chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 minutes after the dose pt had tingling of the roof f the mouth, no difficulty breathing ,no rashes, no swelling, no cough ,vomiting or drooling  pt got 50 mg of Benadryl and monitored for another 60 minutes. Vital signs were checked and wnl.  HR-82, 98% O2.  patient symptoms were resolved prior to discharge.  She was sent home with the care of her husband who drove her.  red flags discussed.  patient has an epi pen on her person at all times and instructed when and how to use it, when to seek attention.
pt recvd vax & while walking out of clinic states don't feel good & slumped to the floor & lost consciousness briefly;
Patient received his first COVID vaccine. He stated that he received the Pfizer vaccine and registered for a Pfizer second dose through our facility. He could not locate his COVID vaccine card and his first dose was not entered into the immunization registry so we could not verify data from his first dose. After administration, he then produced his COVID vaccine card and it was noted that he actually received the moderna vaccine for his first dose.
injection site became itchy and then bled when scratched, this lasted for 2 1/2 months; funny sensations in my chest; sporadic hard heart beats
This spontaneous report as received from a registered pharmacist concerning a 62 year old female patient with mastocytosis who on 26-FEB-2013 was vaccinated with ZOSTAVAX (lot # H019092, Exp 09-FEB-2014) subcutaneous (dose not provided). Concomitant therapies included pravastatin sodium, MOBIC and FIORICET. The pharmacist stated that on 01-MAR-2013, the patient developed 3 inch wide, red, swollen rash at the site of ZOSTAVAX injection. There was no treatment given for the events. There were no labs performed. The outcome of 3 inch wide, red, swollen rash at the site of ZOSTAVAX injection was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report as received from a 61 year old pre-diabetic patient refers to herself. The patient had an allergy to preservatives in local anesthesia. On 15-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported). Concomitant therapies included vitamin B (unspecified) drops and vitamin D (unspecified) drops. On approximately 12-NOV-2015 (reported as 4 weeks after vaccination), the patient experienced iritis / inflammation of eye. This condition recurred 4 times. In July 2016, the patient noticed her right eye had a twitch that was coming and going intermittently. No laboratory diagnostic studies were performed. An unspecified treatment was given for the adverse events. The outcome of events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
ACCORDING TO THE PATIENT'S DAUGHTER, THE PATIENT WENT SEVERAL DAYS AFTER THE VACCINE AND ON THE FOURTH DAY SHE STARTED DEVELOPING SHORTNESS OD BREATH AND PAIN IN THE ARM - AFTERWARDS SHE WENT TO THE EMERGENCY ROOM AND SHE WAS ADMITTED OVERNIGHT - THEY DID A WORKUP FOR A HEART ATTACK AND AFTER ALL WAS OVER SAID THAT IT MAY HAVE BEEN AN ADVERSE REACTION FROM THE VACCINE
covid test date=10Jan2022 / covid test result=Positive; covid test date=10Jan2022 / covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and administered in arm right, administration date 14May2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test date=10Jan2022 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab. The lot number for bnt162b2 was not provided and will be requested during follow up.
TESTED + 8/2/22 FOR COVID.  MULTI-ORGAN FAILURE SEPTIC SHOCK ACUTE RENAL FAILURE WITH HYPERKALEMIA BACTERIAL PNEUMONIA DUE TO STREP PNEUMONIAE __ COMPLICATIONS RELATED TO RECENT COVID-19 INFECTION  DECEASED 8/7/22.
Two weeks after the last shot my left arm and hand went numb and my left foot and leg up to my knee went numb the shots where both given in my left arm.. I have had an MRI 's done the one on my head they said showed what they thought was a stroke
feeling weak, felt faint Pt given ice pack to back of neck, placed in exam room and observed for 30 min.
