chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1:30 in the morning of Friday June 29th, 2018, I awoke with severe body shaking and chills and nausea. Did not know what was going on. My son rushed me to the ER in town, and the nurse and doctor there gave me warm blankets, and took 5 vials of blood. I suddenly threw up before they could give me some nausea meds. Took my temperature and it was 101.1 They then started an IV in case of what results came back, as well as give me a shot of meds for the nausea and a headache. Also gave me some TYLENOL for the fever and headache, but the TYLENOL did not seem like it was helping much. I did not throw up anymore, but still was groggy and I was dizzy and felt weak. Went home at 5 am to try to sleep. Did not feel myself all day Friday June 29, 2018. Finally felt somewhat better on Saturday June 30, 2018, but still not fully well. I have been experiencing diarrhea on Sunday night July 1, 2018 and all day Monday July 2, 2018.
Redness at back of left arm about 5 inches in length and 4 inches across, warm to the touch, sensitive to the touch, "felt bumpy" large hive in the center of the redness approximately 3" x 1 1/2".  Itching at site.  Discomfort and some swelling at axillary. Symptoms lasting until 03/17/2013 approximately 9:00. By morning on 3/18/2013. Redness began to lessen. Axillary became less tender.  Into HD on 03/18/2013. Pictures taken. Referred to PMD. if any further symptoms or if symptoms do not continue to decline.
I am reporting an incorrect injection of the Pfizer COVID vaccine. I received my first dose subcutaneously at a 45 degree angle rather than intramuscular as recommended. I have video evidence showing the improper injection. I brought this to the attention of the office manager at the location I received the vaccine who spoke with their head doctor and I was advised that they will not be reporting the incident. I currently have a red mark near the injection site that is approximately the size of a half dollar that is slightly swollen and feels ?hard.? I also have a sore arm, slight headache, and fatigue. I am concerned about potential side effects from the improper subcutaneous injection as well as the efficacy of my 1st dose. Also, I am concerned with how many others have been injected this way at this establishment by this tech, and hope that actions will be taken to make sure this doesn?t continue to happen there.
CLIENT REPORTS REDNESS AT INJECTION SITE X 2 DAYS POST VACCINE GIVEN 1-29-2021 AND PROGRESSIVELY SPREADING REDNESS AND POSITIVE ITCH TO LEFT UPPER ARM X 2-5-2021 .CLIENT SEEN AT PROVIDERS OFFICE 2-11-2021 AND PRESENTED WITH A LARGE AREA OF DEMARCATED VERY RED , RASH LEFT UPPER ARM, EXTENDING TO THE INNER ASPECT OF LEFT ARM, SKIN WARM TO TOUCH. CLIENT REPORTS NO PAIN AT INJECTION SITE . REDNESS MEASUREMENTS OF 8 INCHES LENGH X 8 INCHES IN DIAMETER WITH RAISED BORDERS. NO OTHER MAJOR ILL EFFECTS REPORTED BY CLIENT.
Mouth ulcers aka canker sores.. 1 on top lip and the other directly on uvula of throat both beginning day 2 after vaccine. Very painful to swallow and eat. Going on day 7 of ulcers. Throat ulcer has continued to get larger and more painful. Lip ulcer is beginning to heal.
A physician reported that a 42 year old female inadvertently received pneumococcal polyvalent and influenza virus, trivalent Types A & B vaccines mixed in the same syringe on 12/10/01 at a drug store clinic. Within a day of immunization, the pt developed a large, very painful injection site reaction characterized by redness, inflammation, induration and rash. She was prescribed unspecified antibiotics and NSAIDS. Additional information received from the physician on 1/11/02 indicated that 2 to 3 days, post vax, the pt "fully recovered".
