chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 5 minutes after the patient received the vaccine, she dropped to the floor. I immediately rushed outside to asess the situation and to see if she was seizing, had an allergic reation to the vaccine, or if she needed cpr. The patient immediately was able to get up and did not require any of the above. I asked her father what happened and he said that she told him that she felt dizzy and she was about to faint when he caught her in his arms and lay her on the floor. I assured the parents that we gave her the right vaccination and that she should come back in the vaccination room to be under observation by me/my intern for a while longer.  I asked the father multiple times if she hit her head anywhere on the way down and he said no since he caught her on the way down. We took her to the vaccination room and had  her sit down. I asked if water she needed some cold water as it may help the dizziness. The  father said yes. We gave her a cold water bottle to drink. I then asked the patient when was the last time she ate and she told me she did not eat until the night prior for dinner. Again, she got this vaccine at around 2:45 pm so she did not eat anything for more than 12 hours. I told her most likely has low blood sugar as well and that we should give her something to eat. I gave her a piece of cake to eat slowly. I also gave the patient an ice pack just in case the dizziness she experienced had to do with heat exhaustion. The patient then said she feels fine and does not think that she needed to stay any longer. He father and her both agreed it was time to go since she was fine. We keep her under observation for about 20 minutes- she was either being watched by me or by my intern, if I had to help other patients. The patient, the patient's father, and the patient's mother all thanked us multiple times. The patient's mother also apologized numerous times to both me and my clerk saying that she should not have yelled at us as we were not to blame for the incident.
Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in 31st January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The patient received 1st dose in 31st January, till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. Reporter consented to follow up. This case was considered as medication error without harm.
the area on my arm where I received the injection turned red; the area on my arm where I received the injection turned red, became inflamed; the area on my arm where I received the injection turned red, became inflamed, and began to itch; rash of tiny bumps around the injection site; rash of tiny bumps around the injection site and it has continued to itch now for two days; site of my injection has been very hard; site of my injection has been very hard and sore; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 15:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included inappropriate sinus tachycardia, occipital neuralgia and fruit allergy to bananas. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included daily multivitamin minerals nos; vitamins nos (CENTRUM) from an unknown date. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. On 01Apr2021, the patient underwent COVID-19 PCR test (test type: Nasal swab) and tested negative. The patient reported that the site of injection had been very hard and sore since the first dose of Pfizer COVID-19 vaccination on 25Mar2021. One week later on 02Apr2021 at 14:00, the area on arm where the patient received the injection turned red, became inflamed, and began to itch. She then developed what seems to be a rash of tiny bumps around the injection site and it has continued to itch now for two days. The patient do not have any other symptoms so far. 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 events. The clinical outcome of the events site of injection very hard and sore, injection site area that turned red, became inflamed and began to itch, rash of tiny bumps around the injection site that has continued to itch were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
- Erythema & mild swelling at injection site - Rt arm - (site of ZOSTAVAX vaccine). - Advised  cold compress. Offered hydrocortisone cream &/or BENADRYL which pt declined.
two friends had a stroke after getting the COVID-19; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored Program. This is the first of two reports. A female patient of unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that two friends had a stroke after getting the COVID-19 vaccine on an unspecified date with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101170640 same reporter, product and AE, different patient
No adverse event; Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 004M20A) for COVID-19 prophylaxis.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], CURCUMIN (THERACURMIN BIOACTIVE), UBIDECARENONE (COQ10 [UBIDECARENONE]), PYCNOGENOL and SAW PALMETTO [SERENOA REPENS] for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 31-JAN-2021, Moderna Dose 2 on 8-MAR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that patient took moderna dose three on 10-Nov-2021 batch number 066F21A, at left arm. Fourth dose on 16-May-2022 batch number 056M21A at left arm. Fifth dose on 25-Oct-2022 unknown batch number at left arm. Patient also experienced Paxlovid COVID rebound. First time getting COVID. Tested on 13-Feb-2023. Began Paxlovid on 13-Feb-2023 in pm with batch number GF3904. Ended 5 day treatment Feb 18th am. Tested negative on 21-Feb. Symptoms cleared. Retested on 23-Feb as precaution. No rebound symptoms. Tested positive again. Later in day, after positive test, began recurring/rebound symptoms of bad head cold.  Treatment medications were not reported.
