chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RN was conducting a call back on her husband who had received a flu shot and had complained of a tingling/pain in his arm, he has MS.  (Adverse form not submitted).  During the conversation, patient had indicated that his wife had not felt well after her flu shot.  Information related as follows to RN.  24 hours after receiving her flu shot patient stated she had bumps on the base of her tongue and a strange feeling in her throat and the roof of her mouth.  States she "very much felt like something was wrong."  Call back took place on 11/7/02, patient stated at that time her symptoms were gone.  Attempted to reach client 11/10/02 unsuccessfully.  Succesfully reached the client today. In revewing her syptoms she indicated that she had itching on her back on the evening of 11/6/02, they were gone by the morning of 11/07.  Approximately around 8am on 11/7, as they were driving, her throat suddenly became scratchy and tight, denies difficulty breathing or swallowing.  She drank water, took a mint to help but she felt like something was caught in her throat, she felt like she needed to clear her throat frequently.  She was frighten and almost turned back.  Eventually the symptoms disappeared but came back later that night.  Today her throat is still a little scratchy but is able to drink and talk without difficutly.  On 11/7, she was advised to take Benadryl which she did and it help.  Advised client to call  if symptoms become worse or to call 911 if her throat feels tight.  This was her first flu shot.  She denies an allergy to eggs, but the smell of eggs nauseate her.  She received a pnuemonia vaccine one year ago without problems
patient reports she had significant vasodilation of extremities and vessels on forehead in conjunction with "serge" sensation. Patient was ordered an ECG (unrelated to vaccine) which had abnormal findings. per patient reports she feels that the abnormal ECG findings were related to vaccine reaction. Per patient report event which occurred after leaving the health care providers office had not yet been reported.
headaches, no appetite, dizziness, loss of balance, head feels heavy, chills, wide spread pain that started in her back , aches behind her hips and knees
pt broke out w/blister all over body on 25JUL95;blisters were inside pts mouth & on hands;pt was seen @ clinic 25JUN95 PM for excessive crying & blisters on body;did not run any fever because was being given APAP 4 hr for 24 hr;cranky
shingles; Information had been received from a lawyer regarding a case in litigation and refers to a patient of currently 67 years old of unknown gender. The patient's medical history, concurrent conditions and concomitant medication were not provided. On or about 15-MAR-2016, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) vaccine (dose, route, site of administration, lot # and expiration date were not provided) by a pharmacist for the long-term prevention of shingles and zoster-related conditions in a pharmacy. Later, on an unspecified date, the patient was treated by a physician for the following injuries resulting from patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The outcome of the singles was unknown and the causality between this event and the vaccination with Zoster Vaccine Live (ZOSTAVAX) was reported as related.
He stated the man contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He stated the man contracted COVID-19) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (He stated the man contracted COVID-19) (seriousness criterion hospitalization). The patient was hospitalized from sometime in December 2021 to 10-Jan-2022 due to COVID-19. At the time of the report, COVID-19 (He stated the man contracted COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were provided.  The caller stated the patient still testing positive on PCR tests and active for COVID-19 per PCR tests and patient has not yet received the Moderna booster dose.  Treatment Information was not provided.  Company comment: This case concerns a 96-year-old, male patient with no medical history reported, who experienced the unexpected event of COVID 19, which required hospitalization. The events occurred after two doses of mRNA-1273. As reported, the patient was hospitalized from sometime in December 2021 to 10-Jan-2022 due to COVID-19. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Case upgraded to serious, Event seriousness criteria hospitalization added, lab test, Reporter information and dosage details updated.; Sender's Comments: This case concerns a 96-year-old, male patient with no medical history reported, who experienced the unexpected event of COVID 19, which required hospitalization. The events occurred after two doses of mRNA-1273. As reported, the patient was hospitalized from sometime in December 2021 to 10-Jan-2022 due to COVID-19. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient came to the clinic to receive his 2nd dose of his Moderna vaccine.  He was monitored for the standard time and sent home.  He did not have any adverse reaction to the medication.  He was 17 at the time of the 2nd dose.
