chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; More than 35 days between Moderna Primary Series vaccines in March to May 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-May-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023).    No concomitant medications were provided. Patient received first Moderna COVID-19 vaccine on 01-Mar-2023 with lot number 071B22A, expiration date was 31-Mar-2023. Injection site arm was not known. No other adverse events reported. No treatment medication was provided.
Rheumatoid arthritis aggravated; Chills; Depression; INTERMITTENT FEELING OF ANXIETY; RED DOT AT THE INJECTION SITE; This case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis aggravated in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), chills, depression, anxiety and injection site erythema. The subject was treated with adalimumab (Humira). On an unknown date, the outcome of the rheumatoid arthritis aggravated, depression and anxiety were unknown and the outcome of the chills and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, chills, depression, anxiety and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. There was no reported medical history. The patient experienced arthritis symptoms worsened and red dot at the injection site with Humira 40MG/0.4ML (Adalimumab) was no reasonable possibility.
pt recvd vax; devel five varicella lesions on lt hip, one lesion on each arm & one on each leg;fussiness that accompanies varicella infection; lesions disappeared w/in 4 days
Patient experienced arm soreness after vaccine was given, then gradual arm pain the next few days. Patient stated that the arm was difficult to move in an "up" motion. Currently the pain comes and goes, it still lingers and he has made an appointment to see his PCP.
Caregiver returned to employee health office the next r/t concerns for rash on bilateral thighs and lower back following the flu shot.  Pt had the same reaction following Tdap in 2/2019.  Injection site was WNL and employee state the rash was not raised today as it was the night the shot was given.  I recommend she receive all  future vaccines and flu shots from PCP for extra monitoring.
Patient started feeling as she described as tingly.   Her skin below the head (neck area of injection) were splotching.  Patient did not report having trouble breathing.  Was responsive to questions.  Patient stated she felt as though she were going to faint.  Emergency number was called.  Emergency persons arrived quickly and attended to the patient.
On 1/28/2021, 3 days after her injection my mom started feeling unwell.  She felt dizzy, drowsy and had no energy (fatigued).  This went on  for 4 days (until 1/31/2021).  She called a nurse at her facility morning of 1/31/2021, who told her it was most likely a side effect from the vaccine.   My mom did not feel reassured and called the front desk at her facility.   Eventually 911 was called, the paramedics came afternoon of 1/31/2021 and they told her her blood pressure was not quite right, and if she wanted to go to the hospital.  She said no.   She was less upset though.   She still didn't feel "normal" until 2/2/2021.  She is prone to panic and PTSD if things don't feel right.
Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 at 16:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonazepam (KLONOPIN), vortioxetine hydrobromide (TRINTELLIX), vitamin d nos (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and metoprolol (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 05Aug2021 at 07:00, the patient experienced vomiting. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported event. The clinical outcome of the event vomiting was resolved on an unknown date in Aug2021.
pt devel inj site rxn following administration of vax;this is one of three pt from this site;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-APR-2015, the patient was treated at a health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir and lidocaine for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient felt they were going to pass out. assisted to floor. called 911. vitals good. slight tachycardia. clammy skin resolved quickly. patient commented they thought their blood sugar was low. administered glucose tablet. patient went to emergency room as precaution- was being discharged when follow up call was made- event approx 12:05pm. discharge approx 2:30pm
I feel very tired; my whole body is aching; little bit of a head ache as well. My nasal breath feels warm although I don't have a fever ( I checked my temperature. It is 98.5)
Adverse reaction to administrator. Nurse with Hx of chicken Pox at 5yr and Hx of shingles 2005. AMR/nurse administrator Broke out 2 days after administrating vaccine 5-6-07. Using handwashing prior and after event 5-4-07. No mask or gloves.
Additional information received from the reporter on 11/08/2002, stated that the patient recovered.  A physician reported that a 40-year old female inadvertently received a "double dose" of expired Pnu-Immune 23 vaccine on 10/22/2002.  The vaccine had expired in January 2002.  That same afternoon, the patient developed an injection site reaction characterized by an area of redness, swelling, and heat which extended from her forearm to her shoulder.  She also experienced chills and hot flashes.
Patient reported 2 separate areas about 1 inch wide below the injection site. Patient stated that the irritated site is about 3 inches below the injection area and there is no redness/swelling  on the injection area, just below it. Patient reported they have a large area with redness and swelling and it is hot to the touch. Patient denied any hives or welts.
