chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot knot, bruised, 3.5 to 4 inches, throbs, - took 2-3 days for hot knot to go away, and 5 days for the everything else to subside.
Patient was given a 0.25mL booster of Moderna instead of the age appropriate booster for Pfizer 5-11 year-old vaccine. We did not have any Pfizer in stock, and mother was insistent on the patient getting the vaccine that day. She did not have a reaction immediately after receiving the vaccine. For the next two days mother reported that she was very tired and slept for almost 2 days, was dizzy, and slightly feverish. Since then she has not reported any side-effects and seems to be doing fine.
Covid arm; Arm hurts him something terrible; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid arm) and PAIN IN EXTREMITY (Arm hurts him something terrible) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid arm) and PAIN IN EXTREMITY (Arm hurts him something terrible).            This case was linked to US-MODERNATX, INC.-MOD-2021-067368 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067368:cross linked case
Patient presented to ED with confusion, found to have GI bleed and COVID, still inpatient.
red, swollen right deltoid; red, swollen right deltoid; red, swollen right deltoid; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old patient who experienced red, swollen right deltoid, while he/she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W (MENINGOCOCCAL VACCINE A/C/Y/W); HEPATITIS A VACCINE (HEPATITIS A); and HPV VACCINE (HPV VACCINE) for Immunisation.  On 10-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot: U6321AA, expiry date: 07-Jun-2021) via intramuscular route in the right deltoid.  On 12-Sep-2019, the patient had red, swollen right deltoid (vaccination site inflammation, vaccination site swelling and vaccination site erythema) two days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Lab data was not reported.  Final diagnosis was red, swollen right deltoid.   The patient was treated with and Tylenol (acetaminophen).  The patient outcome was not reported (unknown).  List of document held by sender: none.
Mom reported to us that her daughter woke with a fever of 101.5 axillary in the middle of the night.  Mom also noticed jerking of arms and legs of and on throughout the night.  She had an episode of staring also where she wouldn't respond.  She vomited once, and had an episode of urinary incontinence.  She does have history of nocturnal eneuresis.  By the next morning she was back to her normal self, except for a persistent fever.  Mom telephoned us, but she was not seen and evaluated.
Chills; High fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on an unspecified anatomical site on 16Mar2021 (at the age of 33-years-old) as unknown, single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. There was no treatment given for the events. There was no known allergies and no allergies to medications, food, or other products. On 16Mar2021 at 22:00, the patient experienced chills, high fever and headache. No therapeutic measures were taken for the events chills, high fever and headache. The clinical outcome of the events chills, high fever and headache were recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information. Reporter details, patient age, suspect vaccine indication updated, events treatment and other clinical information.
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). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Microscopic colitis" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19.  Clinical course: There were no other medications received in two weeks prior to COVID-19 vaccination. The patient received COVID-19 treatment with Paxlovid in Aug2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with HAVRIX, (GlaxoSmithKline).  Concurrent medications included METHOTREXATE.  On an unspecified date, the subject received 1st dose of HAVRIX (unknown).  Three weeks after vaccination with HAVRIX, the subject experienced not responding to therapy.  She experienced a negative antibody titer three weeks after one dose of HAVRIX was administered.  Relevant test results included (laboratory results/hospital investigations).
Skin peeling; Swelling; Skin discoloration; Localised rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin peeling), SWELLING (Swelling), SKIN DISCOLOURATION (Skin discoloration) and RASH (Localised rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB for Dermatitis atopic.    No Medical History information was reported.   In September 2019, the patient started DUPILUMAB (Subcutaneous) 300 milligram. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (Skin peeling), SWELLING (Swelling), SKIN DISCOLOURATION (Skin discoloration) and RASH (Localised rash). At the time of the report, SKIN EXFOLIATION (Skin peeling) had not resolved, SWELLING (Swelling) and RASH (Localised rash) outcome was unknown and SKIN DISCOLOURATION (Skin discoloration) had resolved.            No treatment medication was reported. Concomitant medication list was not provided.
Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown.  No product quality  complaint was involved.  Additional information has been requested.
