chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee was known to have a history of prior anaphylaxis to another vaccine and medications she had received in the past so was advised to receive Covid vaccine in acute care setting, About 20 minutes after receiving 1st covid vaccine, she started to have chest tightness with increasing hoarseness and wretching vomiting. Epinepherine given IM and transferred to ED for further monitoring and treatment. In the ED, received zofran, iv benadryl, albuterol neb, additional IM epinephrine dose, solu-medrol 125mg.  She was observed for several hours and discharged home.
8-7-18 SHINGRIX GIVEN IM...8-10-18 PT SAYS HE HAD SHINGLES ON HIS HEAD, FOREHEAD AND RIGHT EYE. HE CONTACTED DR. PHYSICAN STARTED HIM ON GABAPENTIN, VALACYCLOVIR, TOPICAL ACYCLOVIR...PHYSICAN ALSO REFERRED PT TO EYE DOCTOR AND WAS GIVEN "ANTIVIRAL EYE DROPS"....PT CAME TO PHARMACY 8-22-18 SAYING HE IS DOING MUCH BETTER BUT WANTED TO TELL US WHAT HAPPENED AND THAT HE IS UNDER THE CARE OF DR. HE ASKED FOR THE LOT # AND EXPIRATION DATE OF THE SHINGRIX THAT WAS ADMINISTERED. PT WAS IN VERY GOOD SPIRITS AND VERY KIND.
migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208414.
Injection site rash, swelling, redness, itching, about 4 inches,area felt hard
Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 57 years old female patient who was vaccinated with a 0.5 ml dose of vaccine MENACTRA (lot U6151AB and Exp. Date 16-MAR-2019) via unknown route in the arm NOS instead of vaccine TENIVAC on an unspecified date. The patient's medical history was not reported and concomitant medications included PNEUMOCOCCAL PNEUMOVAX 23 given in arm for Immunisation. It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient reported arm being sore and tender. Her upper arm started swelling and turned red on 12/1/16, but then the swelling began to spread past her elbow as time progressed. The swelling was warm to the touch. After a visit with her PCP, it was decided that she see him for assessment. He prescribed a medrol therapy pack for the swelling.
4/19/21 my left arm hurt and was numb/tingling from my shoulder to my finger tips. 4/20/21 I started to feel nauseated and extremely tired. Later in the day the nausea went away and a headache started. 4/21/21 my left shoulder, wrist, and the bend hurt. Still extremely tired with a slight headache.
It was reported that a 56 year old female pt received Fluzone (U0962BA) administered in her left arm IM at 9:50 am on 11/13/2002. Five minutes after administration the pt developed localized erythema, an area the size of a 50 cent piece on the left deltoid above bendaid, not at injection site specifically. Vitals were taken, upon request from pt, Benadryl 25mg per oral was given. Pt was monitored for 30 minutes-no swelling, no SOB, no pain or numbness was noted, pt returned to work. Pt was instructed to use cool compresses and Tylenol, pt instructed to call infection control nurse as occasion requires. Reportedly the pt recovered from this experience. This case is closed.
large 4 inch raised welt on the arm at injection site  4/15-contacted the patient , tried the Benadryl cream , didnt really help as of yet .
swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 12:15 (Lot number: EN6208) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1999 (unspecified if ongoing); "Breast cancer", start date: 2012 (unspecified if ongoing); "Blood pressure", start date: 1998 (unspecified if ongoing); "vitamin D low" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Iron low" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "stomach" (unspecified if ongoing); "lymph nodes taken out for examination back when she had breast cancer" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis, start date: 1999 (ongoing); POTASSIUM CHLORIDE taken for blood cholesterol abnormal, blood pressure abnormal, start date: 1999 (ongoing); CLONIDINE taken for blood pressure measurement, start date: 1999 (ongoing); FOLIC ACID taken for rheumatoid arthritis, start date: 2001 (ongoing); TIAZAC XC taken for blood pressure measurement, start date: 1999 (ongoing); LOSARTAN taken for blood pressure measurement, start date: 2005 (ongoing); METOPROLOL taken for blood pressure measurement, start date: 2006 (ongoing); HYDRALAZINE APS taken for blood pressure measurement, start date: 2008 (ongoing); VITAMIN D2 taken for vitamin d decreased, start date: 2010 (ongoing); IRON taken for blood iron decreased, anaemia (ongoing); DICYCLOMINE taken for gastrointestinal disorder (ongoing); OMEPRAZOLE taken for gastrointestinal disorder (ongoing). Vaccination history included: Bnt162b2 (Dose number:01; Left arm, Lot Number: EN6200, Administration time; 15:00), administration date: 25Feb2021, for Covid-19 Immunization, reaction(s): "swollen lymph nodes". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Mar2021, outcome "not recovered", described as "swollen lymph nodes". Additional information: Got the second dose 19Mar2021 at 1215PM in the left arm. She noticed swollen lymph nodes on her shoulder in the collar bone area on the left side; first noticed Sunday 21Mar2021. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to Emergency Room?  No. Physician Office? No. Prior Vaccinations (within 4 weeks): None. Family History: No. Relevant test: None.  No follow-up attempts are possible. No further information is expected.
