chrisvoncsefalvay/vaers-outcomes huggingface dataset:
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible.  a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
@ site of inj: inflammation, blisters of varying size & 1cm firm nodule;starting p/inj given w/new blisters developing up until last office visit of 21FEB97;rx Eryped;
This spontaneous report was received from a pharmacist via company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and exp. date were not reported). On an unknown date, the patient experienced hard lump at the injection site, it was reported that the hard lump started at the injection site but moved toward the inner part of the patient's arm (the date was not reported). The patient sought medical attention and called the pharmacy. The outcome of the events was not reported. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
Report received from a pharmacist on 20-SEP-2010 (received via Merck, WAES: 1009USA04048). A 56 year old female patient received 0.5ml of AFLURIA (batch M50907, expiry 30-JUN-2011) for vaccination on 10-SEP-2010. The patient had a medical history of cancer. The patient had no concomitant medications. On 9-SEP-2010, the same day as vaccination, the patient developed severe pain, warmth and swelling at the injection site. The patient even complained of severe pain during the administration. The patient could not move her arm for 3 days. The patient sought medical attention. The event outcome was recovered on 16-SEP-2010. The reporter did not give an assessment of seriousness or causality. The company considered the case to be not serious. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow-up received 16-NOV-2010. Lot number was changed to 09949121B (EXPIRY 15-JUL-2011) and date of recovery changed to 14-SEP-2010 as per new source data from reporter. Time of AFLURIA administration (15:00) also added.
One of the pre-drawn syringes malfunctioned at administration of the vaccine.  Unknown amount leaked out of the syringe at injection.  It was explained to the patient since he may have not received the complete dose it would be recommended to repeat the vaccine at which time the patient refused.
Developed a rash on face and neck from the Pfizer booster shot within 15 hours of the vaccination. The rash started out on the right side of my face and neck, and moved to the left side throughout the day.
Chronic spontaneous urticaria beginning on October 20th, 2021. Outbreaks of hives/itching/swelling occur on various areas of the body with the most prevalent sites being the lower legs, eyes/lips/ears, wrists, and upper back. Episodes usually resolve within 20 minutes of taking an allergy medication such as Zyrtec. No triggers have been identified.  Dermatology visit 1: November 5th, 2021; recommendation to switch to sensitive skin products (lotions, detergents, etc..) and begin taking over the counter Claritin 3x/day, Benadryl as needed Primary Care Provider Visit: November 11th, 2021; switch from Claritin to Zyrtec, add hydroxyzine 10mg as needed Dermatology visit 2: January 5th, 2022; continue Zyrtec/hydroxyzine/benadryl, labs ordered, refer to allergist
fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 51-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Oct-2023, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN in October 2023 at a dose of 500 milligram twice a day. At the time of the report, PYREXIA (fever) and HEADACHE (headache) had resolved.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   Concomitant medications were not reported.  Patient had Grade 1 headache on Day 3. Resolved Day 4.  Patient received Acetaminophen on day 2.
Injection site swelled and over time increased in size and spread. Patient went to PCP and diagnosis of cellulitis. Patient given antibiotic and is recovering.
A report was received from a nurse on 10/02/2001, concerning a 67 year old female patient (hl) who experienced redness and swelling at the injection site and flu-like symptoms including fever, malaise and nausea on 09/22/2001 after receiving an IM injection of Fluvirin 0.5ml at the right deltoid area on 09/21/2001. The patient was treated symptomatically with Tylenol and her current condition was described as better at the time of reporting.  It is unknown whether the patient has received any prior influenza vaccination. The reporter has assess the relationship of study medication to the event probable. See PJP-2001-00295 and PJP-2001-00298.
states 40 minutes after her vaccine she developed facial parasthesias and  numbness that eventually resulted in an "ache".  No muscle weakness.  This has since improved.
Symptoms began around 12pm on June 9th: lethargic, headache, chills, fever Symptoms mostly gone morning of June 11th
12/18 arm soreness, sunday was nothing too worrisome and on Tuesday I started feeling lethargy, muscle soreness. 22nd  I went to the urgent care where I was given a rapid covid test was positive and then the longer wait test was also positive two days later
Information has been received from a physician concerning a patient who on approximately 30-JUL-2006 was vaccinated with a first dose of Vaqta. Concomitant vaccination on the same day included a first dose of Recombivax HB (manufacturer unknown). On 30-AUG-2006 it was reported that the patient was vaccinated "one month ago" and then performed liver function test. The patient had positive hepatitis A IgM and borderline liver enzyme (ALT) elevations. The patient sought unspecified medical attention. There was no product quality complaint involved. No further information is available.