This spontaneous report as received from a pharmacist refers to himself of unknown age. In 2012 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (lot#, dose, dose# and route not reported. The patient developed a mild injection site reaction after receiving ZOSTAVAX (in 2012). The outcome of the event was reported as recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received Flu seasonal TIV on 11th November 2014. The subject's estimated date of delivery was 26th May 2015. The subject received Flu seasonal TIV during the first trimester of pregnancy. On 11th November 2014, an unknown time after receiving Flu seasonal TIV the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: No adverse events occurred as a result.
Diagnosed with covid and presented to ED with labored respirations, and edema of both lower extremities.  Started on IV heparin by continuous infusion.  Completed Remdesivir.  GI bleed, and 1 unite of PRBC transfused.  Family requested hospice care.
No additional adverse effects reported; a patient was administered an improperly stored dose of either VAQTA, PEDVAXHIB, or GARDASIL9; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 16-DEC-2019, the patient was vaccinated with an improperly stored dose either of hepatitis a vaccine, inactivated (VAQTA) VIAL (lot # S010727, expiration date 26-JUL-2020; strength and route were not reported), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006471, expiration date 22-JAN-2022; strength and route were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1621926, expiration date 28-NOV-2021; strength and route were not reported) for prophylaxis (product storage error). The administered dose of the vaccine was stored with the temperature of 34.9 degrees Fahrenheit for 7 minutes and 48.2 degrees Fahrenheit for 5 hours. Data logger was involved. There was no previous temperature excursion. No additional adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: 1621926; expirationdate: 28-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
9:20 shot  9:30 tingling in fingers on left hand  10:30 tingling, swollen tongue; tingling in chest and right arm  11:00 tingling in head, thirsty 17:00 arm and joints pain chemical odor in urine 3/30 next day:  0700 mild fatigue, thirsty 1300 itchy under skin 1700 upset stomach 3/31 dark circles under eyes; dry cough, hoarse voice, red eyes, sinus congestion, headache shooting from sinuses around the right to back of head 4/3-4/4 migraine, night sweats, periodic hot flashes itching under skin for a few days after shot
He presented to the ER complaining of chest pressure & nausea in the evening the day he received his 2nd dose (received it around 10am that morning). Upon presentation, his initial troponin was 6.5 & his EKG showed ST elevation in I, aVL, V3-V6. He was given aspirin & admitted to the cardiac intensive care unit. Given his age, unremarkable medical history & family history, there was low suspicion for acute coronary syndrome. Initial suspicion was for myocarditis. Transthoracic echocardiogram revealed EF 50-55% with no other acute abnormalities. Cardiac MRI revealed evidence of late gadolinium enhancement (LGE) of the lateral & anterolateral walls extending from basal to apical segments; LGE was predominantly epicardial in distribution with some mid-myocardial enhancement. These findings were suggestive of myocarditis. He was treated with steroid. His troponin peaked at 14.4 then trended down. He remained stable and was discharged home on 8/28/2021.
Guillain Barre Syndrome, while traveling; developed diarrhea followed by ascending weakness - required mechanical ventilation.
Soreness at injection site, starting 2-3 hours after injection, still existing, though faded, 54 hours later. Headache night of injection, though 1 naproxen sodium tablet relieved it. Light fatigue the day after injection.
Periods have become lighter and shorter in the month that followed and have not returned to normal. Unexplained fertility after having a successful pregnancy in 2012 and actively trying to conceive since last year. Ruled out structural issues yesterday in myself and my partner this past month.
Information has been received from a female patient who on "25-SEP-2008" was vaccinated with a "single dose" of PNEUMOVAX 23. "A couple days after receiving shot", the patient developed a "lump that was hard and warm, and it also hurt". The patient stated that "the lump went away after a month". The patient visited office for medical attention. At the time of the report, the patient was recovered. No further information is available.
0945: given Varicella/DTaP   1530: call from parent that pt awoke from nap congested & wheezing-advised to give albuterol nebulizer per Dr. and if no improvement 15-20min will need to be evaluated  1730: seen in Pediatric Dept by Dr. with mild respiratory distress, inspiratory stridor, occ barky cough Tx: Racemic Epinephrine nebulizer & Decadron 6.5mg IM--improved but not completely resolved   1852: Admitted to hospital with Dx:Croup--tx: Oxygen & mist, prn racemic Epi tx and NS neb treatments--no neb tx's required  2/23/09 Received hospital medical records of 2/10-2/11/2009. FINAL DX: croup Records reveal patient experienced barky cough, acute onset wheezing, stridor & respiratory distress.  Had been seen in PCP office w/slight cough which then progressed throughout the day.  Return visit to PCP & tx w/nebs which helped but did not resolve.  Sick sibling w/URI s/s.  Admitted for observation & further therapy.  Tx w/steroids & additional nebs.  Improved & d/c to home next day on continued steroids.
