chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; an improperly stored dose of PEDVAXHIB was administered to the patient on 30AUG2022; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 30-AUG-2022, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) dose 0.5 milliliter, lot #U029145, expiration date: 30-MAR-2024, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, and anatomical location were not reported) after a temperature excursion (temperature: 35.7 Fahrenheit (F); time frame: 4 hours and 26 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Lethargy; Feeling miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset 07Jun2021, outcome "unknown", described as "Lethargy"; FEELING ABNORMAL (non-serious) with onset 07Jun2021, outcome "unknown", described as "Feeling miserable". It was unknown if therapeutic measures were taken as a result of lethargy, feeling abnormal.  Additional information: It was unknown whether prior to the vaccination, the patient was diagnosed with COVID-19. Unknown if the patient received any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient states the night after receiving her 2nd Moderna booster she started to notice her eye was blurry. She saw her eye doctor on 07/28/2022 and stated there is a 'hole in the back of her eye.' Her information has been sent to a different eye institution from her eye doctor. She is waiting to hear from them. Her eye doctor is concerned this may be related to Moderna.
PATIENT PRESENTED WITH ITCHING TO FACE/CHEST, CHEST TIGHTNESS, HIVES CHEST/ARMS.
Developed red itchy spots on my torso and upper thighs the day after the vaccine but no other side effects.  Put anti-itch (TechNu) spray on them and they have begun to go away.  Lasting about 4 days
Pt developed 6 shingles lesions along the right mid-thoracic tract.  Denies pain, some itching.  Saw Dr. today (08/08/2011).
I had a persistent cough. It wasn't severe though. It continued for about a month. I am now using nasal rinse and decongestion. It seems to be under control and going away.
I was at RCSJ-Meg After 15-20 minutes my vision blurred, I had bad headache, felt very hot, somewhat dizzy and tired.  I sat for 45 minutes until I felt better.  Vision cleared, headache disappeared after 15-20 minutes thereafter ..  I iced my arm when I came home, and fell asleep for a few hours.
101 temp., painful, red, swollen, inflamed area by injection site. Nauseous first 12 hours. 24 hours of 101 temp.with inflamed area spreading encircling his entire upper arm.  With his auto-inflammatory disease we increased his prednisone to 20 mg.for 2 days, then 10 mg.for 2 days, then back to his normal daily 6 mg. No longer has temperature, arm still red, hot and painful.
"Pt w/ no NKDA but with hx of anaphylaxis of unknown cause.  PMH significant for anaphylaxis of unknown cause x1, allergic rhinitis and intermittent urticaria (possibly heat induced).  Pt has an Epi Pen due to hx of anaphylaxis. Pt was vaccinated @10:00.  At 10:15, pt c/o dizziness.  BP 112/70, HR 49, RR 20.  Pt indicates that he did not eat breakfast.  Pt given orange juice and graham crackers.  10:30 pt stabilized and released from the vaccination site."
I received my Covid- 19 vaccine in October18,2022. On 12/15/2022 I woke up with a cough and fever. Next day I contact my health provider and tested Positive for Covid-19.  I was prescribed Paxlovid. Symptoms Lasted 4 days.  Tested negative on the 4th day. However, I contacted Covid again on 12/24/2022. Symptoms  of cough is still on going
Due to misinformation, a 4th booster dose(0.25 ml) of the Moderna vaccine was administered to the patient on 3/4/2022. There were no acute signs and symptoms that occurred at the time of the event. The patients case manager, family, and primary care provider were informed of the event. Multiple follow up interactions were done and the patient's caregiver reported no adverse reactions.
Nausea, body aches, skin hurts, headache, very sore arm, fatigue, dizzy
Diarrhea, fever of 100 and abdominal pain started 48 hours after getting vaccine.
Patient vaccinated x3 (Pfizer: 3/11/21, 4/1/21,  11/24/21)  Patient tested positive during admission on 5/23/22
within a few days following the vaccine, I developed urinary urgency, frequency and severe burning, physician treated as a UTI. Now, 9 months post vaccine I am showing signs of renal disease with elevated protein levels in urine, elevated GFR. These were all normal prior to the vaccine. Continued urinary urgency, frequency and urine leaking.
Case number PHEH2016US028658, is an initial spontaneous report received from a consumer on 30 Oct 2016. This report refers to a 02 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) intramuscularly on 21 Oct 2016. On 24 Oct 2016, the patient experienced vomiting and diarrhoea. It was reported that vomiting started before diarrhoea. On 25 Oct 2016 and 26 Oct 2016, the patient was fine. On 27 Oct 2016, the patient started throwing up again and diarrhoea too started again. The final outcome of the events was unknown. The seriousness and causality of the events were not reported. The case was lost to follow up at initial.
Had immediate swelling at injection site with bleeding, requiring compression. She then developed flushing on her neck and patchy, non raised, non itchy rash on right upper arm near site of injection.  The hard area at the site of the injection did not change.  She experienced  no respiratory symptoms. Bp 130/60, pulse 60 bpm. Observed for 60 minutes post injection with no further worsening of findings or symptoms.
