chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive/positive test; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive/positive test) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive/positive test). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive/positive test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) The patient tested positive..     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.   Concomitant medication was not reported. Treatment medication was not reported
headache; soreness; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown.   The reporter considered the headache and pain to be related to Shingrix.  Additional details were provide as follow: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had headaches and soreness from Shinglrex vaccine also asked could the patient take Advil or Tylenol.
Information has been received from a physician concerning a 21 year old female student with no medical history who on 12/14/87 and 3/10/93 was vaccinated SC with the first and second doses, respectively, of varicella virus vaccine live. There was no illness at the time of vaccination. The vaccinations were given as part of a medical research grant and yearly serum varicella zoster virus specific glycoprotein antigen based ELISA antibody titers were done through 1995. In 1993 the patient's titer was 880 and in 1995, the titer result was 187. In the spring of 2004, the patient was diagnosed as having a serious case of varicella. Unspecified medical attention was sought and the patient required hospitalization. At the time of this report, the patient had recovered. No product quality complaint was involved. No additional information was provided. Additional information is not expected.
Per mom, the patient has had a 101.9 fever, been very tired and a large welt the size of a softball at the injection site.
More Swelling than Usual; Swollen Lymph Nodes; COVID Like Symptoms; Initial Report Received on 23-Mar-2023  This spontaneous report was received from a nurse regarding a 32-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   Medical history included lupus.  The patient had no known drug allergies.   Concomitant medications were not specified.    On 28-Feb-2023, a dose of HEPLISAV-B (Lot # 947582, expiration date 24-Jan-2025, NDC 43528-003-05), was administered in the left deltoid.  On 28-Feb-2023, the patient received a dose of HEPLISAV-B for employment.  The patient was described to have more swelling than usually reported.  The patient had swollen lymph nodes and her symptoms were described like she had COVID.    The reporter noted that no other information is available.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
No additional AE reported; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse regarding a 12-month-old patient of an unspecified gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002601, expiration date: 24-JAN-2024 (dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine underwent a temperature excursion for 1 hour and 45 minutes with previous excursions. No adverse events were reported (no adverse event).
Among those who received two dose moderna vaccine 72 died of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Among those who received two dose moderna vaccine 72 died of COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Among those who received two dose moderna vaccine 72 died of COVID-19) (seriousness criteria death and hospitalization). The reported cause of death was among those who received two dose moderna vaccine 72 died of covid-19. It is unknown if an autopsy was performed. Not Provided          No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This fatal spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Among those who received two dose moderna vaccine 72 died of COVID-19
Patient complained of dizzyness and lightheadedness after receiving vaccine. Onsite EMS was called vitals BP 112/78  HR 88 99% O2 . She felt better but was going to stay in parking garage a little longer before her 1 hour drive home.
On the first day after the vaccine, I had 102 degree fever, lack of appetite and was dehydrated.  Second day fever was 100 and still had lack of appetite.  Also, in the evening, the left check got red and very warm.  On the 3rd day the fever was gone and jus felt tired for a few days.
She is experiencing symptoms of Covid 19 like coughing and headache after the 1st shot; She is experiencing symptoms of Covid 19 like coughing and headache after the 1st shot; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called asking if she can take the 2nd shot of the vaccine because "she had been experiencing symptoms of COVID-19 like coughing and headache" since an unknown date after the 1st shot. The events outcome was unknown at the time of the report.  Information on the lot/batch number has been requested.
nausea, vomiting, fatigue, sore throat, fever, dizziness, disorientation, numb tingling sensation in both hands & back of head, h/a, & hot flashes;
Patient reported onset of joint pain and general body aches with temperature rise of 5 degrees, resting pulse 98 degrees. At 2:00 am temperature increase to 102.3 degress; 0800 temp drop to 100.3 dregrees; took Motrin 200mg/4hrs.
20 mins. after receiving the vx (vaccine) I felt some dizziness. Within a few hours of that I felt very tired and developed a sore throat. I also found the slightest exertion left my chest feeling as though someone put a weight on it or the sensation when I can't hold my breath much longer. I was NOT panting for breath or feeling like and asthma attack. I was extremely cold during the night. I went to sleep at 9:30 PM Friday and slept until Saturday 4:00 PM (18.5 hours). I was very achy during that time to the extent that it was painful to be touched.  I felt very weak throughout, as though I had weights attached to my limbs, that entire evening. The dizziness worsened that night to the extent that I felt I might pass out. I still had the sore throat for the entire day. I slept for 10 hours that night (Saturday). I woke Sunday and the dizziness was gone unless I bent over or got up suddenly. The sore throat and achiness were gone. I did have a headache that day. The dizziness returned in the evening and I started to experience nausea as well which made sleeping difficult (Sunday night).  I only slept 3 hours, but other than being tired, I felt that I was getting more energy back and not exhausted like I'd been during the weekend. I had minimal dizziness. I did experience nausea on occasion throughout the afternoon and night. I slept 8 hours Monday night. Tuesday morning  I woke up completely exhausted again. I had a raging headache. As of now (4:20 PM Tuesday) I still have bouts of dizziness. I  have no energy and feel lethargic. I am experiencing a bit of tightness in my chest again when doing minimal exertion.
