chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received her first Moderna COVID-19 vaccination on 12/29/2020.  However the patient was diagnosed with a positive COVID-19 test on January 4, 2021.  Patient complained of nausea, vomiting, back pain, and sharp chest pain.     On January 13, the patient presented to the emergency department again with shortness of breath and sharp, stabbing left-sided chest pain radiating to her back and right side. Initial work up ruled out cardiac etiologies. CTA chest demonstrated COVID-19 pneumonia.    The patient complained of bilateral lower extremity weakness which had been progressing since her COVID-19 vaccination, per patient report.  However, during her hospitalization the patient's bilateral lower extremity weakness began to accelerate.  On the 13th, the patient was able to ambulate to and from the bathroom herself.  Then on January 14 the patient required maximum assistance. Neurology was consulted and work up initiated for suspected possible Guillain-Barré syndrome (GBS) secondary to recent COVID-19 infection.    On January 15, 2021, the patient became obtunded and unable to protect airway.  She was emergently intubated for acute hypercapnic respiratory failure secondary to GBS. Neurology started GBS treatment with IVIG. Patient also developed NSTEMI and Takotsubo cardiomyopathy. Patient remains critically ill requiring mechanical ventilation.
Fever reaching 104.9 degrees F occurring about 12-13 hour following vaccine. Fever remained above 103 for following 8-10 hours. gradually reducing to normal temperature 62 hours following vaccine with other side effects lingering.
Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
Expired First Dose Administered; Initial Report Received on 09-Oct-2023  A pharmacist reported that a 38-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  No relevant concomitant medications were reported.  On 22-Sep-2023, the patient received the first dose of HEPLISAV-B (Lot #937228, expiration date: 30-Aug-2023, and NDC # 43528-003-05) intramuscular in the left deltoid.  Concomitant vaccination given was reported as COVID vaccine (details not reported).  No adverse reactions were experienced by the patient to the reporter's knowledge.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Patient received moderna vaccine on 3/13/21, 4/10/21, and 11/22/21. Presented to ER on 8/5/22 due to unwitnessed fall. Found to be COVID positive on 8/2/22. No treatments during this admission for COVID
Generally feeling unwell; Rash; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (Generally feeling unwell), RASH (Rash) and CHILLS (Chills) in an elderly female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Generally feeling unwell), RASH (Rash) and CHILLS (Chills). At the time of the report, MALAISE (Generally feeling unwell), RASH (Rash) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
temperature of 99.6 Fahrenheit; a cut body; rhinorrhea; congestion nasal; earache; This is a spontaneous report received from contactable reporter (consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "COVID-19," start date: 2021, stop date: 2021, notes: She suffered from COVID-19, approximately 1-2 months prior reporting; although she was not hospitalized, she required oxygen support and had not been vaccinated prior to infection. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown," described as "temperature of 99.6 Fahrenheit;" DISCOMFORT (non-serious) with onset 2021, outcome "unknown," described as "a cut body;" RHINORRHOEA (non-serious) with onset 2021, outcome "unknown," described as "rhinorrhea;" NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown," described as "congestion nasal;" EAR PAIN (non-serious) with onset 2021, outcome "unknown," described as "earache." Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: One day after receiving the vaccine, the patient had a temperature of 99.6 Fahrenheit, a cut body (as reported), rhinorrhea, nasal congestion, and earache. This was the first and only dose of vaccine received. The events occurred after use of the product.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
19JUL93 pt exp fever 7 hrs p/vax; 20JUL @ 5 AM fever became worse-104F & pt had sz; taken to ER febrile & irritable; hospitalized 5 days; rx'd w/Rocephin; final dx febrile sz; pt recovered; also dx'd for bilateral OM;
Pt c/o rapid breathing, dizziness, chest tightness.  Pt has a hx of reaction to the first dose w/  "very fast heartbeats, wheezing, and sweating" that had started several hours after vaccination 3/23/21.  PCP authorized second dose of Moderna.  BP 112/79, HR 77, RR 20 -- > 118/70, 70, 18 -- > BP standing 119/70, 67, 14.  Pt given Albuterol 2puffs ~20min post vaccination. Pt also given crackers, juice, water.  Pt stable and released from the vaccination site.  Recommended that the patient follow up with their healthcare provider, f/u instructions provided.  Pt has a hx of Asthma but is not currently taking routine medications.
Pt adm Hep B vax (recombinant) on 4SEP90 & 4OCT90; 10DEC90 recvd third dose of vax which does not follow the six month protocol; @ time of the report there were no other adverse exp; No further details were provided;
Skin swelling, erythema (10 x 10 cm area) itching, mild induration directly under injection site (2 x 2 cm area).
Day 1 after injection chills, fever, fatigue, headache, arm soreness, body aches. Treated with sleep, ibuprofen.  Ended the next day.  Day 2 after injection- injection site swollen sore and rash. Day 3 - injection site rash and swelling increased in size about 5 inches. Sore and itchy, warm to touch.
LOCAL VACCINE REACTION. ON RIGHT LATERAL PROXIMAL THIGH, TWO VERY CLOSE PINPOINTS SLIGHTLY RAISED SOMEWHAT VESICULAR LOOKING LESIONS.INDURATION SURROUNDING LESION. LOCAL SKIN RACTION EITHER FROM VARICELLA OR MMR IMMUNIZATION IN RIGHT THIGH. PATIENTS GRANDMOTHER TOLD TO WATCH FOR ANY SIMILAR LESIONS OR HIGH FEVER, CHILLS AND TO RETURN TO OFFICE IF THEY OCCUR, OTHERWISE LOCAL WOUND CARE WTIH TOPICAL BENADRYL OR ORAL BENADRYL AS NEEDED FOR ITCHING. SYMPTOMS BROUGHT TO GRANDMOTHERS ATTENTION ON 3-11 DUE TO ITCHY AREA ON PATIENTS THIGH. PATIENT HAD NO OTHER SYMPTOMS.
Case number PHEH2014US022366, is an initial spontaneous report received from a consumer (patient) on 05 Nov 2014. This report refers to a 57 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscular on 03 Oct 2014. It was reported that on 05 Nov 2014 she experienced pain at injection site and muscle weakness. The outcome of events was reported as unknown. The seriousness and causality of the events were not reported.
she developed little tiny red bumps like little fire ant bites and they kinda went away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune deficiency/tolerance" (unspecified if ongoing); "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "she developed little tiny red bumps like little fire ant bites and they kinda went away.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme left lymph node swollen causing more than discomfort for a couple of weeks; Extreme left lymph node swollen causing more than discomfort for a couple of weeks; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19,, Prev dose brand=PFIZER,, prev dose brand unknown=False,, prev dose lot number=EW0170,, prev dose lot unknown=False,, prev dose administration date=26Apr2021,, prev dose administration time=12:00 PM,, prev dose dose number=2,, prev dose vaccine location=Right arm,), administration date: 26Apr2021, for COVID-19 immunization; BNT162b2 (prev dose product=COVID 19,, Prev dose brand=PFIZER,, prev dose brand unknown=False,, prev dose lot number=8743,, prev dose lot unknown=False,, prev dose administration date=05Apr2021,, prev dose administration time=02:00 PM,, prev dose dose number=1,, prev dose vccine location=Left arm), administration date: 05Apr2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), DISCOMFORT (non-serious) all with onset 07Dec2021 at 11:30, outcome "recovered" and all described as "Extreme left lymph node swollen causing more than discomfort for a couple of weeks"; HEADACHE (non-serious) with onset 07Dec2021 at 11:30, outcome "recovering". Therapeutic measures were not taken as a result of lymphadenopathy, discomfort.  No follow-up attempts are possible. No further information is expected.
About 4 days after my second Moderna Covid-19 vaccine, I began breaking out in a rash in areas of my body where there are lymph nodes (armpits, groin,).  In another day, the rash began spreading throughout my arms and legs.  It is extremely itchy. I visited the Dr. 3/3/21, who confirmed the rash and said it was consistent with a drug reaction.  I began taking Benadryl and an antacid.
loss of taste; Temperature reading of 99 degrees; body aches; chills; fatigue; A report was received from a pharmacist concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and developed fatigue, body aches, loss of taste, chills, and temperature of 99 degrees.   The patient's medical history, as provided by the reporter, included cancer and type II diabetes. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient began feeling fatigue on 31 Dec 2020.  ON 02 Jan 2021 he had a temperature of 99 degrees, body aches, chills, and loss of taste.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fatigue, body aches, loss of taste, chills, and temperature of 99 degrees were not reported.  Reporter causality for the events was not provided.; Reporter'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.
On Saturday patient woke up saying he was in extreme pain with his left arm.  At 5  o'clock that night he lost his equilibran and I had to call 911.  They came and after an initial examination took him to Hospital's emergency room.  They did c-scans, MRI.  and they said that a blood clog was showing in his brain and that he had atrium filibration of his heart.  His vision has been affected, though the hospital thinks it will improve.   The left side of his body is not function right and he needs a walker to walk.  He has been in ICU since Sunday.  This is late Tuesday.
Elevated BP; This is a spontaneous report from a contactable consumer reported that. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The caller explains her neighbor had the same reaction and her blood pressure was elevated as well. She states they got their vaccines on the same day on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on an unspecified date. The event outcome was unknown.  No further details were provided or obtained.  Information on the lot/batch number has been requested.
PT VERBALIZES BROKE OUT WITH 4 SMALL RED BUMPS ABOUT 2 INCHES ABOVE NAVEL 10 DAYS AFTER SHINGLES SHOT. ITCHED FOR 45 THEN WENT AWAY. NOW SPOTS ARE DISAPPEARING. WENT TO PRIVATE PHYSICIAN AND HE RULED OUT SHINGLES. FEELS FINE, NEVER FELT ILL. UNSURE WHAT CAUSED RED BUMPS.
Pt. presented with mild swelling and erythema, tenderness and itching to right deltoid at the Td administration site 2cm in diameter. Supportive tx with ice packs, OTC Tylenol and OTC Hydrocortisone cream 1% topically BID. S/s resolved with supportive care and resolved by 11/25/19.
A cluster of 2 female patients who received FLUZONE (lot number UT3172BA) and developed injection site redness, lump, and burning one day after vaccination. Initial report received on 24 September 2009 from a healthcare professional. A 50+ year old female patient, whose medical history was not reported, received a left deltoid intramuscular injection of FLUZONE (lot number UT3172BA) on 23 September 2009. Concomitant medications and illness at the time of vaccination were not reported. She had received no other vaccinations within the four previous weeks. She has received previous flu shots and had no adverse event following prior vaccination. One day after vaccination, 24 September 2009, the patient developed redness, a lump, and burning at the injection site. Corrective treatment was not reported. At the time of the report, the patient had not recovered. Follow-up information was received from the health care professional, who is also the patient, on 13 October 2009. The patient was 55 years old at the time of the event. She did not receive any other vaccines on 23 September 2009, and the events subsequently recovered. Case 2009-04080, with the same reporter and same FLUZONE lot number, contains the events for the second patient.
Flu-like symptoms for 48 hours, headache and pain at injection site for 72 hours
Shot given and needle was faulty half the dose did not get injected into patient arm. Doctor made aware.  This was administered in the pharmacy
SEVERE SYSTEMIC ITCH, SEEMS LIKE IT TRAVELS IN THE NERVES TO ALL PARTS OF THE BODY INCLUDING THE EYES, NOSE, EARS AND THE WHOLE BODY. ON PREDNISONE NOW AND BENADRYL.
PATIENT HAD SENSITIVE URINATION, ALMOST FELT LIKE A UTI.  IT HAPPENED THAT DAY OF THE VACCINE UNTIL ABOUT 24 HOURS.  PATIENT DIDN'T TAKE ANY MEDICATIONS FOR IT
On day 1 of injections, Patient reported pain and was favoring his right leg.  Mother noticed a rash developing on day two.  It initially looked like a couple small bug bites... Throughout the day, the rash/redness expanded and there were multiple red bumps that were harder under the skin and painful to the touch. Skin/rash was hot. Took child to clinic to see Dr. who marked for monitoring.  Rash continued to grow into the third day. It went outside of the marked lines.  Mother marked new lines on night three. By the midmorning or early afternoon on day four, the rash started to improve. The doctor had prescribed medicine that we did not give Patient... He seemed to be acting normal other than when we touched it, so we didn't give the medicine.
injection site soreness; little redness at sight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old 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, less than 3 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age could be 66 years or 67 years at the time of vaccination. The patient received Shingrix and had slight soreness at sight, and a little redness at sight.  For tolerances of 2nd dose, refer case US2020AMR070625, reported by same reporter for the same patient.