Dose 1 just got a little red at site of injection & i was a little tired. (was received on 1/18/21 @ 9:30am)  Dose 2 it got red, hot & a lump at the site of injection. Also, had lump under armpit, was told it was lymphadenopathy, had moderate pain in lower back & mild pain in other joints, also developed fever of 99.4 (my normal temp is 97.4) & chills. This was mostly on the 1st & 2nd day after the vaccine. the swelling under armpit & in arm are better but not completely gone yet & it is now day 4 after the injection (injection on 2/8/21) (was received on 2/8/21 @ 10:37am)
1/4 started with a headache dull, 1/5 evening body aches started, headache continued, 1/6 all SX worsened and low grade fever started, 1/7 continued, arm was hurting, all other sx resolved, 1/8 are started itching red/hot/swollen, this is still the case today 1/13
Pregnant caller received both doses of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant caller received both doses of the Moderna vaccine) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 29-Jan-2021 and the estimated date of delivery was 05-Nov-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant caller received both doses of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant caller received both doses of the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pregnancy test: positive (Positive) Positive. On 01-Apr-2021, Ultrasound scan: normal (normal) Everything OKAY.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by patient.  This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.  Treatment of this event was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Updated Pregnancy Information - added prospective, pregnancy test, ultrasound scan, para to 0, birth type, fetal outcome; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Employee presented for Dose #1 Moderna injection for COVID 19.  Prior to injection, employee verbalized her anxiety and fear of the possible side effects of vaccine.  Employee received vaccine in R arm with no issues.  While in observation area, employee reported new onset headache and dizziness.  HX: reflux. No allergies. 0957 VS 143/73 HR 78 99%on room air 1003 143/71 HR 78 08% on room air 1017  141/71  HR 76 99% on room air (employee began to feel shaky and cold)  Warm linens and OJ provided 1038  112/57  HR 74 99% on room air. T 98.2 1045 121/57 HR 76 99% room air  Employee states shakiness has resolved.  Headache and dizziness have improved. Employee taken via wheelchair to valet where her daughter was awaiting to take her home.  Employee given VACCINE hotline number to call should her symptoms worsen or if she has further questions.
Initial numbness adjacent to his left eye.  Numbness on left side. occasional left foot numbness.  on clinical exam in the ER no significant findings. Patient refused lyme disease testing.  MRI shows no acute abnormalities. CBC and CMP within normal limts.
back stiffness; mid back pain; arm was pretty sore and swollen, around 10 cm,  right knee was more swollen and sore; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demographic who experienced back stiffness (Musculoskeletal stiffness), mid back pain (Back pain) and arm was pretty sore and swollen, around 10 cm,  right knee was more swollen and sore (inflammation), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included ACL tear in 1981, Chondrectomy in 2004 and Chondrectomy in 2007. The patient's past vaccination(s) included fluzone vaccine received on unknown date of 1994 and experienced swelling. Concomitant medication not reported.  On 22-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed back stiffness (musculoskeletal stiffness), mid back pain (back pain) and arm was pretty sore and swollen, around 10 cm, right knee more swollen and sore (inflammation) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that on the evening after vaccination patient arms was pretty sore and swollen which continued into the next two days. It was more swollen than it usually is with fluzone after every year vaccination since 1994. This resolved but following Monday patient noticed right knee swollen and sore and unusual mid back pain and stiffness. It worst on following day. After taking Ibuprofen, swelling resolved. Patient visited to orthopedist on Wednesday and received Mobic and after one dose the symptoms had largely resolved. He felt that the swelling didn't suggest Lyme or RA as there was no redness or warmth and that possibly early osteoarthritis due to an increase in activity. Also reported that overuse of opposite site is a possibility.  Details of lab data not reported.  Final diagnosis was arm was pretty sore and swollen, around 10 cm, right knee was more swollen and sore, mid back pain and back stiffness.   The patient was treated with IBUPROFEN (IBUPROFEN) and MELOXICAM (MOBIC).  On an unknown date, the patient had recovered from events.  Information on the batch number was requested.
Presented with acute left cerebellar stroke on 12/25/2021. Also tested positive for covid 19 on 12/20/2021 with out active respiratory symptoms.  Workup for eitology of stroke ongoing. Unclear if due to covid 19 infection.  Although less likely caused by  J&J  as got vaccine 6 months ago report filed for your evaluation
One 3-5 inch and one 2 inch redish patches on left leg. NO itching, NO pain. Rough skin.
This spontaneous report was received from a health care professional refers to a 21 year old female patient. Pertinent medical history and drug allergies: None. On 03-JUN-2015 the patient was vaccinated with first dose of GARDASIL intramuscular injection (lot # K011562; expiry: 08-APR-2017) (dose unspecified). Concomitant medications was reported as none. On 03-JUN-2015, the patient experienced vomiting and vasovagal response in the office immediately after administration of the GARDASIL. The patient recovered approximately in June 2015. No further information was provided. Causality assessment was not reported. Additional information has been requested.
This spontaneous report was received from a pharmacist and healthcare student concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided. The pharmacist reported that the aforementioned patient received the first dose of GARDASIL (strength, dose, route of administration, lot number and expiration date were not provided) and subsequently, on 06-JUN-2015 the patient was vaccinated with the second dose of GARDASIL (strength, dose, route of administration, lot number and expiration date were not provided), leading to an inappropriate schedule of vaccine administered. No adverse events or product quality complaints were reported. Additional information has been requested.
Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022; expired vaccine was given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was given) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was given) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 but moved from freezer to refrigerator on 08-Apr-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was reported that, affected vials did not experience temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-539457, MOD-2022-539467.
Ongoing pain in teeth, ear, head, neck, shoulders, mostly centered on left side of body.  First shot was in left arm. Second shot in right arm.  Previously, I have never had TMJ or bruxism issues, both of which have been diagnosed in the past two months and seem to have resulted from the post-vaccine pain. My GP prescribed anti-inflammatory pills that have helped to some extent with the neck pain and helped diminish the clenching. The original post-vax pain continues unabated, now three months later.
She did not have any bad reactions to the previous COVID-19 vaccines other than soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tetanus toxoid (Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid.), for immunisation, reaction(s): "Allergies". The following information was reported: PAIN (non-serious), outcome "unknown", described as "She did not have any bad reactions to the previous COVID-19 vaccines other than soreness".  Additional information: The female patient wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and how often elderly female patients experienced side effects. Caller mentioned that her doctor recommended her to get it. Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. She reacted before to Tetanus toxoid. There's other vaccines she cannot take because they contain the diphtheria toxoid. No other product names provided. She wanted to confirm if the vaccine is still being studied and under emergency use. Pfizer's 4th vaccine shot, the COVID-19 vaccine, the latest vaccine for the Omicron. She wanted to know what are the adverse. She was 82 years old and was leery of taking this vaccine. She worked as a medical secretary. She had a hard time hearing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300088187 same patient/event, different vaccine dose;US-PFIZER INC-202300088188 same patient/event, different vaccine dose;
Severe urticartial rash  thigh rubale  baby but not at nite of vaccination. Meconium 1mg adm IM, Benadryl 12.5mg adm  IM.
I had fever, weakness, joint pain, coughing, and fatigue. I had to stay in bed for 2 or 3 days. I could not eat. These lasted for about 20 days but the coughing I had for about 2 months. I went to my doctor about this. They did a Covid-19 and Flu test, negative results.
Parent states child had low grade fever on 2/3/06 & 2/4/06; very irritable; cheeks on face were bright red, raised, puffy on 2/6/06. Developed 2 small red bumps at vaccine site on right thigh on 2/6/06. Then became 1 larger one with a scab.
Fever 103.4 chills  129 Bpm at rest raspy breathing  tiredness  nausea  symptoms with fever high heart rate lasted through 7/21/21
This spontaneous report was received from a consumer(patient's mother) regarding a 23 year old female patient. The patient was not pregnant. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. The patient received her first vaccination of VARIVAX (by subcutaneous route, exact dose and frequency not reported) on 20-JAN-1999 and then a second booster of VARIVAX (by subcutaneous route, exact dose and frequency not reported) on 26-NOV-2008. On an unknown date, the patient experienced an adverse event with VARIVAX.  During a recent (exact date unknown) pre-employment physical her prospective employer asked if she needed to be re-immunized with VARIVAX due to undetected titers(antibody test negative). The patient did not sought medical attention. She did not receive any treatment for the events. The consumer asked how often re-immunization is necessary. The outcome of the events were considered to be unknown. Causality assessment was not provided. Additional information has been requested.
