chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had been experiencing chest discomfort after eating and activity for a month, that resolved with rest. Family history of ischemic heart disease. Pt is a smoker, HTN and dyslipidemia. I was just informed a patient received the Pfizer vaccine yesterday @ 1129. Arrived to ER @1700 with a STEMI. He went for a heart cath yesterday and CABG this morning. Per the cath report his LAD was occluded.  I believe he was more aware of his symptoms after receiving the vaccine and that is why he finally came in.
Arm Swollen burned and very hard with itchy red bumps. Very large knot in arm. Treated by Hospital for Allergic reaction.
Received vaccine 12/17/18; Patient experienced sore throat on evening of 12/18/18 and on 12/19/18 at bedtime patient's symptoms progressed to tongue swelling and tingling with cough. This kept patient up most of night and had trouble breathing. Today 12/20/18 (event reported), pt better able to breath but tongue still swollen. RPh recommended pt to be evaluated by physician today and if continue to worsen call 911 or go to ER.
Breakthrough case admission after 3 vaccines Pfizer 4/1/21 Lot# Ew8734;  Pfizer 4/19/21 Lot# Ew0165;  Pfizer 11/5/21 Lot# 33026BD LOT NUMBER IS FROM DATABASE
Night sweats 4 random times in last month.  Lower extremity aches, feet, and ankles, after waking up every morning.   Typically lasts 10 min or less.  Overall body soreness compared to usual.
Presents to urgent care with sore throat, SOB, joint pain, fatigue and mild chest pain
Pt reported on 12-19-05 to his doctor (incidentally) that he had experienced an adverse reaction to Pneumovax given on 8-5-05. Two hours following the immunization he suddenly became faint and became unconscious for 3 minutes, according to his wife. He had "swelling of both eyelids, as well as his face and body." He had swelling redness and heat at the injection site. The swelling subsided after another hour and was gone within another 1/2 hr. He did not seek medical attention, and has not had further problems related to the immunization. An allergy to this product has been included in his record.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 30 children ages ranged from to seven who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Approximately 30 -45 minutes after receiving the vaccine, I started getting a sharp pain in my lower back and it seemed to be coming from my spine.  It continued for two days and affected my movement.  It seemed to improve with rest and not sitting in an upright position.  At times, it radiated down my legs.  Within 48 hours, the pain had decreased to a minimal level and has since gone away.  I did not report the back pain to a doctor because at the time, I did not think it was related to the vaccine.  The pain seemed to be in the region I received an epidural 17 years ago.
8 year old child given the adult HEP A vaccine. Had history of receiving 2 Hepatitis doses in the past but record was not checked prior to administration.
Light-headed sensation starting the day after vaccinations and intermittent episodes of very brief vertigo (several seconds) with nystagmus noted by parents during the times of vertigo. No overt viral symptoms at the time. Had been swimming in the heat and not adequately hydrating for several days leading up to the symptoms. On the 3rd day of symptoms (7/13/18) came to the office for assessment and had orthostatic tachycardia noted, but otherwise appeared well and had a normal exam. Increased hydration was recommended along with salty snacks and rest. Returned on 7/16/18 due to heightened parental concern (and to follow up with primary MD who was not available for the 7/13 appointment). At that time, the symptoms had resolved and the exam was normal. Discussed that it was not clear if the symptoms were a vaccination side effect or from a combination of dehydration and anxiety exacerbating symptoms as this patient and mother both have significant anxiousness.
minimal soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minimal soreness at the injection site) in a patient of an unknown age and 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minimal soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (minimal soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: No specific follow-up information recorded.
This case was reported by a pharmacist via sales rep and described the occurrence of joint pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. Co-suspect products included PREVENAR 13 for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose and PREVENAR 13 at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. The pharmacist reported that on unspecified dates, multiple unspecified patients were administered PREVENAR 13 (manufacturer unknown by reporter) and SHINGRIX (manufacturer unknown by reporter) and an unspecified amount of time later experienced Joint pain. No clarifying information were provided. No additional details were provided.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a pt who experienced hives. The pt received vaccine. The pts concurrent illness includes an allergy to eggs. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The pt experienced hives (urticaria). No additional information was available at the time of this report.
a patient had waited 5 months before the application of the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 15th May 2023).   On 18-SEP-2023, the patient received the 2nd dose of Twinrix. On 18-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient had waited 5 months before the application of the second dose).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-SEP-2023 The pharmacist called in to report that a patient had waited 5 months before the application of the 2nd dose and wanted to know if there was information about the need to restart the series.  Partial information about vaccine, event and patient provided. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose after 5 months, which led to lengthening of the vaccination schedule. The reporter consented to follow up.
