chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second vaccine she had reactions/feeling some type of way/like she's been used as a guinea pig/looks like a "junkie" walking down the streets; she had black spots and red spots all over her body, on both of her arms, and on her face; constant migraine headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After the second vaccine she had reactions/feeling some type of way/like she's been used as a guinea pig/looks like a "junkie" walking down the streets), PIGMENTATION DISORDER (she had black spots and red spots all over her body, on both of her arms, and on her face) and MIGRAINE (constant migraine headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 07B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2021, the patient experienced VACCINATION COMPLICATION (After the second vaccine she had reactions/feeling some type of way/like she's been used as a guinea pig/looks like a "junkie" walking down the streets), PIGMENTATION DISORDER (she had black spots and red spots all over her body, on both of her arms, and on her face) and MIGRAINE (constant migraine headaches). At the time of the report, VACCINATION COMPLICATION (After the second vaccine she had reactions/feeling some type of way/like she's been used as a guinea pig/looks like a "junkie" walking down the streets), PIGMENTATION DISORDER (she had black spots and red spots all over her body, on both of her arms, and on her face) and MIGRAINE (constant migraine headaches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medications were not provided.  Treatment information was not provided.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 59-year-old female patient who received FLUARIX QUADRIVALENT (batch number D2L7K, expiry date May 2018). On 11th October 2017, the patient received FLUARIX QUADRIVALENT (subcutaneous) .5 ml. On 11th October 2017, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hemorrhage, injection site pain, injection site swelling and intramuscular formulation administered by other route. On 12th October 2017, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site hemorrhage, injection site pain, injection site swelling and intramuscular formulation administered by other route were unknown and the outcome of the injection site bruising was recovering/resolving. It was unknown if the reporter considered the injection site hemorrhage, injection site pain, injection site bruising, injection site swelling and intramuscular formulation administered by other route to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The petite patient received a FLUARIX QUADRIVALENT (intended via intramuscular route) and some of the vaccine have gotten into the subcutaneous tissue inadvertently, which led to intramuscular formulation administered by other route. The healthcare professional (HCP) was uncertain if the vaccine was into subcutaneous or intramuscular tissue. The HCP planned to revaccinate the patient as per Centers for Disease Control and Prevention recommendations following an inappropriately administered dose. After 1 day of vaccination, the patient experienced injection site bruising.
Prior to vaccination bowel movements were every 2 or 3 days with mild constipation. Mild diarreah like symptoms began the morning after the vaccination. Bowel movements were at least 4 to 5 times a day for the first 3 or 4 days and then to 3 to 4 times a day. Bowel movements included sticky/slime looking substance what may have looked like blood clots. Symptoms lasted from 4/2/2021 to approximately 4/11/2021. Bowel movements are now 2 to 3 times a day but normal, with no other substance.
2-3 episodes of dec responsiveness;mom & grandma report apnea (unsure of duration <1min); pale, white & limp;events occurred 25hr p/vax;
2 days after receiving the vaccine I developed shingles at the sight of my vaccination on my left upper arm. 3 days later I developed  lock jaw which lasted for 4 months.
Had shot Tuesday, Woke up Wednesday felt ok until about 10:00 A - got worse throughout the day, got home from work with 101 fever. and severe chills. Arm felt like it was beat with a baseball bat.  102 fever thru the night and severe body aches.  Felt like I had Covid all over again.  Sick all day Thursday with the same symptoms, Friday morning was better and fever again Friday night.  Today has been somewhat better.  Still not much strength.
Second dose: A big red spot in shot area, hurts, and headache.   First dose: nausea, headache, tired, body hurts.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C12A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 5:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Farenheight   This case was linked to MOD-2021-402935 (Patient Link).
Itchy rash appeared on inside of left thigh and left side of torso Sept. 27, 2022. The rash stays for 12-24 hours and then changes locations on the body, which includes feet, legs, hands, arms, torso (front, back and side), neck and crotch. I stopped doxycycline 100mg after two doses and began generic Zyrtec in the morning and generic Benadryl at night, then was prescribed steroids. I have finished all of that and the rash has not dissipated. Nurse suspected possibility of stress rash (I appeared partway through the toughest three weeks of my work each year).