The back of the right arm where the Varicella was administered has some edema which is approximately the size of a ping pong ball. The area has some ecchymosis and erythema as well. The area is not hot and there is not any exudate present. Patient complains of a tingling sensation in the right ring and little fingers.  This was noted Saturday after rising.  No problems were noted on Friday following the Varicella Vaccination. No rash, hives or difficulty breathing.
patient with 26years old has tested positive for COVID19 on 22Dec2022; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Dec-2022 and was forwarded to Moderna on 27-Dec-2022.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient with 26years old has tested positive for COVID19 on 22Dec2022) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Dec-2022, the patient experienced COVID-19 (patient with 26years old has tested positive for COVID19 on 22Dec2022). At the time of the report, COVID-19 (patient with 26years old has tested positive for COVID19 on 22Dec2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was stated that a patient has tested positive for COVID19 on 22-Dec-2022 who previously received 3 doses of the Moderna COVID19 vaccine.  No treatment medications were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 78-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 29th July 2018, the patient received SHINGRIX .5 ml. On 29th July 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 30th July 2018, the patient experienced injection site rash, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site rash, injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site rash, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was inadvertently administered a dose of SHINGRIX in the side of the bicep not the deltoid, which led to vaccine administered at inappropriate site. One day after receiving vaccination, the patient developed a rash which was swollen and warm to touch, at the injection site.
Breakthrough case admission after 2 vaccines Janssen 3/16/21 Lot# 1802068;  Janssen 11/22/21 Lot# 1822811
1/14/21 8 AM patient noticed BILATERAL TEMPORAL RASH WITH PURITIS progressively getting worse spreading down and getting worse on both side meeting at nose. Pt. states that it is gradually getting worse. Pt. states that she has been taking zyrtec twice daily for one week. pt. states that rash developed on bilateral wrists. Pt. states that she started using hydrocortisone cream to face and wrists. Pt. states that this looked like plaque psoriasis. Pt. states that her rash is red and streaky and right side worse than left. No swelling, no throat closing. Puffy eyes as well.
weakness, paralysis, administered stress dose IV dexamethasone, regained strength in 1 hour
red spot size of quarter (day 5) whole shoulder was red swollen (day 6)
Rash over body and fever. Ax temp 101. Reports history of child very stiff legged pt was treated for this at home. Had gotten better until vaccines on 3/29/05. Pt was seen by MD and was told pt had a reaction to combination of vaccines. Treated w/ anti inflammatory meds and sent home.
C-19 Positive 08/06/2021 @ 08:41 Am
Patient was here last week for varicella vaccine on Thursday, 9/04/2008.  The next day, he had about a two inch area around the varicella injection site that was red and swollen.  Then on Saturday, it was red and swollen from the elbow to the shoulder.  No pain but warm and itchy.  No fever.  She gave him Benadryl, iced area, and that seemed to help. She almost called but had a friend who works at a hospital take a look at it.  Now, today the swelling is back to the two inch area with redness and itch.  Still no fever and no pain. Mom stated it's getting better but she just wanted to let someone know the type of reaction he had to the injection.  Advised if s/s increase or patient develops pain or fever to call for assessment.  Mother stated appreciation and agreement.
PATINET RECIEVED INJECTION IN RIGHT LEG ON 02-26-2007, AND THEN ON 02-27-2007 DEVELOPED A RED LUMP IN LEG APRROX 2 INCHES FROM INJECTION SITE. PT ADVISED TO MONTIOR SITE AND USE ICE.
Rebound COVID on day 13; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID on day 13) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulfa).    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (Rebound COVID on day 13). At the time of the report, COVID-19 (Rebound COVID on day 13) had not resolved.            No concomitant medication information provided. It was reported that patient received unknown drug for treatment of COVID-19 from 13-May-2022 till 18-May-2022. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that on 25-May-2022, rebound covid on day 13. Patient previously had received a COVID-19 Vaccine.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19, approximately 7 months after the third dose of mRNA-1273 vaccine, no details of previous doses were reported. As per source document, the patient experienced a rebound of COVID-19 after receiving Covid-19 treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious of COVID-19, approximately 7 months after the third dose of mRNA-1273 vaccine, no details of previous doses were reported. As per source document, the patient experienced a rebound of COVID-19 after receiving Covid-19 treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Mother described swelling and redness with tenderness over left parotid gland area with pain on opening in jaw, lasted 48 hours, used Ibuprofen.
