chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after 2nd shot, I got high fever, trembling and body aces and I was tiered weeks after. Then ended up in hospital ER on June 29th 2021. I stop breathing talking and could not walk Withing 48 hours I had to be put on ventilator. On July 3, 21 I was air lifted to hospital. That time I was completely paralyzed and in tube feeding. After numerous test I was diagnosed with Guillain Barre Syndrome and Plasma ephoresis treatments started. 2 of the neurology's diagnosed my GBS caused by Covid  vaccine. I also had tracheotomy done over there. on 08.06 I was transferred by air Ambulabce to Hospital. During that stay I was getting respiratory therapy, still in ventilator with trach and tube feeding, started to get some physical and occupational therapy in bed. On October 14,2021 I was transferred by Ambulance to Hospital. I started to get physical and occupational therapy. Oct 20th trach and feeding tub were removed. I started also speech therapy, On Oct 23rd 2021 I was released to come home. Still today learning to re-do things and learning to walk with walker. I need daily assistance in everything. My current Neurology Dr. is my current Neurology but not the one who did initial diagnoses. Dr. agrees with Hospital
Patient developed a 3 x 5 cm area on swelling & erythema on left anterior thigh; noticed today by mother.
vaccine expired on 8/31/2022; vaccine administered on 9/2/2022 no known adverse reaction
Signifant redness and urticaria/swelling below(not directly at) site of injection on the left arm that stopped just before the elbow.
3 patients received the 2nd dose of the vaccine before 28 days; A spontaneous report was received from a nurse concerning three patients (age and gender unspecified) who received second dose of Moderna's COVID-19 vaccine (mRNA-1273), before the recommended window of 28 days, after 1st dose.  The patients' medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patients received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration and unknown arm, for prophylaxis of COVID-19 infection.  On an unspecified date, one patient received the second dose 14 days after the 1st dose and 2 patients received the second dose 20 days after the 1st dose (inappropriate schedule of vaccine administered).  No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the event of 3 patients received the 2nd dose of the vaccine before 28 days was considered as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Presented to ED 1/17/2022 with increasing exertional dyspnea and sats of 67% (history of bronchiectasis on 3 L by nasal cannula). Increasing shortness of breath.   Transition to Vapotherm on 1/19/2022. Transferred to the ICU on 1/21/2022.  Transitioned to BiPAP.  Consults with  pulmonology, intensivist, infectious disease.  Dexamethasone and transition to high-dose methylprednisone 60 mg every 6 hours. Started on remdesivir and vitamin C/E by infectious disease. Vaccinated with Pfizer vaccine x2 in March 2021 but had not yet received her booster shot.
reaction; Soreness in arm; This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE REACTION (reaction) and PAIN IN EXTREMITY (Soreness in arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM;COLECALCIFEROL]) for Prevention.    On 06-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 ADVERSE REACTION (reaction) and PAIN IN EXTREMITY (Soreness in arm). At the time of the report, ADVERSE REACTION (reaction) and PAIN IN EXTREMITY (Soreness in arm) outcome was unknown.        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.   Treatment information was not provided.   This case was linked to MOD-2021-031439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Follow-up information received on 31-MAR-2021 contains significant information- Patient contact details, patient demographics, concomitant medications, event added. On 21-May-2021: Follow-up information received on 21-MAY-2021 contains non-significant information.
Upper arm is swollen, red, tender, and is a little itchy. No systemic symptoms. Local reaction only. Swelling down to his elbow.
Pt had typical second dose Moderna reactions:  Fever, chills, aches.  This was upsetting becuase she only inteded to get the flu shot but we gave her the Moderna booster by mistake.  She was however due for this vaccination.
Severe facial swelling  (angioedema) reported 2 days after the vaccination, received vaccine Saturday 10/02/2021 without incident, reported back to pharmacy on Monday morning 10/04/2021 reportinf allergic reaction that started early mornin on 10/04/2021, reported to ER then to pharmacy to notify.
No adverse effects reported; Received an improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs, drug reactions and allergies was not provided. The patient's concomitant therapies included sterile diluent.   On 19-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(rha) lot # R004441, expiration date 12-AUG-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range of -14°C to -10°C (-14.3°C) for 2 hours and 7 minutes. There was previous temperature excursion from -14°C to -10°C (-12.8°C) for 51 minutes and from -9°C to 8°C (-8.2°C) for 37 minutes. It was reported that digital data logger was involved. No adverse effects were reported.  This is one of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012682: US-009507513-1905USA009915: US-009507513-1905USA012684:
Patient developed a 5.5 x 5.5 cm area of induration and erythema on right deltoid in the area where DTAP dose was given.
