chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     Concomitant products included blood pressure medicine, APIXABAN (ELIQUIS) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown. Not Provided      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.   Treatment details included went doctor last week and gave her to take Montelukast scd 10mg 1 day and hydroxyzine hcl, 25mg, and cream ointment. She takes 2 Benadryl before going to bed and cortisone at night.
Red welts on the face (rash) body itching, sensation from the inside of my body to the outside (inside my body).
Itchy rash around injection site, roughly 2 sq inches in size.; Itchy rash around injection site, roughly 2 sq inches in size.; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 14Apr2021 at 11:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (AUROVELA FE 1/20) taken for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 15Mar2021 at 12:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 20Apr2021 at 01:30 the patient experienced itchy rash around injection site, roughly 2 square inches in size. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event itchy rash around injection site, roughly 2 square inches in size was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
On 01/18/2022- COVID symptoms- sore throat, and then I had a fever, and then I had coughing and phlegm and the sore throat got worse and worse until about Monday, 01/24/2022, the symptoms started receding. On Monday was the 1st day I did not take Tylenol for controlling the fever and the sore throat was gone on Tuesday, 01/25/2022. Yesterday was probably the 1st day were I had nothing. I also had like a lot of fatigue and muscle aches, just aches, that part was pretty miserable. My wife called in the nurse hotline- I was coughing and there was a little bit of blood in there and they told us it was probably okay, and to just monitor it.
Narrative: Covid +, J&J vaccine 3/13/21, mild cough, low oxygen sats, dizzy, weak
Fully vaccinated with Pfizer x 2. Tested positive for COVID 19 on 2/22/2022. Admitted to Hospital on 02/17/2022. Expired on 03/02/2022 while still hospitalized.
sore arm; This is a spontaneous report from a contactable consumer. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that her mother who was very old maybe in her late 70's had a sore arm after her shot. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left arm tender/edema, afebrile. Plan: Ice to area 20 min per hour, increase arm movement.
Stiff arm( 5 days after injection) Then red rash on arm (2.5 inch diameter) (7 days after injection) Then swollen lymph nodes in armpit of injection arm (2 weeks after injection) Then (3 weeks after vaccine) - full body rash/hives, itchy
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild
Tiredness began approximately at noon the day after receiving the injection, and then shivering at approximately 10:00 pm  later that day. I took 600 mg of ibuprofen at that time. The shivering stopped approximately 20 minutes after taking the ibuprofen. There were no other side effects.
On March 13, I woke with a headache, a sinus pain, and generally feeling exhausted and groggy.  This persisted through Sunday.  On Tuesday March 16 I awoke and could not focus my eyes: I was seeing double.  This got better during the course of the day but I could not work on my computer.  On Wednesday March 17, I woke with double vision again.  During the day I gradually became able to focus if I looked at an object, but as soon as I move my eyes, it was back to double vision.  I felt much better physically that day.
The patient's arm swelled up to the size of a small apple. It was red, and hot. The patient's husband came into the pharmacy with pictures. It has already started to go down in size.
Vasovagal syncope post HPV injection. Supportive care only. Patient recovered and was stable upon leaving office.
Pfizer-BioNTech COVID-19 Vaccine: patient with COVID-19 infection who presented with worsening dyspnea and admitted for acute hypoxemic respiratory insufficiency. Received 4 days of dexamethasone and remdesivir. Discharged to home medically stable on oxygen.
(1/7) 2 days after vaccination, onset of paresthesia like symptoms such as tingling and crawling throughout body,  most significant at inner right thigh, right foot at toes, right bicep and forearm, under right eye. Also notable at abdomen. Subsided 4 days after vax with occasional flare-ups. Doctor recommended follow-up with Neurology. (1/9) 4 days after vaccine, abdominal pain accompanied with burning sensation at abdominals. Pain bursts at upper abdominal - upper right to center abdominal. Progressed to worsen 5 days after vax, impacting sleep and diet. Awaken from sharp pains at upper abdominal area. Persistent pain after eating at upper abs - center. Inflammation and tightness at entire abdominal area throughout the day. Much worse at night. Discomfort along digestive track including throat. (1/13) GI doctor diagnosed epigastric pain.
Visual field distortion. Not vertigo. Looking off to left or right, vision field is distorted. Fever.
