chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after I received the vaccination my arm was very sore and I was tired and had a headache.  10 days after the vaccine I developed a red mark directly under the vaccination site on my left arm.  It was 4 inches long and 2 inches wide at the widest point (it was shaped like a guitar). The mark was very red and hot to the touch.  I noticed it on the morning of the 10th day and by evening time it was the reddest it got (it was not itchy or painful, just hot and red).  By the next morning it had lightened and was no longer hot, as of writing this (Feb 24th) the mark has continued to lighten, it is still visible on my left arm.
pt. experiencing dizziness. pt. denies any difficulty swallowing & / or other s/s.  Resolved w/ calming / comfort measures.
The patient was given PNEUMOVAX and FLUCELVAX and developed fever 6 to 7 hours  later. He also reported swollen arm, redness and felt like compression.
presented with weakness/SOB . COVID positive.  He required 4 L of supplemental oxygen on admission. The patient uses 2 L at baseline for his COPD. CT chest was done which was negative. The patient was treated with IV steroids, IV remdesivir, zinc supplementation and Lovenox. Gradually his symptoms improved and he was feeling better clinically. However upon ambulation he was noted to be desaturating and requiring 6 L of oxygen. He was continued on IV steroids with gradual improvement in his symptoms. He had a walk study done today and required 4 L of supplemental oxygen with ambulation and will be discharged home on the same.
Patient presented to  hospital with increasing SOB, dyspnea on 2/22/21 (vaccine dose on 2/9/21). Patient is still currently admitted to monitor respiratory status and has been diagnosed with unilateral diaphragmatic paralysis.
pt began to feel pain in the back of lt thigh & into buttocks the afternoon p/shot; the pain inc to 3AM that noc & disappeared by morning-no treatment;
Patient received Pfizer vaccine dose #2 and start developing difficulty breathing and tightness in the cheek. An 0.3mg epi-pen was administered into the right thigh at 4:03pm and then paramedics were called at 4:04pm. Patient was being monitored by husband, pharmacist, and technician to see how she was doing. A second 0.3mg epi-pen was administered at 4:19pm since the paramedics had not arrived yet and patient was developing signs of breathing difficulty. Patient reported seeing signs of seeing spots so a followup call was made to emergency responses to check ETA. Paramedics arrived at 4:24pm and was checking up on patient. Patient remained conscious and alert during the whole situation and was able to talk to paramedics.
Entire left arm has rash. Swollen, cannot left left arm.  Painful, itchy. Swollen lymph nodes under left arm (armpit).
shingles; This spontaneous report was received from a 57-year-old female consumer (also reported as employee), who was reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was not immunocompromised (to her knowledge).   On unknown date in March 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical site, lot # and expiration date were not provided) for prophylaxis.  On 24-APR-2019, the patient was diagnosed with shingles. The outcome of the event and the causality assessment between the event and the suspect vaccine were not provided.
Information has been received from a medical assistant concerning a 17 year old female patient, with no known medical history and drug reactions or allergies, who on 22-AUG-2011, was vaccinated with the second dose of GARDASIL (lot # 668262/0841AA, Exp. Date: 08-APR-2013) (dose not reported) intramuscularly. Secondary suspect vaccinations received on the same date, included VAQTA (lot #, dose and route not reported), VARIVAX (Merck) (Lot #, dose and route not reported). Concomitant therapy included MENACTRA (lot #, dose and route not reported), DAPTACEL (Lot#, dose and route not reported) administered on the same date 22-AUG-2011. Upon internal review, the patient could not see was determined to be an other important medical event. Additional information has been requested.
Within 24 hours of the vaccine, patient developed a fever that went up to 102 and body aches that lasted for one week.
Strong chills and high body temperature lasting 48 hours; strong body aches lasting for 3 days; soar arm on injection location lasting 4 days; Herpes simplex (cold soar) on the left side corner of lower lip starting within 18 hours of vaccine (patient hadn't had a cold soar for at least 6-8 years before the vaccine); very itchy, slightly raised, pinkish skin rash on both sides of the thighs that went away with antihistamine (Loratadine) and appeared again every 24 hours (this side effect is persisting several weeks after the vaccine).
Starting about 12 hours from shot I had excruciating muscle seizures.  My entire body's muscle system was pulling and yanking for minutes at a time, as if I were on the rack. I was screaming in agony from the pain.  When it stopped, it was only a few minutes before the next seizure.  This went on for about 14 hours.  Then it tapered off in severity and the time was extended between seizures.  I was finally free after about 18 hours.  I also experienced extreme fatigue for 5 days.
