chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without adverse event). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient stated that she had fever and chills from the recent SHINGRIX shot. She stated she did not experience these side effects from the first shot of SHINGRIX and she wanted to know how long they would last. The patient declined to provide phone number, her date of birth (DOB) and healthcare provider information. The reporter did not give consent to follow-up.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown demographic patient who was inadvertently vaccinated with two injections of ADACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date in three weeks time period. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to extra dose administered. It was reported that the patient had inadvertently received two injections of ADACEL in a three week time period. It was unknown whether the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. List of documents held by sender: none.
BIB mother for concern for vaccine reaction Mom states that 3 days ago patient had vaccines That night patient had right arm pain, cough, and a tactile fever with chills on monday and tuesday Mom states symptoms lasted all night Patient also had headache and stomach ache Last fever was yesterday Patient states pain is improving Denies vomiting, nausea, shortness of breath, other swelling
Left leg with bruising following DTAP and superficial rash. (Mom had a peculiar reaction locally to DT in her arm).
This is a Solicited report based on the information received by Pfizer (manufacturer control number: 21K-163-4122639-00) from a contactable female consumer reporting for herself.  A 27-year-old female subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 10Sep2021 (Batch/Lot number was not reported) (at the age of 27-year-old) as single dose for COVID-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency for moderate to severe rheumatoid arthritis.  The subject medical history included ongoing moderate to severe rheumatoid arthritis.  The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (at the age of 27-year-old) for COVID-19 immunization. The subject experienced increase in arthritis symptoms after COVID-19 vaccine in Sep2021 with outcome of not recovered, swelling on an unspecified date with outcome of recovered, joint warmth on an unspecified date with outcome of recovered, vaccination adverse reaction in Sep2021 with outcome of unknown, body aches on an unspecified date with outcome of unknown and chills on an unspecified date with outcome of unknown.  The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event swelling, joint warmth, generalized aching, chills after Pfizer/BioNTech Covid Vaccine was not provided and for the events rheumatoid arthritis aggravated, vaccination adverse reaction was possible. Pfizer opinion for the events of swelling and joint warmth with adalimumab (HUMIRA) was no reasonable possibility and for the events of increase in rheumatoid arthritis symptoms after COVID-19 vaccine, body aches and chills was not provided.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events rheumatoid arthritis aggravated, swelling, joint warmth, vaccination complication, pain and chills cannot be totally excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 10-AUG-2016 the patient was vaccinated with PROQUAD (rHA) (lot # L007230, expiration date 03-SEP-2016, 0.5 ml, once, subcutaneous). No adverse effects were reported. Additional information has been requested.
Administration of second dose of vaccine past the 36 day window; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Administration of second dose of vaccine past the 36 day window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Administration of second dose of vaccine past the 36 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Administration of second dose of vaccine past the 36 day window) had resolved. 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.   No concomitant medications were reported No treatment drugs were reported
at 10 mins post vaccination, patient began vomiting.  Blood glucose 114mg/dl EKG wnl.  EMS responded moved to ambulance and evaluation.  patient released home at 1248
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medication and drug reaction or allergies reported. On 09-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot# L009213, expiration date, dose anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Complaining of dizziness beginning 10/18/00 PM. Also, complained of stomach discomfort and temperature of 100.7F. On 10/25/00, per call to mom, dizziness lasted 1-2 days. Did not see a doctor.
Information has been received from a physician's assistant concerning a 28 year old female who in 1976 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . The physician's assistant reported that a second dose status was unknown. On 11Nov03 the pt underwent a mumps immunoglobulin G antibody test, which was noted to be negative. The pt sought unspecified medical attention. The outcome of the pt's negative mumps titer was unknown. Additional information has been requested. The physician's assistant also reported a 40 year old female who was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  and developed a negative mumps titer.
lip swelling; blistering of lips; dry / chapped; This is a spontaneous report from a contactable consumer or other non-HCP.   This consumer reporting for multiple patients. This case was reported for best friends that:  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lip swelling, blistering of lips and dry or chapped. The outcome of all events was unknown. Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985957
PT COMPLAINED OF A RED SWOLLEN AREA NEAR  RIGHT WRIST ABOUT 45 MINUTES AFTER VACCINATION.  ADMINISTERED 25MG OF ORAL DIPHENHYDRAMINE AND MONITORED.