received menquadfi instead of bexsero,with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] instead of Bexsero,with no reported adverse event.  The patient's past vaccination(s)has already had their booster Meningococcal (Groups A, C, Y, W) Conjugate Vaccine (MENACTRA) back, on 27-Jul-2022. The patient's past medical history, medical treatment(s) and family history were not provided.   On 15-Sep-2022, the patient received 0.5ml  dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot U7450AB; Expiration Date 10-OCT-2024) via intramuscular route in the right arm for immunization instead of bexsero,with no reported adverse event (wrong product administered) (latency: on same day).  Action taken : not applicable.  Outcome : Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Breakthrough case admission after third vaccine 3/4/21 Pfizer EN6205 3/25/21 Pfizer ER8733 10/15/21 Pfizer FF2590
This spontaneous report was received from a registered nurse refers to 12 month old child patient. On 08-OCT-2013, the patients were inadvertently vaccinated with a dose of MMR II HSA, (lot # 009784, expiry date 15-MAY-2014) which was improperly stored. No adverse effects reported. This is 2 of 2 cases from same reporter. Additional information has been requested.
Self inoculated self on Right index finger. Lesion developed.  Also developed lesions in mounth and on Pharynx (stated she put finger in mouth) unable to confirm lesions in mouth are due to vaccine.  No other rash but did experience some itching. Did report some SOB following vaccination and slight fever.  3/20/09 MR received. One week s/p smallpox vax pt inadvertently scratched innoculation site and then ate finger food.  Developed papular lesions on index finger and in pharynx.  Also c/o extreme fatigue and myalgias, sore throat. Assessment:  Auto-innoculation by scratch, then spread on R index finger and posterior pharynx.  Myalgia and myositis. Tx: pain meds
Left side pain under left arm and into left heart region; right side facial swelling associated with lymph nodes; right side facial swelling associated with lymph nodes; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 10Feb2021 at 10:15, at single dose, for COVID-19 immunisation. Medical history included type 1 diabetes mellitus (for 48 years), penicillin allergy, sulfonamide allergy. Patient did not have COVID-19 prior to vaccination. Patient received unspecified medications in two weeks. Patient did not receive other vaccines in four weeks. The patient experienced right side facial swelling associated with lymph nodes (non-serious) on 12Feb2021 with outcome of recovered in Feb2021 (6 hours later), right side facial swelling associated with lymph nodes (non-serious) on 12Feb2021 with outcome of recovered in Feb2021 (6 hours later), left side pain under left arm and into left heart region (non-serious) on 12Feb2021 at 21:00 with outcome of recovered in 2021. The patient did not know if this was swollen lymph nodes or heart condition. Patient did not test for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient recieved the second dose of moderna vaccination 21 days after first dose instead of 28 days. Patient did not experience any adverse reaction from the vaccination.
About 20 minutes after vaccination patient vomited several times and experienced increased blood pressure and heart rate. Physician assistant consulted and recommended to continue to monitor for patient improvement. Patient blood pressure and heart rate began to decrease.
Pt diagnosed with PDD NOS (mid form of autism) at 3.5 years. Symptoms noticed at 18 months. Treated with behavioral therapy, vitamins and nautral detox for heavy metals. Symptoms included speech delays, tantrusm, no eye contact, abnormal play, not social. Cumulative effect of various vaccines and possibly mercury build up from vaccines. The following are the pt's immunization record: 02/12/96 hep B; 03/25/96 Tetramune, OPV, Hep B; 05/22/96 DPT/Hib, polio; 07/17/96 DPT/Hib, polio; 02/11/97 Tetramune, Hep b. On 06/02/97, fever of 103 deg since 05/30; told it was viral. 18 month visit temperament tantrums. 2 year visit temperament tantrums. 2 8/12 year visit consult to birth to three program after continuing to complain to doctor that all transitions are difficult, speech delays and speaking "own language," obsessive compulsive behavior, abnormal play and social prob. 02/16/99, 3year continues tantrums. Started speech and OT at school. On 06/28/99, got PDD-NOS diagnosis. 10/99 started behavioral therapy with wise early autism project. 03/16/2000, requested labs RE:Immune deficiency-refused immunizations-told not to return. 01/25/2001, started vitamin therapy and natural detox for 6 months. 02/28/2001, titer done for MMR. 05/16/01, IPV given. 08/2001, completed therapy-dropped speech and OT at school. The annual follow up received on 7/17/03 states, "pt was diagnosed with PDD-NOS, a mild form of autism at age 3. Through therapy (speech, occupational, and behavioral) and natural supplements and delox therapy, I would sy pt is 90-95% recovered. Some behavioral problems remain as well as sound hypersensitivity and some learning disabilities and hyperactivity." A 60-day follow report received 9/9/2002 adds: Pt has a mild form of autism including hearing sensitivity; difficulty with social aspects of life, rigid play, some difficulty with transitions and other sensory issues. Pt has made a lot of progress with therapy-behavioral, speech and occupational therapy. These 2 vaccines were given at the county health dept due to switching insurance and jobs. Actual diagnosis was obtained at the neuropsychiatric clinic. Received therapy for 2 years and speech and occupational therapy through another program and then school.