This spontaneous report was received from a male patient of around 67 or 68 yea old, regarding himself. Patient's pertinent medical history and drug allergies were unspecified. About 7 years ago in 2007, he received PNEUMOVAX23 (dose/frequency, therapy route, lot # and expiry date unspecified). He experienced a red, hot, swelling, itch and tenderness sensations on his arms, at the point of injection. He stated that these symptoms lasted for a week and he recovered on an unspecified date. Causality assessment was not provided. This is one of several reports from the same reporter (MARRS # 1503USA013656). Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of medication errors in approximately 20 subjects and possibility 200 residents and employees at a long term care facility. Two of the subjects seen at the facility following the medication errors were female subjects of unspecified age who were vaccinated with influenza virus vaccine (Fluarix), for prophylaxis. This subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received Fluarix at 0.5 ml, subcutaneously in an unknown deltoid. This was considered to be a medication error, as the Fluarix should have been injected intramuscularly. At the unspecified time after vaccination with Fluarix, the subject experienced (1 1/2 in. diameter) area of swelling at the injection site, injection site pain, a black spot at injection site with redness around it. Tylenol was given for pain. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination wit Fluarix.
Hours 12-27 after: fever, chills, headache, fatigue, tender at injection site Day 2:-3: dizziness, fatigue, mild headache, tender at injection site Day 4: pain in lymph nodes, fatigue, tender at injection site
the powder in vial A was mixed with sterile diluent however it was not the CYW diluent. Error was found during an audit on 6/6/22 Contacted 6/6 and they advised for a repeat dose. Notified mom on 6/20 that child needs repeat dose.  Child had no adverse reactions.
Patient was administered the vaccine after the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date) 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 considered EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date) to be possibly related.    On 18-Jun-2021, product was moved to refrigeration, it should be used by 18-Jul-2021 and date of administration was 21-Jul-2021.   No concomitant medication reported.  No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contain Non significant information. On 21-Jul-2021: Follow up received and  Added patient demographics. Added vaccine start date and Route of administration. Added Event start date and stop date. On 29-Jul-2021: Follow up received and added patient Demographics like ethnic group and race, reporter added. Event term updated.
pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) outcome was unknown.            No concomitant medications were reported Treatment medication included over the counter pain medications for pain in the arm  Patient had expected the pain after vaccination.   Reporter did not allow further contact
developed pustules/papules different sizes, stages on head, chest, arms, legs, trunk and diaper area.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 81-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 03-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 at 15:00 as dose 1, single (Lot number: EL9265), in left arm, on 10Mar2021 at 15:00 as dose 2, single (Lot number: ENU199), in left arm, on 02Nov2021 at 09:45 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 11Apr2022 at 10:15 as dose 4 (booster), single (Lot number: FJ8762) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "herpes (sacral)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Clinical course: Reverb infection. Began Paxlovid 36 hours after symptoms and 12 hours after first positive covid test (evening of Day 2 of infection). Followed intake rules-every 12 hours until ten (3-pill) doses were swallowed without chewing. Rapid test outcomes related to onset of covid (Day 1) and period of Paxlovid intake. Day 1 symptoms begin, test is negative; Day 2 symptoms worse, test positive (distinct band); begin Paxlovid in pm; Day 3-6 symptoms begin to lighten, one test (Day 5) positive( distinct band); Day 7 last Paxlovid dose in am, test positive, light band; Day 8 milder symptoms, test positive (distinct band); Days 9-11 mild symptoms, test positive (nearly invisible band); Day 12 symptoms increasing, test positive (distinct band); confirmed with 2nd rapid test. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Negative; (28Jun2022) Positive, notes: (distinct band); (01Jul2022) Positive, notes: (Day 5) positive (distinct band); (03Jul2022) Positive; (04Jul2022) Positive, notes: (distinct band); (05Jul2022) Positive, notes: Days 9-11 (nearly invisible band); (06Jul2022) Positive, notes: Days 9-11 (nearly invisible band); (07Jul2022) Positive, notes: Days 9-11 (nearly invisible band); (08Jul2022) Positive, notes: (distinct band) Day 12. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 treatment included Paxlovid from 28Jun2022 to 03Jul2022.
He got his vaccine, had medium pain in the right shoulder, pain when he rolled over on the right side to sleep and when he raised his arm.  Then Friday, Saturday and Sunday noticing coughing, felt he had a fever but never had a temp higher than 99.  No sweating or perspiring, overall some body and muscle aches.  Sunday night on 12/25/22 is when he noticed a rash on both front of his thighs, both knees were the thigh join on the inside, abdomen area on both sides.  Was taking Tylenol for 3-4 days and saw that it could cause a rash as well, so he stopped taking it.  He has been checking since Sunday and it is still there, not as bad as Sunday, but is still there.  It is red, not as bright red as it was before.  He reported this to his doctor yesterday after messaging him, saw him and said that something got into his body (pretty vague about it), told him he had the Shingrix vaccine and was quiet about that.  He also told him that he had been taking Tylenol and asked if it was from the vaccine, etc.  He was told that if the rash did not go away to call him back and may send him to an allergist.    He did get the first Shingrix vaccine on 10/21/22, and did not have any reaction to that one.