Pain, redness, swelling, fever, chills, widespread muscle aches & joint pain. Redness & swelling, measured 8 x 10 cm total induration & erythema was 16 x 18 cm.
On 3/31/07 pt started having headaches approx 7:30 pm-Headaches over left eye-no other s/s-duration of headache until approx 9 pm 4-5-07 (as stated by doctor)
No Adverse Event; Bivalent vaccine was given 2 days beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No Adverse Event) in an 86-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jan-2023, 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 19-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD).    No concomitant medication were reported. No treatment medication were reported.
This case was reported by a consumer and described the occurrence of elevated liver enzymes in an adult female pt who received hepatitis B vaccine. The reporter is the pt. A physician or other health care professional has not verified this report. On an unspecified date in 7/03, the pt received the 3rd dose of hepatitis B vaccine. Approximately 2 months after the administration of the 3rd dose of hepatitis B, on an unspecified date in 9/03, at the pt's "annual physical", a blood test revealed elevated liver enzymes. The pt reported that, on an unspecified date following the 3rd dose of hepatitis B vaccine, "an ultrasound and MRI of the liver found no abnormalities". The event was ongoing at the time of initial reporting. Comment: Elevated liver enzymes was assessed as medically serious by mfr.
Fever, chills, headache, N/V, injection site pain beginning 3/13/2021, reports that she "passed out" on 3/13/2021. Spoke with PCP who advised her to go to hospital but she did not go. Taking tylenol as needed. Started feeling better yesterday, eating and drinking. Advised to follow PCP recs and we will follow up with her tomorrow.
Febrile Seizure - lasted 25-30 mins - double dosage of Ativan to stop it only to have another at 6:25 PM lasting over 40 mins with vomit and bleeding.
Patient was admitted for back pain, dysuria, and possible pneumonia. Presumptive COVID positive.
Achy after 2nd dose; Prickly skin after 2nd dose; Less joint pain, including hip and feet, since 2nd dose; Chills; diarrhea; fever of 100.4/fever lasted 36 hours; headache again after the second shot/headache and it came and went; body aches again after the second shot/body aches lasted 3 days; nausea; Injection site arm pain after both doses; unbearable fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy after 2nd dose), SKIN IRRITATION (Prickly skin after 2nd dose), DIARRHOEA (diarrhea), PYREXIA (fever of 100.4/fever lasted 36 hours) and HEADACHE (headache again after the second shot/headache and it came and went) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (fever of 100.4/fever lasted 36 hours), HEADACHE (headache again after the second shot/headache and it came and went), MYALGIA (body aches again after the second shot/body aches lasted 3 days), NAUSEA (nausea), VACCINATION SITE PAIN (Injection site arm pain after both doses) and FATIGUE (unbearable fatigue). On an unknown date, the patient experienced PAIN (Achy after 2nd dose), SKIN IRRITATION (Prickly skin after 2nd dose), ARTHRALGIA (Less joint pain, including hip and feet, since 2nd dose) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) at an unspecified dose and frequency. At the time of the report, PAIN (Achy after 2nd dose), SKIN IRRITATION (Prickly skin after 2nd dose), DIARRHOEA (diarrhea), PYREXIA (fever of 100.4/fever lasted 36 hours), HEADACHE (headache again after the second shot/headache and it came and went), MYALGIA (body aches again after the second shot/body aches lasted 3 days), NAUSEA (nausea), VACCINATION SITE PAIN (Injection site arm pain after both doses), FATIGUE (unbearable fatigue), ARTHRALGIA (Less joint pain, including hip and feet, since 2nd dose) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature increased: 100.4 (High) High. On an unknown date, Body temperature increased: 101.5 (High) Fever of up to 101.5 degrees F for 12 hours.         On 22-Apr-2021, after second shot  drank a lot of water as a treatment.  No concomitant  information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up document was attached on 01-Jun-201 which contains updated events : Fatigue, Arthralgia, Chills, Skin Irritation and Pain.
1 week after the first dose had vertigo. was prescribed meclezine on 9/7/2022.  since then hasn't felt the same . had long lasting dizziness, brain foggy, headaches.  was prescribed topiramate .
received the second dose of the Moderna Covid-19 Vaccine 21 days after receiving the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the Moderna Covid-19 Vaccine 21 days after receiving the first dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the Moderna Covid-19 Vaccine 21 days after receiving the first dose). On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the Moderna Covid-19 Vaccine 21 days after receiving the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
t101.6 t on 5APR x 3 days body aches, stiff arms & legs beginning 6APR to 7APR92;
A 13 year old boy who died after receiving Moderna; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (A 13 year old boy who died after receiving Moderna) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 DEATH (A 13 year old boy who died after receiving Moderna) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown. No concomitant medication information was provided. No treatment medication was provided.  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 is a spontaneous case of product administered to patient of inappropriate age for this 13-year-old, male patient with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non-significant FU appended On 27-Sep-2021: Non-significant FU appended; Sender's Comments: This is a spontaneous case of product administered to patient of inappropriate age for this 13-year-old, male patient with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Death.