FLU LIKE SYMPTOMS; SKIN INFECTION IN LEFT LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced flu like symptoms, and skin infection in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms and skin infection in left leg was not reported. This report was non-serious.
Bronchitis; Sick; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 (Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history included bronchitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced bronchitis, sick on an unspecified date. Therapeutic measures were taken as a result of bronchitis and sick. The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from nurse refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M043562, expiry 03-JUN-2018 (dose and route not reported) for prophylaxis. No adverse effects reported. No additional information was provided. Temperature: 32 F to 35 F Time frame: 30 minutes. Data logger was used. Previous temperature excursion? Yes 32F to 35F (34.6F) for 5 minutes 32F to 35F (35.1F) for 30 minutes. This case is one of the 3 reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA009024: US-009507513-1707USA009025:
Information has been received from a physician concerning an adolescent female patient who on an unspecified date, was vaccinated with GARDASIL. The physician reported that the patient experienced injection site pain and blisters under eye. the outcome is unknown.  Additional information has been requested.
Throat swelling after 10mins of shot - heavy steroids to assist in allergic reaction right foot tingling 1 day after shot. Left and right foot tingling day 2 after shot partial numbness in left leg from foot to knee day 3 after shot - still occuring partial numbness in right leg from foot to groin day 3 after shot, loss of reflexes i ankle and knee, severe muscle weakness - still occuring numbness and pressure and stiffness in neck and lower part of back of the head, pressure in sinuses - 30mins after eating since day 4 after shot - still occuring. muscle weakness in right arm day 4 after shot - still occuring
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
administration of an expired diluent with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via  Medical Information  (Reference number- 00690445) and transmitted to Sanofi on 20-Jul-2021.  This case involves a 36 year old female patient who had administration of an expired diluent with no reported adverse event at the time of receiving YELLOW FEVER VACCINE - [YF-VAX] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) and HEPATITIS B VACCINE RHBSAG (YEAST) (HEPLISAV B) for prophylactic vaccination.  On 19-Jul-2021, the patient received a dose (0.5ml) of suspect YELLOW FEVER VACCINE - (lot number: UJ371AB; expiry date: 21-JUL-2022; expiry date of diluent: 21-Jun-2021) via subcutaneous route in the left arm for prophylactic vaccination.  It was case of actual medication error due to expired product administered (latency: same day).  The outcome of the event was unknown.    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.
Clinic lead diluted gray top Pfizer with diluent.  Client received diluted vaccine
Information related Health Department via client's supervisor.  Client stated to her supervisor that following administration of the Rabies vaccine on Tuesday, September 19, she felt fine the rest of the day.  She did relate to her supervisor that on Wednesday, September 20 she was dizzy, had nausea, head ache, and fatigue.    On Friday, September 22, client stated to her supervisor that she no longer had the nausea but continued to be light headed and felt tired.  Client had previously received a Rabies vaccine on June 6, 2006 but failed to return at the appropriate time to continue the series.  Because of this, was required to begin series again on Aug. 29, 2006
HEADACHE (LASTED ABOUT 2 MONTHS); This spontaneous report received from a patient concerned a 71 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced headache (lasted about 2 months). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache (lasted about 2 months). This report was non-serious.