Severe pain & swelling at site, headache, muscular aching all over body, lethargy.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of GARDASIL (dose, route, lot and expiration date were not reported) that were exposed to 52F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Patient was under 65 years old and received Fluad for 65 and older. Patient requested the vaccine because of a medical condition lowering her immunity. This was discovered about 1 year after the event because the patient was looking for "the same shot I got last year". After stating she wants the high dose shot because of her disease. Patient did not report any issues or adverse events associated with getting the vaccine.
Patient was given first Pfizer dose on 4/24/21 and asked at the time if he had received any other Covid vaccine doses reported that he had not.  When he returned for his second Pfizer dose on 5/25/21, documentation was found in his chart that he had received Janssen from a pharmacy on 3/10/21.  On 4/24/21, the Janssen dose was still not in his chart.  The second Pfizer dose was held and not given on 5/25/21.
Severe Bruising at injection site and left leg; Severe Bruising at injection site and left leg; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Severe Bruising at injection site and left leg) and CONTUSION (Severe Bruising at injection site and left leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Severe Bruising at injection site and left leg) and CONTUSION (Severe Bruising at injection site and left leg). At the time of the report, VACCINATION SITE BRUISING (Severe Bruising at injection site and left leg) and CONTUSION (Severe Bruising at injection site and left leg) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) Patient had her blood investigation done and  they were awaiting for the result.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR added. Disconnected call without providing any information.
This case was reported by a pharmacist and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site lump and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump and injection site itching to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a manufacturer. The age at vaccination was not reported. The healthcare professional (HCP) states patient had injection site redness, swelling, rounded, and itching. The HCP was contacted on the reporting date, and was asked if second dose site reactions were to be expected and had any recommendations on vaccine timing available.
Fever, Chills, General Aches, joints, muscles.....head congestion, runny nose
4/1 ? Ear started hurting, headache, and tired 4/3 ? ER visit due to face drooping ? Bells Palsy diagnoses ? RX ? Prednisone and Valcyclovir 4/4 ? Ear hurting, notices that drinking is difficult as liquid won?t stay in mouth.  Using Visine as eye won?t blink properly and while showering he gets soap in his eye because he can?t shut it all the way.  4/? Followed up with doctor.  Advised not to get second shot. 4/?  Symptoms have corrected themselves.
This patient received her initial vaccines as scheduled at 2 mo of age. She did have fever and congestion within the first 48 hours after receiving the vaccines. Approximately 4 days after receiving the vaccines, she developed frequent watery stools and vomiting. The patient was taken to the Emergency Center by her parents and subsequently admitted to the pediatrics floor. Diagnosis severe dehydration;gastroenteritis due to Rotavirus vaccine. Labs indicated hyponatremia, hyperkalemia associated with severe metabolic acidosis.
H1N1 vaccine 9-23-09 about 2 weeks later came down with the flu. Was very sick I lost my ability to go to sleep. It never returned will be 8 years in Oct 2017!! The sleep disorder I developed is deadly without sleep medication and is very debilitating. I developed some rare freak sleep disorder that has almost killed me on more than one occasion-It began in Oct 2009 and I have desperately been looking for answers ever since. No one seemed to be able to help me. I was finally able to put a huge piece of the puzzle together about 6 months ago when I was reading through my diary which I noted my flu vac. date and when I came down with the flu as well as like a switch my ability to sleep was turned off-literally overnight and was never to return!!! All in Oct 2009-I read about the 800 children in another country who developed narcolepsy from the H1N1 flu vaccine. I developed the opposite of that: I can NEVER go to sleep-I have been to countless Doctors and on countless medications for this problem for almost 8 years now!! My life has never been the same and my Doctor says I will need to be on sleep medications the rest of my life. I am currently on 60 mg temazepam every night. I have been on 10 mg SILENOR the temazepam since 2011. That gives me some quality of life however I went from a 9-10 hrs a night sleeper to 5 hrs (Average) per night. This is a very debilitating sleep disorder that I probably should not have survived. I hope and pray that someone can shed some light on this horrible disorder and maybe save someone else from having to go through what I have and still am going through.
12d post vaccination (MMR/VAR/HAV/INL) developed erythematous maculopapular rash mostly face/arms/legs - pruritic sore very discretely umbilicated/scabbed.