Second dose of vaccine was inadvertently administered to patient 1 day earlier than recommended.  He received the 2nd dose on day 16, instead of day 17 or later as recommended.
Post vax the patient was unconsolable, crying, and irritable for approximately 4 hours.
A medical assistant reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with DTAP (Infanrix) for prophylaxis.  The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 05/15/03, the subject received his fifth injection of IPV. On 05/16/03 one day post-immunization, the subject developed an injection site reaction characterized by swelling and redness. The subject was seen by the physician, who prescribed Benadryl. The injection site reaction resolved on 05/18/03.  The reporter considered the injection site reaction to be unrelated to Infanrix.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 09-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 47 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756544A, A0756546A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
SEVERE REACTION ALL OVER CHEST AND HANDS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced severe reaction all over chest and hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction all over chest and hands was not reported. This report was non-serious. This case, from the Others is linked to 20210411605.; Sender's Comments: V0: MAC comment not required for non-serious cases as per standard protocol
Mistakenly gave a patient diluent for MENVEO without adding it to the powdered vaccine. Age of patient at time of event: 24 years. Type of Event: Vaccine/component omission - Diluent given without the vaccine.
had 4 doses and I recently got Covid; had 4 doses and I recently got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had 4 doses and I recently got Covid".  Clinical course: It was reported that patient had 4 doses and I recently got Covid but it wasn't a very bad case. It was mostly sinus and in my chest. I was fatigued for about a week but I feel it could have been much worse if I wasn't vaccinated. Again thank you for all the hard work in making the vaccine.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received
Swelling, heaviness and pain in left arm. Tenderness to touch and extreme pain an swelling from shoulder to elbow. The swelling has lasted for weeks. I have seen the doctor for a ultrasound to rule out a blood clot on 11/02/2021. The swelling has come down a bit. But it still is tender to touch and heavy.
I found out in May22nd that I had a positive pregnancy test - five weeks pregnant - 10 days later - symptoms subsided. June 7th - Ultrasound - dated at 5/1/2 weeks and I went back 8 days later - showed pregnancy was nonviable at that point. My miscarriage symptoms on the 17th. The miscarriage was pretty much completed that day and then I bled five or six days. No complications. I didn't need any follow up care. I had miscarriage three and half years ago and there were complications for that. I met with my midwife a few days afterwards here now but they didn't do an examination or blood draw. Pregnancy history - 13th pregnancy - 6 miscarriages and 7 live births.  Estimated date of delivery - January 22, 2022
5 min. /p admin of  OPV & DTP, pt turned pale & slowly sagged to the floor. He arched his back & then was limp. Attack lasted 60 sec . Regained consciousness & hugged his mother. Resembled a simple faint
joint pain in the legs; This is a spontaneous report received from a contactable consumer (patient).  A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date in May2021 (at the age of 46 years), as a single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date, as a single dose for covid-19 immunisation. On an unspecified  date, the patient stated that she received her second dose of the vaccine 3 weeks ago and is still experiencing joint pain in the legs. At the time of reporting, the outcome of the event were reported as not recovered.  Information on lot/batch number has been requested.
My daughter tested positive for Covid on the first Saturday of February 2022. The following week, Pt began to sniffle a bit so we went ahead and tested him for Covid and it was positive. Beyond the sniffles, he never really developed any symptoms. I wouldn't have thought anything of it had I not tested him for Covid. I informed his primary care provider but since his symptoms were minor, we just let him recover on his own and he was fine by the end of the 5 day isolation period.
Child developed pneumococcal bacteremia and pneumonia. Was this a vaccine failure? Rec'd three doses of Prevnar 1/9/02, 3/13/02, 5/3/02.
