chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 2/20/08.  On about 2/26 pt went into CHF, symptomatic. She recovered spontaneously by about 3/12/08.  Background:  Severe mital regurgitation due to mitral valve prolapse and prior bacterial endocarditis about 30 years ago.  Echo after this episode unchanged from preimmunization.
Feeling nausea, HOH after injection she stated. Same s/s after 1st injection she stated.  @16:34        BP=71/38            Pulse=67         O2=97% @16:38         BP=76/47            Pulse=64         O2=97% @16:43         BP=90/61             Pulse=67          O2=98  Pt.presented with dizziness and hypotension. Mother refused IV fluid therapy stating "she's ok, she's just being dramatic." Mother signed refusal and released.
No adverse reaction to the vaccine, just a little tired, soreness at the site of the injection; only that after 4 months I got COVID-19. I had a home test and it was positive; my son was not feeling well so I tested, and it was positive, I had a running noise. I called my doctor and had a video conference, he prescribed PAXLOVID to treat the symptoms. Between 3PM-7:00PM I was feeling worse. I took PAXLOVID for 5 days, very bad headache, muscle ache all over my body, tired, but I after 2 days I felt better, by the time I finished the prescription I felt much better. The only side effect to PAXLOVID was the terrible taste. 24 hours after I finished with PAXLOVID, my left wrist started to feel irritated, my whole arm was red & bumpy. The right arm started to do the same thing. I used BENADRYL, after using, it stopped.
Parent reported that child was feeling hot and sweating 10 minutes after receiving vaccine. Parent also stated that patient had a similar reaction after previous influenza vaccination, but she did not disclose that at the check in station when asked.  On assessment, patient had visible perspiration and reported feeling tired, patient's parent also reported that patient had not eat breakfast. Vital signs completed, patient was provided with a lollipop and reported feeling better after eating lollipop. Vital signs were redone, and patient was transported the to facility ER  in wheelchair for observation accompanied by staff and the patient's father.
Thursday morning the patient woke up with the left side of his face droopy, eye closed. The patients mother took him to the ER and the patient was diagnosed with Bells Palsy. The patient was prescribed from the hospital valacyclovir 1gram and prednisone taper. The patient did not have any reactions to the first dose in the vaccine series.
Chest pain left side; Tightness in the chest 2 nights; Pain on the side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain left side), CHEST DISCOMFORT (Tightness in the chest 2 nights) and PAIN (Pain on the side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CHEST PAIN (Chest pain left side), CHEST DISCOMFORT (Tightness in the chest 2 nights) and PAIN (Pain on the side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain left side), CHEST DISCOMFORT (Tightness in the chest 2 nights) and PAIN (Pain on the side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received form a physician concerning a 29 year old female with no pertinent medical history and no history of drug reactions allergies who on 8/9/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F) inappropriate schedule of vaccina administration. There was no concomitant medication. On 8/9/06 the pt experienced a fever, nausea, body aches, joint pains and experienced flu like symptoms. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the fever, nausea, body aches, joint pains and flu like symptoms.
Monday I had pain on my right ear. My salivary gland I have issues with and they thought I had cancer but I had an infection and was taking clindamycin. I started my medication as prescribed but this time the pain was different. I had a sharp pain. Normally once I take my antibiotics I start to feel better but this time I didn't feel better. I had like numbness to right side of my face and tongue. I decided to go to the emergency room on December 24th, 2022. I noticed when I brushed my teeth in the morning when I put water in my mouth, my mouth would not close on the right side. They did tests in the emergency room and was seen by a neurologist. She ordered me an antiviral BACTRIM. I was negative for stroke. The ultimate diagnosis was Bell's Palsy. The following Tuesday I started having trouble with my eye, it was slowly closing. I had had Bell's Palsy previously in 2018 but this was completely a different feeling. I had trouble with speech too because I couldn't close my lips. I was not able to pronounce properly because I couldn't close my lips. On about Thursday December 22nd, 2022 when I stood up from my desk, my right side labia was completely numb.
VERY SORE ARM AND LARGE RED CIRCLE OF THE INSIDE OF UPPER RIGHT ARM. not IN THE AREA OF THE INJECTION.
Severe nausea and vomiting, body aches and joint aches, chills, sweating, fatigue. Lasted about 24 hours. I slept for a total of 16 hours the day after getting the vaccine and could not do daily activities. I took Tylenol and drank fluids.