Shortness of breath; Unable to pass stool; Extreme water retention; Excessive mucus drainage; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; This is a spontaneous report from contactable consumer (patient) reported for himself. A 54-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization, at the age of vaccination of 54 years old.  Medical history included sleep apnoea syndrome, irritable bowel syndrome, high blood pressure, congestive heart failure, diabetes. Patient known allergies included Sulfa drugs and Lisinopril. Concomitant medications included metformin; hydrochlorothiazide, omeprazole, Blood the (as reported), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced shortness of breath after 2 min walk, unable to pass stool, extreme water retention, excessive mucus drainage, swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved, all on an unspecified date with outcome of not recovered.  The patient was hospitalized for events for 4 days. The patient underwent lab tests which included computerised tomogram Cat scan): unknown result magnetic resonance imaging (MRI): unknown result, x-ray: unknown result, all on unknown date. No other vaccine in four weeks. The events resulted in: Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment received for events. No Covid prior vaccination. No Covid tested post vaccination.  Information about the Lot/batch number has been requested.
A non-serious event of expired vaccine administered occurred in a 30-month-old Caucasian female. The report was received from a registered nurse. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No medical or drug history information has been reported for this child. The child received a 0.5 ml dose of Flumist intranasally. On 19-Nov-2007 the reporter indicated a child was inadvertently administered Flumist that had expired. The reporter indicated that there is a program to return unused medication and this medication should have been returned but was not, the medication was still in the freezer. No adverse events were observed. Outcome: the child had no ill effects. Further dosing with Flumist is not indicated. Causality assessment is not applicable for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
tested positive to COVID-19; tested positive to COVID-19; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Apr2021, patient tested positive to COVID-19. His second dose schedule was postponed. His doctor told him that he needs to be strong first before getting the second dose. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (her friend had received a Pfizer bivalent booster on 23Sep2022 and he just received the Moderna Covid 19 Bivalent on 04Mar2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (bivalent booster) on 23-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.       No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.
Vaccine administered to patients between 16 and/or 17 years old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patients between 16 and/or 17 years old) in a 16-year-old patient of an unknown gender 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patients between 16 and/or 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patients between 16 and/or 17 years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Incidental COVID +. Admitted 12/18 for suicide ideation with n/v diarrhea. COVID negative on admission. Treated for pneumonia and other bacteremia and candidemia. Found to have thickening of mitral valve with endocarditis. Plan for surgery when COVID +.  Mental and functional status declined prior to scheduled surgery.  Previous wishes for DNR/DNI.  Comfort measures initiated 1/16.
Shivering, night sweats two nights in a row. Awful chest pain for 6 hours straight on the day after vaccine. Fatigue and low grade fever.
~18-24 hrs post shot 2, I started to experience vertigo  plus othwr expected  symptoms. 2 days post vaccination, I was still experiencing small moments of vertigo or dizziness accompanied by strange neurological sensations and  neck tension/ slight stiffness. Neurological sensations include rubber band pulling feeling and pain on frontal area, pulling feeling on base of head and neck  and sore feeling on left side of neck. Sometimes that comes with pain or airful sensations on left ear or pain in cheek/ tooth area. 2 weeks post vaccine, I am still experiencing these symptoms usually after any tension. These are somewhat held back by NSAIDs and pressure point therapy daily. I do not think this is normal.
10-12cm area with redness and swelling started on 09/20/2005.  Mom brought child in and patient was given Orapred - 2 teaspoons once a day for 3 days.  Site was left leg.
Pt. had an acute onset of fussiness at 6:40pm followed by an episode of pallor, limpness/weakness, and non-responsiveness lasting approximately 2 minutes. His eyes were glazed over and he did not respond to repeated tapping/stimulation. EMS was called and he showed signs of improved perfusion and was making eye contact and facial expressions by the time EMS arrived.
severe arm and leg pain on left side.; severe arm and leg pain on left side.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE taken for immunisation, administration date 17Sep2021. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 17Sep2021, outcome "recovered" (2021) and all described as "severe arm and leg pain on left side.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pain in extremity.  Additional information- It was reported that Prior to vaccination,  the patient was not diagnosed with COVID-19 and Since the vaccination,  the patient had been tested for COVID-19   The lot number for bnt162b2 was not provided and will be requested during follow up.
