chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since then, she has not had her period; Her period was not regular when she received the booster, however, it is non existent at this time; weight loss; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent. A 16-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "Her period was not regular when she received the booster"; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "Her period was not regular when she received the booster". The following information was reported: AMENORRHOEA (non-serious), outcome "not recovered", described as "Since then, she has not had her period"; MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Her period was not regular when she received the booster, however, it is non existent at this time"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported as, Daughter received the primary series last year. She received the booster in Nov. Since then, she has not had her period. Her period was not regular when she received the booster, however, it is non existent at this time. The daughter also has gone through some weight loss. The only difference from everyday life is the fact that she received the Pfizer BioNTech Covid-19 vaccine booster. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Low grade fever for 5 days (from 4/14-4/20 Urinary tract infection  (blood in urine, including clots, pain while urinating, strong, constant urge to urinate)
TOOK FIRST DOSE AND FORGOT TO TAKE THE REMAINING DOSES; This spontaneous case report (PVX2019-2507) was received from a pharmacist on 07-Oct-2019. It described a male consumer who took first dose and forgot to take the remaining doses (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.   Case report: The consumer started oral Vivotif on 02-Oct-2019. He took the first dose and then forgot to take the remaining doses.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took first dose and forgot to take the remaining doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose and forgot to take the remaining doses" was considered as not applicable.
2" x 3" raised erythema on L thigh, slightly tender to palpation.  No fever, otherwise acting normal.
Vaccination was administered without adverse event at COVID-19 clinic.  Individual was noted to be a healthcare volunteer.  Upon  logging person into tracking process for scheduling a second dose appointment, it was identified that this recipient was under the age of 16, not in the correct age range for vaccination with the Pfizer BioNtech COVID19 vaccine.
no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manager and refers to a patient of unknown age and gender (number reported as 65414). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 09-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency: 1, lot # T021823, expiration date 25-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
After shot patient developed lump that was believed to be local reaction to vaccine and over last several months lump persisted and then in November area became more red and swollen. It went down with Benadryl. Has been having intermittent redness and swelling since November. In December she was treated with keflex for possible cellulitis in area due to pain, redness, and swelling. On 12-28-16 redness had resolved but patient complained of pain around area and had questionable swelling. Had ultrasound done of area which was normal.
Child became tired and lacked energy shortly following  the  vaccine. Child remained tired and lacking energy continuously following the vaccine. The child was expected to start menstruation and it appears that puberty has stopped for her. The child has not started menstruation to date.
Swelling and pain in left foot with a dark red lesion on the left pinkie toe. Difficult and painful to put pressure on the foot when first standing, but will gradually subside enough to walk with a limp.  Started as a sore pinkie that gradually increase in soreness. Lesion and swelling was very pronounce on 4/30/2021. Swelling hit a peak on 5/01/2021, appears to be significantly less on 5/02/2021.
PATIENT REPORTED A SMALL DARK ITCHY RASH THAT STARTED 2 DAYS AFTER INJECTION AND EXPANDED TO APPROXIMATELY A 6 INCH CIRCLE WHICH HAS GOTTEN  LIGHTER IN COLOR OVER TIME.  SHE ALSO METIONED A SLIGHT HEADACHE SINCE SHE HAD THE VACCINE
One mother had a mini stroke; This spontaneous case was reported by a nurse and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (One mother had a mini stroke) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (One mother had a mini stroke) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (One mother had a mini stroke) outcome was unknown.   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.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter  Company comment Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-294118 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Contracted Guilliane Barre Went into the hospital on January 7, 2022; after becoming paralyzed from the chest down; put on ventilator to breathe for 6 days; had to learn to walk again; left hospital on February 22, 2022. Still suffering from some residual effects.
Patient was very nervous to get the vaccines and she stated she did not like shots. She was seated. She received both shots as indicated above and shortly about 1 minute after her face became red, she was sweating, and she was flushed. After that point, she seemed to pass out for a short period but was moaning and was semi-responsive. We fanned patient and she came back around after maybe a minute of this seemingly vaso vagal reaction. She was given juice and upon asking her she told me she had not ate very much that day. This is the second patient I have had that has ate very little or not at all that has gone vaso vagal with two vaccines. Not sure if there is a correlation with sugar levels and getting vaccinations that result in a vagovasal response. Patient was fine afterwards. Refused EMS. Waited for 10 minutes before leaving. Her mom was by her side and mentioned she passed out with giving blood before but never with vaccines. Called patient 10/14/2023 evening time and she is doing fine other than having body soreness but her mom has same symtpoms and she got the same vaccines as said patient at the same time.
Headache; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN (Arm pain) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient is taking blood pressure medications).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PAIN (Arm pain). At the time of the report, HEADACHE (Headache) and PAIN (Arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, International normalised ratio: 1.7 (Inconclusive) Patient's blood work checked and his INR dropped to 1.7.         Concomitant medications taken by the patient included blood thinner, blood pressure medications.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received
I have suddenly started experiencing chills. No fever but consistent chills. Not sure why. It could be unrelated to vaccine but I have no way to know.
stroke in eye; lost partial vision in right eye; eye flashes/they were more constant; eye flashes/they were more constant; edema; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included bp meds (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization, and experienced eye flashes, stroke in eye and edema. The patient experienced that after receiving Pfizer shots in Mar2021, he/she had a stroke in eye. After the first dose was given patient was having eye flashes. After the 2nd shot was given shortly after he/she noticed they were more constant and that patient had lost partial vision in right eye. Patient went to the opthalmologist and was told to go to ER because he/she had a stroke in eye. Patient also had edema for months after receiving the vaccine. Patient thought it reacted with his/her bp meds. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
right after vaccination, my arm started feeling slightly sore.  Then by 9:30 pm- feeling more arm soreness up until today.