Initial consumer (patient) report received on 05 Jan 2011: This patient with an unknown medical history was vaccinated with 1 dose of FLUVIRIN 2010/2011 (batch number: unknown) intramuscularly on 25 Oct 2010. The patient experienced a grand mal seizure on 27 Oct 2010. He did not have other incident since this seizure. The outcome and causality were not reported.
light headed; palpitations; tingling/numbing in both legs and arms; tingling/numbing in both legs and arms; a near syncope episodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Lot number: EW0185) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peniccilin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headed"; PALPITATIONS (non-serious), outcome "unknown"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "tingling/numbing in both legs and arms"; PRESYNCOPE (non-serious), outcome "unknown", described as "a near syncope episodes". The events "light headed", "palpitations", "tingling/numbing in both legs and arms" and "a near syncope episodes" required physician office visit and emergency room visit.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Patient was put on steriods and nerve meds. No covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Vomited; Fatigue; Nausea; Headache; Not feeling well; Wrong Injection Technique; Wrong Injection Technique; This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 15-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of RabAvert. On 27th September 2019, the patient received the 1st dose of RabAvert. On an unknown date, less than a day after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced vomiting, fatigue, nausea, headache, feeling unwell, vaccine administered at inappropriate site and vaccine administered at inappropriate site. On an unknown date, the outcome of the vomiting and headache were recovered/resolved and the outcome of the fatigue, nausea, feeling unwell, vaccine administered at inappropriate site and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the vomiting, fatigue, nausea, headache and feeling unwell to be related to RabAvert.  Aditional details were provided as follows: The batch number and expiry date of RabAvert was unknown. The nurse reported that, the patient received 1st and 2nd dose of RabAvert (post-exposure) in the buttocks, which led to vaccine administered at inappropriate site. After vaccination with dose of RabAvert, the patient had fatigue, vomited one time, nausea, headache and overall was not feeling good. On the day of reporting, the patient's mother reported that, the patient had no further vomitting, he was hungry and the headache has improved. The RabAvert administered in the emergency room, and not at office contact was calling from. No further contact information provided for hospital. The reporter consented to follow up.
Child started with erythematous macular rash - descendant type at night on 4/11/09 - taken to ER next morning -(not sure if case was reported). Child was seen today, still with macular rash, no palms/soles, mild on face, more on trunk/limbs. (+) retro auricular soft no tender nodes, no coryza. Temperature 100.4 F rectally. No history of fever or other symptoms.
Myalgia, Arthralgia, Fever, HYPERtension,  chest pressure about 8 hours after vaccine Narrative:  Patient developed chest pressure about 8 hours after vaccine being given. BP was elevated to 150/90's. Patient reported severe hip althralgias as well.  Other Relevant History:
More swollen today at injection site; Warm to the touch at injection site; Slightly swollen at injection site; Arm hard; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Arm hard), PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (Warm to the touch at injection site), INJECTION SITE SWELLING (Slightly swollen at injection site) and INJECTION SITE SWELLING (More swollen today at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, CHOLESTEROL and VITAMIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INDURATION (Arm hard) and PAIN IN EXTREMITY (Sore arm). On 11-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch at injection site) and INJECTION SITE SWELLING (Slightly swollen at injection site). On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (More swollen today at injection site). At the time of the report, INDURATION (Arm hard), PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (Warm to the touch at injection site), INJECTION SITE SWELLING (Slightly swollen at injection site) and INJECTION SITE SWELLING (More swollen today at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Jynneos administered intradermally; Case reference number US-BN-2022-003796 is a spontaneous case report initially received on 14-Sep-2022 from other health care professional via Communications (reference number: USBAV22-1398) and concerns a 50-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number not provided), at an unknown dose, site or route of administration, for unknown indication.  On 09-Sep-2022, an unknown amount of time the first dose, the patient was vaccinated with the second dose of Jynneos (Smallpox and monkeypox vaccine, live, nonreplicating, batch number FDP00016) at an unknown dose, intradermally for unknown indication (explicitly coded as 'intradermal injection').   At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos vaccination.  Additional information was received from Bavarian Nordic on 15-Sep-2022 and included the local BN case ID.  Additional information was downloaded from VAERS portal on 26-Sep-2022, and the information included route and site of Jynneos administration.; Reporter's Comments: A 50-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date, at an unknown dose, route or site of vaccination. Reportedly, no wheal was formed following vaccination. On 09-Sep-22 the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine was administered intradermally, and this was coded as intradermal injection. The event is considered listed as per the Company conventions. The patient's medical history and concomitant medications were not provided. It was unknown if the patient experienced any adverse events following vaccination. The case is non-serious. Intradermal injection is assessed as not related to the suspect vaccine but related to a human factor.; Sender's Comments: A 50-year-old male patient was vaccinated with the first dose of Jynneos vaccine on an unspecified date, at an unknown dose, route or site of vaccination. Reportedly, no wheal was formed following vaccination. On 09-Sep-22 the patient was vaccinated with the second dose of Jynneos vaccine. The vaccine was administered intradermally, and this was coded as intradermal injection. The event is considered listed as per the Company conventions. The patient's medical history and concomitant medications were not provided. It was unknown if the patient experienced any adverse events following vaccination. The case is non-serious. Intradermal injection is assessed as not related to the suspect vaccine but related to a human factor.
PT CAME TO PHARMACY ON 9/28/22 REPORTED THAT REDNESS ON SITE OF INJECTION, SWOLLEN AND HIVES LASTED 2-3 DAYS
pt rcvd vax; 1 to 2 min later pt felt dizzy & lightheaded; pt devel tunnel-vision & had nausea w/ stomach discomfort; there was urinary incontinance;
9pm - Chills & aches 4am - Woke up & must have been breathing through mouth....nose completely clogged.  Vision was foggy/smoky.  Oxygen level was 89. Fever of 101.