Info has been received from a pharmacist concerning a pt who on approximately 10/21/2002 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Subsequently, the pt developed a "high fever" and swelling of the left arm. Unspecified medical attention was sought. Additional info has been requested.
Our daughter (patient) became overwhelmed with emotion, both sadness and happiness, uncontrollably sobbing and then laughing. She acted as if she was under the influence of "drugs", and it subsided about one and half hours later, and she appeared to be "crashing" from a high! At bedtime, she had further episodes, and the next night, more sadness at bedtime, but not as intense. To us it seemed like the vaccination effected her "affect" or maybe serotonin. She also had the Flu vaccine at the same time, same arm. She has had flu vaccines before without incident.
Atypical seizure like activity. 3 minutes for episode, 2 hours for complete return to himself. Hospital admittance, EEG.
soreness at injection site; swelling in left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in left armpit) and VACCINATION SITE PAIN (soreness at injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Nose infection NOS since 01-Jan-2009. Concomitant products included LORATADINE from 01-Jan-2018 to an unknown date for Allergy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling in left armpit). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 18-Jun-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, LYMPHADENOPATHY (swelling in left armpit) was resolving.            No treatment medication provided. It was reported swelling in left armpit of patient had gotten better.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up received :- Outcome change from Unknown to Recovering/Resolving, concomitant drug added, medical history updated
Breathing difficulty, wheezing, asthma flare up resulting in doctors' appointments. Doctor prescribed antibiotics and steroids to help control breathing. On 80 mg Prednisone daily and getting worse. Now told to go to an ER to be evaluated.
From prescriber progress note: "The patient is a 35-year-old the presents emergency department with sudden onset of scratchy pain in the throat that is worse with swallowing and numbness and tingling in the lips and tongue with difficulty breathing without cough that all started suddenly less than 20 minutes after receiving her 2nd COVID-19 vaccination.  Patient states that since then pain is worse with swallowing and difficulty breathing is becoming worse.  She denies any fever or chills.  She states she does feel short of breath.  She states she has not taken medication for this as of yet.  Patient is hospital employee and was at hospital COVID clinic."
Patient called the pharmacy about 1pm on 02/04/2020 and stated that she had felt tired and had a slight fever the night of having the vaccine (02/0/3/2020). After she woke up about 4:45AM on 02/04/2020, she fainted and hit her head. Her husband called for an ambulance that took her to the hospital.
Fever (up to 103), chills, headache, fatigue, weakness, leg  weakness, leg tingling
Per MOC, evening of 6-30-10 child vomited, was losing her balance & falling down. Next day mom stated "she would swing herself over backward" & couldn't sit up, stand or walk. MOC called her MD who advised her to be seen at walk-in care. She took child to walk-in care & was told by health care provider to return if child was not able to walk after one week. Per MOC child was wobbly & needed assistance with walking after a week but eventually improved & recovered.
Delayed reaction. 5 days after injection - itching, rash at site of injection , shoulder down to elbow. Still treating with Benadryl and hydrocortisone cream.
Information has been received from a nurse practitioner concerning a patient who on 16-SEP-2008 was vaccinated with the first dose of oral ROTATEQ, 2 ml, at 22 weeks of age. The patient has not experienced any known symptoms. No product quality complaint involved. Additional information has been requested.
had them; they hurt; Joint pain/ knees elbows all my joints killed; lack of hand movement/ couldn't even move my hands; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: had them), pain (Verbatim: they hurt ), joint pain (Verbatim: Joint pain/ knees elbows all my joints killed) and mobility decreased (Verbatim: lack of hand movement/ couldn't even move my hands ). The outcome of the shingles, pain, joint pain and mobility decreased were not reported.   It was unknown if the reporter considered the shingles, pain, joint pain and mobility decreased to be related to Shingrix.     It was unknown if the company considered the shingles, pain, joint pain and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date: 8-Aug-2023 The case was received from the patient via interactive digital media. The patient stated that he had them, they hurt and could not even move his hands. The patient mentioned that knees, elbows all his joints killed.
