chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to an adult patient of unknown age and gender. Information regarding pertinent medical history, drug reactions/allergies or concomitant medication was not reported. On 05-OCT-2016, the adult patient was vaccinated with a pediatric dose of RECOMBIVAX HB (strength: 5/0.5 microgram/ml, lot # M000442 with expiration date 31-MAR-2018), intramuscularly (inappropriate schedule of drug administration and incorrect dosage administered). No adverse effects were reported. Additional information has been requested.
6/12/2003 client called complaining of full body hives with shortness of breath.  Client instructed to seek emergency medical services immediately.  Client was taken to the Emergency Department with severe allergic reaction.  Client was 10 days post Japanese Encephalitis vaccine.
shortness of breath; headache; body aches; dizziness; fatigue; heart palpitations; This is a spontaneous report from a contactable other Health Professional (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), paracetamol (TYLENOL). The patient did not receive other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via intramuscular on 23Dec2020 08:00 at single dose om left arm for COVID-19 immunization and experienced headache, body aches, dizziness, fatigue. It was reported that with 2nd dose, the patient experienced heart palpitations, shortness of breath. With both doses, experienced headache, body aches, dizziness, fatigue on an unspecified date. No treatment was received for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Moderna vaccine was administered outside of source - reported by patient  I95.9 HYPOTENSION 6/3/2021 ACUTE VISCERAL ISCHEMIA
This spontaneous report as received from the consumer mother refers to a 26 year old female patient. No information regarding the patient's medical history was provided. In April 2012 (reported as about 1 year ago) the patient was vaccinated with GARDASIL dose 1, subdermally. No dosage information was provided. No concomitant medication was reported. On date of this report the patient's mother questions how to proceed. She was advised to see a health care professional. Additional information has been requested.
Spouse advises on 11/14/2013 at approximately 5 pm that patient was in this morning to see Dr. and received a Pneumonia shot and now the area at the injection site is swollen the size of a grapefruit, warm to touch and is very painful.  Patient denies rash, shortness of breath, difficulty breathing, or chest pain.  Instructed spouse to have patient elevate arm, apply cold compress to swollen area and suggested Ibuprofen as needed confirming that patient can take Ibuprofen.  Also instructed spouse to have patient evaluated at local urgent care or ED if symptoms worsen or new symptoms develop especially difficulty breathing or chest pain.  Encouraged patient call back in the morning with status.  Called patient on 11/15/2013 and requested nurse visit to evaluate reaction. Patient was seen by provider and it was noted swelling in left upper arm and warm to touch.  Patient advises that his left arm was less swollen than yesterday evening.  No other complaints.  Patient instructed to take on hand Benadryl and prescribed Prednisone. Patient may use cool pack to affected area as needed.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There is no information regarding patient's concomitant medications, pertinent medical history, drug reactions, or allergies provided. On 21-OCT-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX, 19400 PFU, lot # M001747, expiration date: 07-APR-2017 (dose and route of administration were not provided). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 16 degrees Fahrenheit for 1 hour and 30 minutes (and back in range). Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
palpitation, tachycardia, elevated BP, sweating, SOB, paresthesia of both legs below knee & inc anxiety;
About 5 minutes after vaccine patient observed listing in seat, was disoriented and minimally responsive for 1 - 2 minutes, also diaphoretic with clammy skin. Rapid improvement followed 5 more minutes until EMS arrived and patient was transported because of low BP.
Received telephone call from mother on 10/31/19 stating child received influenza injectable vaccine on 10/29/19 at school flu clinic in the AM. That evening developed fever but did not check temperature. Child was shaking. Also has softball size knot to (L) Deltoid that is warm to touch. Did not see PCP.