Low back pain -> radiated to buttocks and down both legs, calf and to toes. 5-days of pain. Self-treated w/ Ketoprofen.
Rash on upper arm.  Painful, hot about 8"x4.   Platelets dropped to 66K down from 99K
Patient reported she presented to MC Immunizations clinic on 7 December to receive her seasonal influenza vaccine and was offered the Zoster vaccine given her age. She indicated she was not questioned regarding which medications she is taking, but stated she was shown a list of medications which would be a contraindication to receiving the vaccine (including Enbrel and Prednisone) after she received the vaccine. She complained of onset of a dull, bitemporal headache the morning of 8 December but denied photophobia, nausea/vomiting, neck stiffness, and fever/chills. She also complained of redness, swelling, and itching affecting the site where she received the Zoster vaccine (examination revealed a 50x60mm area of erythema, induration, and warmth at the vaccination site). She denied rash. She is currently taking Prednisone 1mg daily and Enbrel 50mg weekly.
Circumstance or information capable of leading to medication error; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a male who was vaccinated with varicella vaccine. The nurse reported that subsequently the pt had come down with chicken pox although he did receive varicella vaccine. The nurse also reported that several of the pt's classmates developed chicken pox post vaccination with varicella vaccine. No further info is available.
I had received a flu shot on October 13. A few days later, I started having symptoms for what turned out to be COVID-19 (sore throat on ~10/17, followed by runny nose; first positive test ~10/20). This would be considered a breakthrough case given my COVID vaccinations on 4/6/21, 4/30/21, 11/12/21, and 9/12/22. Given that I was barely a month past my latest COVID booster vaccination date, healthcare professionals said it was unexpected that I suffered from COVID, and recommended I report this in case the flu vaccine somehow makes immune systems temporarily more susceptible to developing sickness from exposure to other pathogens.
Fever; headache; Body ache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, headache and body aches.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient began to have a fever, headache and body aches. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fever, headache and body aches was unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS expected fever, headaches, myalgia. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
This spontaneous report was received from a pharmacist referring to three patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 01-FEB-2017 and 11-FEB-2017, 2 patients and 1 patient were vaccinated respectively with an improperly stored dose of PNEUMOVAX 23 lot # M040804, expiration date 20-MAY-2018 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered doses of PNEUMOVAX 23 were exposed to a temperature excursion of >8°C but <25°C (>46°F but <77°F) for 10 hours. Data logger was involved. There were previous excursions reported as follows: >8°C but <25°C (>46°F but <77°F) for 10 hours. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007980: US-009507513-1703USA002298: US-009507513-1703USA002300.
Patient complained of chest tightness, Shortness of breath, nausea, dizziness.
Pt recvd 2 doses of Engerix-B & 2 hrs p/2nd dose exp h/a, dizziness, flu sx, nausea, vomiting, diarrhea, neck & back pain, somnolence, tachycardia & palpitation;
Initial flu shot had shooting pain down back of left upper arm, pain not improve for a month, worse with lifting left arm.
This spontaneous report was received from a 78 year old female patient with multiple allergies reporting on herself. In approximately December 2015, reported as 1 month ago, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular into the patient's left upper arm (lot number and expiration date were not provided). Concomitant therapy information was not provided. In approximately December 2015, the patient experienced a terrible drug hypersensitivity to PNEUMOVAX 23. 5 hours after the administration of PNEUMOVAX 23, the patient experience nausea and body-shaking. The next day, on an unknown date in December 2015, the patient felt ill and her left upper arm became red, hot and swollen. It was also difficult to raise her left arm. The patient called the doctor's office and was advised to be evaluated at a local urgent care facility. The patient did not go to the facility because she felt too sick to get out of bed. No treatment was given to the patient. There were no laboratory diagnostics studies performed. The patient inquired about the ingredients on the vaccine she might have reacted to, so she could add them to her allergy list. The symptoms gradually improved and resolved within 3 days (in approximately December 2015). The patient considered the event as related to the PNEUMOVAX 23. Additional information is not expected. There was no authorization to contact physician.