States she took a covid test 2 weeks after had covid infection and it came back positive; States she took a covid test 2 weeks after had covid infection and it came back positive; 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 female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient stated she also had covid infection in January after an ER visit. The patient stated she took a covid test 2 weeks after had covid infection and it came back positive. Stated she was told by someone that it will always come back positive which is why they dont recommend testing. She was asking if this is true and stated someone else told her it wasn't.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given a 3rd dose of the Hepatitis A vaccine when it was not necessary. Patient's mother was notified. No adverse reactions were reported.
Information has been received from a 49 year old female consumer was vaccinated on 09-SEP-1999 with Meruvax II. Concomitant therapy included vitamin E. On approximately 23-OCT-1999 the pt developed joint pain and swelling in her hands. She experienced nodules on her wrists and her elbows swelled to twice the normal size. She had spasm on the tops of her hands and was in severe pain. She was diagnosed by a rheumatologist as having rubella arthritis. her symptoms moved around and into her feet where she experienced severe pain and swelling. For therapy she was also given NSAIDs which she could not tolerate. The pt subsequently experienced nosebleeds while on therapy for 4 days with rofecoxib. She had immune system problems and also liver function problems. It was reported that the symptoms of "pain" have been resolved. Additional information has been requested.
Drug effect decreased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4493693-00.  A 32-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "Drug effect decreased". The action taken for adalimumab was unknown.  The reporter considered "drug effect decreased" related to BNT162b2.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  Causality: The reporter's causality of Humira for the event(s) Drug effect decreased (Therapeutic product effect decreased) was Causality as per reporter (Drug/Vaccine): Not Reported and Causality as per Mfr. (Drug/Vaccine): No reasonable possibility.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: The event of Therapeutic product effect decreased is assessed as possibly related to the suspect drug BNT162B2 based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Severe pain, edema, erythema, and induration.  Also had a fever of 102 for more than 2 days.
three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help). At the time of the report, HEAVY MENSTRUAL BLEEDING (three days after vaccinated with moderna, Got her period. But it lasted for 7 weeks before she called for help) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  It was classified by ER team as adverse event after vaccination.  No treatment medications were provided by the reporter
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 08-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Pt had prominent redness and swelling of the L deltoid traveling down to the mid upper arm by report
Pt. received 0.25ml of Moderna from a vial that was opened beyond the recommended time. No adverse effects noted. Dr  and pt. notified. Per Moderna no additional booster recommended.
Patient was given second dose of Pfizer 16 days after first dose instead of 17-21 days after first dose
pt recvd vax 9JAN95 & devel fever on morning of 10JAN & started w/convuls that evening;taken to hosp;recurrent szs requiring hospitalization;discharged 13JAN; EEG neg according to family;neuro consult neg;LP neg
Enlargement of parotid Gland x 2 weeks with mild cellulitis. no improvement with ABTX.
Patient is a 35 year old male who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - dizziness, near sycope, diaphoresis. Janssen/J&J COVID-19 vaccine #1 in series administered.  o Action(s) taken: Other - monitored BP, normal vital signs, rest, cold compress  o Vitals: o   o 12/20/21 1500 o 12/20/21 1505 o 12/20/21 1510 o BP: o 128/81 o 131/78 o 122/78 o BP Patient Position: o LYING o LYING o LYING o BP Location: o LA-LEFT ARM o LA-LEFT ARM o LA-LEFT ARM o Pulse: o 95 o 85 o 85 o Resp: o 15 o   o   o SpO2: o 99% o 99% o 99% o   o   o No SOB, no hives no rash noted. Speaks in full sentences. o Allergy to COVID-19 vaccine documented in Allergies activity: No, not allergic reaction o Patient advised to discuss reaction to clinician, and see doctor if condition worsens o D/c home at 1530. Stable. Ambulatory. Wife is driver
Moderate chills and fever occurred approximately 18 hours after second dose. Fever was as high as 101.4. The event lasted approximately 30 hours. By late Saturday night and into early Sunday morning the chills stopped and fever returned to 98.2. Have had no additional issues after the time line listed above.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2022 at 8:40 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided. Its 30 days Exp. date vaccine went into 2 to 8 °C  thaw state on or about to 24-Dec-2021, this vaccine administered until its Mfg. date of 04-Apr-2022. No treatment medication information provided. This case was linked to MOD-2022-542869 (Patient Link).