HIB vaccine given IM to (R) deltoid on 3/10/14. Next AM temp of 100 and crying. T Max on 3/11/14 103.9, vaccine sites were a little red per Mom. On 3/12/14, seen in office and (R) deltoid hard, mild warmth, temp 99.9.
Tested NAAT positive for COVID 11/21/21 after being fully vaccinated.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 11 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Lungs felt like they were itching, had retention of fluid all over; Diarrhea/ GI stuff is still going on; Lungs felt like they were itching, had retention of fluid all over; Eyes extremely irritated; Joint pain; Swelling on their shoulder puffy shoulder; Temperature of a 102 ºF; Skin feels odd; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated) and HYPOAESTHESIA (Skin feels odd) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HYPOAESTHESIA (Skin feels odd), SWELLING (Swelling on their shoulder puffy shoulder) and PYREXIA (Temperature of a 102 ºF). On an unknown date, the patient experienced RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated) and ARTHRALGIA (Joint pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT IRRITATION (Lungs felt like they were itching, had retention of fluid all over), DIARRHOEA (Diarrhea/ GI stuff is still going on), FLUID RETENTION (Lungs felt like they were itching, had retention of fluid all over), EYE IRRITATION (Eyes extremely irritated), HYPOAESTHESIA (Skin feels odd), ARTHRALGIA (Joint pain), SWELLING (Swelling on their shoulder puffy shoulder) and PYREXIA (Temperature of a 102 ºF) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Oil cream for shoulder puffing.
Deltoid region swollen, warm to the touch, itching with some discomfort. Denies S.O.B.  No hives noted, no difficulty swallowing  or  other swelling noted. No elevated body temp. Parent gave 2 - 25mg tabs of Benadryl approximately 10 minutes before calling. No other medications given. Advised mother if condition worsens please call 911 or take child to E.D. Mother states father is a Paramedic and will watch for any worsening symptoms.
Soon after vaccination administered pt had vomited for 5 to 10 minutes.  Patient also appeared uncomfortable and crying.  In addition, 1 small urticarial lesion forehead.  After about 15 minutes patient was acting himself.  The vomiting resolved after about 5-10 minutes.  There was no wheezing. after about
Client came in for ppd reading on 4/6/12. She stated she was feeling very sick since vaccination with Hep B, MMR, & ppd test. Denies fever, feels nauseated, vomiting, diarrhea, achy joints (hips).
Fever 102 to 104.3, severe muscle & joint pain, lethargy x 24 hours, Fever 101 to 102.4, muscle & joint aches, fatigue, mild swelling, soreness & redness at injection site
3 1/2 " x 3" swelling of (Rt) vastus lateralis area. Red, warm to touch. Vaccine administered on 9/5/07. Tx: Tylenol 1 1/2 tsp Q4 hr prn, cold compress to (Rt) leg, Prn
Sore arm badly aches for a few days then a week after began having shortness of breath on exertion was diagnosed with Pulmonary embolism on Aril 7 2021
1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (typically 125/80) the next day.  2. Also that night, I had significant body aches (joints and muscle) that was strong enough to effect my sleep.  3. I developed a sore throat 3 days post vaccine that persisted approximately 2-3 days.
Moderna vaccine- I can?t keep any food or medicine down without throwing up. I?ve thrown up 15 times yesterday and about 5 times for everything I?ve tried to eat or drink today
Anaphylaxis  throat felt like it was closing 15 minutes after getting vaccine  Narrative:  Employee self administered epi shot (has history of anaphylactic reaction to several nsaids, tessalon pearls). Bendadryl IM was given at observation area. She was sent to the ER where she was given Solumedrol and Pepcid. She's been seeing an allergist for past 3 months; reports she's had 2 previous shots of epinephrine from "something that was sprayed at work"
Fever from 99.6-101.8 with chills and aches 3/8/2021-3/11/2021.  Sore arm and unexplained diverticulitis flare up 3/6-3/8. Not sure flare up related to vaccine.