Her throat started hurting; She did have fibromalagi. her fibro flared up worse than she has ever had it.; She did have fibromalagi. her fibro flared up worse than she has ever had it.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received second dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient's medical history included fibromyalgia from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced her throat started hurting, her fibro flared up worse than she has ever had it on an unspecified date. Caller stated when she had the first dose of the Covid vaccine she did not have problems except her arm was sore. She did have fibromyalgia. She had her second dose last Sunday on 18Apr2021. Her throat started hurting and her fibro flared up worse than she has ever had it. She wanted to know if she need to go to her doctor or what to do. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Allergic reaction including hives, pruritis,  throat tightening starting hours after injection. Patient received diphenhydramine at home & given an epinephrine injection (epi-pen when experienced throat tightening.  Seen in Clinic 36 hours later & given Diphenhydramine to take prn, routine cetirizine, epinephrine Pen for home use (prn respiratory distress) & a prednisone dose pack to start if urticaria worsening (this was not used).  Throat tightening improved after epinephrine and the hives persisted off and on for approximately 5 days. It is noted that the patient had received a Td booster on 7/20/2004
cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Full body itching; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in left arm on 06Apr2021 at 15:00 (at the age of 54-years-old) as single dose for COVID-19 immunisation. Medical history included diabetic, hyper tension, penicillin allergy and bee pollen allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included enalapril maleate (VASOTEC) and metformin (MANUFACTURER UNKNOWN); both from unknown dates and for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 06Apr2021 at 16:30, the patient experienced full body itching and slight headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event headache which included treatment with TYLENOL. The clinical outcome of the events full body itching and slight headache were recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness, swelling, black ring around arm, stiffness, painful, traveling up towards neck and down arm, veins in hand were very purple, like a rubber band around my arm cutting off circulation going down my arm, very painful like a 10, dizziness, nausea. In office shot of steroids 40mgs and to take 40mgs there after for 5 days. After shot within 24 hours pain was gone, swelling was gone.
MENTAL INJURY / NOT MENTALLY OK AT ALL; PHYSICAL INJURIES; VERY ILL; This spontaneous report received from a consumer concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on MAY-2021 for covid-19 prophylaxis. The patient experienced difficulty remembering anything that has occurred, mental injury / not mentally ok at all, physical injuries and very ill (Dose number in series 1). The patient had not recovered from difficulty remembering anything that has occurred, mental injury / not mentally ok at all, physical injuries and very ill. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient became very ill, had mental injury / not mentally ok at all and physical injuries from the shots (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very ill, mental injury / not mentally ok at all, and physical injuries. This report was non-serious. This case, involving the same patient is linked to 20230429085. This case, from the same reporter is linked to 20230108455 and 20230109456.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Myalgia, Fever, NauseaVomiting, chills, malaise Narrative:
Pt received adult DT on 01/14/2004 then given Decavac on 10/18/2005. No adverse affects were reported by patient after 6 days. Pt denied any discomfort at injection site, Pt health remains unchanged as prior to injection.
Bladder urgency and pain starting 30 minutes after injection. Malodorous cloudy urine started within 24 hours. Asthma  type attacks, with complete closure of airway for 60-90 sec started within a week. Shingles outbreak in the first month. I have no history of allergies, asthma or shingles prior to the vaccine. Urine tests are negative for UTI,  and I have no history of interstitial cystitis. I take antihistamines 24 hrs/day, to prevent asthma attacks, the bladder symptoms are ongoing.
Client awoke @ 4am with right arm pain and right hand tingling and swollen nodes under her arm. She saw Dr on Monday 7/26/2004, her Dr told her to take Benadryl 50mg one today and one today and one tomorrow and Ibuprofen 600mg and Ibuprofen 600mg and she should tell better by 7/27/2004.
Pt. called on 12/1/21 and complained of side effect from Shingrix. Reported "rug burn" sensation from toes intially then between finger as well.
Vaccine administered to pregnant patient; Diarrhea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) and DIARRHOEA (Diarrhea) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 25A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included BUPROPION for Depression, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Jul-2020 and the estimated date of delivery was 23-Apr-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) and DIARRHOEA (Diarrhea). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with reported AEs, myalgia, fatigue and diarrhea in a 34 year old patient. Patient will be continued to be monitored for further AEs during her pregnancy.   This case was linked to US-MODERNATX, INC.-MOD-2021-069796 (E2B Linked Report).; Sender's Comments: This is a case of product exposure during pregnancy with reported AEs, myalgia, fatigue and diarrhea in a 34 year old patient. Patient will be continued to be monitored for further AEs during her pregnancy. US-MODERNATX, INC.-MOD-2021-069796:Second dose case
Within minutes of injection, the pt had a syncope episode with a possible small seizure. The pt's hands and head were jerking. The pt was advised to sit for awhile. Given cold clothes and a drink. The pt continued to feel extremely dizzy, was unable to stand without feeling extremely dizzy. The pt stayed in the office for approximately 2 hours before being transferred to the ER.