2-3 minutes post administration, Patient complaint of blurry vision & sweating. sweat was visible on her forehead.  Blood pressure was measured (102/84 mmHg). water was given to drink, patient said she probably didn't eat anything for lunch. After drinking 120 ml of water, she felt better. She was monitored for next 30 minutes, with no other symptoms to report.
itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts.; Sore arm at injection site with arm movement or palpation; Sore arm at injection site with arm movement or palpation; Sore arm at injection site with arm movement or palpation; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient (non-pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EU), via an unspecified route of administration, administered in Deltoid Left on 02Feb2021 at 13:15 as 1st dose single for COVID-19 immunization. Age at the time of vaccination was reported as 57. Other vaccine same date and details was reported as (02Feb2021, EU5318, Dose 1, L deltoid). Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing DMII, hypothyroidism from an unknown date and unknown if ongoing hypothyroid, metabolic syndrome from an unknown date and unknown if ongoing, polycystic ovaries from an unknown date and unknown if ongoing PCOS. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took griseofulvin and wellbutrin and experienced drug hypersensitivity. Location of injection information is available for all vaccines received on the same date. On 03Feb2021 at 04:30 patient experienced itching at skin folds, palms of hands, scalp, eyelids, behind ears, followed by swelling and welts (Itchy skin, Itching both hands, Itchy scalp, Eyelids pruritus, Localized itching, Swelling and Urticaria) and Sore arm at injection site with arm movement or palpation (Vaccination site pain, Pain upon movement and Trigger point pain). Treatment received for the adverse event was unknown. Seriousness criteria was reported as No. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an unspecified number of adult subjects of unspecified gender who were vaccinated with ENGERIX B. On an unspecified date the subjects received ENGERIX B series. At an unspecified time after vaccination with ENGERIX B vaccine series, the subjects experienced not responding to therapy. The nurse reported that the insufficient hepatitis B antibody titers show immunity to hepatitis B even though previously vaccinated with the ENGERIX B vaccine series. The reporter did not know how long ago the subjects received the vaccine or if they ever demonstrated an initial response to the vaccine at the time. The vaccination were all done at the other clinics. At the time of reporting the outcome of the events was unspecified.
MFGR: Aventis -   Patient presented with Papular rash one day after vaccine.  Rash reported to be itching and burning sensation over thighs and dorsal aspect of hands.  Treated with Prednisone dose pack and Atarax oral. - Pending follow up
Swelling/erythema of R UE from shoulder to elbow (site of Dtap), Sudden drowsiness, pallor, unresponsiveness improved after 1/2 hr.
very fatigued; fever; joint and body pain; Slight headache; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Freezing), FATIGUE (very fatigued), PYREXIA (fever), ARTHRALGIA (joint and body pain) and HEADACHE (Slight headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (Freezing). On 25-Mar-2021, the patient experienced FATIGUE (very fatigued), PYREXIA (fever), ARTHRALGIA (joint and body pain) and HEADACHE (Slight headache). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, CHILLS (Freezing), FATIGUE (very fatigued), PYREXIA (fever), ARTHRALGIA (joint and body pain) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided No Treatment information Provided   This case was linked to MOD-2021-278874 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received contain significant information about second dose information
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 not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced irritating itchy rash on middle of foot and keens. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritating itchy rash on middle of foot and keens. This report was non-serious.
sore arm; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, Intramuscular on 21Dec2020 06:00 at single dose on left arm for COVID-19 immunization. Medical history was none. The patient had no Allergies to medications, food, or other products. Concomitant medication included atorvastatin. The patient had sore arm after the fist dose of BNT162B2 on unknown date. No treatment was received for the event. 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 had not been tested for COVID-19. The outcome of the event was resolved.
The vaccines were were given in the thighs at the request of mom at approximately 5 p.m. on Monday, October 5th, 2020. By bedtime at 8 p.m., patient had some swelling, reddness and pain in his left thigh to his knee and a temperature of 99.1 F. Mom gave Benadryl, Zertec, and iced thigh. Mom notified the pediatrician the next day and on Wednesday at 9 a.m., she brought patient to the ER. Patient was given a steroid injection and given 5 days of oral steroids. He was ambulating one hour post injection and better by that evening. The pain, reddness, and swelling resolved in one week. On Tuesday, October 13th, patient developed hives after completing the course of steroids which resolved in one week. The pediatrician told mom that he should not have any further flu shots. I spoke with mom today, 11/14/2020, who informed me that patient had swelling in his arm and into his chest after his flu shot last year. There was also some redness that was not reported on the screening form. Here is the list of influenza vaccines previously given to patient: Fluzone Quadrivalent pediatric given 3/12/2019 Lot UT63155A Expiration Date 6/30/2020 (thigh), Fluzone Quadrivalent pediatric given 04/09/2019 Lot UT63155A (thigh), Fluzone quadrivalent preservative free given on 10/07/2019 Lot U6648CA (arm).
swelling face; red rashes on cheeks; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling face), RASH ERYTHEMATOUS (red rashes on cheeks) and PAIN IN EXTREMITY (sore arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING FACE (swelling face), RASH ERYTHEMATOUS (red rashes on cheeks) and PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 2 tablets total. At the time of the report, SWELLING FACE (swelling face), RASH ERYTHEMATOUS (red rashes on cheeks) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed fever to 103. Seen in ED dx'd with virus. Seen in office approximately 12 hr later. Dx'd with LAOM. Acute Tonsillitis.
fever; chills; aching; nausea; lethargy; Flu like side effects set in 12 hours after 2nd dose.; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 26Apr2021 at 12:00(at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER8730) via an unspecified route of administration in the left arm on 05Apr2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 00:00 the patient experienced Flu like side effects set in 12 hours after 2nd dose. On 27Apr2021 at 12:00 (24 hours after symptoms began) the patient experienced fever, chills, aching, nausea and lethargy. Felt 100% recovered within 36 hours of vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event.  The clinical outcome of the event flu like side effects, fever, chills, aching, nausea and lethargy was recovered on 27Apr2021.  No follow-up attempts are possible. No further information is expected
Sick; Diarrhea; Mucus-y eyes; Tightness in my chest; Cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), DIARRHOEA (Diarrhea), EYE DISCHARGE (Mucus-y eyes), CHEST DISCOMFORT (Tightness in my chest) and COUGH (Cough) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced ILLNESS (Sick), DIARRHOEA (Diarrhea), EYE DISCHARGE (Mucus-y eyes) and CHEST DISCOMFORT (Tightness in my chest). At the time of the report, ILLNESS (Sick), DIARRHOEA (Diarrhea), EYE DISCHARGE (Mucus-y eyes), CHEST DISCOMFORT (Tightness in my chest) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported. The patient states she got sick in July; she did not have COVID. She had three tests done between 07Jul2021 and 18Jul2021, and they were all negative.
pt states temp went up to a little over 104 last noc & lt leg swelled up; called the MD for medicine;
There was a small rash on my left hand. of which I was applying an ointment. it was perfectly fine until the vaccination but after 2 days, i had a burning sensation and redness on the rash. along with it, I observed pimples/red bumps on my face near the nose too.  since then, the rash is flaring up badly and turned red even after applying ointment too.
Patient claimed started to have chills/fever after midnight the day after received the flu shot. Also stated face turned reddish color. Also stated this happens when he get steroid shots.
Dizziness, rapid pulse (124bpm), temp 101df; site soreness for 3 days
Two events within 24 hours after vaccine given. Pt saw blue spots in eyes for 15-20 minutes vomited 1x after 1st episode.
Redness, pain, swelling since 6-15-16 will see primary md today at 12:30pm.
Had 3 phizer vaccinations/ Treatment of COVID-19; Had 3 phizer vaccinations/ Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Hashimotos disease" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Overweight (not obese)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Had 3 phizer vaccinations/ Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site warm; Injection site itching; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Increased asthma exacerbation; Wheezing; Severe diarrhea; Headache still is not resolved since the vaccine; Migraine for 4 days; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) receivedBNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 29Jan2022 11:45 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "hashimotos disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: cats" (unspecified if ongoing); "known allergies: dander" (unspecified if ongoing). Concomitant medication(s) included: IPRATROPIUM BROMIDE; ALBUTEROL [SALBUTAMOL]; PREDNISONE; trazodone hydrochloride (TRAZADOL). Past drug history included: Codeine, reaction(s): "known allergies: codeine". The following information was reported: ASTHMA (medically significant), outcome "not recovered", described as "Increased asthma exacerbation"; WHEEZING (non-serious), outcome "not recovered", described as "Wheezing"; DIARRHOEA (non-serious), outcome "not recovered", described as "Severe diarrhea"; MIGRAINE (non-serious), outcome "recovered" (Feb2022), described as "Migraine for 4 days"; HEADACHE (non-serious) with onset 29Jan2022 11:45, outcome "not recovered", described as "Headache still is not resolved since the vaccine".  The patient underwent the following laboratory tests and procedures: Binax: (31Jan2022) negative, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of asthma, wheezing, diarrhoea, migraine, headache. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information the event asthma is most likely related to the underlying condition hence unrelated to the suspect drug.