admitted to the hospital on December 24, 2021 I was into my 9th day of having covid and running a fever of 103.5 however the hospital registered it as 104 .  X ray taken of lungs indicating I had viral pneumonia.  I was then given remdesivir and steroids.  I was released on Dec. 30, 2020.  My initial injection was on March 14, 2021  over 90 days from the onset of the virus.  My second shot was given on April 4, 2021.  Both times I ran a fever of over 103.  From that point on I had not felt well.  Now five months later I have been diagnosed with autoimmune hemolytic anmeia
sensation as injection was moving thru body-down left arm and across shoulder blade- till in evening -up neck, flushing of face-left side of  tongue tingling, general heat from body, alternate with chills,  lymph node behind left ear very sensitive, 2nd day sore developed in front of left ear and on top of left side of tongue and under tongue, still first day symptoms, 3rd day sores continue half way to lip in a line, still  all other symptoms- 4th day- line of sores is to mouth and on chin of only left side mouth has numerous small blisters- gums, cheek, still other symptoms. 5th day worse on sores - diagnosed with Shingles
Huge red rash on arm with raised edges. Appeared within days of receiving the vaccine. After 2 weeks, it appears to be getting/have gotten larger.
received first dose in 20Jan2021/not received the second dose yet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose in 20Jan2021/not received the second dose yet) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose in 20Jan2021/not received the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose in 20Jan2021/not received the second dose yet) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided by the reporter.
Next day. facial swelling, Lf. side facial swelling, head congestion, blurred , double vision, dizziness. Took OTC meds. Seen by VA 23rd. Placed on Amox, decongestants, warm clothes. Improved. Still has some blurred vision.
Fever 102+, headache, stomache ache, ear ache, body and muscle pain, skin hurt, chills, muscle pain
5 min p/DTP was administered, pt was weak, limp, & pale; pt stated she wasn't feeling well; MD available to assess pt; pt skin warm & dry; color good; VS WNL; pt vomited white substance which mom felt pineapple from lunch; Eval by MD advise