Patient was in office to receive BEXSERO #1. 3 mins. after vaccination was given had a syncopal episode. The patient fell from the exam table with injuries to the nose/chin/lower lip areas. The fall was not witnessed unsure of source that caused the injuries. Transferred to ER for further evaluation.
After receiving vaccine he go t light headed at the sigh of blood. Shortly after he passed out and hit the floor.  He stated that he has never had a adverse reaction to shots before.
Immediate pain and loss of range of movement of left shoulder. Physical examination today demonstrates a healing injection site which is fairly superior on the left shoulder, and abduction of the left shoulder which is limited secondary to pain.  Patient's physician's impression is that he has a subdeltoid bursitis which was temporally associated to the COVID-19 vaccination.  (SIRVA)
Sore arm, 24hr; tiredness the next day; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) administration date 02Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: " neurocardiogenic syncope (P.O.T.S)" (unspecified if ongoing). Concomitant medication(s) included: FLORINEF taken for syncope. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm, 24hr"; FATIGUE (non-serious), outcome "unknown", described as "tiredness the next day".  Additional Information: Caller said that she experienced the next day after vaccine, Sore arm, 24hr, "felt like someone punched me" and tiredness the next day. She have heard that people who had COVID had worse side effects after shot, she asked if was that true. She had been prescribed 0.1mg FLORINEF, which her husband was also taking for about a week for -POTS- neurocardiogenic syncope She was asking for information about how the medication might affect the vaccine, since it was a corticosteroid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8-23-13 Per mother, patient felt hot, flushed, and nauseated, called her mother, mother found her "shaking, and then her eyes rolled back in her head. This lasted just for a few seconds."  8-29-13, nurse noted rash on (L) deltoid, measuring 50 mm x 65 mm outside edges, no erythema in center.
pt recvd vax;2 days later,noticed rash (raised red welts) on side of both arms,from armpits to wrists like goosebumps; not itchy; gradually faded, but noticeable for 1 wk;
Symptom onset 9/12 with coughing. Admitted to hospital on 9/15 with worsening symptoms but currently doing much better and discharged planned tomorrow for rehab
pt presented to ED with increasing SOB; positive for COVID; condition worsened requiring intubation with mechanical ventilation; pt experienced an acute MI and GI bleeding; respiratory status worsened and pt became hypotensive; multi-system organ dysfunction; family decided no chest compressions, shock or ACLS medications; pt died in the hosp
Temp 101 for 48 hours with muscle cramps for first 24 hours and weakness to follow.  Unusual "chickpox" lesions on thighs started to appear after first 24 hours - not sure if it is related to fever or injection.  Started to fade after 72 hours.
At first I had no side effects other than a sore arm. However, later on the same day, I began experiencing severe cold chills. The next morning I experienced hot and cold flashes and had a fever.
3 days post vaccination, patient had eruption of hives and developed extreme fatigue, arm and leg pain, and muscle weakness, severe enough that she had to discontinue participation in track. Symptoms are slowly resolving, but lower extremity weakness complaint persists.  4/24/09 MR received from PCP.  OV 3/17/09 with c/o pruritic rash, fatigue and heaviness and aches in the legs. Sore throat last week. PE (+) for nasal mucosa and throat erythematous, increased anterior nodes, erythematous, hive-like lesions on the arms, legs and back.  Assess:  Urticaria.  URI.  Constipation.  Office note 4/14/09 states pt still c/o leg heaviness, rib pain, stomach pain, muscle aches and fatigue.  RTC 4/16/09 with c/o fatigue, extremity pain and weakness.  Had to quit track 2' lower extremity weakness. PE (+) for 1+ patellar DTRs and able to get out of chair using arms. Assess:  ? myalgias and lower extremity weakness 2' to Gardasil.
Since the injection have suffered from nighttime (around 3-5am) heartbeat and shallow/difficult breathing.  During the day, I do not really notice anything, but when I wake up around 3-5am to use the bathroom (pee), my heart is beating around 80-90 BPM and I noticed the last few nights, my breathing--each actual breath--does not draw in as much oxygen as I am used to, or need.  After I prop myself up a bit, and concentrate of calming myself, it seems to go away (I don't know if that is the reason or if it would have subsided anyhow).  I then get up for work around 630am anyhow.  I am in good health, I work out, don't drink or smoke, engaged in recent years in athletic training (powerlifting and.  My Tinnitus is service connected, as a veteran, and my migraines have been connected by another health care provider.