This spontaneous report as received from a consumer referring to herself, a 61 year old female patient. The patient had no pertinent medical history or allergies. On 31-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date unknown) 1 time vaccine (dose unspecified), via subcutaneous in the left arm. There were no concomitant medications. On 02-JUN-2013, she had a mild reaction to ZOSTAVAX; she stated that she had redness at the injection site on her left arm. The patient did not seek medical attention and no treatment was given and lab diagnostics studies were not performed. The outcome of redness at the injection site on her left arm was unknown. Additional information is not expected.
sore throat gradually increasing every day; Her gums are sore; Her tongue is turning red; hard at hearing; She has been experiencing pain.; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red), HYPOACUSIS (hard at hearing), PAIN (She has been experiencing pain.) and OROPHARYNGEAL PAIN (sore throat gradually increasing every day) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for an unknown indication.     No Medical History was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Jul-2021, the patient experienced GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red), HYPOACUSIS (hard at hearing) and PAIN (She has been experiencing pain.).   On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat gradually increasing every day). At the time of the report, GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red) and OROPHARYNGEAL PAIN (sore throat gradually increasing every day) had not resolved and HYPOACUSIS (hard at hearing) and PAIN (She has been experiencing pain.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and DOB of the patient added, sore throat gradually increasing every day new event added.
Client had just received his flu shot in the right deltoid muscle by School Nurse.  Fluzone vaccine by Sanofi, Lot # UH478AB, Exipration 6/30/12.  He stood up after receiving the injection and immediately fainted, falling to the floor and hit his head on the hard gym floor.  School Nurse assisted the client to lie on his back but stay lying down.  This nurse was called over with the Emergency Kit.  This nurse's assessment showed the client awake, alert, and orientated.  His skin was pale in color and cool to the touch.  He complained of his head hurting.  A large bump approximately 1 and 1/4 inch in diameter with redness and contusion was noted to the left forehead and eyebrow area.  No other injury noted.  Client was able to move all exremities by command.  Vital signs at 1615 hours by this nurse: Blood Pressure 98/64, Pulse 70, Respirations 24.  His pupils reacted to light quickly equal and bilaterally.  A cold pack was applied to the client's forehead.  Client was encouraged to take slow deep breaths and to stay resting on the floor for another five minutes.  Repeat vital signs at 1620 hours by this nurse: Blood Pressure 100/64, Pulse 64, Respirations 20.  His skin color was still pale, but improving.  Client was assisted to a sitting, and then a standing position.  He walked across the gym with assistance to side wall.  He sat down on a mat and still complained of being dizzy, so was laid down on the mat to rest.  His grandmother had accompanied him to the flu clinic, so the client's mom was notified of the incident at this time.  His mom stated she would come to get him.  Repeat vital signs at 1632 hours by School Nurse: Blood Pressure 90/54, Pulse 64, Respirations 20.  Client still complained of his head hurting and feeling dizzy, so he continued to stay lying down on the mat.  This nurse left to resume flu clinic duties as School Nurse stayed with the client to monitor him.  Per School Nurse there was no change in the client's condition.  Per School Nurse she spoke with the client's family about monitioring for any signs of complications and recommended seeing a doctor for any concerns.  When the client's mom arrived they left the clinic to rest at home.  11/16/11 0800 hours Per School Nurse she spoke with the client's father this morning.  He stated to her that the client does have the large bump on his forehead, but is fine otherwise and had no complications overnight.
Appproximately 3-5 minutes after receiving vaccine, the patient "stiffened up", she lost consciousness for a couple of seconds while she was sitting on bench during the 15 minutes observation period. The medical assistant helped patient place her head between her legs, she immediately regained consciousness-patient did not realize what had just occured. Patient assisted to laying position, vital signs taken and PNP assessed patient. Pallor, clammy skin, diaphoretic. Patient stated that she suddenly felt a warm sensation and does not recall what happened. Patient reports she did not have breakfast or lunch and had minimal fluid intake. Juice and crackers provided. She continued to feel lightheaded-patient assisted to exam table and propped legs with pillows. Patient monitored for 55 minutes. Patient reported she felt fine and no longer lightheaded. Patient accompanied by guardian contacted Dr on 11/12/2021 by this writer. Patient had a headache the night after obtaining her vaccine-guardian adminsitered Tylenol 500 mg at 9 pm and then again on 11/10/2021 @ 6 a.m. According to guardian all symptoms have resolved.
Patient became dizzy and felt weak.  Passed out for about 5 seconds on bed.  No injuries.  No SOB.  Blood pressure 92/70 prior to vaccine administration and 92/62 after admnistration.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received BOOSTRIX (batch number P7S4B, expiry date 11th February 2019). Concomitant products included FLONASE, FLOVENT Inhaler, MOBIC, SINGULAR, VALIUM, Albuterol, atenolol, SYNTHROID, XARELTO, ZOCOR, LASIX and amiodarone. On 23rd September 2017, the patient received BOOSTRIX (intramuscular). On 24th September 2017, 1 days after receiving BOOSTRIX, the patient experienced injection site pain, swelling, generalized pruritus and generalized rash. The patient was treated with BENADRYL and steroid cream. On an unknown date, the outcome of the injection site pain, swelling, generalized pruritus and generalized rash were recovering/resolving. The reporter considered the injection site pain, swelling and generalized pruritus to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the generalized rash to be related to BOOSTRIX. Additional details were provided as follows: The patient's concomitant medications included Potassium. A nurse administered the injection to the patient in the pharmacy and not the pharmacist. The patient reported that the next day after an injection of BOOSTRIX, she experienced a rash, which began around the chest, neck and arms. The rash spread across her body and was accompanied by itching and raised skin. The patient reported that there was arm pain around the injection site. The pain was still present, but the other events were improving. The patient was told to use BENADRYL and a steroid cream for the rash.
MRSA infection; Nose bleeding; >36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (MRSA infection), EPISTAXIS (Nose bleeding) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>36 days from first vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (Lung cancer survivor), Broken wrist in 2018 and Arm fracture (Broke arm prior to vaccine). Concurrent medical conditions included Allergy to vaccine (Tetanus vaccine allergy), Drug allergy (Septocaine) and COPD. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>36 days from first vaccination). On 05-May-2021, the patient experienced STAPHYLOCOCCAL INFECTION (MRSA infection) and EPISTAXIS (Nose bleeding). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (SMZ-TMP) for Adverse event, at a dose of UNK (800/160 mg) and MUPIROCIN (topical) for Nose bleed, at an unspecified dose and frequency. On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>36 days from first vaccination) had resolved. On 05-May-2021, EPISTAXIS (Nose bleeding) had resolved. In June 2021, STAPHYLOCOCCAL INFECTION (MRSA infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Staphylococcus test: negative (Negative) MRSA infection was gone.     Concomitant medication also mentioned "rescue inhaler" NOS, and steroids for 3 months prior vaccine for broken arm.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
After 36 hrs after vaccination patient noted to have red area 11cm x 8.5 cm warm to touch and firm with induration.
Left arm, rash, swelling/welts and warm to touch.   No treatment  Area was inflamed for several days.
High fever 102.2 Chills, body aches, total body pain and weakness headache burning eyes pain in arm at site of injection with numbness and tingling down arm post vaccination
3-4hr p/vax pt devel fever 101, chills, nausea, vomiting; resolved within 8-12 hours
First day, pain, red, swollen at injection site.  102.2 fever followed by muscle ache. My right kidney was painful & I became incontinent. From there my health got increasingly worse. I would eat & defecate 10 minutes after, then I eat the next day & became so nauseous that I had to sleep it off. The next day, I ate & immediately felt pain right under my rib cage that radiated to the left & right. The pain continued  to get worse until i finally went to the ER. They found my lipase elevated in my pancreas but no swelling.
mild nausea immediately following Gardasil #1 injection.  Sxs resolved spontaneously over course of next 30 minutes while being seen in clinic.
Day after vaccine given swelling and redness, achy 3 x 2 cm.
Numbness and tingling in arm, more severe in hand and fingers.  These sensations are felt throughout the day, sometimes more sever at  night or when arm/hand has been in a still position for longer period of time.  This adverse was noticed on the same day of vaccination, and has not yet subsided.
I began feeling cold sweats and very tired that evening a few hours after taking the vaccine.  During the night,  I began having a severe headache, body aches, extremely lethargic and continued being feverish with sweats. I basically slept the next 2 days as These symptoms lasted in their severity until  Friday, February 26th.  I continued with a headache and lethargy until Saturday February 27th and finally felt better by Saturday evening and was 100% back to normal by Sunday.   I missed 3 days of work dealing with the response to the vaccine but would do it all over again as I work as medical support and fully support the vaccines.
Eight and a half days after receiving the 2nd vaccine, I began experiencing a rapid heartbeat that instantly made me dizzy.  These symptoms continued on and off throughout the day.  That evening my heart continuously was beating hard and very rapidly.  I was awake most of the night because of an irregular heartbeat.    This continued the next day on and off and again became much worse that evening.  The next morning I went to urgent care where I was immediately sent to the ER for a cardiac workup.   Approximately an hour after arriving my heart monitor began to signal an issue with my heart and an EKG was done.  My heart rate went to 198 BPM and I was admitted to the ICU for treatment of Afib and observation.  I am now waiting to meet with a cardiologist to perform ablation surgery.
This spontaneous report as received from a healthcare worker/medical assistant refers to patients of unknown demographics. No pertinent medical history and drug reactions/allergies were reported. Since 31-MAY-2016, an unknown number of patients have been administered doses of VARIVAX (Lot#L034370, expiry date: 08-SEP-2017/Lot# M000761, expiry date: 06-JAN-2018/Lot# M004326, expiry date 25-JAN-2018) which were improperly stored. No adverse effects reported. Data Logger was yes and outcome was all supported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.