Patient phones pharmacy about an hour after receiving flu shot. Experiencing tingling of the tongue and some swelling of the tongue. Recommend taking diphenhydramine which resolved the symptoms. Follow up patient had no further complications or treatment required.
Incorrect product storage; No AE/PQC reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with two dose series of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W031813, expiration date 05-OCT-2024, 0.5 milliliter; route was not reported) for prophylaxis. The vaccine was improperly stored at temperatures above recommended range (product storage error). No adverse event was reported.       This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA001484:
Diagnosed with viral meningitis; gout (legs hurts when touched); He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENINGITIS VIRAL (Diagnosed with viral meningitis), GOUT (gout (legs hurts when touched)) and PSYCHOTIC DISORDER (He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PSYCHOTIC DISORDER (He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping) (seriousness criterion hospitalization). On 04-Apr-2021, the patient experienced MENINGITIS VIRAL (Diagnosed with viral meningitis) (seriousness criteria hospitalization and medically significant) and GOUT (gout (legs hurts when touched)) (seriousness criterion hospitalization). The patient was hospitalized on 04-Apr-2021 due to GOUT, MENINGITIS VIRAL and PSYCHOTIC DISORDER. At the time of the report, MENINGITIS VIRAL (Diagnosed with viral meningitis), GOUT (gout (legs hurts when touched)) and PSYCHOTIC DISORDER (He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping) had not resolved.            On 4th April 2021 the patient looked like he was dying, replies but not very coherent, After 2nd shot 7-8 days later he was "gone", "Little weird things" that would happen when he's sleeping.  No concomitant medication included.  Very limited information regarding these events has been provided at this time.  Further information has been requested  Antibiotics are added as treatment medications.   This case was linked to MOD-2021-072700 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Seriousness criteria upgraded.Events updated; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Breakthrough case admission after third dose Moderna 2/26/21 Lot# 025A21A Moderna 3/26/21 Lot# 028A21A Moderna 11/12/21 Lot# 039F21A
Patient stated arms was sore at injection site next morning (11-20-18), and red and swollen from site to about halfway to elbow. On 11-22-18, was more swollen and red to elbow. Today, 11-23-18, patient states arm better, swelling and redness less. Patient stated his doctor was out, but that he would see him tomorrow if not resolved.
sharp, unremitting R axillary pain; lymphadenopathy/swelling; This is a spontaneous report from a contactable physician, reporting for herself. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), intramuscularly at the right deltoid on 04Feb2021 12:30 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. The patient's medical history and concomitant medications were not reported. 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. There were no other medications received within 2 weeks of vaccination. There were no known drug allergies. The patient previously received fist dose of BNT162B2 (lot number: EL3246), intramuscularly at the right arm on 14Jan2021 14:30 for COVID-19 immunization. On 05Feb2021 22:00, the patient developed sharp, unremitting right axillary pain and lymphadenopathy. She had a normal mammogram earlier this year and no injuries or other reasons to suspect this pain and swelling was due to anything other than a reaction to the 2nd COVID-19 vax. The patient was not worried nor upset, just wanted to pass along this information. No treatment was received. The outcome of the events was not recovered.
Received vaccine 9/25/15. Pain that night at injection site. Next day (9/26/15) developed redness and swelling at site "golf ball size". Next day 9/27 increased pain, swelling and redness "softball sized", hard to move arm, warm to touch. Pain with movement. Exam: (L) upper arm/shoulder 8 x 10 cm area of redness, swollen, warm, tender. No discharge, no red streaking. Hurts to fully elevate.
Hep A vaccine given on 3/16/16 had expiration date of 3/7/16.
Seconds within administration patient complained of itching at the injection site. Examined by physician told to give BENADRYL. To ER if any respiratory issues developed.
Rash, raised skin approx 1-2"  around injection site.  Slight itchiness
The patient arrived requesting the Pfizer bivalent booster as well as an influenza vaccine. I administered the influenza vaccine and accidentally administered a Pfizer monovalent booster instead of the bivalent, since the vials are nearly indistinguishable from each other. I explained the error to the patient and her mother and offered the correct bivalent booster which they accepted. On follow up, the patient reported headaches, chills, myalgias, and low grade fevers beginning from the evening of the vaccine administration.
Fever to 103 the following day. Patient developed thrombocytopenia with a petechial rash on 3/19/22. Lowest platelet count was 38K.  Platelets recovered to 106K 2 days later. Further evaluation pending
stomach ache; very bad diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (very bad diarrhea) and VOMITING (vomiting) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (very bad diarrhea) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (very bad diarrhea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Patient called to report that she received the Moderna Covid-19 on 2 Feb 2021 in her left arm. After vaccination, the patient started experiencing stomach ache, vomiting, very bad diarrhea. Patient wanted to know what to do now, and why she need to receive the second dose of Moderna COVID vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non-significant FU added.Declined email address or fax number
This 86  year old male received the Covid shot on  1/20/21    and went to the ED on  1/23/21     and was admitted  on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs
Acute CVA (cerebrovascular accident)  Cerebral infarction, unspecified
Pain at injection site lasting 2 days; Elevated temperature 99.5 overnight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 09:00 (Lot number: ER8730) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CALCIUM; MELATONIN. Vaccination history included: Bnt162b2 (Dose 1, lot number: EN6206, administration time: 09:00, vaccine location: Left arm), administration date: 05Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Mar2021 02:00, outcome "recovering", described as "Pain at injection site lasting 2 days"; BODY TEMPERATURE INCREASED (non-serious) with onset 27Mar2021 02:00, outcome "recovering", described as "Elevated temperature 99.5 overnight". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, body temperature increased.  Additional Information: Concomitant medication also included multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient has no allergies to medications, food, or other products. The patient age at vaccination was 61 year (as reported).  No follow-up attempts are possible. No further information is expected.
DOS 12/19. Fever, myalgias, color change, tenderness and swelling. TX Cephalexin 500mg.
PATIENT ARRIEVED COMPLAINING OF ITCHING AND PAIN AT INJECTION SITE. THE AREA WAS HOT TO THE TOUCH; RED AND RAISED ABOUT 4" X 2" IN SIZE. THE PATIENT VISITED HER DOCTOR AND WAS PRESCRIBED MOMETASON 0.1%. WHICH CLEARED THE RASH IN 3 DAYS AFTER APPLICATION.
This case was reported by a healthcare professional (the subject) and described the occurrence of indentation at injection site in a 59-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included high blood pressure. Concurrent medications included blood pressure medication (medication for high blood pressure). On 19 November 2008 at approximately 11:30 the subject received unspecified dose of FLULAVAL (.5 ml, unknown route, left deltoid). In April 2009, 5 months after vaccination with FLULAVAL, the subject experienced indentation at injection site, hardness injection site and pain. The subject's skin was hard an inch and a half around where the vaccine was administered. The pain episodes occur 20 times a day, but resolve before she can take any treatment. She described her pain as 10 plus when looking at a pain scale of 1 to 10. The subject was treated with LIDODERM patch, steroid, KEFLEX and prednisone. The subject visited two different dermatologists. The LIDODERM patches and topical  steroid did not help her symptoms. The KEFLEX and prednisone had helped some. The physician told the subject that this was a chronic condition. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up received on 25 August 2010 from a physician: The physician reported that the subject had developed an indurated, ulcerated area of the skin with underlying granuloma and shooting pain 20x a day. The physician considered the events clinically significant (or requiring intervention). The induration, ulceration, granuloma and pain were worse at the time of reporting. The physician considered the events were possibly related to vaccination with FLULAVAL.
Painful swelling, redness , swelling and rash on the upper arm  of injection site.
Severe HA (8/10), BP increase to 177/89, 182/90 (no hx of hypertension), HR remained in the high 90?s, pulse ox 98%, minimal diaphoresis, c/o numbing to face, when asked to smile, states she cannot.  Patient sent to ED for evaluation.
Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 33-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 18Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The event "contracted covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: There was no other vaccine in four weeks. There was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
flu-like symptoms; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills) and PYREXIA (fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Chills and Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had no throwing up after the first dose. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-293913 (Patient Link).
Patient presented to the ED and was subsequently hospitalized for aspiration pneumonia within 6 weeks of receiving covid booster vaccination.