For 3 weeks / Large red patch / on her upper arm where the injection was given; Had a poor reaction' / stabbing stomach pain; Had a poor reaction'  / shins ached; Had a poor reaction'  / Fever; Had a poor reaction'  / racing heart/palpitations; Felt so bad / sat on the sofa with her front door unlocked / called her neighbors / in case she needed help; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 59EA2, expiry date August 2020) for prophylaxis.   Previously administered products included PNEUMOCOCCAL VACCINE with an associated reaction of nonspecific reaction (had reaction in 2018) and Shingrix with an associated reaction of pyrexia (received 1st dose on 19th April 2019, refer case US2021009441). Concurrent medical conditions included low blood pressure and drug allergy (Allergic to thimerosal, cilantro and codeine). Concomitant products included medication unknown (Bioidentical Hormones (Generic Ingredient Unknown)).   On 29th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, stomach pain, leg pain, fever, heart racing and feeling bad to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The patient was healthy, had no kidney problems, no heart issues and exercises daily. The concomitant medication included thyroid medication. The patient got both Shingrix shots at the same pharmacy.   The patient received Shingrix and stated the expiration date listed was August 2020 which did not match the expiration date in our system. The patient had a poor reaction to the second shot symptoms included stabbing stomach pain, shins ached, fever, and racing heart palpitations and stated that lives alone and she felt so bad that she sat on the sofa with her front door unlocked in case she had to call 911. The patient called neighbors to let them know what was going on in case she needed help and said for 3 weeks she had a large red patch, about the size of a dessert plate, on her upper arm where the injection was given. All these events resolved and stated she did try to call to report her experience but we were closed for holiday Labor Day weekend. The reporter did not consent to follow up and did not want to share her physician contact information because the Shingrix injections were given at the pharmacy not the physician's office.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021009441:Same reporter, Same patient. 1st dose
Fatigue; headache; pain at injection site; shortness of breath; This is a spontaneous report from a contactable other health professional (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included Lyme disease, early onset arthritis, allergy to latex. Concomitant medication included diclofenac (VOLTAREN). The patient experienced fatigue, headache, pain at injection site for 2 days, shortness of breath for 20 minutes on day 2 afternoon, all on 23Jan2021 13:30. No treatment received. The reporter considered the events as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event pain at injection site was recovered on 25Jan2021 13:30, of the event shortness of breath was recovered on 23Jan2021 13:50, of the other events was recovered in Jan2021.   Information on the lot/batch number has been requested.
chest/lung pain/discomfort when taking a breath; chest/lung pain/discomfort when taking a breath; chest/lung pain/discomfort when taking a breath; Periodic fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis affecting lungs, relapsing polychondritis and bipolar type II. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 11:00, the patient had periodic fast heart beat from time of injection over 24-hours period. On 15Apr2021 at 15:00, about 4 hours after injection, the patient experienced chest/lung pain/discomfort when taking a breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest/lung pain/discomfort when taking a breath was resolved on an unknown date in Apr2021 and of the event periodic fast heartbeat was resolved on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
Fever 102, pain in left arm, nausea, vomiting, diarrhea.
Hives on back, legs, arms, and sides, itching at site. Treated with Benadryl cream and tablets(25mg to 50mg)  Clarin as well..
p/vax pt exp dizziness; nausea; felt like was going to pass out; tx w/fluids & sugar water;
Comvax given at age 2m, 4m, 12m. Haemophilus Influenza B vac response done 8/21/03 <0.15 ug/ml, non protective antibody level. HIB vaccine given again 9/19/03.
pregnancy; chills in the middle of the night; really tired/ Fatigue; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy), FATIGUE (really tired/ Fatigue) and CHILLS (chills in the middle of the night) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 18-Feb-2021 and the estimated date of delivery was 25-Nov-2021. On 12-Mar-2021, the patient experienced FATIGUE (really tired/ Fatigue). On 13-Mar-2021, the patient experienced CHILLS (chills in the middle of the night). On 17-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy), FATIGUE (really tired/ Fatigue) and CHILLS (chills in the middle of the night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Pregnancy test: positive (Positive) positive pregnancy test 5 days after the first dose..     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.
postnasal drip; think this might be COVID symptoms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (postnasal drip), COVID-19 (think this might be COVID symptoms) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011320A) for COVID-19 vaccination.     Concomitant products included VITAMIN B NOS for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (postnasal drip), COVID-19 (think this might be COVID symptoms) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 18-Jan-2021 at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) on 19-Jan-2021 at an unspecified dose and frequency. At the time of the report, UPPER-AIRWAY COUGH SYNDROME (postnasal drip), COVID-19 (think this might be COVID symptoms) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included antidepressants.
This spontaneous report as received from a pharmacist refers to an adult female patient (exact age was not provided). Patient's medical history was not reported. On an unknown dates also reported as when "she was 20 years old", the patient was vaccinated with her first two doses of GARDASIL (frequency, route of administration and lot # were not provided). Concomitant medication was not reported. The patient stated that she would like to receive her third dose of GARDASIL. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.