chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nightmares; Vivid dreams; Congestion; PND; Oversleeping; Headache; Site soreness for 48 hours; Asthma; This is a spontaneous report from a non-contactable consumer. A female non-pregnant patient patient of 38-years of age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the via an unspecified route of administration in the right arm on 02Oct2021 at 13:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, urticaria and known allergy to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received ketorolac tromethamine (TORADOL) and erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 04Oct2021 the patient experienced nightmares, vivid dreams, congestion, PND (paroxysmal nocturnal dyspnea), oversleeping, headache, site soreness for 48 hours, asthma. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event site soreness for 48 hours was resolved on 06Oct2021 after a duration of 48 hours and the outcome of the events nightmares, vivid dreams, congestion, PND (paroxysmal nocturnal dyspnea), oversleeping, headache, asthma was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VAERS report submitted due to pt receiving the HPV vaccines on 4-26-07 (lot # 0962F) and 5-29-07 (lot # 0384U), at age 27 years (beyond the recommended age recommendations).
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   It was reported that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date.   The vials expired on 08-Oct-2021 and were left in the refrigerator past that date.   No adverse reactions had been reported by the patient from the 3rd dose.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-364913 (Patient Link).
First it was severe upper abdominal pain and nausea lasting 7-10 minutes, followed by severe diarrhea lasting on/off about 4 hours. Body aches, chills, headache and soreness at injection site throughout following day. Very tired for the 2 days following injection. Treatment was water and rest.
Hives; Fatigue; Ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 02:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included allergy to nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), esomeprazole (NEXIUM), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR) and fexofenadine hydrochloride (ALLEGRA); all for unknown indications from unknown dates and unknown if ongoing. On 19Apr2021 at 02:30, the patient experienced hives, fatigue and ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, fatigue and ringing in ears were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
COVID-19 diagnosis after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 diagnosis after vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (COVID-19 diagnosis after vaccination). The patient was treated with MONOCLONAL ANTIBODY 17-1A on 18-Mar-2021 at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 diagnosis after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Unexpected vaginal bleeding. I am currently a breastfeeding mother and have not had a period since Feb. 14th 2020. 3 weeks following my covid 19 vaccine I had unexpected vaginal bleeding. Blood was bright red and lasted for 4  days. Bleeding was lighter than a normal period, but larger than ?spotting?. I felt lots of cramping. I am also currently using the Paragaurd IUD. And have been since Janurary 2021.
Took her 1st dose a year ago and had not received her 2nd dose yet; No additional AE reported; This spontaneous report was received from a pharmacist regarding a patient who was currently 21-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On an unspecified date in February 2021, reported as "a year ago" the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, anatomical location, route of administration, lot number and expiration date were not reported).   It was reported that the patient missed her second dose and at the reporting date she had not received. No additional adverse event was reported.
Botox not working for the patient; This spontaneous case was reported by a non-health professional and describes the occurrence of INHIBITORY DRUG INTERACTION (Botox not working for the patient) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product BOTOX injection for Migraine.    Has Alzheimer's. (mhb).  Concurrent medical conditions included Alzheimer's disease, Migraine and Cognitive impairment.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started BOTOX (unknown route) at an unspecified dose. On an unknown date, the patient experienced INHIBITORY DRUG INTERACTION (Botox not working for the patient). At the time of the report, INHIBITORY DRUG INTERACTION (Botox not working for the patient) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
I received the vaccination 12/1/2021 and the next day I felt heaviness and soreness in my arm. I then started spiking with fevers of 101. I took Tylenol for the symptoms and the symptoms somewhat subside. The next day my grandson noticed the big bump and it was very red. It was also hot like my arm had a fever. I put ice on my arm and called the Pharmacist. I noticed that the bump started to subside after a few days. I also started getting rashes here and there but they would go away. I used ointment to treat the. I still experience outbreaks from time to time.
9/20 date of vaccine administration, arm was very red. Next day it looked like it was bruising but spreading to most of upper arm
Systemic: Nausea-Mild, Additional Details: Patient described nausea beginning several minutes after receiving her second Pfizer COVID vaccination. She stated she hadn't eaten all day and thought that might be a contributing factor. She denied having the urge to vomit.