He began sweating / resolved about 4 hours later; Husband is feeling very fatigued / has not yet resolved; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th July 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th July 2021, 5 days after receiving Shingrix, the patient experienced sweating and fatigue. On 25th July 2021, the outcome of the sweating was recovered/resolved. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the sweating and fatigue to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's wife. The reporter reported that the patient received  dose of Shingrix vaccine in the right arm and he began sweating for about 4 hours and he was feeling very fatigued on 25th July 2021. The fatigue had not yet resolved. The reporter did not consent to follow up. The reporter does not gave permission to contact HCP.
Rash on groin and shin on both legs.   Lasted 3-4 days.
I do routinely get Eczema; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves adult patient (unknown gender and unknown age) patient who experienced "I do routinely get eczema" after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious I do routinely get eczema (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "I received a Flu Vaccine here at work on Friday. Yesterday, I noticed an eczema flare up near the injection site. I do routinely get Eczema and this particular spot flared up last year after I got the Flu Vaccine. Within the weeks following my flu vaccine, I went on a beach trip and this one spot became the only spot on my arm that would not brown in color. I didn't correlate the two at the time but the area still will not brown like the rest of my skin. When I showed the nurse administering the vaccine this year, I asked if she could place the vaccine in the same area and she said no as that was not the ideal location. The area that is flared up with eczema know is approximately two inches from the injection site this year".  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the batch number for this case.
Case number PHEH2015US020297, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 28 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly on 07 Oct 2015. Nurse reported that the administered FLUVIRIN vaccine was stored out of temperature range at 47 F. No adverse event was reported following this medication error.
Vaccine administered to a 17 year old. Only approved for an 18 year old.
Pt diagnosed with COVID-19 on 05AUG2021 after exposure to a confirmed positive case earlier that week. Pt became symptomatic on 01AUG, was evaluated on 02AUG and tested for COVID-19, which was negative. Pt was retested on 05AUG after his symptoms significantly worsened, and his test resulted positive. He  is currently being managed outpatient with medications.
I can't use my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOTOR DYSFUNCTION (non-serious), outcome "unknown", described as "I can't use my arm".  Additional information: The patient stated, he/she did not want to hear, wanted to talk to somebody, they gave him/her down the shots and he/she could not use his/her arm. Patient was not a healthcare professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had only complained of a sore arm after receiving the vaccine- pt died on 2/25/21 from what they feel was a massive heart attack- unsure if related to vaccine at all
Patient had a little sore arm after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had a little sore arm after receiving 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient had a little sore arm after receiving 2nd dose). At the time of the report, PAIN IN EXTREMITY (Patient had a little sore arm after receiving 2nd dose) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination (Immunization).  On 10-Oct-2023, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE with no reported adverse event (expired product administered) (latency: same day) (Powder and solvent for solution for injection) Frequency = once, Strength = standard (lot UJ801AA and expiry date: 05-Oct-2023) via intramuscular route in the left thigh for immunization.   It was reported that "Physician wants to know what to do or how to proceed and if this will be harmful to the child. She wanted to know if there was a grace period.'  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red blotch in left arm shot area, welts, very itchy, like hives. Mild itchiness in other parts of body and head, but no redness. I already take one Allegra-D 12 hours every morning, had to take one at night too for a couple of days beginning 3/30/2021. Currently still have light pink blotch in arm and light itchiness sometimes, still have light itchiness in other parts of body.
pt recv vax 8NOV94 & 5 to 10 mins following vax exp diff breathing, wheezing, hyperventilation & carpal pedal spasm; MD dx exp as an anaphylactic rxn; pt treated w/Epi, DPH & 02 & was transported to hosp
UrticariaPruritus & Hives on upper thigh that went away after one day