Received dose 2 of COVID vaccine. Within 12 hours of receiving the vaccine, started to have intensifying symptoms all of a sudden: low grad fever of 100.0, cold chills, cold intolerance, a migraine, joint pain, muscle pain, injection site pain, increased hart rate and a heaviness in the chest that made it slightly more difficult to breathe. At 24 hour mark, only injection site pain and headache persisted.  Reported injection site swelling 36 hour after vaccination.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 733D2, expiry date 25th October 2022) for prophylaxis.   On 12th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th April 2021, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The patient received 2nd dose of Shingrix vaccine and was seen by his healthcare professional and was diagnosed with Shingles. Till the time of reporting, the shingles was not resolved. The pharmacist did not have patient's healthcare professional information. The reporter did not consent to follow up.
This spontaneous reprot as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 01-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There was 87 hours exucrsion. This lot number was received on 08-APR-2015. This is one of several reprots from the same reporter. Additional information is not expected as all correspondence was received.
pt recv vax 14FEB96&same day pt began to run a fever&devel a blistery rash which was dx as hand,foot&mouth disease;no further details were provided;
severe pain; joint pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and pain in joint involving shoulder region. On an unknown date, the outcome of the pain in arm and pain in joint involving shoulder region were unknown.   It was unknown if the reporter considered the pain in arm and pain in joint involving shoulder region to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had severe pain in upper arms and shoulder joints. The patient asked how long will the events last. This case has been linked with case US2019AMR135411, reported by the same reporter.
Fever, lethargy, cold chills, achy muscles started on 2nd day and still present today (4th day) post shot
Not feeling good, no appetite, low grade fever, chills, fatigue.  Vomited later in day.  Barely could walk due to joint pain that night/sat morning.
This spontaneous report as received from a health professional concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL (lot # K006960, expiration date 19-FEB-2017) (strength, dose, route and frequency were not informed). Concomitant therapy was not reported. It was unspecified if there was any adverse event. Additional information has been requested.
INCORRECT PRODUCT STORAGE; TEMPERATURE EXCURSIONS FOR UNPUNCTURED VIALS ADMINISTERED TO THE PATIENTS; This spontaneous report received from a physician concerned a 30 year old male. 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, batch number: 216D21A expiry: 06-MAY-2023) dose was not reported, administered on 20-MAR-2023 for covid-19 prophylaxis. The drug was associated with Medication error. Temperature excursion occurred on 02-JAN-2023 0.2 C for 15 minutes and 0.4 C for 15 minutes then 1.5 C for 15 minutes then 1.5 C for 15 mins and on 02-APR-2023 Minimum 0.2 C and maximum 1.5 C for 1 hour total. Age at time of vaccination 30 years old. No concomitant medications were reported. On 20-MAR-2023, the patient experienced temperature excursions for unpunctured vials administered to the patients. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursions for unpunctured vials administered to the patients and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked.
Patient said arm had a rash about 3 to 4 inches around and that it did itch .  Today October 28th no itching but rash is still present
Cough, chest congestion, sore throat,  runny nose.  This started Sunday night the 30th . Saw the PA on 11/1at 11:30 Am. Thought it was an upper respiratory infection. On 11/2 felt nauseous and  had a regular type headache. Took At home Covid test at 6:30 pm. Positive . 11/ 3, 6:30 AM  did second Covid at home test Positive.  Returned to the Walk in Clinic to see if I could get Paxlovid.  Saw medical again and he shared that too much time had passed to get Paxlovid.