Diarrhea; Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp) and DIARRHOEA (Diarrhea) 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 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced BREAST PAIN (Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp). On 18-Nov-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, BREAST PAIN (Pain on side of her breast/pain that is coming and going/it is on the right side/it is sharp) and DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Patient said he had an increase in his bp 170s and that is not normal and the only thing different was that he got the 1st Shingrix dose
So I felt pressure and chest pain and I went home and took a rest and the next day I was trying to schedule an appointment with my doctor and I could not get an appointment so I contact the urgent care via phone and I was advised to come in person so they could check the status of my heart but by the time I got there I didn't have the chest pain just the pressure. They did a Electrocardiogram and there was no sign of a heart attack, I went home and today I feel better the chest pain is not there but hopefully the pressure will go away tomorrow. I was advised to take ibuprofen for the discomfort.
Immediately after receiving this vaccine the patient felt weak and lethargic. They lost balance and fell on floor and lost consciousness for a few minutes. After a couple of minutes they gained consciousness and recovered.
Ct was to receive PPD 0.1cc ID on 8/16/04, instead Ct. received Adult Td 05.cc ID in left forearm. Ct. Unable to reach parent for follow up.
Numbness first in the hands, then leg pain. Progressive weakness since onset. Loss of LE DTRs  Dx: Guillain-Barré  12/18/09, 12/21/09, 12/29/09, 12/31/09, 1/1/2010, 1/4/2010 Discharge summary, hospital records received. Service dates 12/12/09 to 12/31/09. Assessment: Guillain-Barre syndrome, restrictive lung disease, urinary tract infection. Patient presents with sudden right hand and bilateral lower extremity weakness, balance difficulty. Numbness fingers and toes. Gait abnormal. Radiating low back pain. Weakness lower extremities. Reflexes absent knees and ankles. Proprioception and vibration diminished on (L) absent (R). Difficulty breathing. Early small airway disease. Cannot drink liquids with straw. Difficulty speaking, bilateral facial palsy. IVIG administration with worsening of weakness. Hyponatremia secondary to syndrome of inappropriate antidiuretic hormone.
This spontaneous report as received from a consumer via Pfizer (MFR # 2014317108) refers to an approximately 76 year old female patient (currently 78 year old). On unknown date in December 2009 (reported as 5 years ago) the patient was vaccinated with PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). There was no concomitant medication reported. On unknown date in December 2012 (reported as 2 years ago) the patient had pneumonia. On an unknown date the patient experienced bronchitis. The outcome of bronchitis and pneumonia was unknown. Additional information is not expected because there is not reporter contact information.
CHEST TIGHTNESS; MIGRAINE HEADACHE THAT LASTED FOR COUPLE DAYS; VERY SHORT WINDED; SICK FOR A COUPLE DAYS; PAIN IN MY BACK & LEGS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease. The patient was previously received with three doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse event post primary vaccination with covid-19 vaccine (Dose number in series 1). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. 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 patient experienced chest tightness, migraine headache that lasted for couple days, very short winded, sick for a couple days, and pain in my back & legs. It was reported as "I got the vaccines, when I went & got the 4th, vaccine, I was sick for a couple days, and having pain in my back & legs, and chest tightness, and very short winded, and migraine headache that lasted for couple days. But if I hadn't of gotten the vaccines, I could of ended up in the hospital on a ventilator or even worse, could have died, due to having copd & being older." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, migraine headache that lasted for couple days, very short winded, sick for a couple days, and pain in my back & legs, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Zostavax 0.65ml given SQ right lateral upper thigh instead of Varicella (accidently) Lot 1122U Exp. 7-2-09
Whole left side of body numb; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Whole left side of body numb) and VACCINATION SITE PAIN (Pain in arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Whole left side of body numb) and VACCINATION SITE PAIN (Pain in arm). On 20-Jan-2021, HYPOAESTHESIA (Whole left side of body numb) and VACCINATION SITE PAIN (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Rash/redness approximately 6 cm x 6 cm.  Denied pain.  No swelling.  Patient point out reaction but denied concern and still requests the 2nd dose.