Patient received his COVID vaccines as indicated in #17. He had a positive test for COVID on 7-22-2021. He developed MRSA in his lungs while in the hospital. Died from his disease process on 8-9-2021.  Break through death Patient received 2 doses of Moderna vaccine 1-27-21 and 2-25-21. On July 22, 2021 was symptomatic for COVID and his COVID test was positive. He was oxygen dependent due to COPD. Other than that I don't know much about this man. He was hospitalized and died 8-9-2021 from COVID-19.
Received vaccine on 12/26/2020.  On 1/5/2021, developed chills, and significant joint and body pain that decreased his movement.  Saw his physician on 1/9/2021, had numerous lab tests done, Covid negative.  Doctor believes the vaccine caused a previously diagnosed autoimmune disease to flare up.  Still has significant pain today, 1/11/2021.
A female consumer reported that she received a dose of influenza virus vaccine, trivalent, types A & B in 1999. Medical history included allergy to sulfonamides. Subsequent to immunization, she experienced soreness at the injection site oh her arm, which lasted 1-2 days. The caller reported she had the same reaction she after she received the influenza virus vaccine in 1998, 2000 and 2001. No further information was available at the date of this report.
Indurated, pruritic, red rash entire left arm (same arm injected with IIV) and then extending onto chest, scratchy throat starting minutes after shot and resolving with diphenhydramine, decadron.
Dx: brachial plexitis. Reaction started 3 days after shot. Developed pain in L. shoulder/arm w/ numbness tingling into hand - taking ALEVE and had Prednisone later.
Patient received 1.0ml of the Moderna COVID19 vaccine instead of 0.5ml.
after the first vaccine I has extreme pain in opposite armpit of vaccine site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 13:15 (Lot number: ER8737) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: AXILLARY PAIN (non-serious), outcome "unknown", described as "after the first vaccine I has extreme pain in opposite armpit of vaccine site.".  No follow-up attempts are possible. No further information is expected.
Patient was hospitalized for gastroenteritis and adrenal crisis.  Thought to be unlikely related to vaccin2 given two months prior.
10/19/2006 pt called c/o arm right sore. Advised pt to put ice on arm and take her normal pain relief med. Pt to call Monday 23rd if not better.
SHORTNESS OF BREATH; COUGHING; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced shortness of breath. On 28-MAY-2021, the subject experienced coughing. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and coughing on 06-JUN-2021. This report was non-serious.
Neurological symptoms: frequent migraines, dizziness, loss of balance, falls, neuropathy/numbness of limbs, vomiting, occasional slurring of speech, insomnia, occasional vision changes.
Shots didn't stop mine nope/suspected vaccination failure; didn't stop mine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that shots did not stop his/her, nope. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Breakthrough case admission after 2 vaccines Pfizer 3/12/21Lot# EN6206;  Pfizer 4/2/21 lot# ER8732
1. Day after injection, I had local reaction to upper arm of redness, inflammation and warmth to skin in more than 1 spot.  No treatment  2. The day after the injection, I woke up with a headache and vertigo.  Took Ibuprofen  for headache, no other treatment  3.  6 days later I noticed red bumps that then over the next few days turned into blisters. I was experiencing a right sided headache and sharp, shooting pains. On Saturday, 7/ 17/2021, I went and was diagnosed with shingles.  I was prescribed Valacyclovir 1gm TID for 7 days. ( however, nothing was given for pain or inflammation. On Monday, 07/19/21 I went to my pcp who again confirmed Shingles, and prescribed Gabapentin 300mg  BID for pain and Prednisone (tapered dose) for inflammation.
Fever, chills, headache and  swallen axillary lymphnodes. Pain and redness in left axillary area limited left arm and shoulder range of motion.  Tylenol and warm compress was used to provide comfort. Today a call is going out to the Dr. to provide any further instruction as today is day 3 and there is still quite a bit of axillary discomfort.