Sudden noticeable round swelling anterior right armpit about 5 cm wide with 2 hard swollen lymph nodes appreciated. Not hot, or red, but painful. Not limiting function. Treating with advil 200 mg every 8 hours to treat inflammation.  24 hours later, swelling slightly decreased but still painful. my husband a radiologist said this may be common. Also, at 16  hours post vaccine, I had shaking total body chills with no fever, just extreme cold for about 5 hours. Site of injection is without problem. Slight headache at 48  hours.
Initial report received from a healthcare professional on 04 February 2013. A 24-year-old female patient, whose concomitant medications were not reported, had received first dose of ADACEL vaccine (batch number C4327AA, expiry date of 27 March 2015) intramuscularly in left deltoid on 29 January 2013. The patient had a history of Pertussis last summer and illness at the time of vaccination was unknown. On 29 January 2013, after receiving ADACEL vaccine, the patient experienced cough, fever and body aches. On 02 February 2013, the patient had a temperature of 98.3 F, had no nodes and lungs were clear. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: None.
Approximately 1 hr. after inj. pt. had pain at inj. site, still hurting & decreasing in range of motion in arm.
Case number PHEH2015US002714, is an initial spontaneous report from a pharmacist received on 04 Feb 2015 and with a follow up report received on 24 Mar 2015. This report refers to a 28-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was administered only MenCYW-135 liquid component of MENVEO (batch number: X13051) without being reconstituted with Men A intramuscularly on 03 Feb 2q015 (at 2:55). The patient returned on 05 Feb 2015 and received full dose. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow up report received on 24 Mar 2015: Added patient demographic details and narrative was updated.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient started therapy with JANUVIA, tablet, per oral (dose, frequency, lot number, expiration date and indication were not provided). Concomitant therapy information was not provided. On an unknown date, the patient experienced an unspecified adverse drug reaction. The action taken regarding therapy with JANUVIA was unknown. The outcome of adverse drug reaction was unknown. The physician rated as related the relationship of the event to JANUVIA. Follow up information has been received on 11-FEB-2016 from the physician via the company representative referring to the currently 61 year old patient. On an unknown date, the patient was vaccinated with an unspecified shingles vaccine (manufacture unknown) (previously reported as JANUVIA). On an unknown date within one week after vaccination, the patient was diagnosed with encephalitis and altered mental status (previously reported as adverse drug reaction). The outcome of encephalitis and altered mental status was unknown. Causality assessment was not provided. Upon internal review, encephalitis was considered to be medically significant. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
I am perimenopausal, and experienced an extremely heavy menstrual cycle with severe cramping on day 12 after 2nd dose. (Have never experienced menstrual cramps my whole life.)
Pt had varicella vaccine in 1996. Presented with vesicular, itcy rash of body on 1/31/00. Dx: varicella & treated with Atarax. Afebrile & no other symptoms.
I received my first dose of the Pfizer Covid vaccine in my left arm. It didn?t hurt and I felt good. I walked to the area of observation and sat in a chair. I was texting friends and looking at social media when all of a sudden I felt very hot for a split second then lost consciousness. When I woke up I was on the ground in quite a bit of pain.  I was told by the paramedics that I was unresponsive for 60 seconds and that I had fallen directly on my head and neck. I was immobilized and taken to the ER in an ambulance. I am very healthy and have never passed out before.  I have no medical history or events that would justify this happening. In fact, I recently got an annual physical and my blood work was perfect. It was about 5 minutes after the first dose that I completely lost consciousness.
fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She was currently taking 3 a day every 8hs, 1 hidoxicin at night before sleeping and pepsomodisin. She was also given a decadron shoot when she first went to the emergency room.  No concomitant medication was reported.   This case was linked to MOD-2022-438651, MOD-2022-436323 (Patient Link).
pt recv vax 15AUG96 & 23AUG96 fine rash w/fever of 101 on 25AUG96 devel whelps on face, neck,stomach & back w/severe itching, swelling around eyes & nose;irritable,runny nose;likely urticarial/serum sickness rxn to vax;
pain, redness, swelling on injection site, body ache, headache, chills, fever.
Immediate reaction of nausea and question of mild throat soreness.  No SOB/wheezing/hives/hypotension.  Resolved within 30 min without intervention.