Information has been received from a consumer regarding her 12 year old daughter with no medical history or allergies who on 07-SEP-2007, was vaccinated with a first 0.5ml dose of Gardasil. There was no concomitant medication. On 08-SEP-2007, the patient experienced a light headache and loss of appetite. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
This spontaneous report was received from a Medical assistant refers to a 26 years old female patient. On 06-NOV-2012, the patient was vaccinated with an improperly stored dose of 0.5 milliliter(ml) GARDASIL (lot # 0630AE, expiry: 21-NOV-2014) intramuscularly in the left arm. This was the patient first dose. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
WARM, RED,SORE, SWOLLEN AREA AT INJECTION SITE. SLIGHT FEVER. CHILLS.
My adverse reaction was about 24 hours of severe flu like symptoms. I received the vaccine Friday afternoon 3/12, and around midnight that night (so 3/13 technically) I developed flu like symptoms. I had a mild fever, severe body aches, severe headache, nausea, fatigue, etc. For the entire day of 3/13 I was pretty much bed ridden. Around 5pm on the 13th I took Tylenol and felt a little better and was able to eat something and fall asleep that night. I woke up on the 14th with just a sore arm where I received the shot.
several hr following vax pt devel non-itchy rash w/no diff breathing, no SOB;
This spontaneous report was received from a physician referring to 6-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # N000235, expiration date 26-OCT-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 21-JUN-2017 till 01-AUG-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 49 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. ; Sender's Comments:  US-009507513-1709USA012766:
This spontaneous report was received from the patient's father concerning a 20 year old female patient. The patient's medical history concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The reporter informed that since an unspecified date (reported as for 2 years), GARDASIL 9 did nothing, and that it would have been better if the patient did not get vaccinated at all. At the time of reporting, the outcome of GARDASIL 9 doing nothing for 2 years was unknown. The causal relationship between the vaccination with GARDASIL 9 and the event was not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA013314.
No other AE/PQC reported; HCP reports a 65 year old patient was given PNEUMOVAX 23 instead of PREVNAR 13; This spontaneous information has been received from a medical assistant, concerning a 65-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 23-AUG-2020, the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter intramuscularly as prophylaxis, lot number P007790 with expiration date 03-DEC-2021 (strength and anatomical location were not provided) instead of pneumococcal 13v conj vaccine (CRM197) (PRENAR 13) (wrong vaccine administered).  No adverse events were reported.
Extreme chills, 102.4 fever, body aches, headache, swelling and soreness at injection site. After 34 hours symptoms diminished and was left with body weakness, soreness and swelling at  injection site and slight headache.
Bouts of nausea; Elevated temperatures/fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Bouts of nausea), PYREXIA (Elevated temperatures/fever) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Bouts of nausea), PYREXIA (Elevated temperatures/fever) and HEADACHE (Headache). At the time of the report, NAUSEA (Bouts of nausea), PYREXIA (Elevated temperatures/fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report was received from a registered nurse concerning to a female patient of unknown age. The nurse stated that the patient on 01-NOV-2012, was vaccinated subcutaneously with a dose of 0.5 ml MMR II (lot # 672573/0011AE; exp. date: 16-DEC-2013) which was later determined to have a temperature excursion that was not supported; MMR II reached 56 degrees F for 16 hours. No adverse effect were reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
'Passing out' at their doorstep; Shortness of breath; Fever blisters on upper lip; Flu-like symptoms; Dizziness; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461321A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, MONTELUKAST SODIUM (SINGULAIR), CLOPIDOGREL BISULFATE (PLAVIX) and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ORAL HERPES (Fever blisters on upper lip), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DIZZINESS (Dizziness) and PYREXIA (Fever). On 13-May-2021, DYSPNOEA (Shortness of breath), ORAL HERPES (Fever blisters on upper lip), INFLUENZA LIKE ILLNESS (Flu-like symptoms), DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS ('Passing out' at their doorstep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included valaciclovir (Valtrex), meclizine (only once for dizziness) and docosanol (Abreva) (for some improvement of fever blisters).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-127691 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.