Was giving patient the MMR vaccine in left upper arm and patient had moved vaccine had come out of his arm, and only half the dose was administered. Did speak with RN in office and she spoke with mom and mom was agreeable to patient getting another MMR vaccine today 11/21/23 since the half dose is an invalid dose. Dr. also spoke with patient's mother.
pt is a 36 y.o. woman with no significant medical history admitted for progressive fevers, rash, oral ulcers, and diarrhea over the past 3-4 weeks -- symptoms started 2-3 days after first dose of covid vaccine. Rheumatology was consulted to evaluate for SLE. She had initially been placed on broad spectrum antibiotics which have been since discontinued as no infectious etiology has been demonstrated. Her labwork on presentation were notable for AST/ALT elevation and hyponatremia. The latter has improved and the former has been variable but trending towards improvement. She also had marked pancytopenia with lymphopenia (ANC>500). Her liver US was normal. She has not had intraluminal evaluation of her colon. Her rheumatologic workup is notable for pending ANA and dsDNA, elevated cardiolipin and B2-glycoprotein, Ro60 1374.60, RNP 172.6, Sm 621.8, ESR 28, CRP negative, C3 24.8, C4 6.48, positive Coombs, negative Jo1, and pending histone. Urine had low spec grav but othwerise bland but UPC 0.63.    Ms.  most definitely meets criteria for systemic lupus erythematosus. It is possible that interferon upregulation after Covid vaccination may have been antecedent cause for this presentation. Given fevers and diarrhea in the setting of lymphopenia, we would be concerned for her presentation being confounded by a gastrointestinal infection acquired after her acute lupus flare. Lupus enteritis is an overall not common sign of acute lupus (only case reports). We recommend gastrointestinal evaluation before high dose immunosuppression to rule out any other causes such as autoimmune hepatitis given elevated LFTs and diarrhea.  Since she is not having diarrhea currently on her abdominal exam is completely benign, a CT of the abdomen can likely be avoid for now. It is even possible that her diarrhea was due to antibiotics. Given the assurances of the  evaluation and negative serologic workup thus far, we would consider initiating prednisone 40 mg daily to be titrated outpatient.  We would also obtain TPMT for possible initiation of long-term immunosuppression in the outpatient setting.  She does have oral thrush and should be treated with that for now with nystatin. An EGD should be considered if she develops odynophagia. Her proteinuria is concerning for renal involvement.  Lupus nephritis Class V confirmed by biopsy
2/5/11: Patient reported complaints of red, itchy rash shortly after receiving the flu shot. He used BENADRYL with no improvement. 2/7/11: Rash improved (per patient) with OTC Aveeno bath, BENADRYL, and hydrocortisone cream. Still itches at night. Treatment: Diphenhydramine UD, Hydrocortisone UD, Oatmeal UD.
patient experienced a similar set of hives on the left arm; Hives his right foot, ankle, knee and calf; Red; Swollen; Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), URTICARIA (Hives his right foot, ankle, knee and calf), ERYTHEMA (Red), SWELLING (Swollen) and VACCINATION SITE URTICARIA (patient experienced a similar set of hives on the left arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced HEADACHE (Headache). On 14-Jul-2021, the patient experienced URTICARIA (Hives his right foot, ankle, knee and calf), ERYTHEMA (Red) and SWELLING (Swollen). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (patient experienced a similar set of hives on the left arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency; ALCOHOL at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), URTICARIA (Hives his right foot, ankle, knee and calf), ERYTHEMA (Red), SWELLING (Swollen) and VACCINATION SITE URTICARIA (patient experienced a similar set of hives on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 19-AUG-2015, the patient was vaccinated with the fourth dose of RECOMBIVAX HB (dose, strength, lot # and route were not reported). The patient's first three doses of RECOMBIVAX HB wer3e respectively administered on 12-MAY-2002, 11-JUL-2002 and 28-JAN-2003 (inappropriate schedule of vaccine administered). No adverse experience was reported. Additional information has been requested.
Information has been received from a physician and a licensed practical nurse concerning a 6 month old male with no past medical history, who on 03-MAY-2006 at 11:00 AM was vaccinated intramuscularly in the left thigh with the third dose of PedvaxHib (lot #652500/1006R). Concomitant vaccination on 03-MAY-2006 included the third dose of Pediarix (lot #AC21B056AA) given in the right thigh. The patient had no illnesses at the time of vaccination, and had no adverse events following prior vaccinations. On 03-MAY-2006, at 4:00 PM, the patient developed a "drawing of the neck to the left". The movement of the neck was repetitive (10-15 times per minute). The movement was described as being "not seizure like" but was described as myoclonus. The patient was previously vaccinated with the second dose of PedvaxHib (lot #652500/1006R) which was "tolerated fine". Unspecified medical attention was sought. At the time of this report, the myoclonus persisted. The patient was scheduled to undergo an EEG. The patient's physician felt that the event was not related to therapy with PedvaxHib. No further information is expected.