Patient received doses on 1/24 and 2/15.  He reports hyperglycemia within 2 days of the first dose up until 2/13.  Glucose values previously ranged 110-160 and after the 1st dose of vaccine were 250-300, with one value of 522 mg/dL.  He denied any pertinent changes (no change in eating habits, no new medications, no illnesses, and confirmed medication adherence).  Unsure if related to vaccine but felt obligated to report.
Information regarding Flumist was received from a healthcare professional regarding a 48 year old male tp who experienced nasal congestion and drainage down his throat. The pt received a dose on 11/6/03. The pt experienced nasal congestion, and drainage down his throat immediately after receipt of the vaccine on 11/6/03. He then blew his nose to relieve the congestion in his left nostril. The reporter indicated that the pt did not have a cold prior to administration. No additional  info was available at the time of this report.
have had Covid 3x + long hauler symptoms; have had Covid 3x + long hauler symptoms; have had Covid 3x + long hauler symptoms; have had Covid 3x + long hauler symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: Private. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: "Endometriosis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "inflammation issues" (unspecified if ongoing); "had Covid 3x" (unspecified if ongoing), notes: Covid 3x Positive long hauler symptoms. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown" and all described as "have had Covid 3x + long hauler symptoms".  Clinical course: The reporter reported about have pre-existing conditions, including Endometriosis, Fibromyalgia, Psoriasis, and a number of inflammation issues, and have had Covid 3x Positive long hauler symptoms. This far, your boosters were the only thing that gave relief.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vax adm 23JUN93; 2JUL t102; 3JUL 101, chills;
Jitters, fever, vomit, jerking of left leg and big lumps in left leg.
This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 16-year-old male patient who received BEXSERO (batch number 168101, expiry date 30th November 2018) for prophylaxis. On 11th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 11th July 2017, less than a day after receiving BEXSERO, the patient experienced tiredness, chills, walking difficulty and hypersomnia. On an unknown date, the outcome of the tiredness, chills, walking difficulty and hypersomnia were recovered/resolved. It was unknown if the reporter considered the tiredness, chills, walking difficulty and hypersomnia to be related to BEXSERO. Additional details were reported as follows: The healthcare professional reported that the patient was tired, slept for about 5 hours, had a hard time walking for about 2 hours, and chills after receiving BEXSERO. The side effects resolved after about 8 hours.
Puritic rash developed about 36 hours after vaccination only in the area of injection L deltoid.  Measuring approx 3cm across mild underlying erythema and distinct non-confluent macules slightly raise and sessile. Complete ROS o/w negative and no systemic symptoms and no respiratory or edema symptoms.  Rash reported 1/12/21 and already improving without medication with less itching and less erythema
Patient received Pediarix, HIB, Prevnar at 12 PM 7/9/04. At 4 AM, patient had fever 102 and gave Tylenol and fever came down to 100. Tylenol repeated 10 AM. At 12:30 the child became unconscious and became limp according to Mom. Child went pale but was never blue, eyes were closed, no tonic/clonic movement, no apnea. This lasted 10 minutes. Mom called paramedics and baby was hospitalized for two days.
eyebrows swollen; area of his eyebrows is swollen and resting right on his eyelids; lymph nodes swollen; This is a spontaneous report from a contactable consumer reported for himself. A 29-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730 and expiration date:  31Mar2021), via an unspecified route of administration on arm left on 09Jan2021 11:45 at 0.3mL, single for covid-19 immunisation. The patient medical history reported as none.  There were no concomitant medications. The patient previously took Influenza Quadrivalent (lot number: 294G5 and expiry date: 30Jun2021) at the age of 29-year-old on 20Oct2020 at 0.5mL and never had any problems. The patient having a side effect from the dose he got on Saturday 09Jan2021. He woke up yesterday on 11Jan2021, with his eyebrows swollen, the area of his eyebrows is swollen and resting right on his eyelids. Also reported woke up yesterday on 11Jan2021 with the swollen eyelids and swollen lymph nodes, are a little swollen but have seemed to subside as of today. The outcome of the events swollen eyelid and swollen lymph nodes was recovering, outcome of the other event was not recovered.
The patient tested positive for Covid-19 on 01/25/2022.  The patient expired on 02/01/2022.  No record of hospitalization.