Pain to left arm that started a few hours after administration described as throbbing, numbess to (L) hand thumb, index and middle fingers.
chills, fever, nausea muscle aches 8 hours; soreness in injection site 4 days
This spontaneous report received from a health care worker refers to 27 patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (dose, lot and route was unknown), which was improperly stored. No adverse effects were reported. The outcome of the events was unknown. This case is linked to MARRS# 1503USA008726 with the same reporter link. No further information was provided. Additional information has been requested.
7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on 8-Mar-2022 (5 doses) and 30-Mar-2022 (2 doses) Dates of administration of vaccine on 29-Mar-2022 gave 1 dose, 31-Mar-2022  gave 4 doses and 05-Apr-2022 gave 2 doses. The vial did not undergo any temperature excursions. No concomitant medication were provided No treatment details were provided   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up information included-Dates of vaccine Administration updated
OBSTRUCTIVE SLEEP APNEA 4/20/2023 IUD MALPOSITION, SUBSEQ
The night after the vaccination I was fatigued, tired with headache, shivers and did not feel well. I felt the same way the next day but went to workout at the gym anyway. All day and that night, 4/25/18, I was not hungry, headache and felt achy and sick all over. This was from the vaccine nothing else. I am generally a very healthy person, eat right and exercise everyday. So I thought I should report it.
Day after vaccine started to feel chest pain; Went to ER 5 days later, was given EKG test; Chest X-ray, COVID-19 test all tests were negative; was given muscle relaxers; Didn't take because was afraid to.
Started with "Brain Fog" on day 2 after vaccine.  Then by the next day had pressure in head with ear pain.  Also, had some chills.  Called doctor on day 4 but was not treated.  On day 7 was started on an antibiotic which did help the pressure but did not help the ear pain and noise in ear.  Better now but still has "noise in head"  but states it is improving.
10/28/03: Awoke with swollen mouth, lip, cheek on right side. Later that day swollen, raised white areas from 1" diameter to 6" diameter over entire body. When they turned red they itched. Other lip followed. This continued 1 month. Now 6 weeks later still raised areas over body that come and go. Tx Benadryl. No decrease in severity.
brain is foggy/can't think; fatigue every single day; having fever/fever of unknown origin/running a fever for 2 months now; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain is foggy/can't think), PYREXIA (having fever/fever of unknown origin/running a fever for 2 months now) and FATIGUE (fatigue every single day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 013L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (having fever/fever of unknown origin/running a fever for 2 months now). On an unknown date, the patient experienced FEELING ABNORMAL (brain is foggy/can't think) and FATIGUE (fatigue every single day). At the time of the report, FEELING ABNORMAL (brain is foggy/can't think) and FATIGUE (fatigue every single day) outcome was unknown and PYREXIA (having fever/fever of unknown origin/running a fever for 2 months now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything came back fine. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient has been tested 5x for COVID and all came out negative.   No concomitant medication information provided.  consumer was not sure if she was given the 3rd or the booster dose. She says she was not categorized as immunocompromised but she was sensitive to medication and in general prone to getting sick.  No treatment medication information provided.
Diffuse rash including palms & soles.  Fine red rash (papular).  Low grade fever.
received the Pfizer covid vaccine on 05Mar2021. A few days later, she tested positive to the covid infection; This is a spontaneous report from a contactable consumer (Patient, Self-reported) via Medical information team.  An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration on 05Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient reported that she received the Pfizer covid vaccine on 05Mar2021 and few days later she has tested positive to the covid-19 infection on an unspecified date in 2021. She further wanted to know when she can get the 2nd dose of the covid vaccine since she has tested positive for covid infection. She would like to know whether she will have to restart the vaccination series if she gets her 2nd dose of the covid vaccine 90 days later due to a current covid infection. The patient underwent lab tests and procedures which included Covid 19: positive on an unknown date in Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
continuous runny nose; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in the left arm on 23Mar2021 at 23:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of lupus, sjogrens syndrome, major depressive disorder and neurological tic disorder. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN), ZOLOFT, hydroxyzine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN). The patient reported allergies to chamomile and turmeric. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 12:00, the patient experienced continuous runny nose which was reported as a clear, liquid with constant stream. The patient did not receive any treatment measure for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of event continuous runny nose was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.