Patient given peds dose of orange top Pfizer 0.2mL. Patient is 12 years old and should have received 0.3mL of gray top Pfizer.
This spontaneous report was received from a consumer referring to an unspecified number of children of unknown ages and genders. No concurrent or historical conditions were reported. The reporting consumer stated that GARDASIL was making lots of children sick and dying. The reporter stated that her granddaughter got really sick just after her doctor gave her the vaccine, she considered that this was not a good drug and that the vaccine was not safe (reported on MARRS case # 1603USA002754). The reporter considered the adverse events were related to GARDASIL. This is one of two reports received from the same source. Additional information is not expected, because no contact details were provided.
I received the Moderna booster on 11/15 at 3:30pm. On the evening of 11/16 I experienced muscle aches, fever and chills which lasted 8 hrs. I took ibuprofen on 11/17 to help with the muscled aches and pain that I was still having. On the morning of 11/18 I could not get out of bed due to severe vertigo and nausea. Stayed in bed all day as I could not walk and could barely function. I have never experienced anything like this and I'm certain it is related to the vaccine.  The following morning, 11/19, I was taken to an urgent care facility and upon exam there, was directed to the emergency department. I was experiencing symptoms of a stroke.  I am a healthy, active 64 year and this is frustrating. The medications are not working and I am still struggling to walk.
Red, itchy rash on arm 2 days after injection Very sore arm 1 day after injection and slightly swollen arm at injection site   A feeling of heaviness in the arm  Some Nausea  3 days after injection
I don't know if this is related, but reporting just in case. I began losing hearing in my left ear about 2 weeks after receiving my first shot. When it continued to get worse, I went to the dr about 3 weeks after my first shot and was diagnosed with labyrinthitis. My symptoms continued to worsen, and I now have severe hearing loss as well as 75% loss of vestibular function (diagnosed by ENT and audiologist) with constant vertigo. My current diagnosis is labyrinthitis, however I'm also getting an MRI in 2 days to rule out other possibilities.
Waited at the vaccine location 30 minutes and felt fine, driving home started to feel tingling and numbness on lips, face, face was puffy, mouth was dry, hard to swallow. Went to Medical Center as it was closest to home. This was about 1 hour after the shot was received. My chest was feeling tight when I arrived at the hospital and started with a slight headache.They checked my vitals BP was 146/91, pulse was 107, SPO2 was 98, temperature was 97.9. They gave me 2 Benadryl pills and had me stay in a room. After a few hours my vitals returned to normal and I was feeling better. They kept me a few more hours to make sure the symptoms did not return. I was discharged with a prescription for benadryl and zyrtec to take as needed. Only took the Benadryl that evening and the next morning with Tylenol. My arm was sore the next day but felt fine.
Mild case of CP. Area on right thigh is red, firm, & warm to touch. Dx: B01.9 - Varicella without complication       L03.112 - Cellulitis of right upper extremity T80.90XA - Injection site Reaction.
Two weeks post vax, pt experienced an injection site reaction with redness, swelling and tenderness. No further information is available.
BPM resting- 95; average is 67; Joint ache especially lower back; Toothache; Fatigue; Headache; Rash post 2 days
Patient initially signed up and requested Pfizer vaccine.  The COVID clinic was held outdoors on May 1, 2021 and had 1 interpreter to help with communication.   During this time there was several other patients getting Janssen and in the mix of interpreters and vaccination counseling to offer Janssen versus Pfizer for 1 dose or 2 dose series..  Janssen was administered inadvertently and wasn't caught until after immunization and didn't update the COVID19 Vaccination card, and wasn't able to contact the participant with the interpreter.  Monday June 7, the pharmacy was informed that the patient tried to get their second dose of Pfizer elsewhere.  On Tuesday June 8, spoke with the interpreter after validating the incident and double checking waste dosage for that day.  It was confirmed the patient did get the Janssen COVID vaccine versus Pfizer.  Mailed out CDC COVID card to patient with address on file.
I have 101 fever, it was oral thermometer; I feel absolutely awful; Chills; Bodyaches; Nausea to the extreme I am in bed; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced fever, feels awful, chills, general body pain and nausea. On an unknown date, the outcome of the fever, feels awful, chills, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, feels awful, chills, general body pain and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-May-2022 Reporter's Comments: The patient self-reported this case. The patient had the second Shingrix vaccine a day before reporting in the afternoon and had 101 degree F fever and felt absolutely awful, the patient wanted to know if he/she needed to go to the hospital. The patient experienced nausea, chills, body aches to the extreme was in bed and fever, and asked if he/she should take an extra strength Tylenol or would this go away by next day. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR074314:Same reporter. Hearsay case.