Case number PHEH2014US003815 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 9-year-old female patient who was inadvertently vaccinated with FLUCELAX (batch number: 004011A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on 06 Jan 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014 of the data received on 21 Feb 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administered" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
This case was reported by a healthcare professional (office manager) via sales representative and described the occurrence of pertussis in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 12 April 2012 the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced pertussis and vaccination failure. This case was associated with a product complaint as the physician questioned the lot number. No further details were provided by the healthcare professional. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. The healthcare professional reported another case with BOOSTRIX. See case A1047553A for details on the other case. Quality Assurance results and safety statement was received 06 November 2013. A safety assessment was requested, an evaluation was performed and the conclusion shows that: considering the currently available data for batch number AC52B077AA (and family), it is unlikely that the reported events are linked to a manufacturing issue. No further investigation is required. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Fever 103 with chills, headache, neck and back pain including nerve pain, nausea all symptoms lasted for about 8 hours and started approximately 10 hours after dose was given.  Took ibuprofen around 11pm when my fever got up to 103. Woke up the next morning still with headache and low grade fever.
Local and general signs and symptoms (redness, itching and inflammation, induration at only on injection site but all over upper arm). Suggested to take BENADRYL and contact doc. Pt. was seen by doctor on 6/29/12 and was prescribed steroids.
Information has been received from a physician for HPV rL 1 6 11 16 18, concerning a 25 year old female with tobacco user and a history of asthma and a history of 1 pregnancy and 1 live birth. No miscarriage, no elective terminations and no birth defected in previous pregnancy who on 01-SEP-2011 was vaccinated with the first dose of HPV rL 1 6 11 16 18, (lot# 666595/0992Z, expiry date in 14-OCT-2012). On 28-OCT-2011 the patient experienced newly diagnosed pregnancy. Patient's LMP was in August 2011 and EDD would be approximately in May 2012. At the time of the report, it was unspecified if the patient had sought medical attention. Follow up information has been received regarding pregnancy outcome information. The physician and other healthcare professional were no longer at the office and they had no additional information to provide. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: 9262, Expiration Date: May2021) at the age of 70 years as dose 1, 30 ug single and administration date 09Mar2021 (Lot number: EN6201, Expiration Date: Jun2020) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Verbatim: Stage 3 kidney disease" (unspecified if ongoing), notes: Verbatim: Stage 3 kidney disease. Concomitant medication(s) included: FLU. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date, the patient's body scan was no infection and nothing looks loose.  No follow-up attempts are possible. No further information is expected.
Refridgeration excursions identified/undergone several temperature excursions; No adverse event; vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 4:57 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 4:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients).    No concomitant medications were reported. It has been identified that there were two unbroken cartons out of 20 vials. The patient received previous three doses of vaccine intramuscular in deltoid. Suspect bivalent vaccine (Dose 4) anatomical location was reported as deltoid. It was unknown if the patient had ever tested or been diagnosed with COVID-19. Vials were moved from freezer to refrigerator on 07-Sep-2022. It was reported that the vaccines had undergone several temperature excursions in Aug-2022. Refridgeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department made aware of the situation. No adverse reactions reported. Treatment information was not provided.
I took the flu shot has well as the pneumonia shot, and I have had a headache as well as feeling real weak and real bad the day that I received it on Thursday 9-12-13. I'm still feeling real weak.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma exercise induced" (unspecified if ongoing); "Known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY, start date: 01Jan2015; FLONASE ALLERGY RELIEF, start date: 01Jan2015; ALBUTEROL SULFATE HFA, start date: 01Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient took Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
One half hour post vax, the pt experienced limited range of motion of left deltoid at site of injection and also pain into left hand. The pt reportedly was seen by physician 3 days later.
Soon after vaccines were given by MA, patient had syncopal event and MA came to get me. When I arrived he was altered, had eye deviation, head turn and upper extremity shaking consistent with a seizure. He then seemed to come to normal state of consciousness for a short time and then had another brief seizure. Patient remained in and out of normal consciousness for the next 20 minutes before EMS arrived. Transported to ER by medic, observed and returned to baseline and was sent home.
pt recvd vax & immed following inj exp severe h/a, which were treated w/non-prescription analgesics; 7NOV94 pt devel shingles, for which was treated w/Zovirac & Darvocet
Psoriasis dermatitis on elbows and knees started about 1.5 months after vaccination
Illness onset on 10/10/2021 with muscle aches, runny nose, cough, fatigue, abdominal pain, diarrhea, and loss of taste/smell
A non-serious spontaneous report of inadvertent administration of expired H1N1 received from a registered nurse/health professional concerning a 42-month-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Headache first,  motion sickness,  Severe lower back pain to where I can't do anything,  Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk  6ft then pain becomes unbearable, Loss of appetite and thirst ,  extreme bloating and weight gain,  Hardly urinate and diarrhea,  Side aches,  chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs   unless I lay down all the time,  Whole body feels swollen and puffy, losing hair,  trouble sleeping,  severe  drooling, eyes burn and hard to focus even with glasses