High fever, chills, delirium, heavy body aches, head aches, nausea -- all felt as if he got COVID again (unknown if acutally had COVID, a theory from being heavily sick for a few days early last year).
Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022; Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 17-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that vaccine their Office administered were expired at the time of administration.  The vials were thawed on same day of administration and the vial didn't undergo any temperature excursions.  On 17-May-2022, the patient received first booster dose of expired vaccine.  The patient had no known reactions at office. No treatment information was provided.
On 1/29/2021 at around 9 PM  I noticed my arm was itching and I noticed a fairly large red spot on the arm I had been vaccinated. It also seems slightly warm to the touch.
Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) tablet 650 mg Ondansetron ODT (ZOFRAN-ODT) disintegrating tablet 4 mg.
Seven days after vaccination I am now experiencing a lump some swelling and itchy on arm vaccine was administered.
VACCINE PUNCTURED AT 9:40 AM ON PREVIOUS DAY AND WAS ADMINISTERED TO A PATIENT AT 12:20 PM ON THE DAY OF REPORT; This spontaneous report received from a pharmacist concerned an 18 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: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 12:20 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced vaccine punctured at 9:40 am on previous day and was administered to a patient at 12:20 pm on the day of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine punctured at 9:40 am on previous day and was administered to a patient at 12:20 pm on the day of report was not reported. This report was non-serious.
I am a healthy female, Never had allergies once I took the  Moderna vaccine hives started coming I?ve been to my pcp, Allergist, Dermatologist and nothing. My labs are completely good. My allergist recommended xzyal once a day I?ve been taking the hives would constantly go away and come back but the xzyal provided comfort. I took the Moderna Booster and the hives came back flaring up worst than before and this time nothing helps. I need help I cannot live like this. The feeling is stressful.
HEADACHE STARTED AT12 NOON.  DIDNT KNOW  IF IT WAS JUST AN ORDINARY HEADACHE OR MIGRAINE.  WAITED UNTIL 5 TO TRY MY MIGRAINE MED(bUTALB-ACETAMIN-CAFE).   SLEPT.   REPEATED MEDICATION .  PAIN ENDED, BUT NEEDED TO SLEEP .  WAS EXTREMELYWEAK FOR TWO MORE DAYS
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the  left arm on 24Feb2021 at 15:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Other medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, after two weeks of vaccination, the patient experienced shingles. Its reported as the vaccine weakened the patient immune system making it vulnerable to shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event of shingles and included treatment with tylenol and ibuprofen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of shingles was recovered on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the  left arm on 24Mar2021 at 15:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation.
grand mal seizure lasting about 20 seconds in the middle of the day. No concurrent illness and otherwise healthy prior to the event.
This 15-year-old patient inadvertently received a pediatric dose of Pfizer (10 mcg/0.2 mL) which is approved for ages 5-11.  Patient was observed for the recommended 15 minutes with no adverse reactions.  This was the third dose for the patient; the first 2 doses were the Pfizer (purple cap) for 12+.
injection site soreness; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No medical history and laboratory data was provided by the reporter.     On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion). At the time of the report, INJECTION SITE PAIN (injection site soreness) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Patient stated to contact only through phone only.
Had a hard time moving; Felt like a train hit her; Shaking chills; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of MOBILITY DECREASED (Had a hard time moving), FEELING ABNORMAL (Felt like a train hit her), CHILLS (Shaking chills) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included THYROID, EZETIMIBE, SIMVASTATIN (VYTORIN), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced MOBILITY DECREASED (Had a hard time moving), FEELING ABNORMAL (Felt like a train hit her), CHILLS (Shaking chills) and PYREXIA (Fever). At the time of the report, MOBILITY DECREASED (Had a hard time moving), FEELING ABNORMAL (Felt like a train hit her), CHILLS (Shaking chills) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, multiple unspecified were vaccinated with improperly stored PROQUAD (Merck) lot # L044056 and expiry date 02-MAY-2017, (strength, route, dose and frequency were not reported). Concomitant medications were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature was 7 F degrees for 10 minutes and temperature excursion was reported as 18.2 F degrees for 5 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
granuloma annulare; severe rash; This case was reported by a consumer via call center representative and described the occurrence of granuloma annulare in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on an unknown date, refer case US2021200847).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced granuloma annulare and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the granuloma annulare was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the granuloma annulare and rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced more severe rash. The patient stated that she had the more severe rash for almost 6 months. The patient also stated that the dermatologist had diagnosed the rash as granuloma annulare. The patient inquired if Shingrix causes granuloma annulare. The patient also inquired what she should do for treatment. The patient did provide consent to contact healthcare professional. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021200847:same patient different dose
Cellulitis @ injection site occurred within 24 hrs after vaccination. Treated w/Cephalexin.