Soreness in arm, mild headache, fatigue, tingling in lip, bleeding at injection site, hip, knee, and elbow pain, twinges in chest, nose bleed, dizzy, red-hot and firmness in arm at injection site, severe joint and body aches
Muscle twitching on right side, burning and tingling on right side, tingling to back of head, episodes of being unable to speak, episodes of elevated blood pressure, feeling faint, sensitive to flashing lights and certain patterns in black and white. Started with burning sensation over whole body, weakness on right side, and inability to speak on March 30, 2022 and the above progressed afterwards.
"An office manager reported that a 2 month old male received the 1st dose of Rota Shield on 1/19/99 and subsequently, developed diarrhea with 12 stools per day. He was seen in the ER on 1/30/99. Rotovirus "culture" was negative, electrolytes were mormal and WBC was 15.200/mL. He was seen by the vaccine provider on 01/03/99, 01/09/99 and 2/16/99 due to persistent diarrhea. He was seen again by the physician on 2/26/99; the diarrhea had resolved. MANUFACTURER'S COMMENT (Wyeth): the reporter indicated that the infant received Rota shield 48021;however,this is not a valid Rota Shield lot number." From follow-up #1 correspondence received at Aventis pasteur Inc. on 02/14/00, additional patient and vaccine information was provided. From follow-up #2 correspondence received on 05/25/01,it was reported that the patient has recovered from this experience. "No further information available regarding this patient or this case. This case is closed.
just a sore arm after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had Covid back in August, mild case, just lost taste and smell." (unspecified if ongoing), notes: I had Covid back in August, mild case, just lost taste and smell.; "just lost taste and smell." (unspecified if ongoing), notes: I had Covid back in August, mild case, just lost taste and smell.; "just lost taste and smell." (unspecified if ongoing), notes: I had Covid back in August, mild case, just lost taste and smell. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "just a sore arm after". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter inquired about side effects for the Pfizer Covid-19 vaccine. He reports that he didnt want to receive the vaccine, but his company mandated it he would get fired or have to quit. He states that he did fine after the first dose, had no side effects, just a sore arm after but after the second dose-4 days or 3 days later, he hasnt felt the same since, his neck feels so sore, stress-feeling sore, sore since Thursday after the shot. Patient had Covid back in August, mild case, just lost taste and smell. Patient went to the doctor this morning, went to his family doctor, he felt patient thyroid and it felt normal, he had blood work done, and just to check he did an x-ray on neck. He was a sales rep and it depressed him and it never happened before. He read about 40 years old, female who had neck pain and got steroids to make it better for neck. The patient got second dose on 29Nov - Monday, then on Thursday it started. The patient stated that he was reading about the lady whos 40 years old had subacute thyroiditis-4 days after second dose severe anterior neck pain for so many weeks treated with Prednisolone which he thinks is a steroid, they scanned her thyroid came back high, thats where her lymph nodes are. He also states that hes not always sore, just when he turns his neck left to right. He also reported that it could be strain, dont think he slept on it, just a coincidence, he went to the chiropractor, but he didnt mess with his neck, but he said the medicine affects the glands in his neck. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PAIN ON LEFT EYEBALL; CAN'T HARDLY SEE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced pain on left eyeball, can't hardly see, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, pain on left eyeball and can't hardly see was not reported. This report was non-serious.
Redness at site (about 3 inches long), itching, swelling, knot at site of injection, hot to touch.
that evening i started feeling pain left side of neck and pain on left hip going down to the left leg by that night i could not sleep started getting numbness on left side of neck and left arm, left hip and leg i thought i was having a stroke, on the following morning had vertigo
When I got the first two and my temperature did go up but it didn''t go up as high as it is now and I just checked it and it''s 101; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose-01), for Immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "When I got the first two and my temperature did go up but it didn''t go up as high as it is now and I just checked it and it''s 101". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101604545 same patient and drug, different event separated in time
This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688: