chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up this morning with top lip swollen; woke up this morning with fingertips swollen; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) via Pfizer sponsored prgram. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Jun2021, the patient woke up in morning with top lip swollen, with fingertips swollen. The patient was due for his second dose Pfizer Covid 19 Vaccine on 03Jun2021 (today). Patient wanted to know if he should get the second dose Pfizer Covid Vaccine today, 03Jun2021 or not. Reporter seriousness was unspecified. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
box has been ripped off, so the vials are exposed to the fridge light; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Rota (Rotarix liquid formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received Rotarix liquid formulation, Bexsero and FluLaval Quadrivalent. On an unknown date, an unknown time after receiving Rotarix liquid formulation, Bexsero and FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: box has been ripped off, so the vials are exposed to the fridge light).  The outcome of the incorrect storage of drug 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: 13-Sept-2023 The health care professional stated that their vaccine fridge had a light inside that stays on all the time.  The top of the Rotarix (liquid only formulation) box has been ripped off, so the vials were exposed to the fridge light and the product had been administered.  Upon further questioning, the facility purposefully ripped the tops off the boxes to make it easier for staff to retrieve the product.  In addition to the Rotarix vaccines, the facility also had FluLaval QIV and Bexsero vaccines that had been exposed to light despite product label instructions to protect from light.  The reporter knew that the vaccines had been administered, but she did not have any information on how many doses, dates of administration, or patient information at the time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received Rotarix liquid formulation, Bexsero and Flulaval QIV after the temperature excursion, which led to incorrect storage of drug.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right arm 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 07Dec2022, Treatment stop date: 12Dec2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness on chest and (R) & (L) upper arm and pt was hoarse.
Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) outcome was unknown.            Concomitant medication were not provided.  The caller had reported the patient got second dose yesterday, thought it was Moderna COVID vaccine and that morning the patient passed out, was on the way to the hospital.  Treatment medication were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Loss of consciousness, which occurred 1 day after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Loss of consciousness, which occurred 1 day after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Pt devel h/a following administration of HEp B vax; No further details were provided;
Arm is red, hot, swollen from shoulder to elbow, irradiating to the chest. She was sleeping all day. When she woke up her bed was soaking in sweat. She applied ice.
sore at injection site; 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 (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 10Feb2021 (Lot number: en5318) at the age of 71 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore at injection site".  Additional information: This report was received. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient also received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 19:15 (Lot number: en6203) for COVID-9 immunisation and experienced pain, symptoms of flu, muscles and joints sore all over, chills, headache, sore throat, ear ache.  No follow-up attempts are possible; No further information is expected.
I had my vaccine on May 24 and I felt terrible on May 25. I had a very bad  headache, nauseated and vomited. I felt full body fatigue. I had a sore throat and cough. It felt just like the flu. It was bad for three days and then on the 4th day, I started to fill better. I alternated TYLENOL and ibuprofen. I take MUCINEX for the cough. I test for Covid with home test and they are negative.
I haven't had a MS relapse in 6 years, I went of of my copaxone in March 2020 I wasn't on any MS at time of Vaccine, I had an MRI 2019 that was normal.  After the vaccine I clinic seizures, it happened out of blue in morning when I got up. The ambulance was called I went To clinic had an MRI My original lesion load doubled and all new ones were active, new lesions on brain and cervical spine. I was put on IV solumedrol for 3 days to bring down the inflammation . I was having weakness, shakiness, visual issues lost about 20lbs in 3 weeks. I went to primary care could not do anything because he had no experience. I'm seeing a new MS specialist.  Dr.  started me on ocrevus , before he went on a leave.
Developed hive on left arm with redness and pruritus.  The patient states about hour  later her face was redden and hive on her neck.  She took a Benadryl at 4:00pm and by 6:15pm she feeling slightly better.  When she awoke in the morning, symptoms had subsided.
Diarrhea, NauseaVomiting, arm soreness at injection site and fatigue Narrative:
PT DEVELOPED ON DAY 21 FROM VACCINE A ZOSTER RASH ON THE T 12 DERMATOME ON THE CONTRALATERAL SIDE OF THE BODY FROM THE VACCINE SITE
Flu: Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a female patient of unknown age who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "it was the same with my grandmother, as soon as she quit taking the shot she quit getting the flu."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild
Severe nosebleed from right nostril like nothing I have ever had. Video consultation with Dr who Instructed me to pinch the soft part of my nose above my nostrils for about 10-15 minutes. The bleeding lasted for approximately 30 minutes
On 7/13/01, the pt had difficulty walking and as of 7/16/01 was reported as being unable to walk. The pt also has joint pain, arm pain and a fever of 102-103F. It was noted that the pt had taken Cedax for a few days prior to the vax for an unspecified condition. The MD reported that the pt's inability to walk was secondary to his generalized arthralgias and not secondary to any type of neurological gait abnormality. The pt is recovering. Upon internal review, "difficulty walking and now unable to walk" was determined to be an other important medical event. Addtl info has been requested.
temperature reached 47.6F for a total excursion time of 55 minutes, with no reported adverse event; there was a patient to receive the vaccine post excursion, with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics and it was reported that the vaccine (IPV (VERO) [IPOL])  temperature reached 47.6f for a total excursion time of 55 minutes, with no reported adverse event and there was a patient to receive the vaccine post excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date the temperature reached 47.6f for a total excursion time of 55 minutes, with no reported adverse event (product storage error).  On an unknown date there was a patient to receive the vaccine post excursion, with no reported adverse event (poor quality product administered) (same day latency) following the administration of IPV (VERO).   This temperature excursion was determined to be human error. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (temperature reached 47.6F for a total excursion time of 55 minutes, with no reported adverse event, there was a patient to receive the vaccine post excursion, with no reported adverse event).  At time of reporting, the outcome was Unknown for all.    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 the 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.
Prolonged (4 wk) diarrhea; weight loss >1 lb. Treated with Poly-Vi-Flor. Recovery in 2 weeks.
I have not had any issues with my pregnancy. My expected date of delivery is 07/09/2021. My adverse event occurred two days after I received my second dose. I woke up and couldn't really see. I had vision, but I couldn't see clearly. I did not have any other side effect though. I went to my OBGYN because they weren't sure if it was onset of rapid pre-eclampsia. They ruled that out and told me to go home and rest. The vision issue only lasted the day after I received my vaccine. The morning after my event, everything was fine. My doctor said that it may have been a "not typical" migraine.
Swollen lymph nodes in neck, chest pain, heart palpitations, heart flutter, chest pressure
5cm to 3cm area of induration @ inj site starting 6 days p/vax;
I had a fever of 101 degrees (my temp is usually about 96.5), cough and congestion. I tested with a home COVID test kit and was positive. I repeated the test and confirmed that both were positive with my daughter. I had a telehealth appointment with an NP, who gave me a prescription for Paxlovid. I was able to get the Paxlovid from my pharmacy the next morning (25 March). In two days my temp was between 97 and 98. I finished the med course and no major symptoms have returned. I still have a cough and a runny nose. I quarantined and have not interacted with anyone without a mask. My wife tested positive on 27 March.
Information has been received from a nurse practitioner concerning a 15 month old female with no allergies, medical conditions, history of chickenpox, or recent exposure to chickenpox or herpes zoster who on 24Jun05 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot649269/0986P). there was no illness at the time of vaccination. The nurse reported that the pt was vaccinated at one year of age and a few months later, in 2005, broke out in a rash on the vaccinated leg. The rash was diagnosed as shingles. The pt was treated with oral acyclovir and recovered. A product quality complaint was not involved. Additional information has been received from the nurse practitioner who reported that in the pm of 06Sep05, the pt developed shingles on the right leg that were tender when touched. Her maximum axillary temperature was 97. The pt had no other systemic symptoms. She was given acyclovir and the rash resolved without any problem. The pt was recovered as of 10Sep05. No diagnostic lab tests including a direct fluorescent antibody or polymerase chain reaction were performed. The pt had no adverse events following prior vaccination. Additionally, it was noted that on 22Aug05, the pt was vaccinated with a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR) (lotA94440F), a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot0992P), and a fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot C2220AA). No further information is expected.
Patient received an expired Havrix; Patient may have been supposed to get Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 01-APR-2023, the patient received Havrix. On 01-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Patient received an expired Havrix) and wrong vaccine administered (Verbatim: Patient may have been supposed to get Twinrix). The outcome of the expired vaccine used and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The pharmacist reported that the  patient who received an expired Havrix dose which was expired on 30th January 2023.  It was also reported that the patient administered wrong vaccine, the patient was supposed to get a Twinrix but she was not sure. The reporter consented to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used. The patient was given Havrix instead of Twinrix which led to wrong vaccine administered.
Mild flu like symptoms, slightly elevated body temperature, body aches, tiredness, shoulder ache, first day.  2nd day body aches, tiredness, sore shoulder, administered Tylenol.  3rd day body aches administered Tylenol
Pfizer 12/21/20 and 1/11. Positive on 9/17
Really bad vertigo; Lightheaded; foggy brain; Fatigue; Vomiting; Nausea; Numbness; tingling in her arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), VERTIGO (Really bad vertigo), DIZZINESS (Lightheaded) and FEELING ABNORMAL (foggy brain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), FATIGUE (Fatigue), VOMITING (Vomiting) and NAUSEA (Nausea). On 16-Jan-2021, the patient experienced VERTIGO (Really bad vertigo), DIZZINESS (Lightheaded) and FEELING ABNORMAL (foggy brain). On 16-Jan-2021, VERTIGO (Really bad vertigo) had resolved. At the time of the report, HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), DIZZINESS (Lightheaded), FEELING ABNORMAL (foggy brain), FATIGUE (Fatigue), VOMITING (Vomiting) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment for the events included OTC meclizine and paracetamol.
mom stated pt started breaking out into a rash around inject sites the following day & 1/2 p/the shots were given; stated the rash is reddened & raised & approx 1 in in diameter around the inject sites;
This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. Patient's medical history and concurrent conditions information were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of PNEUMOVAX23 lot # K007826, expiration date 03-FEB-2016, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
A physician reported that a 2 month old infant, five hours post vax, became pale and developed grunting. The infant was taken to an ER and treated with oxygen, IV fluids and Solu-Medrol. The infant recovered. These events are considered medically important. Additional information, received from the physician on 4/25/2000, indicated that the 2 month old female developed an anaphylactic reaction. She remained recovered.
Right upper arm pain when I reach up, reach back, reach around and lift something heavy and with reduced range of motion and use in right arm.  This started about 2-3 days after vaccine administration.  I had no difficulty with right arm before vaccine.
heart rate range from 74 - 209 according to Apple Watch - manual checks were 5-15 BPM lower consistently. I was unaware this was an issue until today and reported to pharmacy and my PCP
Large round red rash size of a baseball at injection site appeared approx 5pm CST on Sat, Oct 31, 2020.  Applied Triamcinolone Acetonide cream, 0.1%, per recommendation of pharmacist via phone call Sun, Nov 1, 2020 at 12:52pm CST.  Rash slowly dissipated over the course of 2 days.
8/2/06 104 temperature within a week lesions noted to back, scalp, forehead, ears. Continued to develop new lesions daily. 9/19 Biopsy = Psoriasis. Severe psoriasis from head to toe developed with 1 month of vaccine. Numerous topical med given in addition to UVA light therapy 3 times each week. To date 2/2/07 continues to be severe.
Patient became visibly flushed within five minutes after inoculation, and she reported having "waves of nausea." A cool compress was applied to her neck.  While she was closely being monitored, she admitted feeling "dizzy right after the shot bit didn't want to tell anyone because she [ic] was embarrased."  At 1532, patient denied that she was allergic to Benadryl, so Benadryl 50 mg/mL IM was injected into her right deltoid.  At 1545, patient reported an alleviation of symptoms.  She was advised to go home to rest, but to immediately contact 911 or go to the ER if symptoms worsened.  Patient voiced understanding and left the facility with coordinated ambulation and in stable condition.  RN  12/29/2020 @ 1318
Patient reported having mild lip swelling Patient seen by medical team and refused medical transport and signed AMA form Patient stated symptoms improved and will take benadryl at home
Nausea, vomiting, headache, fever 100.3, chills, body aches
Stiff arm, soreness in joints, fatigue, headache late the 13th and all day the 14th.  Better but not gone today, the 15th of October. I did not feel these effects from my first 4 vaccinations.
Fatigued, Nausea, Headache, Slight Fever, Occasional Irony taste in throat
After getting over the 5 days of what I call "the reaction to the shot" I was using my puffer everyday for my asthma, and that lasted about 6 months. I saw the provider via telehealth, told her I had to use my puffer everyday and she did not seem to concerned about it.