I started having symptoms on Feb 8th, bad head cold, low grade fever and body aches. It was about two weeks before I got help because I started to improve and then it got worse. I was starting to cough more so I saw a doctor. I did a home test which was positive, and I was told to treat the symptoms with over-the-counter medication. I was improving and then two days ago (03/22/2023) I started to feel sick again. I plan on testing myself again to see if I am positive for COVID-19 again.
Patient complained of itching in the throat, had swelling of the lips, redness of the face and rash/irritation under the right arm, approximately 45 minutes after recieving the varicella vaccine.  Patient was advised by triage nurse to give 1 1/2 tablets of chewable benadryl and bring patient immediatley to the ED.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with hypertension, hyperlipidaemia and type 2 diabetes mellitus and no known allergies. On 15-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX intramuscular in the left deltoid, lot # reported as L032184, expiration date: 25-NOV-2016. Concomitant therapies included PLAVIX and metformin, unspecified "cholesterol medications" and "hypertensive medications". On 16-DEC-2015, the patient experienced "a quarter sized" red and raised area at the injection site. The injection site was "slightly swollen" and the patient had a mild fever. No treatment was given for the events. No lab diagnostic tests have been performed. The patient did not seek medical attention. The outcome of the events was unknown. Relatedness between ZOSTAVAX was not reported. Additional information has been requested.
My histamine levels have been so high; She had a full body rash/Broke out a rash like a full body rash from head to toe and it was two days afterwards and I still have it; She always had itchy skin; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included urinary prolapse, itchy skin and dry skin. The patient's concomitant medications were not reported. On 19Feb2021, the patient had itching and scratching and after a day she had a full body rash. She said that it comes and goes. She has spoken to her doctor about the rash (her rash actually disappeared when she was talking to her doctor) and she was prescribed with Benadryl. The rash had simmered down and she was getting better. She wanted to know if this was considered a severe allergic reaction. After two days, the patient still had rash. The patient's histamine levels have been so high. The outcome of rash was not recovered and the outcome of other events was unknown.  No follow-up attempts are possible; Information about Lot/batch number cannot been obtained.
Onset of generalized muscular pain and mild headache within first 4 hours. Twelve hours post-injection additional onset of symptoms included fever/chills, general weakness/fatigue/pain, intense headache, nausea, sweating,dental pain/increased sensitivity, loss of appetite. Treated symptoms with PO NSAIDs q 6-12 hours. Applied ice packs to neck and torso frequently to decrease body temp. Afebrile on Day 2 but other symptoms remained, although not as severe. Symptoms continued to decrease and today, Day 3, I'm a bit weak but able to perform ADLs better. Was on total bed rest for most of the first and second days post-immunization.
fever of 100F-101F; throwing up; hallucinations; diarrhea; shortness of breath very intense for 2 days; attention span of 10-15 minutes decreased; stomach pain like somebody beat me with a sledgehammer; still have weakness/no strength to go downstairs; my sugar level is high; soreness in arm; spent most of last 4 days sleeping; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN (HUMALIN R) for Diabetes mellitus insulin-dependent, INSULIN GLARGINE (LANTUS) for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HYPERSOMNIA (spent most of last 4 days sleeping), BLOOD GLUCOSE INCREASED (my sugar level is high) and VACCINATION SITE PAIN (soreness in arm). On 09-Apr-2021, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant), DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath very intense for 2 days), DISTURBANCE IN ATTENTION (attention span of 10-15 minutes decreased), ABDOMINAL PAIN UPPER (stomach pain like somebody beat me with a sledgehammer), ASTHENIA (still have weakness/no strength to go downstairs) and VOMITING (throwing up). On 10-Apr-2021, the patient experienced PYREXIA (fever of 100F-101F). At the time of the report, HALLUCINATION (hallucinations), DIARRHOEA (diarrhea), DISTURBANCE IN ATTENTION (attention span of 10-15 minutes decreased), HYPERSOMNIA (spent most of last 4 days sleeping), ABDOMINAL PAIN UPPER (stomach pain like somebody beat me with a sledgehammer), ASTHENIA (still have weakness/no strength to go downstairs), BLOOD GLUCOSE INCREASED (my sugar level is high), VOMITING (throwing up) and PYREXIA (fever of 100F-101F) outcome was unknown, DYSPNOEA (shortness of breath very intense for 2 days) was resolving and VACCINATION SITE PAIN (soreness in arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Oxygen saturation: 94 (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
BUD date excursion, BUD was 4-7-23 and vaccine was administered 4-16-23.
Erythema induration 5x8 cm diam noted 24 hours after injection. Pt noted little itching also Px reported to health unit 48 hour after administration of vaccine, Diphenhydramine and KEFLEX given