Tiredness Headache Muscle and joints pain Chills Fever 100.8F
On the morning of the 8th day after getting my first shot I noticed my deltoid muscle of my left arm (the arm where I received the shot) was swollen and mildly sore. It was also periodically itchy throughout the day. I put ice on the arm but did not use any OTC medications to treat it. The next day the location was still swollen and sore and itchy but there was also a small rectangular rash. The day after that the swelling at the location was gone as was the rash. It is still periodically itchy but infrequently and for shorter periods than initially
local tenderness over deltoid w/in hrs followed by progressive prostration, fever to 103, chills, arthralgias, myalgias; seen in ER w/t102.8; inc ESR to 118;
stiffness; pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE PAIN (pain at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with ARNICA MONTANA (ARNICA (PLANTA TOTA) "WELEDA") for Pain in arm, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        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.    This case was linked to US-MODERNATX, INC.-MOD-2021-080157 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080157:2 nd dose of vaccine
This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient developed rash after receiving ZOSTAVAX. The outcome of rash was unknown. Additional information has been requested.
Lt. upper thigh red and warm to touch beginning day after imm. Decreased erythema on exam 07/10/13, but (+) firm near site. Afebrile. 6 cm x 4 cm area of (erythema). (Mod. localized imm. reaction). Tx with PRN children's BENADRYL, ADVIL and ice pks.
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-297493, MOD-2021-297494 (Patient Link).
fever; muscle pain; bone pain; chills; She might have infected of COVID-19; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration on 19May2021 (at the age of 70-year-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She was vaccinated on 19May2021 and next day on 20May2021 she experienced fever, muscle pain, bone pain, chills and basically all the symptoms described on information she was provided with. All symptoms persist after a week of vaccination except for the fever. She might have infected of COVID-19 and not knowing since she has all symptoms. Outcome of event fever was recovered in May2021, for COVID-19 was unknown, for other events was not recovered.  Follow-up attempts completed. No further information expected.
11 doses administered from a cracked vial; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (11 doses administered from a cracked vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 22M20A) 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 03-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (11 doses administered from a cracked vial). On 03-Mar-2021, POOR QUALITY PRODUCT ADMINISTERED (11 doses administered from a cracked vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Report concerns 11 patients (age and gender unspecified). No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: The reporter confirmed that no patient identifiers could be provided.
A nurse reported the occurrence of an injection site reaction in an 18 month old female who was vaccinated with Infanrix for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not specified. On an unspecified date, the subject received her fourth injection of Infanrix (572A2). Within 12 hrs post-immunization, the subject developed an injection site reaction characterized by "normal" tenderness, redness, and swelling. The injection site reaction resolved within 72 hrs. The nurse reported the injection site reaction was possibly related to Infanrix administration. This report has been linked to report A0382174A due to same reporter.
Case previously recorded as MA2009-4588. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. Reference no: NA09-008308.
Patient states that felt like throat was closing and had difficulty breathing, went to Mercy Ambulatory Care Center where she was given IV Benadryl and Steriods
w/in 2-3min pt reported being  faint p/vax;pale;BP 120/70, 118/68;hand arms, legs & feet kinetic;
pt to ED after a witnessed seizure at home; encephalopathic and hypoxic; O2 supplementation; CT of chest showed PE; pneumonia; AKI; transferred to ICU; given heparin; pt's condition worsened; recurrent seizures; transitioned to DNR/DNI, comfort measures; transferred GIP hospice where she passed away
Within 5 minutes of receiving the vaccine, I experienced extreme dizziness. This dizziness lasted for 2 days. The following day I felt extreme fatigue, body aches and arm soreness at the injection site in addition to the dizziness.  Exactly 7 days later on 3/13/21 (after my initial side effects had resolved), my left arm began to itch painfully and intensely. The itch began on my left wrist and by the end of the day, the itchy spot on my wrist had progressed to itchiness on the majority of my left arm. It's not very visibly red, but it's incredibly itchy and painful, like fiberglass under my skin. The itch is not obviously localized to the injection site but is on the same arm as the injection and nowhere else on my body. It has lasted for 24 hours, and I currently still have it today (3/14/21). I have taken antihistamines and NSAIDs and applied cortisone cream, but it is still very, very uncomfortable. It kept waking me up while I slept during the night. I am wondering if this could be "COVID arm."
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M006708 and expiration date 02-JUN-2018, lot # L033343 and expiration date 13-SEP-2017, exact doses and route of administration were not reported. It was reported that the vaccines were exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported.  This is one of the several reports received from the same source. Additional information has been requested.