chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 3 hours of receiving vaccine: muscle aches, headache, chills, stiff and sore arm. Lasting through night into next day. No fever.  On a pain scale 1 - 10, pain was a 4 or 5. Im still within the 24 hour window, but didn?t expect side effects this strong. I?m reporting this so that you have data. My hunch is that for my body, the typical amount of vaccine was just too much.  This is true for me with other medications and anesthesia.
Approximately 8 hours after receiving the second dose, I noticed my forehead started to itch.   After looking into the mirror, I observed red dots all over my forehead.   I received the dosage on 12/27/21.  Today is 01/09/22, and I still have the itchiness and dots present on my face/forehead.  I have also noticed prolonged pain in my arm that this same dosage was received in.
I called patient 5/31/19 as she is on our list to receive her second dose of shingrix and she stated "I don't know if I want to get the second dose I had a really bad reaction the first time", when I inquired about the reaction patient stated that a few hours after injection she had severe arm pain at injection site and then started with body aches, chills and fever of 101. She says the arm pain lasted about 2 weeks and the area was hot to touch- she states she did not seek treatment. I never had any physical contact with patient- this conversation was over the phone-and I was not the clinician who administered the vaccine- history and vaccine details are based on documented chart.
Patient states approximately 5 minutes after her vaccination, she started to feel like her vision was slightly blurry, then experienced tunnel vision. Pt states felt almost like an "out of body" experience, but she did feel pressure to the left side of her head as she fell off of her chair and her head hit the floor. This fall was witnessed by another patient, who flagged the medical staff for help. A medical assistant notified me of the incident and I went to examine the patient, who was sitting on the floor, alert and conscious. I asked the staff to get the patient an ice pack, which was placed to patient's forehead and back of neck, and glass of water. Patient is able to swallow.   A&O x 3, HR 81 and O2 sat 98% on room air. EOMI, PERRLA. Auscultation of heart & lungs was normal. No bony step-offs palpated. No tenderness upon palpation to patient's head, face and neck/c-spine. No visible contusions, abrasions noted. Normal ROM of all extremities and normal sensation. Observed patient over the course of 15 minutes and patient states she is feeling much better.
Scratchy throat, temp of 101.7,, persistent cough, sniffles, fatigue ,chills. ,
Severe itching under arm and around shoulder blade.  Severe nerve pain in Breast.  Outbreak of Shingles began 10/8/2010 diagnosed at ER on 10/10/2010.
Rash above wrist. 10/21 red spots with white dots in center on palm of hand.
Redness, swelling, itching and hot in left arm the day after receiving flu vaccine (11/17/2016). BENADRYL OTC not helping.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media, concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple health problems. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient developed covid (before the booster) and ended up in hospital (hospitalized) for 6 days, but had no complications which was suspected covid-19 infection (Dose number in series: 1). It was reported that "My husband & I had the J and J vaccine plus booster and we had no side effects, My husband has multiple health problems and he developed Covid (before the booster) ended up in hospital 6 days but no complications and I had no sign of it in spite of caring for him for 2 days with no precautions We would take another J and J booster if it were available We will not take the other ones". The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 2 administered for covid-19 prophylaxis. No adverse events were reported following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000265517.; Sender's Comments: V0: 20230104841- suspected covid-19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
Headaches, severe joint pain with random stabbing pain, sustained fever, heavy sweating, red arm rash with swelling and inhibition of motion
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 72 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "radiation", stop date: 10Mar2023, notes: 6 weeks of radiation ended 10Mar2023; "Known allergies: milk" (unspecified if ongoing); "Known allergies: banana" (unspecified if ongoing); "Known allergies: adhesive tape" (unspecified if ongoing); "Known allergies: trout fish" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
I had nose bleed, vomiting headaches, fatigue, congestion, cough, nausea, joint pain, upset stomach, muscle weakness and a rash.
0701.   Since starting the COVID-19 vaccine program, the has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer's recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.  When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Two small hives on left side of neck, fatigue, headaches, body aches, increase in tachycardia symptoms, shortness of breath. Tachycardia was treated in ER with IV saline.
I got the pneumonia-adult shot in my left arm. It felt like my shoulder and arm was breaking in prices. The pain traveled to my left side of neck and down to my left leg/hip that it was very painful to even walk. I couldn't move my arm at all was extremely painful.
Admitted with DKA, resolved now, also tested positive for COVID-19; had acute respiratory failure with hypoxia and required high-flow oxygen, steroids and abx; received Actemra on 01/19; DC home on RA.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 14 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Post herpetic neuralgia; Multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 29-APR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for the prevention of shingles. After the vaccine, the pt suffered multiple outbreaks of herpes zoster, and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care.. As a direct and proximate result the patient symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experience mental and emotional distress due to resulting physical limitations and serious condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster reactivation and post herpetic neuralgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered herpes zoster reactivation and post herpetic neuralgia to be disabling events.
noticed a red cirlce around the area where I received the vaccine.  Does not hurt, no itch, no swelling. Just there and really red after shower for example.  Notice it when I work out as well.  It is more red when I am working out.  The shot was injected on my left arm.