Within 24 hours: Chills, body aches (both successfully treated with ibuprofen 800mg every 6-8 hours, lasted 24 hours after vaccine), abdominal pain and cramping without eating or drinking anything prior (just water) and without gas or bloating (untreated, still occuring almost 72 hours later). Redness at injection site (untreated, appeared within 24 hours, subsided within 48 hours). Pain at injection site (occurred immediately after injection, subsided within 72 hours with heavy use of arm and 800mg ibuprofen q6-8h prn).
Injection in deltoid-initially had soreness and tenderness in deltoid-currently pain is supraspinatus and insertion on same side. Was sent for PT for ROM to prevent frozen shoulder.
Client had an unwitnessed loss of consciousness after vaccination in the hallway outside of vaccination room.  Nurse manager notified by client standing in doorway between hallway and vaccination room, responded immediately.  Client was standing, stated she was feeling fine, appeared slightly confused.  Nurse manager began to walk client to chair, client stated "I feel like it's going to happen again," had another loss of consciousness, this time assisted to the floor by two nurses.  911 called.  client taken to cot inside medical consultation station via wheelchair, vital signs assessed- BP 130/78, O2Sat 99%, HR 72., RR 18.  Client reporting feeling fine, denies pain.  States she was leaning against the wall the first time and slid down the wall, states she doesn't believe she hit her head, denies head or neck pain. Client given water. Paramedics arrived, assessed client, all vitals normal, client decided not to be transported to the hospital.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 24-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches starting 2/8 and ongoing Fatigue starting day of injection 2/6 and ongoing; Body aches starting 2/8 and ongoing Fatigue starting day of injection 2/6 and ongoing; This is a spontaneous report from a contactable consumer (patient). The 46-year-old non pregnant female patient received bnt162b2 (COMIRNATY, solution for injection, (Batch/Lot Number: EM9809) via intramuscular route of administration in right arm on 06Feb2021 at 01:45 PM as SINGLE DOSE for covid-19 immunization. Patient had other medical history of covid 19. The concomitant medication was not reported. On 06Feb2021 at 04:00 PM patient experienced body aches starting 2/8 and ongoing Fatigue starting day of injection 2/6 and ongoing. Patient received treatment of NSAIDs, Tylenol, caffeine and rest. Patient had known allergies. The outcome of the event was reported as recovering.
Information has been received from a 72 year old female consumer with no known allergies and a history of shingles for 45 years who on 05-SEP-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck).  Since 06-SEP-2007, the day after vaccination, the patient had 3 outbreaks of shingles on her right leg.  Patient advised that the rash had cleared but she was having pain that was radiating from her big toe to the base of her spine.  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been received from the consumer who stated that she had developed two additional outbreaks of shingles on 02-NOV-2007 and another on 07-NOV-2007.  The patient had 2 lesions on her gluteusmaximus.  Additional information has been requested.
arm soreness; itchy around injection site; fatigue; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: Not reported), via an unspecified route of administration on 22Feb2021 (at the age of 77 years-old)  as Single dose for covid-19 immunisation.  Medical history included thyroid disease, high cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine, rosuvastatin taken for an unspecified indication, start and stop date were not reported. On 22Feb2021, The patient experienced fatigue and arm soreness, itchy around injection site on 23Feb2021. The date of when she was aware of these symptoms was 22Feb2021 (fatigue) and 23Feb2021 (arm soreness, itchy around injection site). The patient was her mom and she had the second shot on 22Feb2021. The outcome of fatigue, arm soreness, itchy around injection site was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
My mother was given dose 1 and dose 2 of the covid 19 vaccine on 2/17/2021 against the POA's wishes. She seemed to have her right foot very swollen which is not normal, she stated she felt her heart was going to jump out of her chest and she was very anxious.
it was rpt by RN pt recv 1dose varivax & subsequently exp failure to seroconvert.