Hives; Itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0158, Expiration Date: Jul2021) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ankylosing spondylitis", start date: 2016 (unspecified if ongoing), notes: Verbatim: Ankylosing spondylitis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot Number EP6955/ Expiry Date Jun2021, Anatomical Location: Left arm  ), administration date: 25Mar2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Apr2021, outcome "unknown", described as "Hives"; PRURITUS (non-serious) with onset Apr2021, outcome "unknown", described as "Itching". Therapeutic measures were taken as a result of urticaria, pruritus.  No follow-up attempts are possible. No further information is expected.
Initial report received on 29 September 2011 from a health care professional; and follow-up information was received on 03 October 2011 from a company representative who had received the information from a health care professional. This case involves a cluster of 8 unidentified patients with unknown medical histories who had received a dose of FLUZONE HIGH-DOSE (lot number UH452AA) at various sites on unknown dates. Between 2 and 24 hours post vaccination (varied between patients), the patients experienced warmth, rash, itching, erythema, swelling and pain at the injection sites lasting approximately 4 days. It was not reported without any of the patients required any medical evaluations or treatments. The patients recovered. The reporter for this case is the same as for case number 2011-09437. Documents held by sender: None.
Spontaneous urticaria developed exactly 1 week after booster moderna vaccine.  Symptoms occur all times of day, worse at night, and all over body with raised hives/wheels.  Extensive blood lab work completed about 1 month after onset of symptoms and unremarkbale; follow up with dermatologist and subsequently diagnosed as chronic spontaneous urticaria as symptoms have lasted > 6week (now 3+ months).  Steroid taper x 2 made symptoms worse.  High dose Loratadine 2x/day with Benadryl at night have made symptoms tolerable, but have been unable to wean off of Loratadine.
08/02/2006 pt started with blisters pm on right tricep. ProQuad (MMR/Varivax) given on right tricep 8/1/06. 8/3/06 seen in office with right tricep multiple blisters and 3 bullous lesions.
Patinet received the vaccine which was delay in shipment with no AE; Patinet received the vaccine which was delay in shipment with no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 1 month old patient of unknown gender who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686LA, expiry date: 30-Jun-2020), via intramuscular route in the left thigh, on 17-Oct-2019.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the incorrect product storage and product shipment delay.   It was reported that the shipment of Fluzone QID received late. On Thursday morning the office had already given 5 children vaccines from this shipment before they realized that the vaccines were not viable.  At the time of reporting, the patient had no adverse event.  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.
A few days later the muscle in my arm started to ache.  I can't raise my arm to take my shirt off or do anything that I had to lift my arm for.  It only hurts in the muscle of my arm.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
The patient developed chills, a fever of 103F, swelling of lips and hands and general weakness post vax. The patient was treated with Benadryl and Tylenol.
patient was given expired vaccine on 07/26/2022. COVID vaccine expired on 06/30/2022 patient reported no symptoms
Patient received full HPV series at 12 years of age but received 4th dose on 1/6/2023.
Diarrhea began and was followed by 6 loose and watery bowel movmements over the course of the next 30 hours. Also vomited roughly 30 hours after vaccination. Irritability and apparent stomach discomfort for approximately 5 days following vaccination, with occasional loose stools.
Vaccine given 6/2/2020. Guillain-Barre Syndrome diagnosed on 6/19/2020 Admitted to ICU, intubated and started on plasma exchange therapy. Planned to stay inpatient ongoing at least thru next week
Information regarding Flumist nasal solution was received from a consumer regarding a 33 year old female patient who experienced cold like symptoms, runny nose, sore throat and feeling achy. At 33 years of age, the patient received a dose on 12/12/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 0.5mL (IN). Patient was not taking concomitant therapy. On 12/13/03, 1 day post immunization, the patient experienced cold like symptoms, characterized by a runny nose, sore throat and feeling achy. Her symptoms continued at the time of this report. No additional information was available at the time of this report.