pt recv vax 5NOV97 & over 6&7NOV97 pt exp erythema & induration of the upper arm;
This spontaneous report was received from a licensed practical nurse, referring to a 19 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 08-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L011846 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
19 year old client came in for 2nd  dose of Moderna covid vaccine. Client was checked  in appropriately, however during administration of vaccine, the health care provider administered 0.25ml Moderna,  covid-19 vaccine( 12+)  instead of 0.5ml Moderna COVIS-19 vaccine at 1115  The error was communicated to the patient appropriately. The patient was also offered another  dose of  moderna 0.25 ml to complete the required dosage for Moderna per MD order. Patient agreed to take another dosage of 0.25ml Modena covid vaccine at 1130. Patient tolerated both vaccines well. No adverse event during observation. Was submitted
Tachycardia with resting heart rate around 120-128bpm. Heart rate would increase to around 150bpm with minimal exertion, such as walking 30? to the bathroom. Tachycardia continued until approximately 33hours post-vaccine. My resting heart rate is still higher than my normal by about 15bpm and continue to have elevated heart rate with minimal exertion (around 120bpm after walking 30? to bathroom).  This is completely abnormal for me. A couple weeks ago I could walk 4 miles and my heart rate would never raise above 115bpm.  Other typical symptoms: Fever for 36 hours Chills for 12 hours Fatigue for 36 hours Headache for 36 hours
achiness  in her body; This is a spontaneous report from contactable other health professional (patient) Pfizer via Sales Representative. A female patient of an unspecified age received BNT162B2 (Pfizer COVID 19 vaccine, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for covid-19 immunisation. The patient had some achiness in her body after the second dose of the vaccine. Adds outside of that achiness, she felt fine. The patient recently received the second dose of the vaccine but was unsure of the exact date, time or the site. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Moderna nor the FDA have approved a 3rd Booster/Dose vaccine. So why then was my brother given a 3rd dose of Moderna?  He was immediately not feeling well and had abnormal unusual exhaustion and sleepiness. He started developing trouble breathing and his legs swell so bad. He went to the Emergency room on the 31st of August and they told him the vaccine had nothing to do with how he was feeling.  Yes, my brother has health issues. But why was he given a booster for Moderna that had NOT YET BEEN AUTHORIZED?  Not only that but we immediately reported the symptoms to his doctors who assured us it was normal for a few days.  My questions are, what is going to happen to my brother since he was given this accidental dose?
Information has been received from a physician concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (it's unspecified if it was the first or the second or the third dose) (lot# not reported). It was reported that the patient fainted when she was walking out of the doctor's office. No medical attention was sought. At the time of this report, the patient's condition had improved after stopping therapy. No further information is available.
Nausea, vomiting, headache, 4 inch circular rash with warmth, erythema and swelling at site. Pt was given ice pack, EMETROL and Fexofenadine.
administer pfizer vaccine without verifying expiration date given by our covid vaccine coordinator that was on the box. Had expiration date written of 06/06/2022. Patient did not have any reaction to vaccine.
Pruritis at vax site 6 bumps, raised area, in quarter-sized.
Information has been received from a physician concerning a 24 year old female with a history of sulfonamide allergy who on 13-NOV-2007 was IM vaccinated with her first dose of GARDASIL (lot number 659435/1265U). On 14-JAN-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot number 659435/1265U). On 29-APR-2008 the patient received her third dose of GARDASIL (lot number 660389/1968U) intramuscularly. Concomitant therapy included APRI. On 13-NOV-2007 the patient experienced injection site pain. On 14-JAN-2008 the patient experienced injection site pain. On 29-APR-2008 the patient experienced body aches, felt like she had the flu and barely slept overnight. The patient's body aches, flu-like symptoms and difficulty sleeping persisted. The patient sought medical attention by calling the office. The patient was told to drink fluids and take TYLENOL. The patient missed work due to her symptoms. Additional information has been requested.
Pt states 1 1/2 hr. after leaving health dept he began feeling numbness on left side of face, including lips, cheek , side of head and neck. Saw clinic doctor 2/24/10. Referred to ER ? of Bells Palsy.
Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under ribs, hard to breathe, went to ER, after several test performed, finding is PE in right lung and DVT behind right knee.  I had signs of these weeks to months prior, have no underlying conditions before this happen, now I on Eliquis for blood clots! Also due to the blood clots have pneumonia!
Body ache; Fever; Rash (on her trunk-front and back); Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills). At the time of the report, PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD21-033093 (E2B Linked Report).; Sender's Comments:  MOD21-033093:
10:20am  Patient c/o dizziness and was put in the recliner chair with feet elevated.  P88 and regular, Respirations 20, B/P 170/82.  He was offered water and had no swallowing issue.  His skin was cool and dry.  He states he has had dizziness in the past. Nurse stat called.  ER nurses arrived within a few minutes and he was agreeable to go to ER to be examined. Transferred via wheelchair with ER staff in stable condition.
Nurse administered High Dose vaccine (Fluad) to patient under 65. Patient did not answer phone when called to inform him of error. Left message for patient to call back.
1406: After receiving COVID vaccine, pt c/o sudden lightheadedness, LE weakness, bilat ear pressure, tingling sensation to nose, HA pressure 1410: BP 118/78 HR 52 RR 16 SpO2 99%  Add. RN called; head of car seat lowered; pt denied CP or SOB.   1417: HR 60 SpO2 98% Missed heart beats noted on auscultation by NP; pt denies cardiac hx; dizziness persisting 1430: HR 62 SpO2 97% Pt requested to stand; 3 RNs on standby to assist 1432: BP 117/70 HR 58 RR 16 SpO2 97%  Pt states, "I feel totally normal." O2 1 L N/C 1450: O2 weaned; no missed beats noted; sxs resolved 1455: Emergency precautions given; pt verbalized understanding; released home